“URICSOL is a non-irritating, alkaline solution, containing Lithium Citrate, Acid Citric and Potassium Nitrate, together with a saline laxative in the form of Glycero Sodium Phosphate, with Vegetable Tonics added.”
“URICSOL is a non-irritating, alkaline solution, containing Lithium Citrate, Acid Citric and Potassium Nitrate, together with a saline laxative in the form of Glycero Sodium Phosphate, with Vegetable Tonics added.”
The Association Laboratory has made an examination of Uricsol to determine its composition and reports as follows:
A trade package purchased in March, 1915, from a wholesale drug house was labeled:
“Uricsol Rheumatic Remedy, Uric Acid Solvent, Kidney and Liver Stimulant, Manufactured by the Uricsol Chemical Co., Los Angeles, Cal.”
“Uricsol Rheumatic Remedy, Uric Acid Solvent, Kidney and Liver Stimulant, Manufactured by the Uricsol Chemical Co., Los Angeles, Cal.”
This package was wrapped in a circular entitled “The Great California Remedy—Uricsol.” The preparation is a viscid, slightly turbid light brown liquid, with a faintly aromatic odor and a salty, bitter taste. The diluted solution is acid in reaction toward litmus and phenolphthalein and alkaline toward methyl orange.
Qualitative tests showed a presence of phosphate, citrate, nitrate, sodium, glycerin, and a small amount of lithium in aqueous solution. Besides these a small amount of some organic, nonalkaloidal substance was found, which from its bitter taste suggested gentian. From the qualitative tests it appeared that the phosphate was the predominating ingredient and accordingly a phosphate determination was made. The results, calculated to sodium phosphate, U. S. P., indicated the presence of 64.20 gm. per 100 c.c., held in solution by citric acid and sodium nitrate.
Uricsol evidently is a solution containing a large amount of sodium phosphate with small amounts of lithium, nitrate, citric acid and glycerin, with probably some vegetable extract.
In general Uricsol is similar to the once widely exploited proprietary “Melachol,” which has been frequently imitated. A preparation essentially identical is in the United States Pharmacopeia, under the title “Compound Solution of Sodium Phosphate.”
The Uricsol Company calls its preparation
“... the latest word in the treatment of Rheumatism and that allied group of ailments which is caused by an excess of Uric Acid.”
“... the latest word in the treatment of Rheumatism and that allied group of ailments which is caused by an excess of Uric Acid.”
Hay fever, bronchial asthma and neuritis are conditions in which it is recommended. The claim is made that
“Uricsol quickly controls Vasomotor Rhinitis and eliminates such conditions from the system.” “In fact, it will correctFAULTY METABOLISM.”
“Uricsol quickly controls Vasomotor Rhinitis and eliminates such conditions from the system.” “In fact, it will correctFAULTY METABOLISM.”
To a few practitioners of an older generation the pharmacologic basis of a remedy for rheumatism was sufficiently defined by saying that it increased the solubility of uric acid or affected it in some way. This theory is obsolete; there is not, and never was, any reliable evidence on which to base the theory that rheumatism is in any way caused by uric acid. The exploitation of Uricsol as a “uric acid solvent” is merely another illustration of the way in which nostrum manufacturers play on disproved theories. Of course the claim that sodium phosphate has any particular power to control vasomotor rhinitis, hay fever, asthma, and to correct faulty metabolism is foolish.
To summarize: Uricsol is a mixture of well-known drugs, marketed with false claims as to therapeutic action, with misleading and meaningless statements as to composition and under a name which invites uncritical prescribing. Uricsol is held ineligible to inclusion in New and Nonofficial Remedies.
The following ridiculous statements are addressed, not to the laity, but to the medical profession:
DO YOU SUFFER FROM Constipation—Hemorrhoids—Enteritis—Mucous discharge—Pituita—Acidity of the stomach—Vertigo—Sick Headache—Disturbed Sleep—Insomnia—Sallow Complexion—Coated Tongue—Offensive breath—Fatigue and depression—Boils—Pimples?“ONE of these symptoms alone shows that there is defective or insufficient function of the intestines, even if the stools are regular.“Excrements remain too long in the intestine and set up fermentation. The harmful poisons and Ptomains which they produce are re-absorbed by the blood and poison the whole system.“The Intestines must be cleared and re-educated with JUBOL.“Jubolise your Intestines.”
