Chapter XX: Appendix (1)

The following letter from the Secretary of the Council was sent to Parke, Davis & Company, March 20, 1917. No reply to it has been received:

The referee of the Council who is conducting an investigation of
silver preparations asked me to inquire if you are willing to
submit your evidence for the following claims which are made in
your circulars for Silvol:

1. How it is possible for the solution to be astringent, and at the
same time nonirritant and noncoagulant?

2. That intestinal irrigation with a Silvol solution containing
10 to 15 grains to the pint is sufficiently bactericidal to “be
used in the abortive treatment of such infectious processes as
dysentery, cholera infantum, and colitis.”

3. What evidence have you as to the degree of antiseptic and
germicidal power of Silvol solutions?

4. What evidence have you as to the degree of antiseptic and
germicidal power of 5 per cent. Silvol Ointment?

A reply to the above questions and any other information in regard to Silvol will receive careful consideration.--(_From The Journal A. M. A., July 13, 1918._)

KATHARMON

Report of the Council on Pharmacy and Chemistry

Following inquiries, the Council took up “Katharmon” for consideration and authorized publication of the following report.

W. A. Puckner, Secretary.

The Katharmon Chemical Company of St. Louis in advertising its Katharmon appeals especially to a profession whose members, should they live up to their ethical code, could not prescribe it.[124] In 1893 (when the publication of “a formula” for proprietary preparations was thought to satisfy the requirements of scientific medicine) an advertisement in The Journal of the American Medical Association gave the following “formula” for Katharmon:

[124] “... it is equally unethical to prescribe or dispense secret medicines or other secret remedial agents,...” Sec. 6, Art. I, Chapter II, _Principles of Medical Ethics_.

“Hydrastis Canadensis, Phytolacca Decandra, Acid Salicylous C. P.
(from Oil of Wintergreen), Acid Boric C. P., Mentha Arvensis,
Thymus Vulgaris, Dist. Ext. Hamamelis Virg. Conc.”

In 1907 an advertisement in the Kansas City _Medical Index-Lancet_ declared that:

“Katharmon represents in chemical combination the active principles
of Hydrastis Canadensis, Gaultheria Procumbens, Hamamelis
Virginica, Phytolacca Decandra, Mentha Arvensis, Thymus Vulgaris,
with two grains C. P. Boric Acid to each fluid drachm.”

Now the advertisements which appear in some medical journals state:

“KATHARMON represents in combination Hydrastis Canadensis, Thymus
Vulgaris, Mentha Arvensis, Phytolacca Decandra, 10-1/2 grains Acid
Borosalicylic, 24 grains Sodium Pyroborate to each fluid ounce of
Pure Distilled Extract of Witch Hazel.”

A comparison of these so-called formulas shows that they have not only varied from time to time, but that in no instance was a quantitative statement with regard to all the asserted ingredients given.

The Chemical Laboratory of the A. M. A. reports: Katharmon has an alkaline reaction and therefore cannot contain boric acid, salicylic acid or “borosalicylic acid” (the latter is unknown to medical literature except as loosely applied to a simple mixture of boric and salicylic acids). The solution gives tests for sodium, borate, and salicylate and therefore probably contains sodium borate and sodium salicylate. Examined by the methods used for the determination of hydrastin in goldenseal preparations, a residue giving only a faint test for alkaloid was obtained; if present at all, hydrastis canadensis (goldenseal) is there only in very small amounts.

A circular wrapped with the trade package of Katharmon contained the following, palpably unwarranted, claims:

“INTERNALLY it is very useful in acute indigestion, Gastric
Catarrh, Diarrhoea and Cholera Infantum.”

“... it has demonstrated its remarkable curative effects, not only
in preventing unhealthy conditions of fresh wounds, but also in
correcting the decaying of putrefactive processes peculiar to the
body under certain circumstances. It has, further, a remarkable
efficacy in surface inflammations, whether produced by accident
or disease, and is an indispensable remedy in the affections of
the mucous membranes of the nose, mouth, stomach, bowels, vagina,
uterus, urethra, bladder and rectum.”

Katharmon is in conflict with Rules 1 and 4 of the Council on Pharmacy and Chemistry because of its indefinite and secret composition and the method of advertising it indirectly to the public; it is in conflict with Rules 10, 6 and 8, in that it is an irrational shotgun mixture sold under unwarranted therapeutic claims and under a name nondescriptive of its composition.--(_From The Journal A. M. A., Aug. 10, 1918._)

IODINIZED EMULSION (SCOTT) AND CREOSOTONIC (SCOTT)

Report of the Council on Pharmacy and Chemistry

“Iodinized Emulsion (Scott)” and “Creosotonic (Scott)” are proprietary preparations of the Dawson Pharmacal Company, Dawson Springs, Ky. The latter preparation used to be known as “Iodinized Emulsion (Scott) with Hypophosphites, Guaiacol and Creosote.” In 1907 these preparations were considered by the Council and found inadmissible to New and Nonofficial Remedies. Examination of the preparations having been again requested, the Council considered them anew because the composition and claims had been changed somewhat and because at the previous consideration no report was published.

The reports which appear below were sent to the Dawson Pharmacal Company for comment before publication. In reply the company offered to revise its claims for the preparations. The Council replied that the report sent explained that both preparations are irrational mixtures, and hence a revision of the claims would not make them eligible for New and Nonofficial Remedies. It advised that publication of the report would be withheld sixty days and that it would be revised if new information or evidence was submitted permitting such revision. After expiration of the stipulated postponement, the Dawson Pharmacal Company wrote that no new advertising matter had been prepared, but that the old circulars were not being sent out.

As these irrational preparations were still sold and advertised to the medical profession and presumably used by some physicians, the Council directed publication of its report with this explanation.

W. A. Puckner, Secretary.

Iodinized Emulsion (Scott)

The label for Iodinized Emulsion (Scott) declares:

“Each fluidram contains: Alcohol, m. 4-3/4; Rectified Ol. of
Turpentine, m. 3-1/2; Iodin, gr. 1/8; Phenol, gr. 1/2; Glycerine
and Elixir Lactated Pepsin with Aromatic Oils in the form of a
perfect emulsion.”

