milk--are unknown to science. Yet medical publications give space
to advertisements of a proprietary--“Nutrolactis”--which is said to
increase the milk supply of nursing mothers. Since dependence on
a preparation of this kind is likely to cause neglect of the only
means of increasing a scanty milk supply of nursing mothers--care of
the general health and a sufficient quantity of proper food--this
proprietary and the drug “goat’s rue,” (_Galega officinalis_) which the
proprietors hint as being the potent constituent, were subjected to a
critical study to determine their possible influence on milk secretion.
For this purpose the Council secured the help of A. J. Carlson, Ph.D.,
professor of physiology, University of Chicago. Dr. Carlson, with
the aid of A. Woelfel, M.D., and Marian Lewis, Sc.M., undertook to
estimate the effect of Nutrolactis and of goat’s rue on nursing dogs
and goats with the intention of extending the study to nursing mothers
if the animal experiments so warranted. The contribution, “The Alleged
Galactagogue Action of Galega and Nutrolactis,” by Marian Lewis and
A. J. Carlson from the Hull Physiological Laboratory of the University
of Chicago, which appears below, shows that Nutrolactis and goat’s rue
are without influence on the milk secretion in nursing animals.
The Council endorsed the work of Lewis and Carlson and held that the
claimed galactagogue effects of Nutrolactis and goat’s rue are not
substantiated.
W. A. Puckner, Secretary.
THE ALLEGED GALACTAGOGUE ACTION OF GALEGA AND NUTROLACTIS[D]
Marian Lewis, Sc.M., and A. J. Carlson, Ph.D.
CHICAGO
[D] From the Hull Physiological Laboratory of the University of Chicago.
[D] This investigation was begun in 1915 by Drs. A. Woelfel and A. J.
Carlson.
It is well established that the food best adapted to the energy and
growth requirements of the infant is normal mother’s milk. Any decrease
in quantity or deterioration in quality of the maternal secretion is
soon followed by a parallel impairment of growth, loss of weight,
or lowered resistance to infection in the infant. The widespread
occurrence of deficient milk secretion is a matter of common knowledge.
The discovery of true lactagogues, or specific substances which
increase the quantity and quality of the milk on being administered to
nursing mothers, would therefore be of very great importance. In view
of this great medical and economic interest in true lactagogues it is
not surprising to find that the medical and biologic literature records
discoveries of lactagogues based on hope rather than demonstration, and
that spurious lactagogues are on the market.
Some of the factors known to affect milk secretion are general health,
food supply, psychic state, and heredity. The mechanism of secretion
and the method by which these factors affect it are imperfectly
understood. In general it has been observed that milk yield improves
both in quantity and in quality with improvement in general health,
better food supply, and more favorable psychic state. The influence of
heredity is taken advantage of by dairymen who are well acquainted with
the potential milk production of the different breeds of cattle.
Among the substances which have been reported to stimulate milk
secretion may be mentioned the extract of the posterior lobe of the
hypophysis. But pituitary extract is not a true lactagogue, because
its action is confined to the smooth musculature of the gland ducts,
causing a more or less complete ejection of the milk already formed;
it has no effect on the gland cells or the actual secretory process in
the direction of increasing the milk yield. Extracts of thymus, corpus
luteum, ovaries, uterus, placenta, fetus, and the mammary gland itself
have also been reported to have a temporary stimulating effect on the
quantity of milk secreted, but when these extracts are given by mouth
they are apparently without specific influence on the mammary gland.
Galega, or goat’s rue (_Galega officinalis_), is an herb described in
the National Formulary as being slightly bitter and astringent. In
1873, Gillet-Damotti,[112] in a communication to the French Academy,
stated that this plant when fed to cows increases the secretion of
milk from 35 to 50 per cent. Other French writers have affirmed that
goat’s rue is a lactagogue. In Germany, Fragner[113] made a preparation
called Galegal, using galega as the active principle and combining it
with lactose to give it a pleasant taste and make it soluble in water,
milk, coffee, and tea. This preparation was reported on favorably
by Scherer,[114] who asserts that he obtained positive results in
fifty-four of the eighty cases in which he used it.
[112] Gillet-Damotti: Comp. rend. Acad. d. Sc., July 7, 1873.
[113] Fragner: Wien. med. Wchnschr. =60=:1033-1036, 1910.
[114] Scherer: Wien. med. Wchnschr. =60=:1033-1036, 1910.
More recently Huët[115] tested the effects of Theinhardt’s Hygiama
lactogene on four lactating women. This preparation is said to be
composed of hygiama,[116] galega and anise. Analysis showed that it
contains albumins, fat, soluble and insoluble carbohydrates, salts
and water. Huët could not observe any influence from the use of this
preparation, either on the quantity or on the composition of the milk
secreted.
[115] Huët: Nederlandsch Tijdschr. v. Geneesk. =1=:1353-1370, 1914.
[116] Hygiama is said to be a food consisting of condensed milk, with
(fatless) cocoa and cereals added to it (Encyclopedia and Dictionary of
Medicine and Surgery, 1907).
Nutrolactis[117] is a commercial preparation sold by the Nutrolactis
Company of New York at $1 a bottle. The label states that it contains
5 per cent. of alcohol; that it contains fluid extracts of the family
of “galactagogic plants,” and that it is intended to “increase the
supply of mother’s milk.” It is recommended to maintain “quality and
quantity until the end of normal lactation.” Nutrolactis is also
recommended for a mother debilitated by lactation. It is claimed that
“Nutrolactis does not _force_ the secretion of milk but merely assists
such secretion.” Years ago Millbank[118] reported good results from the
use of Nutrolactis. After more than a year’s use he concluded that it
was more satisfactory than any other lactagogue hitherto employed by
him, which is not saying very much, as specific lactagogues are as yet
unknown. Nutrolactis is still (1916) extensively advertised in various
medical journals as a lactagogue.
[117] The North Dakota Agricultural Experiment Station has recently
published (Bulletin 22, 1915, p. 386) a complete chemical analysis
of Nutrolactis. It contains only 0.60 per cent. solids (including
strychnin and emodin). It has a bitter taste. The alcohol content was
3.5 per cent. The report concludes: “a little strychnin, a little
alcohol, and a little laxative is about all there is to cause an
increase in the milk secretion.”
[118] Millbank: New York M. J. =50=:544, 1889.
METHODS OF INVESTIGATION
The alleged lactagogue action of galega and Nutrolactis was tested
on lactating dogs and goats. In these animals the psychic factors,
or suggestion, are largely eliminated. If the results had been
positive or had indicated lactagogue action, the test would have been
extended to nursing women. The puppies and kids were weighed before
and after nursing and a record kept of the amount of milk obtained at
each nursing (the animals nursing from three to five times daily).
The mothers were fed with varying doses of the drugs, and the milk
yield compared with that of a control period during which no drugs
were administered. An effort was made to keep the conditions of the
experiments uniform throughout.
The galega was ground and mixed with the food. The Nutrolactis was
mixed with food given by the stomach tube, or in some cases with a
spoon. Galega was tested on two goats and Nutrolactis on one goat and
nine dogs. The results are given herewith:
GALEGA
_Goat 1_: Control period, 1,600 gm., milk av. daily yield for 7 days.
Galega period (30 gm. galega mixed with oats), 860 gm., milk av.
daily yield for 8 days. Kids weaned at end of period.
_Goat 2_: Control period, 1,161 gm. milk av. daily yield for 9 days.
Galega period (30 gm. galega mixed with oats), 860 gm. milk av. daily
yield for 8 days. (25 gm. galega in same way), 810 gm. milk av. daily
yield for 10 days.
Control period, 896 gm. milk av. daily yield for 6 days.
NUTROLACTIS
_Goat 3_: Control period, 896 gm. milk av. daily yield for 6 days.
Nutrolactis period (30 c.c. Nutrolactis mixed with oats), 658 gm.
milk av. daily yield for 9 days.
Control period, 666 gm. milk av. daily yield for 5 days.
_Dog 1_: Control period, 176 gm. milk av. daily yield for 7 days.
Nutrolactis period (8 c.c. Nutrolactis by stomach tube), 55 gm. milk
av. daily yield for 12 days.
_Dog 2_: Control period, 189 gm. milk av. daily yield for 6 days.
Nutrolactis period (8 c.c. Nutrolactis by stomach tube), 72 gm. milk
av. daily yield for 11 days.
_Dog 3_: Control period, 93 gm. milk av. daily yield for 8 days.
Nutrolactis period (8 c.c. Nutrolactis on bread), 17 gm. milk av.
daily yield for 5 days.
_Dog 4_: Control period, 28 gm. milk av. daily yield for 7 days.
Nutrolactis period (8 c.c. Nutrolactis by stomach tube), 47 gm. milk
av. daily yield for 6 days.
(10 c.c. Nutrolactis by stomach tube), 43 gm. milk av. daily yield
for 8 days.
Control period, 41.5 gm. milk av. daily yield for 6 days.
Nutrolactis period (10 c.c. Nutrolactis by stomach tube), 33.5 gm.
milk av. daily yield for 4 days.
_Dog 5_: Control period, 67 gm. milk av. daily yield for 6 days.