DO YOU SUFFER FROM Constipation—Hemorrhoids—Enteritis—Mucous discharge—Pituita—Acidity of the stomach—Vertigo—Sick Headache—Disturbed Sleep—Insomnia—Sallow Complexion—Coated Tongue—Offensive breath—Fatigue and depression—Boils—Pimples?
“ONE of these symptoms alone shows that there is defective or insufficient function of the intestines, even if the stools are regular.
“Excrements remain too long in the intestine and set up fermentation. The harmful poisons and Ptomains which they produce are re-absorbed by the blood and poison the whole system.
“The Intestines must be cleared and re-educated with JUBOL.
“Jubolise your Intestines.”
Jubol tablets are sold in the United States by Geo. J. Wallau, Inc., New York, and are said to be prepared by J. L. Chatelain, Paris, France. The following incomplete and nonquantitative “formula” is furnished:
“... compounded chiefly [!] of Agar-Agar, Biliary Extracts and pure Extracts from all the intestinal Glands.”
“... compounded chiefly [!] of Agar-Agar, Biliary Extracts and pure Extracts from all the intestinal Glands.”
It is asserted that
“The tablets are coated with a protective covering in order that they may act on the intestine only.”
“The tablets are coated with a protective covering in order that they may act on the intestine only.”
The tablets contained in a regular-size trade package, obtained direct from the agent, readily separated into two halves and disintegrated within a few minutes when agitated with water. It is thus evident that, under ordinary conditions, the intestinal ferments in Jubol (if they are present, as claimed) would be destroyed during their passage through the stomach. In direct tests, however, practically no tryptic activity was demonstrated.
The composition of Jubol is not declared; grossly unwarranted and incorrect claims are made for its therapeutic actions; the name does not indicate the alleged ingredients and so much of the composition as is declared indicates an unscientific mixture. The Council decided that Jubol should be held ineligible for New and Nonofficial Remedies, and that this report should be published.
Urodonal is said to be “produced in the laboratory of J. L. Chatelain,” Paris, France. It is marketed in this country by Geo. J. Wallau, Inc., New York.
The preparation is claimed to be a chemical compound, and the advertising matter furnishes a “formula,” which consists of the formulas of lysidin, sidonal and hexamethylenamin, connected by plus signs:
That the substance is a chemical compound is highly improbable, and no evidence has been submitted to substantiate the claim. On the contrary, in the following statement the phrase “based on” is a virtual admission that the preparation is merely a mixture:
“Urodonal... is a granular effervescent preparation based on methylglyoxalidine [Lysidine], quinate of diethylene-diamine [Sidonal] and hexamethylene-tetramine [Formin, urotropine].”
“Urodonal... is a granular effervescent preparation based on methylglyoxalidine [Lysidine], quinate of diethylene-diamine [Sidonal] and hexamethylene-tetramine [Formin, urotropine].”
Mystery is added by the mention of undefined “special products” in the following:
“The fact of combining these two salts [lysidin and sidonal] in Urodonal, in strictly determined proportions and in the presence of special products, gives this preparation very considerable power in dissolving uric acid.”
“The fact of combining these two salts [lysidin and sidonal] in Urodonal, in strictly determined proportions and in the presence of special products, gives this preparation very considerable power in dissolving uric acid.”
These contradictory statements of composition conflict with Rule 1.