A circular which gives what is asserted to be the composition of Iodinized Emulsion, declares that, among other ingredients, each fluidram contains “one and three quarters m. Tincture of Iodine.” Both the statement on the label that the preparation contains “iodin” and the one in the circular that tincture of iodin is present in the product are incorrect, for the A. M. A. Chemical Laboratory reports that no free iodin could be detected in the preparation, and that it responded to tests for iodid instead.

An advertising circular for Iodinized Emulsion (Scott) makes unwarranted claims for the therapeutic properties of the constituents. For example:

“... the great usefulness of Turpentine in diseases, especially of
the Intestinal Infection, such as the Meteorism and Tympanites of
Typhoid.”

And this absurdity:

“... where Turpentine, Carbolic Acid or Iodine or even Pepsin is
indicated, that it will give satisfaction in each and every case.”

Iodinized Emulsion (Scott) is not a “pharmaceutical triumph”; it is an irrational mixture--a reminder of a decadent polypharmacy--sold under misleading and unwarranted claims. It is inadmissible to New and Nonofficial Remedies for conflict with Rules 1, 6, 8 and 10.

Creosotonic (Scott)

Creosotonic (Scott), advertised as a “reconstructive tonic” for the tuberculous, according to the label, contains in each fluidram:

“Alcohol, m. 2-1/2; Creosote and Guaiacol sulphonates of each,
gr. 1; Compound Hypophosphites, gr. 1 (including Quinine
Hypophosphites, gr. 1/36 and Strychnine Hypophosphites, gr. 1/256),
with Iodinized Emulsion (Scott) m. 30.”

As in the case of Iodinized Emulsion (Scott), the advertising makes exaggerated therapeutic claims for the individual constituents of the preparation and for the heterogeneous mixture of guaiacol and creosote sulphonates, hypophosphites, quinin, strychnin, turpentine, phenol, iodin, “lactated pepsin,” etc. Thus, while it is well established that in guaiacol sulphonate and creosote sulphonate the phenolic constituent is bound so firmly that, when administered, but very little is split off in the organism, yet the advertising claims “that the system can be saturated in a shorter time and with smaller doses of creosote and guaiacol sulphonates than with any other form of these drugs” and that (on the false premise that the guaiacol and creosote from these drugs will permeate the tissues of the lungs) “they help to clear up the local infection and thus aid in returning to normal the diseased mucous membrane.”

In the advertising pamphlet, following a discussion of the effect of climate and food in the treatment of the tuberculous, we read:

“While admitting the great importance of the foregoing points, we
are firmly of the opinion that proper medication is a great aid in
the treatment of pulmonary tuberculosis, and, with this in view, we
offer to the profession Creosotonic (Scott) believing that in it we
have a superior preparation for this purpose.”

This is unwarranted. Of course suitable medication to meet special conditions is proper in the treatment of tuberculosis, but the routine administration of a complex and irrational mixture such as Creosotonic (Scott) is bound to cause inattention to the prime requisites for the proper treatment of the tuberculous--hygienic surroundings and good food.

Creosotonic (Scott) is an irrational mixture, sold under misleading and unwarranted claims. It is inadmissible to New and Nonofficial Remedies for conflict with Rules 1, 6, 8 and 10.--(_From The Journal A. M. A., Aug. 24, 1918._)

CAMPETRODIN AND CAMPETRODIN NO. 2

Report of the Council on Pharmacy and Chemistry

The following report on Campetrodin and Campetrodin No. 2 has been adopted by the Council and its publication authorized.

W. A. Puckner, Secretary.

The following report of the A. M. A. Chemical Laboratory on “Campetrodin” and “Campetrodin No. 2,” sold by the A. H. Robins Company, Richmond, Va., was submitted to the Council by a referee of the Committee on Pharmacology:

Campetrodin and Campetrodin No. 2, Double Strength, are called “ethical medicinal specialties” by the A. H. Robins Company, Richmond, Va., which sells them. An advertisement in the _Maryland Medical Journal_ (December, 1917) contains the following claim for composition:

“CAMPETRODIN (Made in Two Strengths of Iodine). This preparation is
an Oleaginous Solution of Iodine in Camphor.”

A booklet describing the “specialties” of the Robins Company contains the following in reference to Campetrodin: “Composition: Camphor, Iodine Element, Oleaginous Solvent.” From this it appears that the preparations are claimed to contain elementary (free) iodine in an “oleaginous solvent.” Since free iodin, as is well known, readily combines with fats, it was decided to determine the form in which the iodin was present in these preparations. The examination demonstrated that both preparations contained but a trace of free iodin. On steam distillation there was obtained from both preparations a distillate amounting to about 35 per cent. by volume which had an odor strongly suggestive of turpentine, while the residue contained the iodin and had the characteristics of an iodized fatty oil.

Quantitative determinations indicated that Campetrodin contained approximately 0.03 per cent. of free iodin and 1.3 per cent. of iodin in combination with the fatty oil. Campetrodin No. 2, Double Strength, contained approximately 0.03 per cent. free iodin and 2 per cent. of iodin in combination with the fatty oil.

Thus, contrary to the published statements, Campetrodin is _not_ a preparation of free (elementary) iodin and Campetrodin No. 2, Double Strength, does _not_ contain twice as much iodin as Campetrodin.

The report of the Chemical Laboratory shows that the statements made in regard to the composition of Campetrodin and Campetrodin No. 2 are incomplete in some respects and false in others. In view of the Laboratory’s findings it appears superfluous to inquire into the therapeutic claims made for the preparations: It is evident, however, that a solution containing practically no free iodin is not, as claimed by the Robins Company, “adapted for use wherever ... iodin is indicated externally....”

It is recommended that Campetrodin and Campetrodin No. 2 be declared inadmissible to New and Nonofficial Remedies because of false statements as to chemical composition and therapeutic action, constituting conflicts with Rules 1 and 6.

The Council adopted the recommendation of the referee and authorized publication of this report.--(_From The Journal A. M. A., Sept. 21, 1918._)

CARMINZYM

Report of the Council on Pharmacy and Chemistry

The Council has authorized publication of the following which explains why Carminzym was not accepted for New and Nonofficial Remedies.