Nutrolactis period (10 c.c. Nutrolactis on bread), 81 gm. milk av.
daily yield for 6 days.
_Dog 6_: Control period, 40 gm. milk av. daily yield for 5 days.
Nutrolactis period (10 c.c. Nutrolactis by stomach tube), 33 gm. milk
av. daily yield for 8 days.
Control period, 26 gm. milk av. daily yield for 4 days.
_Dog 7_: Control period, 283 gm. milk av. daily yield for 9 days.
Nutrolactis period (10 c.c. Nutrolactis by stomach tube), 155 gm.
milk av. daily yield for 15 days.
(15 c.c. Nutrolactis by stomach tube), 82 gm. milk av. daily yield
for 6 days.
Control period, 33 gm. milk av. daily yield for 3 days.
_Dog 8_: Control period, 238 gm. milk av. daily yield for 8 days.
Nutrolactis period (20 c.c. Nutrolactis on bread), 223 gm. milk av.
daily yield for 4 days.
(20 c.c. Nutrolactis on bread), 46 gm. milk av. daily yield for 6
days.
_Dog 9_: Control period, 223 gm. milk av. daily yield for 6 days.
Nutrolactis period (10 c.c. Nutrolactis on bread), 178 gm. milk av.
daily yield for 15 days.
(15 c.c. Nutrolactis on bread), 146 gm. milk av. daily yield for 5
days.
COMMENT AND CONCLUSION
Goat 1 had already been lactating for over two months, and the yield
was gradually decreasing at the time the observations were begun. The
administration of galega did not check this decrease. Goat 2 should
have been a very favorable subject, for the kid was about a week old
at the time the observations were begun. Both galega and Nutrolactis
caused a decrease in milk yield of this animal. This decrease is
perhaps partly due to the animal’s distaste for the drugs and her
consequent failure to eat as well as during the control periods.
Administration of Nutrolactis was accompanied by an increase in milk
in only two animals, Dog 4 and Dog 5. A detailed examination of the
records of these two dogs shows that in both cases _there was a
progressive increase in milk yield during the control period_ and that
administration of the drug failed to accelerate this increase. On the
contrary, the curve for Dog 5 takes a sudden drop immediately after the
first administration of the drug.
The records of Dogs 6 and 7 show that the yield during the second
control period is lower than that of the preceding periods. Although
the administration of the drug in both cases was followed by a decrease
in the yield, it may be urged that the drug has some lactagogue action,
for its discontinuance was followed by a decrease in yield. This
effect, however, is also apparent rather than real, for the data show a
gradual falling off in yield during the period of administration of the
drug, which decrease was not accelerated by withdrawing the drug.
Our data show that galega and Nutrolactis, when taken by mouth,
and the elements of suggestion excluded, had no beneficial effect
on lactation--at least in so far as the quantity of milk is
concerned.--(_From The Journal A. M. A., May 26, 1917._)
THE RUSSELL EMULSION AND THE RUSSELL PREPARED GREEN BONE
Report of the Council on Pharmacy and Chemistry
The following report on “The Russell Emulsion” and “The Russell
Prepared Green Bone,” marketed by the Standard Emulsion Company, was
submitted to the Council by a referee. The Council endorsed the report
and authorized its publication.
W. A. Puckner, Secretary.
The Russell Emulsion is put up in a neat package and advertised in an
attractive pamphlet, on the cover of which we are told: “Truth Always
Justifies The Superlative Degree.” As what follows in the booklet and
in the printed circulars certainly does not lack superlatives, this is
doubtless a warning.
In addition to the pamphlet and circular advertising, the product seems
to be systematically boomed by a lecture scheme in which one Dr. Hague
talks before medical societies and distributes advertising matter.
The lecture is succeeded by a follow-up letter scheme through which
matter is sent to members of the society. Hague ostensibly discusses
“lime starvation in tuberculosis,” but medical societies soon learned
to estimate his work as essentially to advertise the Russell products.
Last April the Medical Society of the State of Pennsylvania sent out
a circular letter to its county organizations on the subject of the
Russell-Hague propaganda which opens in this way:
“You have doubtless received a letter from Dr. William Grant Hague of
New York, offering to address your county society on Tuberculosis.
After due investigation, it is respectfully suggested that it may not
be desirable to ask him to address your society....”
The statements in the pamphlet and circular published are typical of
the whole method of exploitation. For example, can such claims as these
be surpassed by the veriest quack?
“SCIENCE cannot improve the means employed in producing THE RUSSELL
EMULSION.”
“GENIUS has not devised better methods than are used in
manufacturing THE RUSSELL EMULSION.”
“MONEY cannot buy better products than are used in THE RUSSELL
EMULSION.”
“EXPERIENCE cannot suggest a more nutritious combination of fats
than we use in THE RUSSELL EMULSION.”
The emulsion is said to be made of equal parts of beef-fat, coconut,
peanut and cottonseed oils, held in suspension by albumin. The latter
we are told is applied to each globule of the emulsion by an “elaborate
technical process” devised by Dr. Russell. The mixture is everywhere
spoken of as a “physiological” emulsion, but the word is always in
quotation marks. Why it is called “physiological” is not clear, but the
term may be counted on to impress the unthinking or the unscientific.
Numerous false and exaggerated statements are made about this
“physiological” emulsion with reference to food value. For instance:
“The nutritional value of fats differ; the nutritional value of
these fats and their increased efficiency by combination over all
others have been determined by extensive clinical observation.”
And also:
“The Russell Emulsion is approximated in food value by no other
emulsion or food product in existence.”
“A ‘physiological’ emulsion is a predigested food. It is absorbed
with little assistance from the digestive juices, and with no waste
of energy. It is, therefore, the ideal food....”
These are sample statements found in the pamphlet and accompanying
circular. A dozen or more pathologic conditions are mentioned in which
this “ideal food” is specifically indicated; but we find, also, this
curious statement: “Patients can rarely take this dose [speaking of the
maximum dose of 2 ounces night and morning] for more than three or four
weeks without showing symptoms of over-feeding.” This unguarded remark
about an ingestion of 48 grams of fat daily prompts one to ask what is
wrong with the “ideal predigested food.”
Russell is wedded to the idea that “lime starvation” is the main factor
in tuberculosis, and insists on the importance of large amounts of fat
for the “lime starved.”
“Dr. Russell was the original interpreter of the Lime Starved State
and originated The Lime Starvation Treatment in Tuberculosis. He
also first pointed out and emphasized the therapeutic importance of
regarding the combination of lime phosphate and casein, as brought
down by the rennet enzyme, as a chemical union.”
This overworked lime-starvation theory certainly lacks any tangible
confirmation (see in this connection a recent paper by Halverson,
Mohler and Bergeim, in The Journal, May 5, 1917), and to urge it
to promote the sale of a fat preparation is preposterous. On the
uninitiated the exaggerated pseudo-scientific language of the pamphlet
and circular advertisement will probably make some impression.
Unfortunately such things count not only with the layman who, having
no technical knowledge of physiology, cannot be expected to weigh the
evidence but also with those medical men who, while scientifically
educated, are influenced by unscientific claims when plausibly
presented. The pamphlet is a striking example of a style which is
dangerous because it smacks of science.
The Russell Company sells also a mixture called “Prepared Green Bone,”
said to be made by partially digesting ground chicken bones with
hydrochloric acid and pepsin and adding glycerin at the end of the
digestion. The product is a sticky, unappetizing looking mass, put up
in little earthenware boxes and advertised as a lime food, apparently
to go along with the fat emulsion. The greater value of a few glasses
of milk daily is evidently overlooked.
“The Russell Emulsion” and “The Prepared Green Bone” were declared
inadmissible to New and Nonofficial Remedies.
[Editorial Comment.--There are always those who are ready to exploit
the unfortunate tuberculous. It is, unfortunately, a fact that many
physicians accept as true, statements clothed with obscure and
voluminous quasi-scientific verbiage. Such men would laugh at the
bald claim that the moon is made of green cheese; when, however, one
plausibly and with due solemnity, affirms that the nocturnal luminous
earthly satellite is composed of an infinite aggregation of molecules
of bewildering and awe-compelling complexity, built up from the
recently discovered polypeptids, the whole being of a verdant tint, the
person addressed looks impressed and opines that it sounds reasonable!
The advertising for The Russell Emulsion and The Russell Prepared Green
Bone is dangerous because it appeals to the thoughtless--layman and
physician, alike.]--(_From The Journal A. M. A., June 23, 1917._)
BROM-I-PHOS
Report of the Council on Pharmacy and Chemistry
Brom-I-Phos (National Drug Company, Philadelphia) was submitted to the
Council with a label bearing the following statement:
“‘ALCOHOL 25 PER CENT.’
COMPOSITION--Per Fluidounce
Iodin 1 gr.
Bromin 1 gr.
Phosphorus 8-100 gr.
Aromatic Base q. s.”
A request for further information in regard to the composition of
Brom-I-Phos was sent to the National Drug Company. It was suggested
that since the preparation cannot contain the stated amounts of free
bromin, free iodin and free phosphorus, the form of combination in
which these elements are present should be set forth. In reply,
the firm said, first, that “Brom-I-Phos consists of Bromin, Iodin,
Phosphorus, Glycerin, Wine, Water and Volatile Oils. The Iodin is
rubbed up with a small percentage of Potassium Iodid and 95 per cent.