Urodonal is marketed in typical “patent medicine” style: the name “Urodonal” is blown in the bottle and the label contains a list of “Indications,” including rheumatism, gout and gravel (Rule 4). That this form of marketing has introduced it to the public is suggested by the following in an advertising circular:
“... Urodonal is now popular—even classic—throughout the world, where thousands of doctors and millions of patients agree in asserting that ‘Urodonal is to rheumatism what quinine is to fever.’ ”
“... Urodonal is now popular—even classic—throughout the world, where thousands of doctors and millions of patients agree in asserting that ‘Urodonal is to rheumatism what quinine is to fever.’ ”
There are also other indications that the mixture is to be exploited to the laity. For instance, the U. S. distributor sends out a portrait of Sarah Bernhardt bearing the legend:
“I am positive that URODONAL preserves youth’s freshness with clearness and strength to brain and heart. I have taken it for two years with the greatest benefit. Sarah Bernhardt.”
“I am positive that URODONAL preserves youth’s freshness with clearness and strength to brain and heart. I have taken it for two years with the greatest benefit. Sarah Bernhardt.”
A circular advises this mixture
“For all who suffer from Arthritis, Rheumatism, Arterio-Sclerosis, Renal and Bilious Lithiasis, Headache, Gout, Gravel, Lumbago, Sciatic Pains, Neuralgia and all uric acid troubles.”“In fact, Urodonal is five times more active than piperazine, and thirty-seven times more active than lithia. We are, therefore, entitled to say that no other eliminator of uric acid can be compared with it.”“Being37 times more active than lithia, it clears the heart valves of any sandy substances which may clog them, and checks the atheromatous degeneration of the blood vessels.”
“For all who suffer from Arthritis, Rheumatism, Arterio-Sclerosis, Renal and Bilious Lithiasis, Headache, Gout, Gravel, Lumbago, Sciatic Pains, Neuralgia and all uric acid troubles.”
“In fact, Urodonal is five times more active than piperazine, and thirty-seven times more active than lithia. We are, therefore, entitled to say that no other eliminator of uric acid can be compared with it.”
“Being37 times more active than lithia, it clears the heart valves of any sandy substances which may clog them, and checks the atheromatous degeneration of the blood vessels.”
These extracts indicate sufficiently the extravagant tone of the advertising (Rule 6): None of the ingredients are notably active in dissolving uric acid when administered by mouth. None produce any marked increase of uric acid elimination. No intelligent physician would use a uric acid solvent for “bilious lithiasis”; and their usefulness in the other conditions is open to doubt, to put it mildly.
Although the preparation is a simple mixture, the name does not indicate the components, but inclines to therapeutic suggestion (Rule 8).
Nothing is to be gained by combining several drugs which are useless, severally, for the purpose intended, as in the present case (Rule 10).
Urodonal is marketed under inconsistent statements of composition and with exaggerated therapeutic claims; the name is nondescriptive and the mixture is unscientific. The Council decided that the preparation should be declared ineligible for conflict with Rules 1, 4, 6, 8 and 10 and that this report should be published.—(From The Journal A. M. A., Aug. 14, 1915.)
The following report has been authorized for publication.
W. A. Puckner, Secretary.
Formamint is a proprietary medicine manufactured by the A. Wulfing Company (New York, London and Berlin), which is affiliated with the Bauer Chemical Company.
It has been widely advertised in Europe for several years, and is now on the American market;14it is advertised in this country both in newspapers and medical journals.
Following is a brief review of the more important alleged investigations that have been reported from time to time in various European journals.
In “The Therapeutical Value of Foramint in Septic Affections of the Oro-Pharynx,” DeSanti15quotes Rosenberg,16who reports the successful use of Formamint in cases of streptococcus infections, tonsillitis and acute symptoms of chronic sore throat. According to Seifert,17Formamint is a chemical combination of formaldehyd and milk sugar. When the tablets are dissolved in the saliva, 0.01 per cent. of formaldehyd in its “status nascendi” is liberated and exercises a strong disinfectant action. Seifert states that the preparation is markedly palatable, since it contains a little citric acid to render the taste cool and refreshing. In some experiments with streptococci, pneumococci, typhoid and diphtheria bacilli, Seifert found that a solution of one tablet in 10 c.c. of water destroyed these germs in from five to ten minutes. A solution of the same strength was also added to culture tubes of broth, agar, and gelatin, with the result that no growth occurred in them, while distinct and characteristicdevelopment of the bacteria took place in control tubes. He does not state, however, how much Formamint solution was added to the mediums.