W. A. Puckner, Secretary.

Carminzym is a tablet sold by Fairchild Bros. and Foster, New York. Each tablet contains, according to claims made, approximately 32 mg. of an extract of pancreas, 50 mg. sodium bicarbonate, 172 mg. prepared chalk, 1.5 mg. powdered ipecac and “aromatics _q. s._” Without considering other possible conflicts with its rules, the Council held the preparation inadmissible to New and Nonofficial Remedies for conflict with Rule 10 which holds that unscientific or useless articles are not acceptable products.

The Council holds that complex mixtures of remedial agents are, from every point of view, inimical to therapeutic progress and therefore to the public welfare. Such mixtures are especially objectionable because it is impossible accurately to determine the effects which follow the simultaneous administration of a number of drugs having dissimilar actions; because the practice of prescribing such mixtures tends to discourage careful consideration of the special needs of individual patients without which there can be no rational drug therapy. On the contrary, with the use of such mixture therapeutic treatment becomes haphazard and mere guesswork.

The Council, appreciating that long established customs cannot be changed at once, has applied Rule 10 concerning the recognition of mixtures with the greatest leniency compatible with consistency. When there has been a reasonable doubt concerning the value of a mixture it has frequently directed that Rule 10 should not apply pending further clinical trial of such mixture. In no instance has subsequent experience shown that a strict interpretation of the rule would have worked hardship or injustice. The Council feels that there is no longer warrant for the admission of complex mixtures to New and Nonofficial Remedies or for the retention of any that have been admitted unless definite evidence of the therapeutic value of such combinations is available. In accordance with this decision several mixtures now described in New and Nonofficial Remedies will be omitted at the expiration of the three year period for which articles are accepted.

Reverting to the Carminzym tablet: When it is desired to obtain the effects of pancreatic extract by oral administration it must be administered with a view of preventing its destruction by the gastric fluid. With this end in view an antacid should be administered to decrease the acidity of the gastric juice. The amount of alkali may be supplied in the form of any of the official preparations, but the amount must be adjusted to the individual patient for the reason that no two successive patients are likely to have the same degree of gastric acidity.

Ipecac has a well defined though limited field of usefulness. When it is used, it should be given with a due regard to the amount needed by the patient and the frequency of the repetition of the dose. There is no reason to suppose that any two successive patients will require ipecac and extract of pancreas in a fixed proportion and with equal frequency. As a matter of fact, the amount of ipecac in Carminzym is so small that no definite therapeutic action can be assigned to it and its use in this combination is purely empirical.

In a word, the employment of mixtures of pancreatic extract, alkalis, ipecac and carminatives in fixed proportion leads to slipshod treatment and irrational therapeutics. Carminzym is an irrational mixture the use of which is detrimental to therapy.

The preceding report was sent to Fairchild Bros. and Foster for comment in accordance with the Council’s usual procedure. The following reply was received:

The long established custom of the use of mixtures of remedial
agents rests upon considerations well known and generally accepted.
This is equally true of combinations of drugs of similar and
dissimilar properties. The drugs of these combinations, especially
those of marked therapeutic action, are well known and used by
themselves when indicated.

In fact, dissimilarity of action is a cause of combination, an
essential of synergism.

Drugs classed as similar are by no means alike in action;
laxatives, tonics, carminatives, diuretics are combined with
distinct advantage, economy of dose, enhanced effect, potency not
obtainable with the single drug.

Your sweeping arbitrary conclusions that complex mixtures
of remedial agents are from every point of view inimical to
therapeutic progress is not, it seems to us, sustained by fact and
experience. There is therapeutic progress in the considerate use
and observation of combinations as well as in the use of a single
drug. Indeed, in the production of a synthetic chemical substance
as a therapeutic agent, the combination of potent and dissimilar
elements is worked out to mitigate and correct an objectionable
side effect, and promote desirable action.

As for ourselves, at the very outset in our line of work we quite
voluntarily declared our principles and our intentions as opposed
to incompatible and therefore unstable or inert combinations
of the enzymes; and against the “unnecessary multiplication of
preparations”--see Fairchild’s Hand-Book of the Digestive Ferments.

Is not this after all the crux of the whole matter--does a
combination contain the ingredients stated, does it possess the
demonstrable properties which are to be attributed to it in
consequence of this composition; and if for a certain purpose, is
it well designed therefor?

Carminzym presents certain agents of well known properties, not
in the least of incompatible or antagonistic action, but indeed
especially suitable for the particular purpose designed; its
efficacy not to be measured and judged by theory or opinion as to
the efficiency of a certain dosage of a particular drug by itself.
That the doses as contained are minimal and effective is distinctly
advantageous.

The alkaline carbonates are in Carminzym in stated quantities;
the physician adjusts the dosage to the individual patient and
with obvious evidence of the efficiency of the adjustment. As
we understand it, the employment of alkaline carbonates is not
based on purely chemic considerations--a definite known quantity
of acid of the gastric juice is to be neutralized; the whole
literature and practice dealing with the alkaline carbonates show
them to be accredited with a much wider field of use and repute in
gastro-intestinal disorders.

The pancreatic extract in Carminzym is designed to be diffusible in
the stomach, the tablet is preferable to be crushed in the mouth
before swallowing, and we believe the pancreatic extract to be an
effective constituent as administered in Carminzym.

You comment as follows:

“Ipecac has a well defined though limited field of usefulness.
When it is used it should be given with due regard to the amount
needed by the patient and the frequency of the repetition of the
dose.”

This in a sense may be said of any of the most useful drugs, but not
in the least special degree does it apply to ipecac, which is, on
the contrary, of quite characteristic, peculiar range of therapeutic
properties, useful in varying combinations and in widely varying
proportions and doses according to the purpose for which it is
employed.

Ipecac in well known official alkaline, carminative, laxative
preparations occurs in the “average dose” in the varying quantities
of 1/14, 1/10, 1/8, and 3/16 of a grain.

The ipecac in combination with the other ingredients in Carminzym is
designed for a tablet which shall carry a minimal quantity whilst
capable of adequate remedial action, thus admitting of increase of
dosage or repetition as occasion requires. The quantity of ipecac
was not taken at random, but chosen after long trial and
consideration.

We believe that Carminzym possesses carminative properties in
a superior degree and that, furthermore, in consequence of its
composition it directly stimulates the gland secretions and thus
exerts a beneficial action upon the whole digestive functions.

