Volume 1 / Part 1 — FOREWORD (continued 7)

The Abbott Laboratories submitted specimens of the products, the advertising matter therefor and a considerable list of references to current literature; all of which was transmitted to the Committee on Serums and Vaccines for consideration. In due time a referee of the committee submitted the following report:

THE COMMITTEE’S REPORT

The referee has studied the literature covered by the references submitted. In general the articles are favorable to the use of vaccines, though many of these papers do not consider “mixed” vaccines; indeed, a number of the articles do not discuss treatment at all, but are devoted entirely to the consideration of etiology of the disease. Many of the papers are by those who are obviously overenthusiastic on the subject of the use of biologic preparations. One paper—not included in the references submitted by the Abbott Laboratories—records an alarming reaction following a dose of mixed vaccine; no claim is made that improvement followed.

The following comments on the submitted references are offered:

M. Catarrhalis-Combined-Bacterin.—Only four of the nine references given deal with the therapeutic use of the vaccine. The reported results in general were favorable, but sometimes in the discussion evoked by certain of the papers, views the reverse of those expressed by the author were brought forward. The enthusiasm of one writer is shown in his statement that following the use of vaccine in cases of carbuncle complicating diabetes the sugar in the urine disappeared or was reduced. One observer, who reports excellent results in nasal pharyngeal catarrh, speaks of certain vaccines as “bulk goods,” while another considers “——’s No. 7” as the proper thing. It is evident that the reports are not based on careful, scientific data, or such unscientific definition of the product employed would not be used.

B. Coli-Combined-Bacterin.—In the references cited in support of this preparation the following general statements are noted: One enthusiastic writer says, “It must be recognized that we have no satisfactory explanation of the action of vaccines, and their use at present is empirical.” One author dwelt on the superiority of autogenous vaccines but admits that occasionally stock vaccines are indicated. One vaccine therapist in concluding an article states, “It is simply impossible to practice modern urology without our modern biologic products.” Yet it is a well-known fact that many successful and capable genito-urinary surgeons avoid the use of vaccines, mixed or simple.

Pertussis-Combined-Bacterin.—These reports are uniformly favorable, but are not controlled and their value is not to be compared with a recent report from the New York City Department of Health which indicates that the vaccine is practically valueless. It is noted, further, that one of the articles cited which dealt rather fully with the treatment of pertussis did not mention vaccines.

Strepto­coccus-Rheumaticus-Combined-Bacterin.—The references cited in support of the preparations by the manufacturer give no support whatever for the use of mixed stock vaccines. The first reference deals with the relation of Strepto­coccus viridans to arthritis deformans and endocarditis and reports the following cases:

Case 1.—Vaccine case—improvement after eight months. Case 2.—Slight improvement following use of vaccine. Case 3.—Slight improvement following use of vaccine. Case 4.—Marked improvement. Case 5.—Prompt improvement. Case 6.—Vaccine not mentioned. Case 7.—Vaccine followed by slight improvement.

In each of the cases other methods of treatment were used. The paper shows the etiologic relation of Strepto­coccus viridans rather than the value of vaccines. There is no indication that stock vaccines were used, though the paper is not clear on this point. The second paper deals with the application of vaccine therapy in the treatment of arthritis. This paper is by a man who is avowedly an enthusiast on vaccine therapy. The indications are that he generally used a mixed autogenous vaccine, but the reports of cases are not always clear. This writer apparently makes no serious attempt at the classification of the joint conditions he treats. The third reference is a purely experimental study and has no bearing on the use of vaccines in treatment. The fourth article was admitted by the manufacturer to be “negative as regards evidence.” The fifth reference specifically states that “the vaccine must be autogenous.” The sixth reference deals with the experimental production of appendicitis by the use of diplococci, and has not the most remote bearing on the use of vaccines in the treatment of rheumatism.

Strepto­coccus-Viridans-Combined-Bacterin.—The article which bears evidence of more care than the others admits that we are not in position to state the value of vaccines in pyorrhea but the author believes they may have value supplementary to local treatment.

It is not surprising that a large number of favorable reports can be accumulated when we appreciate how promptly men report what they consider to be their successes and how commonly they leave their failures unrecorded. Bearing in mind the fact that these stock mixed vaccines, though before the profession for many years, have not been used, or continued in use, in hospitals where work is rigidly controlled and that they are used practically not at all in the large government hospital service, a candid critic must hold that there is no substantial evidence in favor of the therapeutic use of a mixed vaccine, certainly not for stock “goods” and that probably there is but a limited field for the employment of autogenous vaccines.