Alcohol, which solution is mixed with a solution of Bromine and
Spirits of Phosphorus which are combined with the base and aromatics.”
The manufacturer also admitted that phosphorus reacts with bromin
and iodin and that other reactions might occur, but maintained that
it was “justified in assuming the greater part, if not all of these
elements, are actually existent in the nascent state,” and asserted
that its “printed formula complies with our working formula in point of
quantities involved as well as existence of elements in an uncombined
state.”
The A. M. A. Chemical Laboratory reported, on the contrary, that
no free phosphorus, free bromin or free iodin could be found in
Brom-I-Phos, and that no bromate or iodate could be found; bromid and
iodid were present. The addition of silver nitrate to an acidulated
portion, diluted with water, gave an amount of silver halid roughly
agreeing with that which would be obtained had the claimed amount of
bromin and iodin (together with some potassium iodid) been used in the
preparation of Brom-I-Phos and in the process of manufacture become
converted to bromid and iodid.
The Council declared Brom-I-Phos inadmissible to New and Nonofficial
Remedies, for conflict with Rules 1, 4, 6, 8 and 10.
The statement of composition is unsatisfactory and misleading in that
it suggests that the preparation contains bromin, iodin and phosphorus
in the free (elementary) state. The presence of the potent elementary
phosphorus is especially suggested by the small amounts of “phosphorus”
declared.
The following statement on the label of the trade package constitutes
an indirect advertisement to the public:
“INDICATIONS: Scrofula, Coryza, Hay Fever Necrosis, Bronchial and
Throat Affections, Catarrhal Pneumonia, Glandular enlargements of
the Spleen, Thyroid, and Lymphatics, Rickets and Syphilis.”
The following claims are therapeutic exaggerations:
“The Ideal Alterative”
“... indicated in all cases where an alterative is desired ...”
“The association of Bromin with Iodin in Brom-I-Phos materially
enhances the product in the treatment of chronic affections of
the skin, depraved conditions of the mucous membranes, tertiary
syphilis, glandular enlargements, etc.”
In that it suggests that the phosphorus in Brom-I-Phos is more readily
assimilated than ordinary phosphate, the following is misleading:
“The Phosphorus contained in Brom-I-Phos is readily assimilated and
at once acts as a nutrient to the nervous and osseous structures of
the body, stimulates metabolism and increases mental activity.”
The recommendation: “Your specification of Brom-I-Phos in the
treatment of Syphilitic cases will immediately prove beneficial to the
patient” is not supported by evidence. The name does not indicate that
Brom-I-Phos is an alcoholic preparation with iodid as its essential
constituent, but suggests that phosphorus is an important constituent,
whereas the amount of phosphate or phosphite, produced by the action
of iodin on elementary phosphorus (if the amount of phosphorus used in
making the preparation is correctly stated) is insignificant.
The combination of bromin, iodin and phosphorus, or bromid, iodid and
phosphate, is irrational because these elements are not of mutual
assistance to each other in the conditions for which Brom-I-Phos is
advertised.
The Council’s report was submitted to the manufacturer of Brom-I-Phos
for comment; the reply contained nothing to permit a revision of the
previous conclusions.
The Council declared Brom-I-Phos inadmissible to New and Nonofficial
Remedies.--(_From The Journal A. M. A., June 30, 1917._)
CREOSOTE-DELSON AND CREOFOS
Report of the Council on Pharmacy and Chemistry
Creosote-Delson and Creofos, or Creosote with Hypophosphites,
were submitted by the Delson Chemical Co., Inc., New York City.
Creosote-Delson is said to be “beechwood creosote from which
the irritating and caustic properties are removed by fractional
distillation.” It is claimed that Creofos contains “2 grains of
Creosote-Delson and 3-3/5 grains of the combined Hypophosphites in each
fluidrachm of the mixture or emulsion, the lime salt predominating.”
It is also claimed that “the primary object of the hypophosphites in
this preparation is that of maintaining the refined creosote in a
pure, unoxidized state, and that no particular claim for therapeutic
action on their part is advanced.” It is explained further, however,
“the addition of the lime was prompted by the belief ... that the
fundamental cause of pulmonary tuberculosis is lime starvation....”
The assertions are made that Creosote-Delson is superior to the
official creosote because it can be taken “abundantly and persistently
without harm to or interference with stomach and kidneys” and can
be “taken uninterruptedly and indefinitely,” while the dosage
is “unlimited by any former knowledge of Creosote Therapy.”
Creosote-Delson is not on the market except in the combination Creofos,
although it is supplied on request.
Creofos is advised in the treatment of tuberculosis, whooping cough,
measles, “Grippe and Colds,” bronchitis, asthma, “Intestinal Affections
(Colitis, Summer Diarrhoea, etc.),” while its use is suggested for the
“prevention of the spread of contagious diseases,” and for “preventing
contagion in minor contagious diseases at any rate, in schools and
families.”
The following advertisement has recently appeared in the _New York
Medical Journal_ and in the _Therapeutic Gazette_:
CREOFOS MEDICATION
is the successful development of the most advanced practice in
the treatment of infectious diseases. It destroys completely the
causative organisms by a bactericide many times more powerful than
phenol, yet absolutely harmless to animal life.
Unlike serums, its activity is not confined to any specific
disease, and its use insures against sequelae (as pneumonia
following grippe).
Especially valuable in the treatment of infants and patients of
delicate constitution and in cases where time is of importance.
The Delson Chemical Co. was requested to supply information regarding
the identity of Creosote-Delson and to support the claim that although
it is “the whole drug” its dosage is “unlimited by any former knowledge
of Creosote Therapy.” The reply was virtually an admission that the
toxic, caustic, phenolic components of creosote were present in
Creosote-Delson just as in the official creosote.
The referee of the Committee on Therapeutics in submitting his report
to the Council pointed out that it is difficult to discuss the
pharmacologic merits of a semisecret preparation, like Creosote-Delson,
claimed to be more acceptable to the human organism than the official
product it is intended to supplant, when the action of the parent drug
is still questioned or disputed by eminent clinicians.
Absorption experiments have been carried out with creosote and creosote
compounds, such as creosote with hypophosphites or calcium or creosote
carbonate, chiefly by a study of the elimination products in the urine.
But any evidence so far offered that these combinations increase
absorption and lessen the irritating, caustic or toxic properties has
been wholly inconclusive. The evidence offered by the Delson Chemical
Co. presented no control experiments with the official creosote and did
not prove that either Creosote-Delson or Creofos was less toxic than a
corresponding amount of ordinary beechwood creosote.
The referee concluded that no proof had been offered that these
preparations are materially superior to ordinary creosote preparations
from the pharmacologic or therapeutic standpoint, and that the claims
made for Creosote-Delson and Creofos are unwarranted in the light of
our knowledge of the properties of creosote. The advertisement quoted
above is an example of unproved and unwarranted claims.
On the recommendation of the referee, the Council declared
Creosote-Delson and Creofos inadmissible to New and Nonofficial
Remedies, for conflict with the rules as follows:
_Creosote-Delson_: The information so far available is not sufficient
to define the nature, or composition, of Creosote-Delson, or to
indicate in how far this product differs, if at all, from the
official creosote (conflict with Rule 1). No methods are furnished
for determining the identity or composition of Creosote-Delson
(conflict with Rule 2). The available information does not show that
Creosote-Delson has advantages over creosote (conflict with Rule 6).
_Creofos_: The composition of Creosote-Delson not having been
furnished, the statement concerning the composition of Creofos is
also unsatisfactory (conflict with Rule 1). The therapeutic claims
are unsubstantiated and grossly exaggerated (conflict with Rule 6).
The name is not descriptive of its composition as is required for
pharmaceutical mixtures (conflict with Rule 8). There is no evidence
that hypophosphites prevent decomposition of creosote (if this
occurs). Hence the inclusion of hypophosphites must be considered
irrational (conflict with Rule 10).
The Council’s report was sent to the Delson Chemical Co. for
consideration. The firm’s reply contained nothing to warrant a revision
of the report, and the Council voted that Creosote-Delson and Creofos
were inadmissible to New and Nonofficial Remedies and authorized the
publication of this report.--(_From The Journal A. M. A., July 7,
1917._)
TRINER’S AMERICAN ELIXIR OF BITTER WINE
Report of the Council on Pharmacy and Chemistry
Triner’s American Elixir of Bitter Wine is a wine to which bitter drugs
and laxatives have been added. Though evidently intended for public
consumption, it is also advertised to physicians, and consequently the
Council publishes this report.
Some recent advertisements read:
“It Acts Well and Is Very Palatable. These are the reasons why so
many physicians recommend TRINER’S AMERICAN ELIXIR OF BITTER WINE.
Free from any chemicals. Prepared from bitter herbs roots and barks
of eminent medicinal value and pure natural red wine. A safe relief
in auto-intoxication, constipation, weakness, etc. Price $1.00. At
drug Stores. Samples gratis upon request only to physicians.”