Carminzym is for use as occasion requires, and this is to be
especially noted. Thus it is not only of direct benefit, but helpful
in promoting systematic therapeutic measures and regimen.

The Council takes the ground that complex mixtures of remedial
agents are so wrong that there is no longer warrant for their
admission into New and Nonofficial Remedies; and that Carminzym
is an irrational mixture.

We hold that certain desirable therapeutic properties may rationally
be attributable to Carminzym; and that these are manifested in
practice.

During the time since the description was sent and the receipt of
the statement of the action of the Council, some ten months,
Carminzym has proved of constantly increasing service.

The statement in the letter of Fairchild Bros. and Foster “The long established custom of the use of mixtures of remedial agents rests on considerations well known and generally accepted” might well be paraphrased to read: The one-time prevalent custom of using ill-considered combinations of remedial agents has been thoroughly discredited and is generally abandoned by progressive practitioners. Such arguments as that “laxatives, tonics, carminatives, diuretics are combined with distinct advantage” have led to the use of irrational mixtures such as the compound syrup of hypophosphites and the electuary of theriaca. The Council is confident that no one who has studied the causes and treatment of digestive disorders will find occasion to prescribe at one time all the ingredients stated to be contained in Carminzym, and certainly not in the fixed proportions present therein.

The comments in the Council’s report concerning ipecac certainly does apply to all active therapeutic agents. Ipecac was mentioned in the report because the several constituents of Carminzym were under discussion and hence it was necessary to point out the futility of the small dosage of ipecac in this mixture.

The announcement that “Carminzym has proved of constantly increasing service” is not convincing. The Council does not know of a single clinical study of the action of Carminzym under conditions which would have afforded satisfactory evidence of its therapeutic value.--(_From The Journal A. M. A., Sept. 28, 1918._)

PHILLIPS’ PHOSPHO-MURIATE OF QUININE COMP.

Report of the Council on Pharmacy and Chemistry

The following report on Phillips’ Phospho-Muriate of Quinine Comp. has been adopted by the Council and authorized for publication.

W. A. Puckner, Secretary.

Phillips’ Phospho-Muriate of Quinine Comp.[125] is sold by the Charles H. Phillips Chemical Co., New York. According to the published formula, each fluidram contains:

Phosphoric Acid 2 minims
Potassium Phosphate }
Magnesium Phosphate }
Calcium Phosphate } 2-1/4 grains
Ferric Phosphate }
Quinin Muriate (equal to nearly 1/2 gr. Bi-Sulph.) 1/4 grain
Strychnin 1/120 grain
Flavoring, Glycerin and Syrup, _q. s._

[125] The evolution of “Phillips’ Phospho-Muriate of Quinine Comp.” from “Phillips’ Wheat Phosphates” may be interesting. Every one knows that therapeutics tends to fashions, and “Phillips’ Wheat Phosphates” appears to have had its inception as the result of the observation that super-refined white flour contains less phosphates than the corresponding amount of wheat. It was assumed that such flour must be deficient in an essential constituent, and the Wheat Phosphates preparation was apparently designed to fill the want. It was exploited for the relief of numerous conditions that were supposed, without satisfactory evidence, to result from this deficiency. When iron, quinin and strychnin mixtures became the vogue a quarter of a century ago, it was only natural to ride on the wave of popularity and the already widely advertised “Wheat Phosphates” was further enhanced--commercially--by the addition of the iron, quinin and strychnin, the amount of alkaloid added being practically negligible. Those who are not familiar with the various phases of the phosphorus, phosphoric acid, lactophosphate, lecithin, nuclein and glycerophosphate propaganda are referred to a report of the Council on Pharmacy and Chemistry in The Journal A. M. A., Sept. 30, 1916, p. 1033.

Some typical claims made for the preparation are:

“With marked beneficial action upon the nervous system. To be
relied on where a deficiency of the phosphates is evident.”

“... brace those tired nerves and aid that worn stomach with
Phillips’ Phospho-Muriate of Quinine.”

“The maintenance of a satisfactory blood pressure level free from
intervals of depression may be accomplished by the use of Phillips’
Phospho-Muriate of Quinine Compound in appropriate doses.”

“The quantities of quinin and strychnin in this preparation are so
well balanced that they relieve the depression and fatigue from
mental or physical exertion, without the necessity of recourse to
alcoholic stimulation.”

“The other ingredients of Phillips’ Phospho-Muriate of
Quinine--phosphoric acid, and the phosphates of potash, magnesia,
lime, and iron--are the most rational as well as convenient
means of administering these tissue remedies, and of introducing
phosphorus--the vitalizing constituent of the nervous system--into
the organism.”

The action of such a mixture as a whole is practically that of the sum of the actions of its constituents. The therapeutic action of strychnin and quinin are described in every text-book of therapeutics, but it is necessary to distinguish carefully between the various conditions in which these alkaloids have been used without discrimination, and those conditions in which they have been proved to be of value. While both have been widely used in a great variety of conditions, neither is of proved value in more than a distinctly limited range of diseases. The manufacturers of Phillips’ Phospho-Muriate of Quinine Comp. seem to appeal to the less discriminating who use these alkaloids without any definite conception of exactly what they seek to accomplish with them. Quinin, although used by the uncritical in a host of diseases, has a definite field of usefulness in the treatment of malaria, both prophylactic and curative, but the required dose in the treatment of malaria is many times larger than that recommended in the Phillips’ preparation. The claim that the “strychnin and quinin in this preparation are so well balanced that they produce a mild, buoyant effect, so advantageous, instead of alcoholic stimulation, to relieve depression and fatigue from mental or physical exertion” is nonsensical, if, indeed, it is not mendacious balderdash.

Calcium and potassium have important functions in the body, but any deficiency that may arise is usually attributable to an inability of the body to utilize that which is supplied, for there is seldom any deficiency of these salts in the food, and when they are needed they are best supplied as simple solutions of the salts in appropriate doses without all of the other constituents of Phillips’ Phospho-Muriate of Quinine Comp.

Phosphoric acid exerts practically the same actions as other mineral acids, hydrochloric being usually preferred for internal administration in certain forms of indigestion, aside from which they are seldom used as such.

In the more recent literature for Phillips’ Phospho-Muriate of Quinine Comp., we find the attempt to utilize the well known craze about phosphorus, which has been through so many phases, every one of which has had its day and has been discarded.