Daus18reports successful treatment of tonsillitis, mumps and middle ear diseases. In these cases no other gargles or mouth washes were used. He states that no indication of irritant or other injurious action made its appearance even after large doses. In the same article, F. Levy reports experiments as follows: Agar plates were prepared with a culture of streptococcus from a severe case of quinsy. One half of the plate was rubbed with saliva containing Formamint in solution. (The strength of the solution used is not given.) In twenty-four hours streaks of growth had appeared on one portion of the plates while the part on which the Formamint saliva had been rubbed remained sterile. Daus also found that agar and broth cultures of streptococcus shaken with Formamint saliva remained sterile.
Rheinboldt,19investigating the effects of Formamint and of ordinary formaldehyd on animals, concludes that formaldehyd is toxic in action while Formamint is not.
How the exploiters of Formamint capitalize the medical profession. Miniature reproductions of typical Formamint advertisements appearing in the newspapers.
How the exploiters of Formamint capitalize the medical profession. Miniature reproductions of typical Formamint advertisements appearing in the newspapers.
Rosenberg20corroborates this statement. He also found that agar plates ofBacillus prodigiosuswere killed by Formamint solutions in about four hours. He fails, however, to give the strength of his Formamint solutions.
Wingrave21suggests the use of Formamint for infants! He recommends that a tablet be crushed and wrapped in “butter cloth.” The ends of the cloth are to be tied with thread, the Formamint is to be moistened, and the packet is to be held in the mouth of the baby several times each day.
Young22published the results of some experiments by himself and Delépine on the human throat. They dissolved a tablet in the mouth and made swab cultures with the following results:
Immediately after taking the tablet0 colonies10 minutes after taking the tablet35 colonies30 minutes after taking the tablet150 colonies
Immediately after taking the tablet
10 minutes after taking the tablet
30 minutes after taking the tablet
They found no staphylococci at any time. Other results of swabbing various parts of the throat before and after the use of Formamint, reported by these investigators, show enormous reductions in the count, claimed to be due to the action of Formamint. The count was made on agar at 37 C., but they fail to state the time elapsing between taking the Formamint and making the swab.Young also reports favorable clinical results in cases of scarlet fever, diphtheria, sore throat, and the like. It must be noted, however, that they state that the mouth and fauces must first be thoroughly cleansed by swabbing and douching before Formamint is used.
The claims made in the advertising literature of Formamint are very extravagant. Many are highly improbable. These statements will be discussed later.
The statement is made that Formamint is a new chemical compound:
“Formamint is Pentamethanallactose, 5 CHOH + C12H22O11. It is an original combination of Formaldehyde with Lactose, a definite chemical compound. The Formaldehyde molecule is locked up in it until solution in the saliva takes place, when the Formaldehyde is liberated in itsnascentstate and is therefore active without being irritant.”
“Formamint is Pentamethanallactose, 5 CHOH + C12H22O11. It is an original combination of Formaldehyde with Lactose, a definite chemical compound. The Formaldehyde molecule is locked up in it until solution in the saliva takes place, when the Formaldehyde is liberated in itsnascentstate and is therefore active without being irritant.”
Furthermore the makers contend that this new chemical compound is entirely harmless. For example, Daus,18in an article on “The Disinfectant Action of Formic Aldehyde on Mucous Membranes,” declares:
“No indication of irritant or other injurious action made its appearance even after large doses. The urine remained free from albumin and sugar.”
“No indication of irritant or other injurious action made its appearance even after large doses. The urine remained free from albumin and sugar.”
Such statements as these are found in the advertising literature:
“Formamint tablets are absolutely harmless and innocuous, even to little children.”“When dissolved in the saliva, Formamint Tablets liberate slowly Nascent Formaldehyde in a most active yet non-irritant form.”
“Formamint tablets are absolutely harmless and innocuous, even to little children.”
“When dissolved in the saliva, Formamint Tablets liberate slowly Nascent Formaldehyde in a most active yet non-irritant form.”