The referee calls attention to a shift in the advertising matter on vaccines—the tendency to recommend vaccines to be used in conjunction with drugs. A heading in the Abbott booklet reads, “The Biologics Do Not Replace Drugs”; and the paragraph speaks of serums and bacterins as “new tools, supplemental to those we already have, but not replacing them.” ... “We need them both.”

The referee recommends that the several mixed vaccines discussed in this report be not accepted on the grounds that satisfactory evidence of their value is wanting.

Having been endorsed by the Committee on Serums and Vaccines the Council adopted the report and declared M. Catarrhalis-Combined-Bacterin, B. Coli-Combined-Bacterin, Pertussis-Combined-Bacterin, Strepto­coccus-Rheumaticus-Combined-Bacterin and Strepto­coccus-Viridans-Combined-Bacterin ineligible for admission to New and Non­official Remedies.

Catarrhal Vaccine Combined-Lilly and Influenza Mixed Vaccine-Lilly

Because of inquiry received, the Council requested Eli Lilly and Company to aid in determining the acceptability of the following products for New and Non­official Remedies: “Catarrhal Vaccine Combined,” said to contain killed cultures of the Bacillus of Friedländer, Micro­coccus catarrhalis, Staphylo­coccus aureus and albus, Pneumo­coccus and Strepto­coccus; “Influenza Mixed Vaccine,” said to contain killed cultures of Staphylo­coccus albus and aureus, Strepto­coccus, Pneumo­coccus, Micro­coccus catarrhalis and Bacillus influenzae.

Lilly and Company sent the circulars, etc., used in advertising these products. A circular for “Catarrhal Vaccine Combined” contained the following claim:

“Catarrhal Vaccine has been especially useful in many respiratory infections, including bronchitis, pharyngitis, rhinitis, chronic catarrh and in the mixed infections of pulmonary tuberculosis.”

A circular for “Influenza Mixed Vaccine” contained the following:

“The vaccine is useful in the treatment of influenza and ordinary colds, and in any infection in which the Bacillus influenzae is the causative agent.”

An advertising pamphlet contained the following:

“Catarrh, Acute and Chronic; Colds, Influenza.—The micro-organisms capable of producing catarrhal conditions of the nose and pharynx and most commonly isolated are B. Friedländer, M. catarrhalis, staphylo­coccus, pneumo­coccus (in infections beginning in the larynx), B. influenza and strepto­coccus. These organisms are found normally in the respiratory passages and acquire virulence only when resistance has been lowered through overwork, exposure to cold, etc.

“The results following the use of Catarrhal Vaccine Combined (in the non-epidemic forms) and influenza Mixed Vaccine (in the epidemic types) have been very satisfactory, due to the great vascularity of the tissues. Acute attacks are aborted altogether or shortened in duration and the danger of complications greatly minimized.”

No evidence was submitted which warrants the preceding claims nor is the Council aware of any reliable testimony to indicate that the administration of the mixture here discussed is warranted or desirable. On the recommendation of the Committee on Serums and Vaccines the Council voted that “Catarrhal Vaccine Combined-Lilly” and “Influenza Mixed Vaccine-Lilly” be not included in New and Non­official Remedies because satisfactory evidence of their value is wanting.

Influenza Serobacterin Mixed-Mulford

Because of inquiry received, the Council took up the consideration of “Influenza Serobacterin Mixed-Mulford,” and requested the Mulford Company to present evidence to establish the admissibility of the preparation to New and Non­official Remedies. The Mulford Company sent specimens of the serobacterin in question, an advertising circular and a letter by the director of its Biologic Laboratories.

According to the label on the package, the preparation is made from the following organisms: Bacillus influenzae, Staphylo­coccus aureus, Staphylo­coccus albus, Strepto­coccus, Pneumo­coccus and Micro­coccus catarrhalis (group). This mixture is recommended by the manufacturer:

“For the prophylaxis and Treatment of Common Colds, Mixed Infections of the Respiratory Mucous Membranes, Acute and Chronic Catarrhal Conditions of the Nose, Throat and Respiratory Passages.”

No evidence is submitted for this recommendation except that in “colds and bronchitis and the other common infections of the upper respiratory passages ... five or six bacteria are very commonly present—two or more of them are nearly always present ...” and the letter by the director of the Mulford Biologic Laboratories expressing the belief that in his own case the use of the mixed vaccine has aborted or prevented colds.