The phosphoric acid and phosphates present in Phillips’ Phospho-Muriate of Quinine are of no more value in nervous diseases than is simple sodium phosphate which does not require the addition of a host of other ingredients for its action. As a matter of fact, the phosphates of calcium and potassium present in a dose of Phillips’ Phospho-Muriate of Quinine are probably devoid of appreciable effect in practically all conditions.

To pretend that one who suffers from physical and nervous exhaustion can be materially benefited by this mixture is sheer nonsense and is unworthy of a moment’s consideration by a clinician who is called on to treat such patients.

Iron is useful in anemia, as every one knows. Iron has practically no other field of usefulness in therapeutics. When it is indicated it should be administered in a simple form, such as the pill of ferrous carbonate, for example, and not in a “shotgun” mixture that is quite as likely to do harm as good.

The claim that a satisfactory level of blood pressure can be maintained by Phillips’ Phospho-Muriate of Quinine is mentioned only to condemn as the limit of impudent therapeutic claims. It is an insult to the intelligence of any practitioner to pretend that any known agent or combination of remedial agents can maintain a uniform blood pressure in any one of innumerable conditions.

In short, Phillips’ Phospho-Muriate of Quinine Comp. is a complex and irrational mixture exploited by means of unwarranted claims. It is a survival of the old days of therapeutic chaos when impossible and fantastic chemical formulas were gravely published and as solemnly accepted without question, and also without the slightest understanding on the part of many; when the most eminent of practitioners did not hesitate to give glowing testimonials for lithia waters that contained no more lithium than ordinary river water; when no therapeutic claim was too preposterous to receive acceptance, no theory too nonsensical to justify the use of all manner of claptrap mixtures for all manner of conditions.--(_From The Journal A. M. A., Oct. 19, 1918._)

B. IODINE AND B. OLEUM IODINE

Report of the Council on Pharmacy and Chemistry

The Council has authorized publication of the following report on “B. Iodine” and “B. Oleum Iodine,” together with the reply submitted by the manufacturer and a discussion thereon by the referee in charge of the preparations.

W. A. Puckner, Secretary.

Specimens of B. Iodine and B. Oleum Iodine (B. Iodine Chemical Company) and an advertising pamphlet were sent to the Council by John Bohlander, A.M., M.D., with the declaration:

“Well knowing the value of Iodin in surgical operations and
dressings, prompted me for the benefit of my fellow physicians
as well as myself, and for Humanity’s sake, to make Iodin my
master-piece in chemistry.

“After several years of diligent work in my private laboratory I
succeeded in discovering a new product of Iodin--Nitrogen, hydrate
of Iodin.”

While “B. Iodine” is said to be nitrogen hydrate of iodin and “B. Oleum Iodine” a 5 per cent. solution thereof, the examination made by Prof. A. H. Clark of the University of Illinois, School of Pharmacy (working in the A. M. A. Chemical Laboratory), indicates that the first is a simple mixture of iodin and ammonium iodid, and the second a solution of iodin in liquid petrolatum. The Council adopted the report of the A. M. A. Chemical Laboratory (which appears below) and declared B. Iodine and B. Oleum Iodine inadmissible to New and Nonofficial Remedies because:

1. The composition is incorrectly declared. B. Iodine is not a newly discovered iodin compound, “Nitrogen Hydrate of Iodine,” but a mixture of iodin and ammonium iodid. B. Oleum Iodine is not a 5 per cent. solution of B. Iodine as suggested by the statement on the label and in the advertising, but a solution of iodin in liquid petrolatum containing about 0.85 per cent. of iodin.

2. Since B. Iodine is a mixture of Iodin and ammonium iodid, its solution in water will have the properties of other solutions of iodin made by the aid of iodid, such as a dilution of tincture of iodin or of compound solution of iodin (Lugol’s solution). Hence, the therapeutic claim that B. Iodine “being of a colloidal nature has the advantage of being more readily absorbed and taken up by all cellular structure, thus getting a perfect cellular medication of Iodine,” is unwarranted.

3. The names “B. Iodine” and “B. Oleum Iodine” are not descriptive of the pharmaceutical mixtures to which they are applied.

4. B. Iodine and B. Oleum Iodine are unessential modifications of established articles. B. Iodine has no advantage over tincture of iodin or compound solution of iodin. (As more convenient of transportation, the Medical Department of the U. S. Army supplies its field hospitals with a mixture of iodin and iodid ready for solution in water, either in tablet form or in powdered form in tubes.) Solutions of iodin in liquid petrolatum may be readily prepared (Reports Council Pharm. and Chem., 1917, p. 88).

[Contribution from the A. M. A. Chemical Laboratory]

B. IODINE PRODUCTS

A. H. Clark, Ph.G., B.S.

“B. Iodine” products are marketed by the B. Iodine Chemical Company, Cincinnati, Ohio; John Bohlander, A.M., M.D., is said to be the discoverer. They consist of “B. Iodine,” “B. Oleum Iodine,” and “B. Aqua Iodine.” B. Iodine and B. Oleum Iodine were submitted to the Council.

In a circular submitted by the B. Iodine Chemical Company, B. Iodine is said to be “Nitrogen Hydrate of Iodin.” It is claimed that “coming in contact with water, H₂O, a chemical change takes place forming Hydro Oxid of Iodin, the Nitrogen of the Nitrogen Hydrate of Iodin escaping, the balance taking up one of oxygen of the water. Its companion, the H₂, escaping at the same time with the Nitrogen then combining with the remainder of the water to form the solution of Hydrogen Oxid of Iodin; so you can readily see that you really have a pure water of Iodin, nothing but the H, the O and the I.”--(_From the Journal A. M. A., Feb. 1, 1919._)

B. IODINE

According to the circular, B. Iodine is soluble in alcohol, chloroform, and ether. Also it:

“Has odor, taste, melting and boiling point, same as regular
Iodin, has a great affinity for water and will respond to all
the tests of Iodin. Appears in a Bluish Black Granulated mass or
Powder. When heated in vaporating dish will throw off large purple
volumes of Iodin leaving a slight white crystalline precipitate,
which on continuous heating will entirely disappear. With careful
manipulation you can get prismatic needle point like crystals,
looking like spores of glass, these dissolving in water will yield
pure Iodin coloring the water Iodin.