They maintain that Formamint is not only absolutely harmless, but actually beneficial to the tissues. It may be used “to tone up and strengthen the tissues, prevent hoarseness, and allay irritation in singers, public speakers,” etc.
The claims urged as to its germicidal power are indeed glittering. This “new chemical compound” is claimed to liberate formaldehyd in some new and peculiar condition which, while it has a soothing and tonic effect on the cells of the human tissues, can at the same time quickly kill any form of bacterial life.
“Dissolving readily, it releases its germicidal, antiseptic qualities, which impregnate the saliva and are carried naturally and easily around the mouth and in the deepest crevices of the throat—destroying the germs where they are causing the mischief. Formamint prevents and destroys infectious germ life in a soothing grateful way.”“In the saliva it frees a germicide, fatal to germs but harmless to the most delicate membranes. And flowing into every tiny corner of the gums, tonsils and throat, into places where no gargle ever reaches, it most effectivelydisinfectsthe throat.”
“Dissolving readily, it releases its germicidal, antiseptic qualities, which impregnate the saliva and are carried naturally and easily around the mouth and in the deepest crevices of the throat—destroying the germs where they are causing the mischief. Formamint prevents and destroys infectious germ life in a soothing grateful way.”
“In the saliva it frees a germicide, fatal to germs but harmless to the most delicate membranes. And flowing into every tiny corner of the gums, tonsils and throat, into places where no gargle ever reaches, it most effectivelydisinfectsthe throat.”
The claims as to the preventive and curative effects of the preparation cover a large portion of the category of human ailments and distresses. The following quotations indicate some of its supposed properties:
“... it is therefore self-evident that Formamint should be looked upon as a necessary part of the treatment of all forms of tonsillitis.”“The value of Formamint is equally great in diphtheric tonsillitis, or as a prophylactic...”“The extraordinary success which I had with Formamint in a school epidemic of scarlet fever during May and June, 1907, was the determining factor which induced me to abandon the use of inhalations, gargles, local applications in the treatment of diseases of the throat, and to use Formamint exclusively for the future.”“There are naturally many similar conditions in which Formamint may be used as a prophylactic, notably scarlet fever, mumps, streptococcal and staphylococcal sore throats, ‘milk outbreaks’ of sore throat, drain throats, hospital throats, and the like.”“Formamint Tablets are indicated in Angina, Tonsillitis, Pharyngitis, Stomatitis, Gingivitis, Glossitis, ulceration, spongy or bleeding gums, Pyorrhea Alveolaris, ‘Smoker’s Sore Throat,’ Abscess or Boils, etc.”“As aProphylacticagainst Diphtheria, Scarlet Fever, Influenza, Measles, Epidemic poliomyelitis, and other pathogenic micro-organisms. To neutralize putrefaction products in and about the teeth, correct fermentative processes, deodorize and purify the breath, etc.”“Totone up, andstrengthenthe tissues, preventhoarsenessandallay irritationin singers, public speakers, neutralize the effects of dust-infection ordisinfect the saliva or sputumin Influenza, Tuberculosis, etc.”
“... it is therefore self-evident that Formamint should be looked upon as a necessary part of the treatment of all forms of tonsillitis.”
“The value of Formamint is equally great in diphtheric tonsillitis, or as a prophylactic...”
“The extraordinary success which I had with Formamint in a school epidemic of scarlet fever during May and June, 1907, was the determining factor which induced me to abandon the use of inhalations, gargles, local applications in the treatment of diseases of the throat, and to use Formamint exclusively for the future.”
“There are naturally many similar conditions in which Formamint may be used as a prophylactic, notably scarlet fever, mumps, streptococcal and staphylococcal sore throats, ‘milk outbreaks’ of sore throat, drain throats, hospital throats, and the like.”
“Formamint Tablets are indicated in Angina, Tonsillitis, Pharyngitis, Stomatitis, Gingivitis, Glossitis, ulceration, spongy or bleeding gums, Pyorrhea Alveolaris, ‘Smoker’s Sore Throat,’ Abscess or Boils, etc.”