As regards the use of this complex biologic preparation:

First, the cause of common colds is, at the present time, quite unknown. One of the most striking things is that at the beginning of a cold the organisms to be cultivated from the nasal mucous membrane are very few in number and there is no uniformity in the type of organism found. If someone of the well-known organisms (Strepto­coccus, Staphylo­coccus, Pneumo­coccus, Micro­coccus Catarrhalis, Influenza Bacillus, etc.) were responsible, we should expect to find one of them preponderating and in overwhelming numbers. This is far from the case. After the duration of the cold for a day or two with the increased production of mucus and apparently with the infection of a mucous membrane whose powers of resistance have been greatly lowered, bacteria of all kinds are to be found in immense numbers. There is considerable reason for believing that an ultramicroscopic organism is responsible for this condition (See Foster, Journal of Infectious Diseases 21:451 [Nov.] 1917).

Second, there is no acceptable clinical evidence that vaccination with the influenza bacillus, the Strepto­coccus, the Pneumo­coccus or the Micro­coccus Catarrhalis will influence the course of an infection due to one or the other of these organisms. It has been repeatedly found that a staphylo­coccus vaccine is of a certain degree of value when the infection with the staphylo­coccus is localized, but it is well known that general systemic infections with the staphylo­coccus are not at all benefited.

Third, the letter submitted as evidence by the Mulford Company is not convincing. The Council is not prepared to accept evidence of this sort unless it is in volume large enough to justify a definite conclusion.

Holding that there is no evidence for the value of this mixture, the Council declared “Influenza Serobacterin Mixed-Mulford” inadmissible to New and Non­official Remedies because its use is illogical.

Sherman’s Mixed Vaccine No. 40

Because of inquiry received the Council decided to consider this preparation and requested the manufacturer, G. H. Sherman, Detroit, Mich., to submit evidence in support of the claims made for it.

This vaccine is said to be made from killed cultures of Strepto­coccus, Pneumo­coccus, Micro­coccus catarrhalis, Staphylo­coccus aureus, and Staphylo­coccus albus. In the printed matter sent out by G. H. Sherman this vaccine is recommended for hay-fever, in which it is stated that some of the symptoms are due to bacterial invasion of the respiratory mucosa; for tonsillitis, both as a remedy and as a prophylactic against rheumatic and other sequelae; for “throat infections”; for rhinitis with the claims that acute coryza can be aborted within twenty-four hours; for pneumonia in which it is advised for all stages; for laryngitis, for bronchitis, and for asthma.

No acceptable evidence was submitted as to the value of the product in the treatment of any of the foregoing conditions. In view of what is known about non-specific reactions, it seems likely that any influence which this vaccine may have on the diverse conditions enumerated by the manufacturer, is due to this, rather than to the combination of organisms used in its preparation.

On the recommendation of the Committee on Serums and Vaccines, the Council declared “Sherman’s Mixed Vaccine No. 40” ineligible to New and Non­official Remedies because the therapeutic claims made for it are unwarranted (Rule 6) and because the combination, in view of its complexity, is irrational and detrimental to sound therapy (Rule 10).—(From The Journal A. M. A., June 23, 1918.)

OPHTHALMOL-LINDEMANN

Report of the Council on Pharmacy and Chemistry

Ophthalmol-Lindemann was taken up for consideration by the Council because of inquiries received. The following report, declaring Ophthalmol inadmissible to New and Non­official Remedies, was adopted by the Council and its publication authorized.

W. A. Puckner, Secretary.

Ophthalmol-Lindemann (Innis, Speiden and Co., New York) is advertised as a treatment for eye diseases by “hyperemia.” The circular advertising the product is written somewhat in the style of “patent medicine” advertisements. It contains testimonials of dubious value. The principle underlying the use of Ophthalmol is that employed to a considerable extent by ophthalmologists, through the use of ethylmorphine (“dionin”), etc., viz., the production of conjunctival irritation in inflammatory eye diseases. Ophthalmol is, therefore, merely a special agent for the production of such ophthalmic irritation.

The advertising circular contains no evidence that Ophthalmol is in any respect superior to the established agents for producing conjunctival hyperemia. On the other hand, there are obvious objections to the use in the eye of a substance of unknown and apparently indefinite composition and uncertain activity. Ophthalmol is said to be an oily solution of “glandular extract of the fish Cobitis Fossilis.” Cobitis fossilis is a small fish said to be common in Germany. According to Kochs, who analyzed Ophthalmol (Arb. a. d. Pharm. Inst. d. Univ. Berl., 4:140, 1907), this fish is popularly believed to predict weather, but medical virtues are not ascribed to it. This “fishy” extract is indefinite, to say the least.

The activity of the preparation is described by the manufacturer thus: “It seems probable that the typical action of Ophthalmol is due to certain organic acids which may have formed during manufacture through the decomposition of protein bodies contained in the crude material.” The profession is not told whether this important decomposition is, or, in fact, can be controlled so as to produce a material of uniform activity.