“PHARMACOLOGIC, THERAPEUTICAL AND PHYSIOLOGICAL ACTION: Same as
Iodin, being of a colloidal nature has the advantage of being more
readily absorbed and taken up by all cellular structure, thus
getting a perfect cellular medication of Iodin.”

A sample of B. Iodine, marked “Nitrogen Hydrate of Iodin” was submitted by the manufacturers and this sample was examined.

B. Iodine was found to be a granular powder, almost black with a purple cast. It has an odor of iodin and dissolves in water readily. It is also quite soluble in alcohol, but not entirely soluble in chloroform and ether. Ether quickly dissolves iodin from B. Iodine, leaving a residue of a white granular substance. Chloroform acts the same as ether except that the iodin is dissolved out with some difficulty. On heating B. Iodine, vapors of iodin escape. If the heating is done on a water bath, a residue of a white granular substance, subsequently identified as ammonium iodid, remains. If heated in a bunsen flame, no residue remains. These tests all indicate that iodin is held in the form of a simple mixture.

_Ammonia_: B. Iodine when mixed with an excess of sodium hydroxid and warmed, evolves ammonia.

_Iodine_: 0.1567 gm. B. Iodine dissolved in water required 5.88 c.c. tenth-normal sodium thiosulphate solution indicating 48.28 per cent. iodin. 0.3721 gm. B. Iodine required 14.18 c.c. tenth-normal sodium thiosulphate solution indicating 48.37 per cent. iodin. The average is 48.33 per cent. iodin.

_Ammonium Iodide_: 0.3453 gm. of the residue after heating B. Iodine on a water bath until all iodin had volatilized was dissolved in water, acidulated with phosphoric acid, and hydrogen dioxid solution added. The liberated iodin was extracted with chloroform and titrated with tenth-normal sodium thiosulphate. 23.78 c.c. were required indicating 0.3447 gm., or 99.83 per cent., ammonium iodid.

A mixture of 5 gm. iodin and 5 gm. ammonium iodid has the properties of B. Iodine mentioned above.

The conclusion is that B. Iodine is essentially a mixture of iodin and ammonium iodid in equal parts, the two substances being finely powdered and intimately mixed.

B. OLEUM IODINE

The following regarding B. Oleum Iodine is quoted from the circular submitted:

“B. OLEUM IODINE: Iodine soluble in mineral oil 5 and 10% for
Nasal, Pharyngeal, Laryngeal, Bronchial, Rectal, etc., and all
meucoid affections and abnormal conditions of the mucous membrane.”

A sample of B. Oleum Iodine was submitted by the manufacturer and examined. The label on the bottle states that it is 5 per cent. B. Oleum Iodine in mineral oil. This sample has the characteristics of a solution of iodin in liquid petrolatum. It is oily and has the characteristic violet color.

_Ammonia_: B. Oleum Iodine, since it is presumed to be a solution of B. Iodine, was examined for ammonium compounds. A small quantity was mixed with an equal volume of strong sodium hydroxid solution and heated. No ammonia was evolved. A few crystals of ammonium chlorid were added to a little of B. Oleum Iodine and treated as above. Ammonia was readily detected.

_Iodine_: 5.255 gm. B. Oleum Iodine was dissolved in chloroform and placed in a separator. A solution of potassium iodid was added and the iodin titrated with a tenth-normal sodium thiosulphate solution. It required 3.5 c.c. indicating 0.85 per cent. iodin.

The conclusion is that B. Oleum Iodine is a simple solution of iodin in liquid petrolatum to the extent of 0.85 per cent. and not 5 per cent. as claimed. Furthermore, it is not a solution of B. Iodine since no ammonium compound is present.

The preceding report was sent to the B. Iodine Chemical Company. The following reply was received:

Your letter of the 21st inst., received and contents noted and
cannot quite agree with your report.

Reasons why: NH₄I, a Nitro Hydrate Iodide; NH₄I₂, a Nitro Hydrate
Iodate; and NH₄I₂I₂, Per Iodide, a molecular compound, which I
claim, they all being of a NH group, so what can be the objection
of Nitrogen Hydrate of Iodine? Of course when your chemist, with
the aid of heat, drove off all the Iodine, he naturally brought it
back to a NH₄I. There’s where he gets the A.M.. I claim a molecular
compound.

The Oil of Iodine I sent you by mistake was a 1 per cent. and not
a 5 per cent. as marked. I claim it is made from the resublimed
Iodine in mineral oil and not the B. Iodine. I claim a 5 per cent.
has heretofore never been accomplished, so I therefore can claim
something new.

Tr. Iodine contains Alcohol and Potash as a base, the alcohol a
dehydrater and Potash an escharotic, and all other soluble Iodines
like the tincture have a metallic base. Mine has not. My iodine is
compatible almost with all the salts, alkaloids, tannates, and even
the metals. You can’t say that for the tincture or the others. Now
why should mine not be superior to others?

Preparations as yet are not on the market and a few pamphlets were
printed to meet with the requirements of your rulings and approval
and shall be corrected if we only can agree on a proper name as you
may suggest.

Yours very truly,
THE B. IODINE CHEMICAL CO.
By John Bohlander, A.M, M.D.

P.S. We are sending you under separate cover another sample of the
Oil of Iodine which is a 5 per cent. solution, and allowing for
deterioration will test at least four per cent.

The referee in charge of the preparations submitted the above letter to the Council with the following comments:

The principal statements in the letter are essentially erroneous or misleading: Mixtures or double salts of ammonium iodid and iodin were not discovered by Dr. Bohlander, and are nothing new. Watery solutions of iodin by means of an iodid have long been known and used in the form of Lugol’s solution.

There is no evidence that ammonium iodid is less irritating than potassium iodid. On the contrary, ammonium salts are generally more irritating than the corresponding potassium salts. B. Iodine is not compatible with alkaloids, but behaves essentially like Lugol’s solution. The A. M. A. Chemical Laboratory reports that the new sample of B. Oleum Iodine contains only 1.2 per cent. of free iodin, instead of the claimed amount. It is therefore somewhat weaker than the iodin petrolatum prepared by the A. M. A. Chemical Laboratory (Reports Council Pharm. and Chem., 1917, p. 88).