“A Laxative Tonic. In cases of constipation and its sequelæ,
autointoxication, weakness and nervousness you should try _Triner’s
American Elixir of Bitter Wine_. This preparation consists of
Cascara Sagrada, Dandelion, Gentian Root, with Licorice in Pure Red
Wine as a base, with Aromatics.”
Triner’s American Elixir of Bitter Wine is put up in bottles said to
hold 1 pint, 5-1/3 fluidounces. The label declares the presence of from
16 to 18 per cent. alcohol by volume, and states that “no special tax
is required by the laws of the U. S. for the sale of this medicinal
preparation.” The circular contains the following recommendations for
its use:
“... It should be used in all cases calling for a safe evacuation
of the bowels, without weakening the body or causing any pain or
other discomfort; in loss of appetite, nervousness and weakness.”
“Triner’s American Elixir of Bitter Wine consists of two principal
ingredients, viz., Red Wine and Medicinal Herbs.”
“Red Wine strengthens the intestines and regulates their work. It
also increases the appetite, stimulates and strengthens the body.”
“Use Triner’s American Elixir of Bitter Wine always when a thorough
cleaning out of the intestines is needed. Arrange the dose to suit
your condition and habits.”
“In Chronic Constipation the dose of Triner’s American Elixir of
Bitter Wine should be increased or taken oftener.”
“Many Female Troubles are caused or aggravated by constipation and
ladies should always pay good attention to this fact.”
In addition to Triner’s Elixir of Bitter Wine, the circular--in
English, Polish, Russian, Spanish and other languages--advises the
use of Triner’s Angelica Bitter Tonic, Triner’s Red Pills, Triner’s
Liniment and Triner’s Cough Sedative.
The composition of this “wine”--some bitter drugs, a laxative and a
tannin-containing, constipating red wine--and advertising propaganda
all tend to the continued use of this alcoholic stimulant and thus to
the unconscious formation of a desire for alcoholic stimulation. As
the medical journal advertisements may lead physicians to prescribe
this secret and irrational preparation and thus unconsciously lead to
alcoholism, the Council authorized publication of this report.--(_From
The Journal A. M. A., July 14, 1917._)
TRIMETHOL
Report of the Council on Pharmacy and Chemistry
Trimethol is the trade name for a substance said to be
trimethyl-methoxy-phenol of the formula C₆H(CH₃)₃(OCH₃).OH--1:2:4:5:6,
originated by J. T. Ainslie Walker. It is sold as a nontoxic germicide,
having a Rideal-Walker phenol-coefficient of 40, even in the intestinal
canal. It is described as insoluble in water and not to be decomposed
in the alimentary tract, and to be excreted unchanged in the feces.
Trimethol itself is not obtainable. Pharmaceutical
preparations--Trimethol Syrup, Trimethol Capsules and Trimethol
Tablets, said to contain Trimethol--are prepared by The Walker-Leeming
Laboratories and sold by Thos. Leeming and Co., New York.
Trimethol preparations are advertised for use in all conditions
dependent on intestinal putrefaction. The advertising claims made are
very extensive and some of them give to “Trimethol” the scope of a
panacea. For example:
“Physicians are constantly reporting cases where Trimethol has been
especially efficient, and describing conditions (until recently not
associated with intestinal infection) which have been distinctly
benefited by its use. This would seem to bear out the contentions
of Charcot and Metchnikoff that 90% of all human ailments have
their origin in intestinal infection.
“The careful practitioner, when in doubt, will bear this in mind,
now that we have a really efficient and non-toxic intestinal
germicide--not a mere antiseptic.”
The Walker-Leeming Laboratories have not formally requested the Council
to consider the Trimethol preparations, though in a personal letter to
a member of the Council J. T. Ainslie Walker invited an investigation
of his compound.
For the investigation of Trimethol and its preparation the Council
secured the aid of a bacteriologist who has given much attention to
the study of the intestinal flora. The Walker-Leeming Laboratories and
J. T. Ainslie Walker were both asked to submit details of experimental
studies and also to furnish a supply of the pure “Trimethol.” But the
only data sent that had any definiteness set forth the bacterial counts
made of plate cultures of stools of one patient before and after the
administration of Trimethol Capsules.
REFUSE TO FURNISH TRIMETHOL
The request for the pure substance was refused, on the grounds that the
substance was not used in the undiluted form. The failure to furnish
the chemical substance claimed as the essential constituent of the
Trimethol preparations is to be deprecated if indeed it has not greater
significance. At least it made it impossible for the Council’s expert
to express his results in terms of absolute Trimethol of established
composition. The data obtained apply only to the market preparations
claimed to contain Trimethol. So far as the investigation and report
go, “Trimethol” is a hypothetical substance.
Clinical or animal tests of the asserted intestinal antiseptics have
hitherto given equivocal results because it is impossible, on the
one hand, to predict the course of any intestinal infection, or,
on the other hand, to determine what effect, if any, was produced
by administration of the medicament. It therefore seemed unwise to
undertake this line of investigation until the more direct laboratory
bacteriologic methods had been exhausted. Consequently the investigator
checked, in the first place, the phenol coefficient of one of the
Trimethol preparations and then also determined its “penetrability”
coefficient. Although by both methods Trimethol was found to be a
germicide, the results did not indicate any remarkable potency or other
properties suggesting that the drug possessed special therapeutic
value. From the results obtained it appeared inadvisable to proceed
further with the work until more definite evidence of the nature and
of the value of the substance should be at hand. The report of the
bacteriologic investigation follows:
THE BACTERIOLOGIST’S REPORT
“I have made no attempt to study the effects of internal administration
of Trimethol on the intestinal flora. The methods available at the
present time of enumerating the numbers of _viable_ bacteria in
the feces are probably not accurate within 100 per cent. and the
precision of such determinations is equally variable. The physiologic
factors involved are so complex that they would appear to make a
really valuable assay a question of many months’ careful study. If
it were possible to administer known amounts of Trimethol, as such,
the problem might be worth while; inasmuch as the available reactive
substance is not at present quantitatively assayable, this phase of the
investigation barely seems practicable.
“‘Trimethol Syrup,’ as such, appears to be about 10 per cent. as
efficient in its germicidal value as carbolic acid. If the assay,
3/4 m. Trimethol per drm. (as the label indicates), is correct, the
substance would appear to possess germicidal merit provided enough
could be administered, if it is not influenced by passage through the
stomach.
“A package containing four four-ounce bottles labeled ‘Trimethol, A
Non-Toxic Germicide SYRUP Representing 3/4 m. Trimethol per drm.,
Alcohol 1-1/2 per cent.’ was received at the laboratory Dec. 15,
1916. Later a smaller package containing, according to the label, 100
Trimethol tablets, each 5 gr., representing 1-1/4 m. Trimethol, was
received. The tablets were apparently chocolate coated.
“Two separate series of tests were made upon the syrup. (_a_) PHENOL
COEFFICIENT, using the method outlined in _Bulletin No. 82_, Hygienic
Laboratory, Method of Standardizing Disinfectants With and Without
Organic Matter. (_b_) A PENETRABILITY COEFFICIENT by the method of
Kendall and Edwards, _Journal of Infectious Diseases_, 8, 250.
“The former method compares the viability of naked germs in a 1 per
cent. carbolic acid solution as a standard, with various dilutions
of the germicide to be tested. The latter measures the relative
diffusibility and germicidal power of carbolic acid and various
dilutions of the germicide to be tested upon _Bacillus coli_ suspended
in 1.2 per cent. agar which is molded in cylinders of one centimeter
diameter after infection with the organism.
“The first method--phenol coefficient--possesses advantages and
disadvantages which are well known and need no mention here. It is
worthy of notice, however, that as the death rate of the bacteria
increases during the progress of the test, it becomes increasingly
difficult to maintain a uniform suspension of living organisms so
that each loopful removed shall exactly represent the developmental
potentiality of the residual organisms.
“The second method theoretically covers the possibility because all the
organisms are immobilized and are exposed to the germicide in direct
proportion to its diffusibility until the center of the agar mass is
reached, where the residual viable bacteria are presumably located.
Inasmuch as the penetrability of an intestinal mass is involved in a
discussion of intestinal germicides, the propriety of utilizing this
‘penetrability coefficient’ in this connection is obvious, in spite of
its patent shortcomings.
“It is unnecessary to discuss the technique--the standard broth
mentioned in the Hygienic Bulletin, a temperature of 70 F., a standard
4 mm. loop and careful attention to dilutions (using distilled water)
were all observed. The various dilutions of Trimethol Syrup were made
with accurate volumetric pipettes, measuring flasks and distilled water
was used as a diluent.
“The results of several determinations, using Trimethol Syrup from
three separate bottles, were in sufficient accord to warrant the
statement that a dilution of 1/10 of Trimethol Syrup was equivalent
to a 1/100 dilution of carbolic acid, using _Bacillus typhosus_ as
the test organism. Both solutions--the Trimethol and phenol--killed
the organism in the interval between 7-1/2 minutes and 10 minutes’
exposure. That is to say, our observations indicate that under
standard conditions as defined above, a 10 per cent. solution of
Trimethol Syrup is equivalent in germicidal powers, as defined by the
phenol coefficient to a 1 per cent. solution of phenol. Naturally, no
predictions can be drawn from these observations indicative of the
value as an intestinal germicide of Trimethol itself.