Kochs concluded from his analysis that Ophthalmol had the properties of rancid olive oil containing about 6 to 7 per cent. mineral oil. The oil contained no nitrogen, left no ash on ignition and though traces of iodin were claimed to be present, no iodin could be found.

It is recommended that Ophthalmol be rejected first, because the use in the eye of an irritant of secret composition and uncertain activity is unscientific and against the interest of public health; second, because Ophthalmol is of secret composition (the composition claimed being practically meaningless), and, third, because no evidence has been submitted to substantiate its claimed superiority over established methods of treatment. The Council declared Ophthalmol inadmissible to New and Non­official Remedies.—(From The Journal A. M. A., July 6, 1918.)

SILVOL INELIGIBLE FOR N. N. R.

Report of the Council on Pharmacy and Chemistry

The following report on Silvol (Parke, Davis & Company) was adopted by the Council and its publication authorized.

W. A. Puckner, Secretary.

The Council took up the consideration of Silvol (Parke, Davis & Company) because of inquiries received. The following report was submitted by the referee in charge of silver preparations:

Silvol (Parke, Davis & Company) is a silver-protein preparation of the Argyrol type. Like Argyrol, it is said to contain about 20 per cent. of silver. The referee finds that, like Argyrol, it is nonirritant to the nasal mucosa in a 10 per cent. solution; does not precipitate with chlorid; dissolves in water readily; a 25 per cent. solution has a high specific gravity (Silvol, 1.137 at 20 C.; Argyrol, 1.147 at 20 C.), and is not very viscid (viscosity, 1.25). A 1:1,000 solution of Silvol is clear and about 50 per cent. deeper in color than a solution of Argyrol of the same strength.

Silvol differs from Argyrol mainly in that its solutions yield a fine precipitate with egg albumin (under suitable conditions), while Argyrol is nonprecipitant; and in that Silvol solutions are not so effectively decolorized by Lloyd’s reagent.

The manufacturers did not reply to an inquiry with regard to the basis for the claims made for Silvol (see Appendix). The referee was therefore obliged to deduce these claims from the firm’s advertising matter. About the same claims are made for the local use of Silvol as are generally made for Argyrol. These may be accepted without detailed evidence in view of the similarity of the two preparations.

Its usefulness, as suggested in the advertising, when given by mouth “in the treatment of acute or chronic gastritis, gastric ulcer, or gastro-enteritis,” or the efficacy of very dilute solutions (0.2 per cent.) against dysentery, etc., is doubtful and requires substantiation by evidence. The claims that Silvol is astringent, though nonirritant and noncoagulant, that it is a “powerful germicide” or even that it is a “powerful antiseptic,” and that it may be used with advantage wherever “a silver salt is indicated,” need substantiation. There is no proof of the assertions that Silvol is “the most efficacious of silver salts”; “the most efficient antiseptic,” and “the most remarkable organic silver compound ...”

As the manufacturers have not presented any evidence for their highly improbable claims, and as they have not signified any intention of making their claims agree with substantiated facts, it is recommended that Silvol be declared inadmissible to New and Non­official Remedies.

The Council adopted the report of its referee and authorized its publication.

APPENDIX

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:

“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, 10¹⁄₂ 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. 4³⁄₄; Rectified Ol. of Turpentine, m. 3¹⁄₂; 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. 2¹⁄₂; 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 Acid2 minims

Potassium Phosphate 2¹⁄₄ grains

Magnesium Phosphate

Calcium Phosphate

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.

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

Starch35 pounds

Barium-Sulphide20 pounds

Zinc-Oxide10 pounds

Calcium-Carbonated-Precip.10 pounds

Potassium-Permanganate10 grams

Menthol-Crystallized10 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 Sulphid2 drams

Zinc oxid3 drams

Starch3 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.

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. They 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, and because the practice of prescribing such mixtures tends to discourage careful consideration of the special needs of the individual patients without which there can be no drug therapy. On the contrary, with the use of such mixtures, 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.

Granular Effervescent Bromide and Acetanilid Compound-Mulford is listed in the Appendix to New and Non­official Remedies. Each 100 Gm. of the mixture contains sodium bromide, 5 Gm., and acetanilid, 1.5 Gm. According to the label, an amount containing acetanilid, 6.5 grains, and sodium bromide, 22 grains, is to be taken at a dose, to be repeated in half an hour if necessary. For “children,” half this dose is advised.

The Council has considered the available evidence for mixtures of this sort, and has reached the conclusion that they are inimical to rational medicine and the public, and therefore in conflict with Rule 10. It holds that the use of mixtures of acetanilid and sodium bromide in fixed proportion is irrational and prone to induce their indiscriminate use by the public. Despite the perfectly frank declaration of the composition of this mixture that is made by the Mulford Company, the “directions” will be followed blindly and the preparation will be given to “children” and “repeated in half an hour, if necessary” in cases in which it would be held unwarranted to administer a dose of 3 grains of acetanilid to a child.