However good Dr. Bohlander’s intentions may be, the statements that he makes about his products are misleading or erroneous, and the products are ineligible for N. N. R.--(_From Reports of Council on Pharmacy and Chemistry, 1918, p. 44._)

ANTITHYROID PREPARATIONS (ANTITHYROIDIN-MOEBIUS AND
THYREOIDECTIN) OMITTED FROM N. N. R.

Report of the Council on Pharmacy and Chemistry

The following report explaining the omission from New and Nonofficial Remedies of antithyroid preparations (Antithyroidin-Moebius and Thyreoidectin) has been authorized for publication.

W. A. Puckner, Secretary.

New and Nonofficial Remedies, 1918, contains a discussion of “antithyroid” preparation and describes two of these: Antithyroidin-Moebius (E. Merck, Darmstadt, Germany) and Thyreoidectin (Parke, Davis & Company, Detroit, Mich.).

The referee reported that these “antithyroid preparations” evidently have not realized the expectations of their promoters, and are viewed with skepticism by practically all critical clinicians.

Consequently, notwithstanding the cautiously worded statements of claims made by the manufacturers of Thyreoidectin, the Council approved the recommendation that this preparation (Thyreoidectin) be omitted from New and Nonofficial Remedies for conflict with Rule 6 (unwarranted therapeutic claims) and Rule 10 (unscientific and useless articles) (Antithyroidin-Moebius had already been omitted because it was off the market). The Council further directed that the general article “antithyroid preparations” be also omitted.

The Council having adopted the recommendation of the referee, Thyreoidectin is omitted from N. N. R., while the general article appears below, as a matter of record:

Antithyroid preparations are obtained from the blood or milk of animals, after the removal of the thyroid glands.

The use of these preparations is based on the theory that the thyroid gland secretes products which are toxic, but which neutralize and are neutralized by, other toxic substances produced elsewhere in the body. Removal of the thyroid glands would then lead to the accumulation of these second toxic substances as evidenced by the phenomena of cachexia strumipriva and myxedema. On the other hand, the blood or milk of such animals is claimed to be capable of preventing the effects of hypersecretion of thyroid substance, such as is supposed to occur in hyperthyroidism (Basedow’s or Graves’ disease--generally called exophthalmic goiter).

These views are largely hypothetical; attempts to give to them a rational experimental basis have failed, but some clinical observers report distinctly beneficial results in the milder forms of the diseases, and in obscure nervous disorders which are supposedly connected with thyroid hypersecretion from the administration of the milk from thyroidectomized goats and also from the use of the proprietary blood preparations listed below. The value of these preparations is very doubtful. The reported improvements may only be psychical or due to associated measures, as is often seen in this disease. Other measures of treatment should not be neglected.

Improvement is said to occur in two or three weeks and to be indicated by an amelioration of the nervous symptoms, tremor, palpitation, insomnia and excitability.

The administration must be long continued. Oral and hypodermic administration are said to be equally effective, but the former is usually preferred. These preparations are not known to be toxic, even when very large doses are used.--(_From Reports of Council on Pharmacy and Chemistry, 1918, p. 50._)

CEPHAELIN AND SYRUP CEPHAELIN-LILLY OMITTED FROM N. N. R. AND
SYRUP EMETIC-LILLY NOT ACCEPTED

Report of Council on Pharmacy and Chemistry

The Council has authorized publication of the following report, which explains the omission of cephaelin and Syrup Cephaelin-Lilly from New and Nonofficial Remedies and the non-acceptance of Syrup Emetic-Lilly.

W. A. Puckner, Secretary.

New and Nonofficial Remedies, 1918, describes cephaelin (an alkaloid obtained from ipecacuanha root) and lists Syrup Cephaelin-Lilly (containing 0.088 Gm. cephaelin hydrochlorid per 100 Cc.) as a pharmaceutical preparation of it.

The period of acceptance for Syrup Cephaelin-Lilly having expired, Eli Lilly & Company were asked to send the current advertising and labels so that the Council might determine if the acceptance of this preparation might be continued. In reply the firm wrote:

“We have changed the name Syrup Cephaeline to Syrup Emetic but the
product remains the same as before. We have no circulars describing
Syrup Emetic and can only send copies of the label.”

The new name “Syrup Emetic” conflicts with the rules of the Council in that it does not indicate the potent ingredient of this simple pharmaceutical preparation and in that it is therapeutically suggestive. Emetics are powerful agents, and physicians should be given every opportunity of knowing what they prescribe for the purpose.

The name being in conflict with Rule 8, the Council voted to omit Syrup Cephaelin-Lilly and not to accept Syrup Emetic-Lilly.

As the cephaelin syrup was the only preparation of cephaelin admitted to New and Nonofficial Remedies, and as the alkaloid appears to have no important therapeutic field, the Council directed that the description of cephaelin also be omitted.--(_From Reports of Council on Pharmacy and Chemistry, 1918, p. 52._)

COLALIN OMITTED FROM N. N. R.

Report of the Council on Pharmacy and Chemistry

The following report explaining the omission from New and Nonofficial Remedies of Colalin has been authorized for publication.

W. A. Puckner, Secretary.

Colalin is a bile salt preparation claimed to consist essentially of hyoglycocholic and hyotaurocholic acids. It is manufactured by Rufus Crowell and Company, Somerville, Mass., and marketed by Schieffelin and Company, New York.

An examination of the current advertising by the referee of the Council in charge of bile salt preparations having revealed that claims were made for Colalin which were not in harmony with the known action of bile preparations, Schieffelin and Company were informed that in the opinion of the referee the Colalin circular matter required radical revision. In this communication the referee’s objections to the claims were set forth in detail.

No reply to this letter was received, and hence a copy of the letter was sent to Schieffelin and Company and also to Rufus Crowell and Company with the explanation that unless the statements in the Colalin advertising which the referee had questioned were substantiated by satisfactory evidence, were suitably revised, or else the advertising matter withdrawn pending revision, the referee would be obliged to recommend to the Council that Colalin be omitted from New and Nonofficial Remedies.

In reply, Schieffelin and Company wrote that they were not “engaged actively in the introduction of Colalin,” and agreed to the omission of Colalin from N. N. R.