“The PENETRABILITY COEFFICIENT resulted as follows: A 5 per cent.
solution of phenol killed _Bacillus coli_, suspended uniformly
throughout a cylinder of 1.2 per cent. agar in the interval between
60 and 90 minutes. A 1 per cent. solution of phenol killed the same
organisms under the same conditions in the interval between two and
one half and three hours. An undiluted solution of Trimethol Syrup
killed the organisms in the interval between two and one half and three
hours. A 10 per cent. solution (nine volumes of distilled water to one
volume of Trimethol Syrup) failed to kill the organisms in four hours.
It would appear that undiluted Trimethol Syrup has the same combined
penetrability and germicidal value as a 1 per cent. phenol solution.
“The PHENOL COEFFICIENT: A 10 per cent. solution of Trimethol Syrup
in distilled water (nine volumes of distilled water to one volume of
Trimethol Syrup) possesses the same germicidal power as a 1 per cent.
solution of carbolic acid. This coefficient takes no cognizance of the
_actual amount of Trimethol as such_--it merely indicates the relative
germicidal power of the Trimethol Syrup as sold.”
The preceding report shows that Trimethol Syrup has a phenol
coefficient of 1/10, and, assuming Trimethol Syrup contains the amount
of Trimethol declared, the substance Trimethol would have a phenol
coefficient of 8-1/3 instead of 40, as is claimed. According to Kendall
and Edwards’ method, the penetrability-germicidal value of the syrup is
equal to a 1 per cent. solution of phenol.
WALKER’S REPLY TO CRITICISM
The report of the bacteriologist was submitted to The Walker-Leeming
Laboratories for comment. The following reply was received from J. T.
Ainslie Walker:
(_May 22, 1917_) “In reply to your letter of the 15th inst., which
has just been placed before me on my return to town, I have to
inform you that the potent constituent of Trimethol Tablets and
Trimethol Syrup is not fully available as a bactericide until it
comes in contact with the pancreatic fluid.
“As you will see from the enclosed extracts from clinical reports,
the therapeutic value of Trimethol has been well established.
“As regards penetrability, no claim has ever been made for
Trimethol in this connection; and, as I pointed out in my original
paper (_American Medicine_, September, 1914), when referring to the
independent tests made by Dr. Frederick Sondern, ‘No attempt was
made to determine the bacterial content of the solid particles,
as in the opinion of the writer sterilization of the interior of
these particles is not only absolutely impossible, but wholly
unnecessary. The fact of the fluid contents of the canal being
sterile may be taken to indicate that the exterior of all solid
particles is in a like condition, and therefore harmless. It is
the organisms in the fluid portions only that produce the deadly
effects through the chemical substances they secrete; those in
the interior of the solid portions (_i. e._, as evacuated) may be
disregarded, as they are not available for good or evil.’
“I must confess to no little surprise on learning that your
investigator is still using the Hygienic Laboratory method of
determining phenol coefficients. I would respectfully suggest that
you call his attention to the critical comparison of the Hygienic
Laboratory and R.-W. Tests, which he will find in the enclosed
reprint from the _New York Medical Journal_ of March 11, 1916:
‘Instead of being an improvement upon the standard R.-W. Test,
the so-called Hygienic Laboratory Method is so defective as to
be wholly unreliable, and incapable of furnishing results of any
scientific or practical value whatever.’”
As to the statement that the potent constituent of Trimethol Tablets
and Trimethol Syrup is not fully available as a bactericide until it
comes in contact with the pancreatic fluid, attention is called to a
leaflet, which accompanies each bottle of Trimethol Syrup, that reads:
“Trimethol is insoluble in water, but when properly emulsified has
a Rideal-Walker co-efficient of 40; that is to say, it is 40 times
more efficient as a germicide than phenol (pure carbolic acid).”
The Trimethol Syrup which was used in the investigation, when mixed
with water produced an almost perfectly transparent solution, which
justifies the assumption that the proper physical conditions were
observed and that this objection is not well founded.
As regards the relation of pancreatic fluid to bactericidal
availability of Trimethol, there is little to say, other than that the
published statements in the advertising accompanying the packages make
no mention of this point. It would be interesting to know what, if any,
relation the pancreatic fluid has to this substance, in view of the
statement that it “has a Rideal-Walker coefficient of 40.”
The Trimethol “literature” does not throw light on the question, What
is the germicidal value of Trimethol Syrup as compared with phenol?
The only available method of determining the germicidal value of a
liquid disinfectant is to make a direct comparison of the substance
in question with phenol under similar conditions. Given parallel
conditions, not obviously prejudicial to the substance tested in
contrast to the standard solution, the results are comparable, and
furnish a basis for estimating the relative germicidal power of the two
substances. In the investigation, Trimethol Syrup and phenol were thus
compared.
As regards the contention that the bacteria within fecal masses are
harmless, this may be granted. But it must also be admitted that
these intestinal masses are constantly being reformed so that buried
micro-organisms do not remain in the interior. For this reason, the
determination of the penetrability coefficient of a germicide is
pertinent.
Regarding the respective merits of the old Rideal-Walker and the
newer U. S. Hygienic Laboratory method of determining the phenol
coefficient, the Rideal-Walker method was found to possess certain
drawbacks, and in an attempt to overcome these the “_Lancet_ Method”
was evolved; this method in turn was improved in the U. S. Hygienic
Laboratory and led to the United States Public Health Service Hygienic
Laboratory method for the determination of the phenol coefficient of
disinfectants (published in _Hygienic Laboratory Bulletin 82_). In
1913 this method was formally adopted by the Council for the valuation
of disinfectants or germicides of the phenol type, and the method is
now in general use for this purpose in the United States.[119] In this
connection Hiss and Zinsser may be quoted (Ed. 2, page 80): “The most
precise method of standardizing disinfectants is that now in use in the
United States Public Health Service.” Stitt, director of the United
States Naval Medical Schools, in his Practical Bacteriology, Blood
Work and Parasitology (Ed. 4, page 473) says: “In the United States
disinfectants are rated according to the Hygienic Laboratory Phenol
Coefficient.”
[119] Those who are interested in the relative merits of the
Rideal-Walker, the _Lancet_ and the Hygienic Laboratory methods for
the valuation of disinfectants, should read the following: Method
of Standardizing Disinfectants with and without Organic Matter,
J. A. M. A., Aug. 24, 1912, p. 667; Standardization of disinfectants,
Report of the Council on Pharmacy and Chemistry, J. A. M. A., April
26, 1913, p. 1316; Standardizing Disinfectants, J. A. M. A., Sept. 30,
1916, p. 883.
The Council adopted the recommendation of the Committee on Pharmacology
to the effect that the claims made for Trimethol are unsupported by
acceptable evidence. Accordingly, Trimethol and the pharmaceutical
preparations said to contain it--Trimethol Syrup, Trimethol Capsules,
and Trimethol Tablets--were held ineligible for New and Nonofficial
Remedies.--(_From The Journal A. M. A., Aug. 11, 1917._)
FERRIVINE, INTRAMINE AND COLLOSOL IODINE
Report of the Council on Pharmacy and Chemistry
E. Fougera & Co., Inc., New York, acting as agent for The British Drug
Houses, Ltd., London, advertise “Ferrivine,” “Intramine” and “Collosol
Iodine” to the medical profession. A circular entitled “Ferrivine, The
New Anti-Syphilitic Remedy” begins:
“FERRIVINE is the name given to ferric tri-para-amino-benzene
sulphonate. This iron compound was first prepared by Mr. J. E. R.
McDonagh, F. R. C. S., by whom it has been both biologically and
clinically tested. It is slightly soluble in water, the solution
having an acid reaction.
“INDICATIONS
“According to Mr. J. E. R. McDonagh’s researches, the phases of
the _Leucocytozoon syphilids_ are killed by the lipoid-globulin
molecules of the serum, which possess a stereochemical molecular
configuration homologous to those of the lipoid-globulin
molecules of the parasite. The process is one of absorption, a
chemico-physical reaction which is in part dependent upon the
supply of active oxygen. Active oxygen is formed directly by
oxidation processes and the peroxide necessary for its formation
directly by reducing processes. Oxidation is increased by metals
and reduction by non-metals. The non-metal which acts in the body
as the normal reducing agent is sulphur, hence the discovery of
Intramine (see separate pamphlet). The metal which acts in the body
as the normal oxidising agent, is iron, hence the discovery of
Ferrivine.”
A circular, “Intramine, a New Non-Toxic Compound for the Treatment of
Protozoal and Chronic Bacterial Diseases,” expounds Mr. McDonagh’s
ideas of the treatment of syphilis with Ferrivine and Intramine by
means of the oxidising action of Ferrivine and the reducing action of
Intramine and asserts:
“As the ultimate administration of oxidising and reducing agents
will benefit almost any infection, it may be said that Intramine is
indicated in all protozoal diseases, and in all chronic bacterial
diseases, especially in tuberculosis, presumably in leprosy and
possibly in malignant disease [cancer?]. To the administration of
Intramine there are no contraindications.”
We are also told that:
“Intramine is useful injected into the urethra.... In cases of
chronic urethritis and perifolliculitis ... invaluable as a local
application to chronic ulcers ...”