The period of acceptance having expired for Granular Effervescent Bromide and Acetanilid Compound-Mulford, the Council directed its omission from New and Non­official Remedies for conflict with Rule 10.—(From Reports of Council on Pharmacy and Chemistry, 1918, p. 58.)

HOLADIN AND BILE SALT MIXTURES

Holadin and Bile Salts-Fairchild; Capsules of Bile Salts, Succinate of Soda and Phenol­phthalein-Fairchild; Capsules of Holadin, Bile Salts and Phenol­phthalein-Fairchild; Capsules of Holadin, Succinate of Soda and Bile Salts-Fairchild.

Report of the Council on Pharmacy and Chemistry

To explain the omission from New and Non­official Remedies of certain mixtures, the Council has authorized publication of the matter which appears below.

W. A. Puckner, Secretary.

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. They 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, and 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 mixtures, 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 any 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 as soon as the three year period for which articles are accepted has expired.

The following preparations are included in New and Non­official Remedies, 1918:

Holadin and Bile Salts-Fairchild.—A mixture of holadin, 5 parts, with bile salts-Fairchild, 1 part, put up in 3 grain capsules.

Capsules of Bile Salts, Succinate of Soda and Phenol­phthalein.—Each capsule contains bile salts-Fairchild, 0.065 Gm. (1 grain); sodium succinate exsiccated, 0.2 Gm. (3 grains), and phenol­phthalein, 0.03 Gm. (¹⁄₂ grain).

Capsules of Holadin, Bile Salts and Phenol­phthalein.—Each capsule contains holadin, 0.13 Gm. (2 grains); bile salts-Fairchild, 0.03 Gm. (¹⁄₂ grain), and phenol­phthalein, 0.065 Gm. (1 grain).

Capsules of Holadin, Succinate of Soda and Bile Salts.—Each capsule contains holadin, 0.20 Gm. (3 grains); sodium succinate exsiccated, 0.20 Gm. (3 grains), and bile salts-Fairchild, 0.03 Gm. (¹⁄₂ grain).

Oxbile has long been credited with a cholagogue action, which, however, has probably been greatly overestimated. When pure bile salts were placed on the market some years ago, they and their compounds were admitted to N. N. R.

Holadin is said to represent all the constituents of the pancreas and to possess great potency in respect to the several enzymes, trypsin, amylopsin, lipase, and the milk-curdling ferment.

It is not clear when such a substance is indicated thera­peutically. While it may be useful when there is a deficiency of pancreatin and gastric secretion, it should be used alone.

It is also quite possible that bile salts may have a distinct, though limited, field of usefulness when there is a deficiency of biliary secretion; but the bile salts are best administered alone, or in combination with such laxatives as may be deemed necessary by the physician while keeping in mind the fact that different patients show the widest difference in their reaction to laxatives, making combinations of these agents in fixed proportion irrational.

Phenol­phthalein was popularized by nostrum makers; and while it has some therapeutic value, this has been greatly overestimated, and it should be used only in amounts deemed necessary for each patient, preferably alone.

Succinate of sodium was introduced as a saline cathartic, with the claim that it exerts an antiseptic action on the biliary passages and gallbladder. There is no satisfactory evidence to substantiate this claim.

The Council maintains a liberal attitude toward new preparations, but it feels that it is impossible to determine the value of the several constituents of such complex mixtures when used as such; it holds that these mixtures are superfluous and that the several substances of which they are composed should be used singly or at most with greater attention to the individual requirements of the patient than is possible when these fixed mixtures are prescribed.

Despite the fact that these mixtures have been in use for more than nine years, there is no satisfactory evidence that they possess any advantage over the simple laxatives or the preparations of bile or pancreatic extract. They are therefore held to be in conflict with Rule 10, and the Council has directed that they be not included in N. N. R. after Dec. 31, 1918.

Having adopted the preceding report, the Council, in accordance with its regular procedure, submitted this to Fairchild Bros. and Foster for comment.

The following reply was received:

We are entirely at variance with you in the arbitrary conclusion expressed concerning the inimical influence of mixtures on therapeutic progress, the practice of medicine and the public welfare.

If the combinations of Holadin and Bile Salts, etc., in capsules, were ever properly within the scope of New and Non­official Remedies, they should be retained. If, however, complex mixtures are to be held as, a priori, unworthy of consideration, the rejection of all would naturally be a logical proceeding.

We believe that the particular combination of Holadin and Bile Salts etc., have been clearly in the line of therapeutic progress—a natural evolution, improvement and development.

For many years combinations of pancreatic extract and ox gall had naturally suggested themselves.

When we realized the fact that the bile salts were quite clearly the active principles of the bile, and that they must necessarily exist in greatly varying percentages in the official inspissated or ox gall, and also because these ox gall products of pharmacy were of extremely varying density, even from that of treacle to resin—and of other objectionable character, we undertook to prepare bile salts.

These combinations are now further justified in view of physiological considerations, the simultaneous secretion of the pancreas and bile, and the state of our knowledge of the function of bile salts, and as co-ferments, promoting and supplementing the pancreas enzymes.

The question suggested as to whether the cholagogic action of ox gall (and bile salts) has been overestimated seems to us no clear purport. The bile salts are obviously employed as the means of administering and thus realizing whatever properties this secretion may have in medicine, of which the cholagogic action is by no means the only consideration.

As for phenol­phthalein, which is credited with purely laxative properties, we are at a loss to see any bearing in the remark that phenol­phthalein was popularized by nostrum makers. We cannot see that the physician’s or chemist’s estimate of phenol­phthalein, its properties and uses, can be in the least degree influenced one way or the other by the statement that “phenol­phthalein has been popularized by nostrum makers.”

The phenol­phthalein and succinate of soda combinations were originally both prescribed, and we have simply placed them at the service of the physician without other exploitation of them than that designed to call attention to their use in the conditions indicated.

These combinations are offered in a form which may be administered by the mouth with the best promise of introducing the substance more directly in the intestinal tract during the digestion period or at such interval after or prior to, the digestion period, as would best, in the judgment of the physician, meet the indications.

These particular combinations are especially desirable in these “fixed forms” since they are stable and reliable resources at the command of the physicians, the enzymes retaining their stability and potency without material deterioration for many years, and they naturally possess the advantages which are obviously due to the character of the particular pancreas and bile products used in the combinations.

Furthermore, the hygroscopic and soluble organic substances in admixture cannot ex­tem­por­aneously be so prepared in sealed capsules as to be readily available under the practical requirements of prescribing and dispensing. And we do not believe that those who practice medicine will be in accord with your view that the pancreas substance should necessarily be administered alone, or the bile substance alone.

It now appears that these combinations are to be dropped from New and Non­official Remedies in consequence of the view, so stated, that in clinical experience “for more than nine years there is no satisfactory evidence that they possess any advantage over the simple laxatives or preparations of bile or pancreatic extract.”

In reply to this we would simply make the following comment:

During these “nine years” these combinations have inevitably been put to an informing clinical trial, because of the fact that they have been employed with success in disorders of the pancreas and bile functions and often in chronic and serious cases where the clinical conditions were obvious and unmistakable.

The reports of these cases come to us from physicians widely separated and each of his own independent initiative. It would seem gratuitous, to say the least, to state that the observers are “disinterested,” since it is quite clear that there is no other interest than that of the practitioner and his patient.

It is not a case of a new drug or combinations of new remedies, but simply resources which, upon well grounded reasons, both from a theoretical and material standpoint, justify clinical trial, and with results which would seem from any ordinary human standpoint to be satisfactory clinical evidence.

As to the interpretation of competent clinical evidence by the Council, we would, in view of the circumstances and without comment, ask to embody in this text this rule:

“Clinical Evidence.”—“To be acceptable, the clinical evidence must offer objective data with such citation of authority as will enable the Council to confirm the facts and establish the scientific value of the conclusions drawn. Clinical data are worthless when the author is not cited. The facts on which claims with regard to the value of a remedy are based must have been rendered accessible for investigation and confirmation by disinterested observers, either through publication or through the records of a hospital or other institution.”

To discredit these combinations would seem to us not only unjustified, but sterile of any real advancement in medicine, or of anything in the way of helpfulness to the patient in the class of cases in which these products have been resorted to with benefit; this on no other ground really than the opinion “that they have no advantage over the simple preparations themselves.”

Naturally we shall continue to prepare these products and shall continue to take such action as we deem best to bring them to the attention of the physician, for the conduct of our business must remain in the hands of those who are personally responsible for it.

And it is now forty years since we took up this line of work and with the declared intention of devoting ourselves to the applied science of the digestive ferments and “to their development and practical application in every useful purpose in medicine.”

We have been consistently in sympathy with the fundamental purpose of the Council, which must first rest upon fact as to the character of the products offered as medicinal agents. The weight of evidence justifies the position that these particular products rationally should be, and as a matter of fact are, of important special service in the utilization of these organic secretions in medicine.