“As aProphylacticagainst Diphtheria, Scarlet Fever, Influenza, Measles, Epidemic poliomyelitis, and other pathogenic micro-organisms. To neutralize putrefaction products in and about the teeth, correct fermentative processes, deodorize and purify the breath, etc.”
“Totone up, andstrengthenthe tissues, preventhoarsenessandallay irritationin singers, public speakers, neutralize the effects of dust-infection ordisinfect the saliva or sputumin Influenza, Tuberculosis, etc.”
One man declares that along with specific constitutional treatment he “had the best results from the use of Formamint tablets” in a case of syphilitic ulceration of the tongue.
In short, Formamint is recommended for the treatment or prevention of almost everything, from a bad breath to such grave conditions as scarlet fever, diphtheria and tuberculosis, conditions in which a delay in proper treatment—for instance, in diphtheria, a failure to administer antitoxin—may result in the death of the patient.
A series of investigations was therefore undertaken in order to discover whether the extravagant claims regarding the germicidal power of Formamint could be verified.
Two fifty-cent bottles of Wulfing’s Formamint were purchased in the open market and were kept well stoppered to prevent deterioration.
Qualitative tests showed the presence of formaldehyd and the amount was determined quantitatively by the hydrogen peroxid method as given by Sutton.23The results were respectively, 1.99 per cent. and 2.03 per cent. of formaldehyd.
Two Formamint advertisements reproduced in miniature typical of those appearing in a certain type of medical journals.
Two Formamint advertisements reproduced in miniature typical of those appearing in a certain type of medical journals.
Some determinations were made of the germicidal power of Formamint in vitro, that is, under controlled laboratory conditions. A twenty-four-hour plain agar culture ofStaphylococcus aureuswas washed off in 10 c.c. of sterile 0.85 per cent. sodium chlorid solution. A 1:100,000 dilution of this was made in each of three flasks containing 100 c.c. of sterile saliva. Flask 1 contained 1 per cent. of Formamint, Flask 2, 5 per cent.; Flask 3, containing no Formamint, was kept as a control. At intervals samples were removed and dilutions made and plated in duplicate on standard agar. The plates were incubated twenty-four hours at 37 C., and plates containing less than 200 colonies were counted. The results are given in Table 1. After seven days there was no appreciable difference in the plates.
TABLE 1.—SHOWING TIME IN WHICH CULTURES OF STAPHYLOCOCCUS AUREUS WERE KILLEDBY DIFFERENT AMOUNTS OF FORMAMINT
Amount of Formamint in Saliva (Per Cent.)Period of Standing at 37 C. (Hours)Average Count When PlatedCount on Flask of Saliva Without Formamint13323200*1607000*51Few5000*5204100*5303200*5607000*
* The last two observations were made at the same time as on the 1 per cent. solutions.
Another test was made by adding a 1 per cent. Formamint solution to plain agar plates inoculated withB. coli. A twenty-four-hour plain agar culture ofB. coliwas washed off in 10 c.c. of sterile 0.85 per cent. sodium chlorid solution. A 1:1,000,000 dilution was made of this and 1 c.c. added to each plate. Varying amounts of 1 per cent. solution of Formamint were added to each plate. They were incubated seventy-two hours at 37 C. After seven days’ incubation the count was the same. The results are given in Table 2.
TABLE 2.—COUNT OF B. COLI CULTURES WITH DIFFERENT AMOUNTS OF FORMAMINT
No. c.c. of 1 per cent. Formamint00.10.30.50.71.01.52.03.0Count1603339261512200
No. c.c. of 1 per cent. Formamint
Count
Another experiment was made thus: One loopful of a twenty-four-hour plain agar culture ofStreptococcus lacticuswas mixed with a tube of North medium. One loopful from the inoculated tube was mixed with a second tube of North medium. Both tubes were poured into Petri dishes and allowed to cool. One half of each plate was well smeared with a 10 per cent. solution ofFormamint in saliva. After twenty-four hours’ incubation at 37 C., only a few colonies appeared on the side to which the Formamint had been applied, while the other half was thickly covered with colonies.