The Intramine circular includes a “Scheme of Treatment for Syphilis”
which advises, in addition to Intramine, Ferrivine or salvarsan,
mercury and iodids, the use of another proprietary called “Collosol
Iodine.” An inquiry addressed to Fougera & Co. in regard to the
character and composition of this preparation, brought the reply that
the firm had no knowledge of its identity.
This “scheme of treatment” is objectionable in that it advises the
“stock” treatment of a disease which demands individualization and
further in that whatever beneficial effects may result from the use
of mercury and iodid is likely to be ascribed to the preparations
“Intramine,” “Ferrivine” and “Collosol Iodine.”
The advertising for Ferrivine and Intramine sent out by Fougera & Co.
contains no experimental or clinical data on which an estimate of their
value may be based. Apparently in England, where these products were
originated, little has been published regarding them.
There is, however, one report which may be accepted as a carefully
controlled clinical trial. In the _Lancet_ (June 17, 1916, p. 1214)
L. W. Harrison, D.S.O., M.B., Ch.B.Glasg., and C. H. Mills, M.R.C.S.,
L.R.C.P.Lond., report on “The Effect of Ferrivine and Intramine on
Syphilis.” After briefly reviewing the theories which form the basis
of McDonagh’s proposed treatment of syphilis with his discoveries
“Ferrivine” and “Intramine” the authors point out:
“... that Mr. McDonagh’s biological discoveries ... have not been
publicly confirmed by any biologist of standing ...”
While:
“... eminent chemists have confessed themselves unable to
understand his chemistry.”
The authors explain:
“Recognizing that this might prejudice our practical tests of
Intramine and Ferrivine, we have taken particular care to guard
against their influence, cross-checking our observations and
submitting them to others for confirmation or otherwise.”
Harrison and Mills chose for a test three ordinary cases of secondary
syphilis, cases with well marked lesions, the clinical progress of
which could easily be watched and from which it was easy to obtain
specimens for microscopic examination. After a detailed account of
the three cases--which records grave conditions resulting from the
treatment and which shows the inefficiency of the drugs--they write:
“From the above account it will be seen that the local and general
reactions which follow the injection of these preparations are
by no means pleasant. In the case of Intramine the pain is
undiluted torture and lasts so for two or three days. One of us had
previously treated four cases with Intramine and the same local
reaction occurred in these. In two of them abscesses have burst
outwardly, one of which is still discharging necrotic débris, ten
weeks after the injection, and will take many more weeks to close.
In those cases where no abscess has yet burst it is easy to feel
by the gap in the muscles that considerable necrosis has occurred.
None of these effects can be ascribed to sepsis, as most rigid
aseptic precautions were taken. Further, particular care was taken
to make the injections strictly intramuscular. The constitutional
symptoms which follow immediately upon the injection of Ferrivine
are distinctly alarming, and such as would cause one to hesitate
before injecting this remedy into any but robust patients.”
Harrison and Mills estimate the therapeutic effects of these drugs thus:
“1. That Ferrivine entirely failed to cause _S. pallida_ to
disappear from the lesions of three well-marked cases of secondary
syphilis.
“2. After the failure of Ferrivine to cause the disappearance of
_Spirochaeta pallida_ from a mucous patch a single dose of 0.3 gm.
salvarsan effected this in 18 hours, and the patch, which had
hitherto been uninfluenced, had healed within 48 hours.
“3. Clinically we were unable to detect any influence of either
or both these compounds on syphilitic lesions, although each of
them was of the variety which heals in a week or ten days under
salvarsan treatment.
“4. Further syphilitic lesions appeared immediately after the
treatment in one of the two cases treated with both Ferrivine and
Intramine. A mucous patch appeared on one tonsil as well as further
syphilitic papules from which spirochetes were obtained. The other
case developed nephritis, with albumin and epithelial casts; which
was not present prior to the injections.”
While from these cases the obvious conclusion was drawn that Intramine
and Ferrivine “have no specific effect on early syphilis,” these
authors subsequently treated a case of tertiary syphilis with the
drugs. An Intramine injection caused pain for several days but did
not stop the progress of the disease. Ferrivine was then administered
“not without a feeling of grave responsibility” in view of their
previous experiences. They state that “the reaction which resulted
in this instance was the most severe” they ever experienced after
an intravenous injection of any of the antisyphilitic remedies with
which they had previously worked. It is stated that “for a period
of some minutes there was grave doubt as to the patient’s survival.”
After resuscitation the patient passed a disturbed night, and rigors
which ensued lasted until the following afternoon. The author’s report
that in this case also no clinical improvement occurred and that the
Intramine-Ferrivine treatment was replaced by a course consisting of
salvarsan, potassium iodid and mercurial inunction.
Ferrivine, Intramine and Collosol Iodine were declared inadmissible to
New and Nonofficial Remedies.--(_From The Journal A. M. A., Sept. 8,
1917._)
ESKAY’S NEURO PHOSPHATES
Report of the Council on Pharmacy and Chemistry
For the information of the profession the Council has prepared and
authorized for publication the following report on Eskay’s Neuro
Phosphates.
W. A. Puckner, Secretary.
Eskay’s Neuro Phosphates (Smith, Kline & French Co., Philadelphia) is
offered to physicians under the claims that it contains alcohol, 17 per
cent., and sodium glycerophosphate, 2 grains, calcium glycerophosphate,
2 grains, and strychnin glycerophosphate, 1/64 grain, in each
dessertspoonful. It is called a “Nerve Tissue Reconstructive,” and its
advertising claims are based on the discredited theories that certain
disorders are due to a deficiency of phosphorus in the nerve structure
of the body, and that glycerophosphates are assimilated more readily
than ordinary phosphates. This assumption was based on the knowledge
that the lecithins, which form a part of the nerve structure, contained
the glycerophosphate radical in the molecule. In line with this, Smith,
Kline & French Co. aver:
“Eskay’s Neuro Phosphates is of marked value in many acute and
chronic conditions, in nervous exhaustion following mental and
physical strain, neurasthenia, paralysis, anemia, tuberculosis,
marasmus, debility and wasting diseases generally, and the
nerve-weakness of the aged. It is particularly useful in
convalescence from acute diseases and in the nervous condition
following la grippe.”
In its report on “The Therapeutic Value of the Glycerophosphates” (The
Journal, Sept. 30, 1916, p. 1033) the Council pointed out that the
therapeutic use of the glycerophosphates was based on the assumption
that the inorganic phosphates cannot supply the body’s needs of
phosphorus or that the use of organic compounds “spared” the system
the necessity of making such synthesis. The report presented evidence
to show that the glycerophosphates are not absorbed as such, but
that they are split into inorganic phosphates before absorption. The
Council showed that there was convincing evidence that the animal
organism synthesizes its complex organic phosphorus constituents from
inorganic phosphates, and that organic phosphorus is of no more value
as a food than inorganic. Despite this the Neuro Phosphates advertising
makes use of the fallacious assumption regarding the action of the
glycerophosphates.
Pleading for the particular mixture represented by the proprietary, it
is asserted that:
“Sodium glycerophosphate is of special value in neurasthenia,
Addison’s disease, phosphaturia and phthisis.”
and that calcium glycerophosphate “is employed in bone fracture,
rachitis, tuberculosis and various wasting diseases.”
The phosphorus content of 1/64 grain of strychnin glycerophosphate is
ridiculously small. Yet it is asserted that this strychnin salt is of
superior value because it combines the effects of strychnin with a
“food-like form of phosphorus.” Eskay’s Neuro Phosphates has an acid
reaction which is capitalized, thus:
“Experiments have shown that the acid glycerophosphates are more
rapidly absorbed and are more efficient than the neutral salts.”
And as a further illustration of extravagant claims:
“As a glycerophosphoric acid in the form of lecithin is
normally present in spermatozoids, it is but natural that the
glycerophosphates should exhibit aphrodisiac effects (as has been
observed), but this result does not seem to obtain in all cases.”
Is this a clumsy attempt to exploit this “nerve phosphate” as a “lost
manhood” cure?
The Council held Eskay’s Neuro Phosphates ineligible for New and
Nonofficial Remedies because unwarranted therapeutic claims are made
for it and because the administration of strychnin, calcium, phosphate
and alcohol is not conducive to rational therapeutics, particularly
when such a mixture is marketed under a name which indicates but one of
its constituents.--(_From The Journal A. M. A., Sept. 29, 1917._)
K-Y LUBRICATING JELLY
Report of the Council on Pharmacy and Chemistry
Because of inquiries received, the Council has authorized publication
of the following report declaring K-Y Lubricating Jelly inadmissible to
New and Nonofficial Remedies.
W. A. Puckner, Secretary.
K-Y Lubricating Jelly (Van Horn and Sawtell, New York), originally
advertised as a lubricant for instruments and the hands, is now also
recommended as a therapeutic agent. If the claims for “K-Y” were
limited strictly to such effects as result from the purely mechanical
properties of a lubricant, it might be held that it would not come
under the purview of the Council. The preparation, however, while
introduced as a lubricant, is now offered for a broader field of use,
and the manufacturers make claims which are not supported by any
evidence available to the Council. Evidence the following, taken from a
circular that accompanies the package:
“K-Y allays smarting and burning at once through its pronounced
soothing and cooling effects, and thus makes an admirable dressing
for burns.”