As explained in the preceding report, 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. They are especially objectionable because it is impossible to determine accurately the effects which follow the simultaneous administration of a number of drugs having dissimilar actions, and because such a practice tends strongly to discourage careful consideration of the special needs of individual patients without which there can be no therapeutic progress. On the contrary, with their use, therapeutic treatment becomes haphazard and mere guesswork.

The dismissal of the holadin and bile salts mixtures does not involve the question of the usefulness of holadin or of bile salts alone; on the contrary, the possible usefulness of these preparations is admitted in the report. It is the combination of holadin, bile salts, sodium succinate and phenol­phthalein to which objection is made.

The statement of Fairchild Bros. and Foster that “these combinations are now further justified in view of physiological considerations” is somewhat misleading. It is true that bile and the pancreatic secretion cooperate in intestinal digestion, but there is no evidence that in every case in which there is a deficiency of one of these secretions there is also a deficiency of the other, and it is an axiom of scientific therapeutics that no drug or remedial agent should be administered except to fill a definite want. Otherwise the practice of therapeutics becomes mere empiricism.

The properties of phenol­phthalein are not in the least influenced by the manner of its introduction, as Messrs. Fairchild Bros. and Foster emphasize; but the important fact in this connection is that the popular conception of their actions is greatly influenced by the mode of introduction, and phenol­phthalein has been widely advertised in a variety of conditions, so that the popular notion concerning it is not that of scientific therapeutics.

In short, the entire argument of Messrs. Fairchild Bros. and Foster concerning the exploitation of these preparations may be summed up by saying that they have been used by clinicians who believe that good results have followed their use, and that the firm will therefore continue to supply the demand. The tendency of some to use anything brought to their notice, and the readiness of manufacturers to market anything that physicians will use, presents the greatest obstacle to therapeutic progress. There was never a nostrum so irrational or worthless that honest but undiscriminating clinicians could not be found who reported wonderful results from its use.

According to Fairchild Bros. and Foster, these holadin and bile salts mixtures have been in use for some nine years. Yet the Council is not aware of any investigation of their merits that meets the requirements of scientific research.

The Council is not acquainted with a single clinical investigation of their action under conditions which afford satisfactory evidence of their therapeutic value.

It is obviously wholly insufficient for a clinician to report that the use of a mixture was followed by good results. The fallacy of such arguments was demonstrated long ago. He must make a comparison of the results obtained with the remedial agent with those obtained in as nearly similar conditions as possible except for the use of the agent. We are not aware that any such study of the mixtures in question has been made. It is in the last degree irrational to hold that because bile salts are the active constituents of bile, therefore such complex mixtures as these are necessary.—(From Reports of Council on Pharmacy and Chemistry, 1918, p. 59)

LIQUOR SANTAIVA, S. & D., 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 Liquor Santaiva, S. & D., has been authorized for publication.

W. A. Puckner, Secretary.

So far the Council 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 any 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.

The Council being engaged in the annual revision of New and Non­official Remedies, the referee in charge of santal preparations reported that the three year period of acceptance had expired for Liquor Santaiva (Sharp & Dohme).

The referee held that Liquor Santaiva, S. & D., declared to be a solution of santal oil and copaiba with aromatic oils, in a mixture of alcohol and water, is plainly in conflict with the current interpretation of Rule 10, because there was no sound evidence to indicate that any useful end is gained by the simultaneous administration of santal oil and copaiba in any proportion, and that so, of course, there is no evidence of the special advantage in the fixed proportions represented by the mixture. He pointed out that the formula is essentially a survival of the discredited shotgun gonorrhea mixtures and therefore recommended that its acceptance be not continued.

The Council agreed to the recommendation of the referee and directed that Liquor Santaiva, S. & D., be omitted from New and Non­official Remedies.—(From Reports of Council on Pharmacy and Chemistry, 1918, p. 66)

MALTZYME, MALTZYME WITH CASCARA SAGRADA, MALTZYME WITH COD LIVER OIL, MALTZYME FERRATED AND MALTZYME WITH YERBA SANTA 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 the Maltzyme preparations has been authorized for publication.

W. A. Puckner, Secretary.

In 1916, the Council voted to omit Maltzyme with Hypo­phosphites, and Maltzyme with Phosphate of Iron, Quinine and Strychnine. At that time the labels used on the Maltzyme preparations still in New and Non­official Remedies contained a list of Maltzyme combinations which included those which had been dismissed. As the Council does not permit an accepted article to be used as a means of advertising an article not accepted, it voted to continue the following preparations for a period of three years on condition that reference to the deleted articles be omitted from the labels when those then in stock had been used up: Maltzyme, Maltzyme with Cascara Sagrada, Maltzyme with Cod Liver Oil, Maltzyme Ferrated and Maltzyme with Yerba Santa. While the Maltzyme Company made no definite agreement to revise its advertising propaganda in accordance with the Council’s requirements, the Maltzyme preparations were retained in the belief that in due time the required revision of the labels would be made.

The Council being engaged in preparing the 1919 edition of New and Non­official Remedies, the referee in charge of malt extracts reported that the Maltzyme Company had not revised its labels in accordance with the stipulation of the Council. The referee further reported he had become convinced that the claim that Maltzyme is “rich in malt enzymes” is unwarranted and that the term “Maltzyme” (malt plus enzyme) is misleading; this because of the recognized instability of malt extracts (Jour. A. M. A., March 30, 1912, p. 954) and because the Maltzyme Company makes no definite statement with regard to the diastase (malt enzyme) content of its preparations.126 For this reason it had been the referee’s intention to propose the deletion of all Maltzyme preparations when their period of acceptance expired in 1919. As, however, the present Maltzyme preparations are in contravention with the Council’s requirements, he recommended that the acceptance of these preparations be canceled now.

The Council agreed to the recommendation of the referee and directed that Maltzyme, Maltzyme with Cascara Sagrada, Maltzyme with Cod Liver Oil, Maltzyme Ferrated, and Maltzyme with Yerba Santa be omitted from N. N. R.—(From Reports of Council on Pharmacy and Chemistry, 1918, p. 67)

METHAFORM 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 Methaform has been authorized for publication.

W. A. Puckner, Secretary.

Methaform is the proprietary name applied by F. Stearns & Co. to chlorbutanol.

Being engaged in the annual revision of New and Non­official Remedies, and the term of acceptance for Methaform having expired, a trade package was purchased to determine if the product was marketed in compliance with the rules of the Council. It was then found that a circular was wrapped with the trade package which advertised Methaform Inhalant, a preparation not accepted for New and Non­official Remedies.

For obvious reasons, the Council does not countenance the use of an accepted article as a means of advertising an article not accepted. Accordingly F. Stearns & Co. was advised that the Council would be obliged to withdraw the acceptance of Methaform unless the objectionable circular was omitted from the Methaform packages. Stearns & Co. did not give the requested assurance, and therefore the Council directed that Methaform be omitted from New and Non­official Remedies.—(From Reports of Council on Pharmacy and Chemistry, 1918, p. 68)

PINEAL GLAND, RED BONE-MARROW AND THYMUS GLAND AND THEIR PREPARATIONS 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 pineal gland, red bone-marrow and thymus gland and their preparations has been authorized for publication.

W. A. Puckner, Secretary.

Pineal gland, red bone-marrow and thymus gland were admitted to New and Non­official Remedies when these products gave promise of having therapeutic value.

The term of acceptance for the preparations of pineal gland, red bone-marrow and thymus gland having expired, the referee in charge of animal organ preparations recommended in his report for the annual revision of N. N. R. that these products and the general articles describing them be omitted from New and Non­official Remedies. He held that the experimental and clinical experience with them leads to the conclusion that they are without value.

In accordance with the recommendation of the referee, the Council voted that the following preparations be omitted from New and Non­official Remedies: Desiccated Pineal Gland-Armour; Pineal Gland Tablets-Armour; Extract of Red Bone-Marrow-Armour; Desiccated Thymus-Armour; Thymus Tablets-Armour.

As a matter of record, the descriptive articles for pineal gland, red bone-marrow and thymus gland, which appeared in New and Non­official Remedies, 1918, are given below.

Pineal Gland

The functions of this gland have not yet been established but there is some pathological and some experimental evidence that there is a relation between the gland and some processes of development and growth; the nature of this relation is unknown. Adiposis is a frequent sign of disturbed pineal function, but observers are not agreed whether to interpret this as indicating hypofunction or hyperfunction, or possibly a concurrent disturbance of the pituitary. In some instances intravenous injections of pineal extract have seemed to cause a distinct fall in blood pressure. It has been inferred from observations in cases of pineal tumors in the young that the gland in young individuals furnishes a secretion which inhibits growth, particularly the development of the reproductive glands, but the results of experimental administration of pineal substance orally have led other observers to infer that the pineal secretion favors physical and possibly mental and sexual development. It has been suggested that, as all evidence points to the fact that the function of the pineal gland is one of early life, extract of adult pineal glands might be expected to be inert. Experiment has also indicated greater activity in glands obtained from young animals than in those obtained from older ones. The Council has decided to admit preparations of pineal gland to New and Non­official Remedies simply for experimental purposes.