This work so far corroborates that reported in the literature quoted by the manufacturers. But the fact that a compound is a germicide when brought into intimate contact with bacteria in a solution or medium in a test tube or flask does not prove that it will be effective when used in the human throat.
An attempt was made to discover whether or not the claims advanced by the manufacturers as to the perfect germicidal action of Formamint in all the nooks and crannies of the mouth and throat could be confirmed.
The first step in attacking this problem was to make comparative counts of the number of bacteria in the throat before and after the use of Formamint. The methods employed were as follows: The throat was gargled with 50 c.c. of sterile 0.85 per cent. sodium chlorid solution. In each case the same length of time, as far as possible, was used in the process. The liquid was collected in a sterile flask. The gargling in a series of experiments was begun not less than two hours after a meal. After some preliminary work the following dilutions of the 50 c.c. of salt solution were found sufficient: 1:1,000, 1:10,000 and 1:100,000. Plates were made in duplicate from each dilution and incubated seventy-two hours at 37 C. The counts were made on plates containing less than 200 colonies. Except where otherwise noted standard agar was used. The mediums were always prepared in the same way.
All the work was carried out under conditions as nearly natural as possible. The Formamint was taken according to the directions accompanying the trade package. Every opportunity was given the Formamint to penetrate all the crypts and recesses about the mouth and throat. The tablet was allowed to dissolve as slowly as possible, the time usually being five to six minutes, and saliva was thoroughly forced around the mouth before being swallowed. Plating was always done immediately after gargling so that no growth could occur in the salt solution. The results are given in Table 3. The numbers are average counts from several plates and calculated to show the number of bacteria washed out by the 50 c.c. of salt solution.
TABLE 3.—SHOWING THAT FORMAMINT DOES NOT GREATLY DECREASE THE NUMBEROF BACTERIA IN THE THROAT
Conditions of TestTime SincePrecedingTestAmount ofFormamintUsedNo. Foundin ThroatBefore Use ofFormamintNo. Foundin ThroatAfter Use ofFormamintNormal...015,600,000...Normal1 hour038,500,000...Normal1 hour030,500,000...Normal...012,500,000...Normal1 hour014,500,000...1 hour023,500,000...Tablet dissolved in mouth and throat gargled one hour later6 days1 tablet...15,000,000Throat again gargled two hours after Formamint was used1 hour0...10,050,000Normal7 days062,000,000...Normal1 hour072,500,000...Normal......61,000,000...Tablets were taken, one per hour, and throat gargled one hour after last tablet was taken2 days12...39,100,000Throat was again gargled 2 hours after taking last tablet1 hour0...59,000,000Normal5 days035,000,000...Normal1 hour062,000,000...Normal1 hour072,000,000...One tablet was taken each half hour for twelve hours consecutively. Throat was gargled one hour after last tablet was taken4 days24 tablets...175,000,000Throat was again gargled two hours after last tablet was taken1 hour0...168,750,000Normal3 days0129,600,000...Normal1 hour0177,000,000...Normal1 hour0147,000,000...Normal3 days079,000,000...One tablet was taken immediately after preceding gargle. Throat was again gargled at end of one hour1 hour1...83,200,000Throat was again gargled two hours after tablet was taken1 hour0...134,750,000Normal conditions except that mouth and teeth were throughly washed with soap just before gargling19 days032,600,000...Same as above1 hour033,125,000...Same as above1 hour040,375,000...Teeth were not washed. Otherwise normal conditions2 days033,500,000...Same as above1 hour043,330,000...Same as above1 hour054,000,000...Same as above1 hour050,000,000...Same as above1 hour067,000,000...Mouth and teeth thoroughly washed with soap just before throat was gargled2 days05,270,000...Same as above1 hour010,916,000...Same as above1 hour08,275,000...Normal conditions, but 1 c.c. of sterile rabbit’s blood was added to each plate3 days0228,750,000...Count from the same gargle as above. No blood used in the plates0060,625,000...Normal conditions, but count was made on blood agar1 hour0431,250,000...Count from the same gargle as above. No blood used in the plates0059,625,000...Normal conditions, count was made on blood