“Many physicians make a practice of anointing the bodies of their
measle and scarlet fever patients with ‘K-Y,’ in this way affording
gratifying relief from itching and irritation, and effectively
preventing dissemination of infectious material.”
And this from another circular:
“I had one of the most troublesome cases of pruritus vulvæ that I
had ever seen. I guess I must have tried everything and the case
had been referred to me by another man, who had previously tried
everything, including cauterization. Well, one day I was examining
her, and of course K-Y on the speculum--the irritation seemed to
quiet down, and the following day she said she felt no effects from
it at all. Then later on, it returned, and I couldn’t imagine what
had done so much good, unless it could have been the lubricant, so
I told her to buy a tube, which she did. Every once in a while she
has a return of it slightly, but she just applies K-Y and clears it
all up.”
The manufacturers state that they do not know why K-Y is so soothing,
but suggest:
“Possibly the cooling action of the combination, and the effect of
the 4% boric acid contained, are factors that enter. Be all that
as it may, the fact certainly remains that oftentimes, after other
local measures fail, ‘K-Y’ lubricating Jelly gives relief.”
Elsewhere it is claimed to be germicidal, and to give relief in other
conditions, thus:
“Diabetic and uremic irritations, not only of the genitalia, but of
other parts, have been found fully as amenable as pruritus vulvae
to the soothing influence of ‘K-Y’ Lubricating Jelly, especially if
the previous application is removed with water every time a new one
is put on.”
The foregoing citations are obviously intended largely for the public,
and make it plain that “K-Y” Jelly is not in the class of nonmedical
and harmless external applications; on the contrary, these claims
tend to create the impression that the spread of measles and scarlet
fever can be _prevented_ in the stage of desquamation. To place
such statements in the hands of the patient supported by the tacit
endorsement of a prescription is to create a false and dangerous
sense of security and to lead to a failure to observe other and more
important means of preventing dissemination of these diseases.
The Council held K-Y Lubricating Jelly in conflict with Rules 1, 4, 6
and 10, and authorized publication of this report.--(_From The Journal
A. M. A., Sept. 29, 1917._)
ZIRATOL
Report of the Council on Pharmacy and Chemistry
Ziratol (Bristol-Myers Company, New York), in compliance with the
federal “insecticide law,” is declared to contain 32 per cent. water
and 30 per cent. glycerin as inert constituents. Regarding its active
constituents the manufacturer makes the following and meaningless
statement:
“Ziratol is prepared from Phenols of the Naphthalene series and
consists of a solution of such Phenols in a mixture of soap, water and
glycerin.”
In response to inquiry, the A. M. A. Chemical Laboratory examined
Ziratol and reported that its essential constituent appears to be
alpha-napthol,[120] and that it has, essentially, the following
composition by weight: Alpha-napthol 18 per cent., soap 20 per cent.,
glycerin and water sufficient to make 100 per cent.
[120] Alpha-napthol was also found to be the basis
of the nostrum Benetol. See The Journal, April 15,
1911, p. 1128.
A Ziratol advertising circular gives a tabulated report of germicidal
tests, said to have been made according to the method of the Hygienic
Laboratory of the U. S. Public Health Service. When this work was
done is not stated. According to these tests Ziratol possesses a
phenol-coefficient of 13.66. The claim that Ziratol is ten times more
efficient than carbolic acid (phenol) is evidently based on this report.
These claims of high germicidal value are contradicted by an
examination made for the Council. A specimen purchased in the open
market was examined independently by two operators, to determine the
Hygienic Laboratory phenol-coefficient. One observer found the phenol
coefficient to be 2.54. The other reported it to be 3.09. Evidently the
germicidal value of Ziratol is greatly exaggerated in the advertising
claims and, in fact, does not exceed that of the official compound
solution of cresol (Liquor Cresolis Compositus, U. S. P.) for which
a phenol-coefficient of about three has been established. (See New
and Nonofficial Remedies, 1917, p. 82.) The claim that Ziratol is
“the Universal Antiseptic and Germicide” is manifestly an unwarranted
exaggeration.
The referee in submitting this report to the Council recommended that
Ziratol be held in conflict with Rule 1 (secrecy of composition) and
Rule 6 (unwarranted and exaggerated claims). After the report had been
submitted, it was found that a new advertising circular, accompanying
a trade package, no longer contained the claim that “Ziratol is ten
times more efficient than Carbolic Acid.” The older circular made the
following statement:
“1. Strong Activity.--Compared with the bactericidal action of
Carbolic Acid by the method of the Hygienic Laboratory of the
Marine Hospital Service, ZIRATOL has the Carbolic Acid Coefficient
of more than TEN, that is, ZIRATOL is TEN times more efficient than
Carbolic Acid,--a strength unapproached by any other of its class.
ZIRATOL in dilution of 1:1400 kills the Typhoid Bacillus in 2-1/2
minutes, thus proving that it is strongly active even in very weak
solutions.”
The new advertising circular reads:
“1. Strong Activity--Extensive bacteriological investigations on
many pathogenic organisms, conducted in the Lederle Laboratories of
New York, prove conclusively the high bactericidal value of Ziratol
in extremely dilute solutions. (A copy of the complete report will
be mailed upon request.)”
In response to a request, the Bristol-Myers Company sent a copy of
the bacteriologic investigations of Ziratol, said to have been made
by the Lederle Laboratories. The organisms employed for these tests
were _Staphylococcus aureus_, _Staphylococcus albus_, _Streptococcus_,
Green pus bacillus, _B. coli_, and saliva. No tests are given with the
typhoid bacillus. The conclusion is reached that “in all the tests the
solutions of Ziratol have several times greater killing efficiency
than those of phenol.” The “coefficients” or comparative values which
can be calculated from the results after exposure of 15 minutes to the
disinfectants range from 2.0 to 4.0. This is in substantial accord
with the referee’s findings as regards the phenol-coefficient with _B.
typhosus_ as the test object. While the new advertising circular avoids
the former claim that Ziratol is ten times more efficient than carbolic
acid, in germicidal value, it still makes the unwarranted claims that
Ziratol is the “universal disinfectant.”
The Council declared Ziratol inadmissible to New and Nonofficial
Remedies (1) because its composition is secret (Rule 1); (2) because
the phenol coefficient, determined according to the method of the
Hygienic Laboratory, U. S. P. H. S., is not stated on the label (Rule
2); (3) because the label and the circular accompanying the trade
package advises its use by the public as a “vaginal douche” (Rule 3);
and (4) because the claim that Ziratol is the “universal disinfectant”
is exaggerated and unwarranted (Rule 6).
Before authorizing publication of the preceding report the Council
submitted it to the Bristol-Myers Company in order to give that company
the opportunity of revising its method of marketing Ziratol. In reply
the company enlarged on its withdrawal (on “our own initiative”) of
the claim that Ziratol had a phenol-coefficient of over ten when this
claim was shown to be incorrect “by authoritative sources.” One wonders
whether this is a euphemistic reference to the proceedings of the
federal authorities under the Insecticide Act against the Bristol-Myers
Company, just made public,[121] because of the false claims made for
the germicidal efficiency of Ziratol. This prosecution resulted in the
seizure and condemnation of two lots of this proprietary which had
passed in interstate commerce.
[121] U. S. Dept. of Agric., Insecticide and Fungicide Board, Service
and Regulatory Announcements, No. 16, issued Aug. 8, 1917. _No. 244_,
Misbranding of “Ziratol.” U. S. _v._ 100 bottles, more or less, of
“Ziratol”; consent decree of condemnation and forfeiture; product
ordered released on bond, p. 248. _No. 256_, Misbranding of “Ziratol.”
U. S. _v._ 936 bottles and 6 jugs of Ziratol, consent decree of
condemnation and forfeiture; product ordered released on bond, p. 260.
The Bristol-Myers Company in replying to the Council’s report made
no offer to declare the exact composition of Ziratol, to state the
actual phenol-coefficient, or to remove the other objections pointed
out in the report of the Council. In other words, the Bristol-Myers
Company has abandoned a definite but false claim of high germicidal
power--a claim which subjected the firm to federal prosecution--and
has substituted therefor indefinite statements which do not define the
actual germicidal efficiency of Ziratol.--(_From The Journal A. M. A.,
Oct. 6, 1917._)
GONOSAN
Report of the Council on Pharmacy and Chemistry
The Council has adopted the following report on Gonosan and authorized
its publication.
W. A. Puckner, Secretary.
Gonosan (Riedel and Company, Inc., New York City) comes in the form of
capsules, each said to contain 5 minims of a mixture composed of oil of
sandalwood 80 per cent., and 20 per cent. of alpha- and beta-resin of
kava, isolated by a patent process. The mixture, as the name implies,
is intended for the treatment of gonorrhea.
This proprietary preparation was under consideration by the Council at
various times from 1905 to 1910. During this time, the Council agreed
to accept the preparation if the suggestive name was changed, the
therapeutic exaggerations abandoned, and the drug kava admitted to New
and Nonofficial Remedies. The name was not changed, the other questions
were left open, and the preparation was not accepted.