In view of the failure to substantiate the claims objected to or an agreement to discontinue them, the Council directed that Colalin and Colalin Tablets be omitted from New and Nonofficial Remedies for conflict with Rule 6 (unwarranted therapeutic claims).

The following are the claims which the referee questioned:

“Colalin embodies the physiological function of the bile in the
intestinal canal and also possesses properties of its own which are
intimately connected with the function of the liver.”

The quotation implies that Colalin has properties essentially different from those of bile salts, a claim which requires substantiation.

“In the liver its action seems to be that of a general stimulant of
all the hepatic functions.”

This is a claim which requires substantiation.

“By the introduction of Colalin it has therefore become possible to
actually utilize the bile for therapeutic purposes.”

This is an unwarranted claim, for bile was used therapeutically before Colalin was introduced.

“As gall-stones are chiefly composed of cholesterin, experiments
were made to determine whether Colalin would dissolve these
concretions outside of the body. These were completely successful
and were then followed by an extensive series of clinical
investigations on persons suffering with cholelithiasis, which
demonstrated that by the administration of Colalin in many
instances gall-stones were evacuated by the natural passages and
their further formation prevented without resort to surgical
intervention.”

This is misleading in that the context shows that “without surgical intervention” is meant to imply a connection between the experiments showing the solvent power of Colalin and the passage of concretions.

“... Colalin not only acts as a solvent of cholesterin calculi, but
prevents their further formation by removing the causes upon which
their development depends.”

This conveys the impression that such solvent action is exerted in the body, that is, that such concretions in the gallbladder may be dissolved and evacuated by the use of Colalin. For this claim there is no evidence.

“To understand the value of Colalin in intestinal disorders it is
necessary to bear in mind the important functions of the bile in
the intestinal canal, namely, its participation in the digestion of
fats, its antitoxic action, and its influence upon the peristalsis.”

“... through its antiseptic influence inhibits the production of
toxins in the intestines.”

The referee believes that there is no satisfactory evidence that bile or bile salts can inhibit the production of toxins in that part of the intestine--the colon--in which they are commonly produced.--(_From Reports of Council on Pharmacy and Chemistry, 1918, p. 52._)

FORAL

Report of the Council on Pharmacy and Chemistry

The following report on Foral, a depilatory preparation, has been authorized for publication by the Council.

W. A. Puckner, Secretary.

Foral is sold by the Foral Products Company, Pittsburgh, Pa., as an “antiseptic depilatory” with the special claim for its use for the removal of hair prior to surgical operation or the dressing of wounds. In addition to claims made for its hair dissolving action, it is asserted that, in removing the hair from an open wound, Foral acts as “an antiseptic, which guarantees against any infection.” It is also claimed that, though hair will return after its use, “by proper use it will diminish the growth of hair and cause the hair to grow much slower, and unlike the razor, the hair will not return coarser and thicker.”

We are informed by the Foral Products Company that their preparation is used in many hospitals and that “... one and all are well pleased and a great satisfaction to do away with the old style razor ...”

Foral is stated to be made according to the following formula:

_To manufacture seventy-five pounds of FORAL_

Starch 35 pounds
Barium-Sulphide 20 pounds
Zinc-Oxide 10 pounds
Calcium-Carbonated-Precip. 10 pounds
Potassium-Permanganate 10 grams
Menthol-Crystallized 10 grams
Carbolic-Acid 1/2 ounce
Lilac or Citronel oil 3 ounces

The four above chemicals are going to a heating process before
mixing or sifting.

In consideration of the preceding, the Council declared Foral inadmissible to New and Nonofficial Remedies for conflict with its rules, thus:

1. Foral is an unessential and irrational modification of an established article.

While its manufacturer states that Foral has been on the market for eighteen years, the following depilatory formula appears in a book published thirty-five years ago (A practical Treatise on Diseases of the Skin, Louis A. Duhring, Ed. 3, 1883) and is to be found in most books on dermatology:

Barium Sulphid 2 drams
Zinc oxid 3 drams
Starch 3 drams

Permanganates and sulphids mutually destroy each other, and therefore the addition of the small amount of potassium permanganate cannot serve any useful purpose. The amounts of phenol, menthol and “Lilac or Citronel oil” are too small to exercise any effect (other than that of a flavor) and must be considered unessential additions.

2. Foral is a pharmaceutical mixture marketed under a non-informing name.

Whereas it is in the interest of rational medicine that physicians should know the composition of the preparations which they use, the name of this pharmaceutical mixture fails to indicate that it contains the well-known and by no means always harmless barium sulphid.

3. Foral is sold under exaggerated and unwarranted claims.

In view of the small amount of phenol present and the method of using the preparation, the claim that the use of Foral which, when operating on open wounds, “guarantees against any infection,” is evidently unwarranted.

There is no evidence for the claim that the use of depilatories such as Foral retards the growth of hair or renders hair less coarse. On the contrary, the commonly prevailing opinion is that depilation, like shaving, makes the hair coarser.

To determine if “one and all” of those who had used Foral were still using the preparation, four of the testimonials, appearing in an advertising pamphlet, were investigated. The pharmacist of the hospital from which the first of these testimonials was stated to have emanated replied that the person whose name appeared in connection with it had left the hospital about ten years ago and that no depilatory preparation has been used in this hospital for some time. So far as he knew, depilatories were not now in use in the surgical wards of the hospital. In regard to the second testimonial, the pharmacist of this hospital wrote that the hospital had not bought the preparation, but that some of it had been obtained for an elderly deaconness, who had personal use for a depilatory. The physician signing the third testimonial replied that the preparation was effectual for the removal of hair from the scalp, but that “... we have gotten out of the habit of using it.” In the case of the fourth testimonial, its asserted author wrote “... if it is applied in too large a quantity or too concentrated, or permitted to remain on too long, it will vesicate. It was for this reason chiefly that I discontinued its use. It is a very bad smelling mixture and patients complain of it very bitterly.”--(_From Reports of Council on Pharmacy and Chemistry, 1918, p. 55._)

GRANULAR EFFERVESCENT BROMIDE AND ACETANILID COMPOUND-MULFORD

Report of the Council on Pharmacy and Chemistry

The following report explaining the omission from New and Nonofficial Remedies of Granular Effervescent Bromide and Acetanilid Compound-Mulford has been authorized for publication.

W. A. Puckner, Secretary.