agar2 days0683,300,000...Same gargle as above, but count was made on plain agar0058,500,000...One tablet was taken just after preceding gargle. After one hour throat was again gargled. Count on blood agar1 hour1 tablet...558,300,000Same gargle as above, but count was made on plain agar01 tablet...55,875,000Normal conditions2 days079,125,000...One tablet was taken just ten minutes before gargle was made1 hour16 min.1 tablet...56,250,000Normal conditions2 days046,750,000...One tablet was taken just ten minutes before throat was gargled1 hour1 tablet...38,500,000Teeth and mouth were thoroughly washed with soap just before gargle was made5 days047,370,000...Teeth washed as above and one tablet taken ten minutes before gargle was made1 hour1 tablet...21,225,000
Normal
Normal
Normal
Normal
Normal
Normal
Normal
Normal
Normal
Normal
Normal
Normal
Normal
Normal
Normal
Same as above
Same as above
Same as above
Same as above
Same as above
Same as above
Same as above
Same as above
Normal conditions
Normal conditions
Finally a determination was made of the number of streptococci in the throat before and after the use of Formamint. The throat was gargled in the manner previously described. The streptococcus count was made by the dilution method as given by Heinemann.24Culture tubes were used instead of fermentation tubes. One per cent. dextrose broth was the medium employed. One cubic centimeter was added to each of a series of ten tubes for each dilution and the following dilutions were used: 1:10,000, 1:100,000 and 1:1,000,000.
The results given in Table 4 are the average count from a number of dilutions and are reported as the total number washed out by the 50 c.c. of salt solution.
TABLE 4.—SHOWING THAT FORMAMINT FAILS TO REDUCE THE NUMBEROF STREPTOCOCCI IN THE THROAT
Conditions of TestTime SincePrecedingTestAmount ofFormamintUsedNo. Foundin ThroatBefore Use ofFormamintNo. Foundin ThroatAfter Use ofFormamintNormal...01,200,000...One tablet was taken and throat gargled one hour later4 days1 tablet...14,750,000Normal3 days09,950,000...One tablet was taken and throat gargled ten minutes later1 hour1 tablet...8,000,000
Normal
Normal
The contention that Formamint contains formaldehyd was confirmed by analysis.
The manufacturers also maintain that Formamint is a new, definite chemical compound, consisting of five molecules of formaldehyd and one molecule of lactose, and that when dissolved in the saliva the formaldehyd is liberated in some new and peculiar form, which they call nascent formaldehyd. This new kind of formaldehyd is, according to the advertising literature, especially powerful in its germicidal properties and at the same time has absolutely no irritating or harmful effects.
Thoms,25retained as an expert by the German government, decided, after a series of chemical investigations, that Formamint was not a definite chemical compound, but that it was probably a solid solution of formaldehyd in lactose. He proved that when the process of manufacture was carried out in exactly the way called for by the Formamint patents, compounds containing a greater or less per cent. of formaldehyd could be made while the other properties remained similar to those of Formamint. The composition of the final product depended on the proportion of the components used in the process. Therefore Formamint did not form a safe means of uniform dosage.
As a result of Thoms’ work the German courts held that Formamint was not a new chemical compound. Consequently the Formamint patent (Number 189036) was annulled in Berlin, Nov. 29, 1913.
Again the contention that formaldehyd in the nascent or active condition is less poisonous and irritating than in its ordinary form is contrary to what would be expected from the behavior of such compounds. If it were liberated, as claimed, in the “nascent” condition, it would be, for that very reason, not only more active but also more harmful.
As a matter of fact, Formamint did have an irritant effect on the worker who carried out these investigations. When one tablet was taken each hour for twelve consecutive hours, marked irritation of the intestinal tract resulted. There was almost sufficient nausea to cause vomiting and uneasiness in the alimentary canal following the experiment. When the twenty-four tablets were taken the results were similar but more pronounced. This is decidedly in contradiction to the assertions of the manufacturers.
Otto Seifert,26moreover, cites the following: