OPHTHALMOL-LINDEMANN

“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. influenzaand 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.”

“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.

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 Diseases21:451 [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.

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 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 fossilisis 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.)

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 (seeAppendix). 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.

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?

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.)

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.124In 1893 (when the publication of “a formula” for proprietary preparations was thought to satisfy the requirements of scientific medicine) an advertisement inThe Journalof 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 CityMedical Index-Lancetdeclared 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, 101⁄2grains 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:

“Internallyit 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.”

“Internallyit 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 and8, 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)” 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.

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 misleadingand unwarranted claims. It is inadmissible to New and Nonofficial Remedies for conflict with Rules 1, 6, 8 and 10.

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.1⁄36and 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.)

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 theMaryland 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 isnota preparation of free (elementary) iodin and Campetrodin No. 2, Double Strength, doesnotcontain 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.)

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 “aromaticsq. 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 rationaldrug 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 of1⁄14,1⁄10,1⁄8, and3⁄16of 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.

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 of1⁄14,1⁄10,1⁄8, and3⁄16of 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.)

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.125is sold by the Charles H. Phillips Chemical Co., New York. According to the published formula, each fluidram contains:

Phosphoric Acid2minimsPotassium Phosphate21⁄4grainsMagnesium PhosphateCalcium PhosphateFerric PhosphateQuinin Muriate (equal to nearly1⁄2gr. Bi-Sulph.)1⁄4grainStrychnin1⁄120grainFlavoring, Glycerin and Syrup,q. s.

Phosphoric Acid

Quinin Muriate (equal to nearly1⁄2gr. Bi-Sulph.)

Strychnin

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.”

“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.)

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:

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