Recent and more objectionable advertising of Gonosan makes it advisable
for the Council to take action and to publish a report. The tone of
this advertising is reflected by the following quotation from a recent
advertising circular:
“The old-established balsamic treatment of gonorrhea, for some
years neglected in favor of the local injection of organic silver
and other germicidal salts, has, with the increasing knowledge
and attention paid to the composition and purity of the balsams,
regained to a large extent the confidence formerly reposed in them.
“It may now be said that the combined treatment with local
injections and internal administration of natural balsamic products
completely dominates modern gonorrheal therapy.”
Any one conversant with current medical literature and practice would
stamp these statements as misleading exaggerations. The balsams,
oleoresins and volatile oils may have some value as minor adjuvants
in the treatment of gonorrhea, but that is all. The position in this
respect has not changed materially in recent years. These agents do not
have a value equal to that of local treatment, as the quoted statement
implies.
The claims made for Gonosan might with equal force be made for oil of
santal alone. Kava kava, the other constituent, belongs to the pepper
family; it had a temporary vogue some two or three decades ago, but has
failed to maintain a place. It has never been recognized officially.
There is no scientific evidence that it has any value either alone or
as an adjuvant to sandal oil. The “clinical reports” quoted in the
advertising circulars, rather curiously, nearly all date back ten
years or more, viz., to a period when the attitude of the profession
toward proprietary remedies was less critical than it is now. It would
be interesting to know whether these authors still adhere to their
opinion, or whether any of them have subsequently had experiences
similar to that of a correspondent who wrote:
“Gonosan, at my hands, did not prove to be of more essential
value in the treatment of gonorrhea than any other sandalwood oil
preparation. The various claims made for Gonosan, that it possesses
sedative and anesthetic properties, that by its continuous use the
urethral discharge disappears more rapidly and that, if combined with
appropriate diet and rest, it is liable to prevent complications, are,
according to my experience, not corroborated by actual results.”
The only experimental work quoted in support of Gonosan, that of Pohl,
is not convincing. The doses that Pohl found necessary to influence
experimental purulent pleurisy makes it impossible to transfer his work
to the clinic. (He found a dosage of oil of santal corresponding to an
ounce per day, for man, inefficient; positive results were obtained
only with 2 ounces per day.)
In order to learn the estimate placed on the therapeutic value of the
“balsams,” an inquiry was sent to the authors of the papers presented
to the section of Genito-Urinary Diseases at the recent meeting of the
American Medical Association in New York. The inquiry read:
“_Dear Doctor_:--An advertising circular for Gonosan ‘Riedel’ which is
now being distributed begins thus:
‘The old-established balsamic treatment of gonorrhea, for some
years neglected in favor of the local injection of organic silver
and other germicidal salts, has, with the increasing knowledge
and attention paid to the composition and purity of the balsams,
regained to a large extent the confidence formerly reposed in them.’
‘It may now be said that the combined treatment with local
injections and internal administration of natural balsamic products
completely dominates modern gonorrheal therapy.’
“Is the statement correct that the combined treatment with local
injections and internal administration of natural balsamic products
completely dominates modern gonorrheal therapy? Your reply to the above
will be appreciated by the Council.”
Seventeen replies were received. They bear out the position that
has been outlined. Only one writer considered the statement even
approximately justified, and this in the sense that “the majority
of cases receive no other treatment” than a combination of local
applications and systemic medication. Another stated that, “in a
general way their statement is true though a trifle too sweeping,” and
then added that the field of the balsams is rather restricted. With
the exception of these qualified endorsements the remaining (fifteen)
replies characterized the statement as incorrect and misleading. The
replies are a valuable contribution to the status of the “balsam”
treatment of gonorrhea, and extracts of them are appended to this
report.
It is recommended that the Council declare Gonosan inadmissible to
New and Nonofficial Remedies, because the therapeutic claims are
exaggerated (Rule 6); because there is no evidence that the combination
of kava resin with oil of santal is superior to oil of santal alone
(Rule 10); and because the therapeutically suggestive name is conducive
of indiscriminate and unwarranted use of the preparation both by the
profession and the public (Rules 4 and 8).
Appendix
The extracts from replies received to the inquiry above referred to,
follow:
Dr. B., Penn., wrote:
“In my practice I have found that local injections are very
valuable in the treatment of gonorrhea, but I have never found that
the internal administration of natural balsamics dominated modern
gonorrheal therapy; while it is an aid, I consider the quoted
statement to be very erroneous.”
Dr. F., D. C., wrote:
“While it is doubtless true that acute urethritis, gonorrheal, is
now generally treated by local injections of solutions of organic
silver salts, and that santal oil is often used, it is not true,
as one would infer from the quotation, that the balsams are now
considered more efficacious than they were formerly. So far as I
know they have not lost or regained anything during the past dozen
years in the way of confidence reposed in them. The indications for
their use is very definite and very limited.”
Dr. B., Ga., wrote:
“... In recent years I have almost abandoned the use of balsams,
etc., in the treatment of gonorrhea. Patients, who are properly
treated otherwise, seem to get along as well without such drugs
as with them, in fact apparently better for they have no gastric
disturbance. It is important for patients to drink freely of
water and when so doing the balsams are so diluted that I cannot
conceive of their doing much good. Formerly my patients often lost
weight during the treatment of gonorrhea; now, without balsams and
with plenty of water, they usually gain in weight.”
Dr. S., Mich., wrote:
“... we believe that in a general way their statement is true
though a trifle too sweeping. We do not ordinarily use the
balsams in uncomplicated anterior urethritis. We do however, find
indication for their administration in from sixty to seventy five
per cent. of all cases of acute gonorrhea at some time during the
course of the disease.”
Dr. L., Mo., wrote:
“I would say that the statement that, ‘The combined treatment with
local injections and internal administration of natural balsamic
products completely dominates modern gonorrheal therapy,’ is far
from representing the facts. While the balsamics may occasionally
have an indirect soothing effect on the mucous membranes involved,
the dominant factor is local treatment, aiming at disinfection and
restoration to normal of the inflamed tissues.”
Dr. R., Mich., wrote:
“Regarding your request although I am willing to reply it is
difficult to do so because if I should do so in the affirmative
that could apply only to certain acute cases without complication
of any kind and such cases are rare. In such, however, the
advertiser is not far from right--since vaccine therapy has proven
absolutely worthless we must fall back on antiseptics in acute
urethritis when there are no objections to such treatment ...”
Dr. K., Ill., wrote:
“I am under the impression that the internal administration of
balsamics is used only when complications arise, such as acute
posterior urethritis. Personally I use the balsamics very, very
rarely. From my observation, however, I am led to believe that many
men still use internal drugs in the treatment of gonorrhea, and
during the past few years, I should say the use of hexamethylenamin
has been on the increase, and the use of the balsams on the
decrease. I do not believe that hexamethylenamin is of any value
in the treatment of gonorrhea, and am simply citing this as my
observation of the widespread use of this drug in the treatment of
gonorrhea.”
Dr. T., Penn., wrote:
“... I believe that more men use salol or hexamethylenamin, or no
urinary antiseptic whatsoever, than use the balsamics.”
Dr. B., Ind., wrote:
“... The only systemic treatment that is considered necessary today
is rest, plenty of water and neutralize the acidity of the urine
with bicarbonate of soda or some sodium salt.”
Dr. Y., Mass., wrote:
“Sandal wood oil during the acute stage of gonorrhea certainly tends to
make the patient more comfortable and undoubtedly does lend some (tho I
believe slight) gonococcidal action. That it plays any _considerable_
part in actual cure I think is doubtful. The statement as quoted
is true in so far as it states that local treatment plus internal
medication with a balsam comprises most of the modern treatment of
gonorrhea but it is grossly misleading in that it lets one draw the
inference that the balsam plays a large if not the principal part.”
Dr. H., New York, wrote:
“For a period of at least three years in my hospital, dispensary
and private practice, I conscientiously tried out most of the
balsamics on the market (including Gonosan, which I favored for
some time) both alone, and combined with local injections. As
a result of this study, I have come to the conclusion that the
balsamics have little, if any value in the treatment of gonorrhea.
During the past few years I have relied almost entirely on local
therapy, and seldom prescribed any of the balsams in my private
practice, certainly in not more than 5 per cent. of the cases.
My results I find are just as satisfactory, and my patients
appreciate the fact that they are not loaded up with disagreeable
medication. Instead of the balsamics, I am using sodium bicarbonate
more and more, and feel convinced that the proper use of this drug
is of more value than all of them combined.”
Dr. K., Cal., wrote:
“The statement that the combined treatment with local injections
and internal administration of natural balsamic products completely
eliminates modern gonorrheal therapy, would at present not be
justifiable even with reference to the initial or acute stage
of gonorrhea, while in the subacute and chronic forms of the
disease local injections and balsams play an almost insignificant
rôle as compared with various other recognized therapeutic
measures.”--(_From The Journal A. M. A., Oct. 13, 1917_).
ALCRESTA IPECAC
Report of the Council on Pharmacy and Chemistry
The Council has adopted the following report and authorized its
publication.
W. A. Puckner, Secretary.
In 1915 Alcresta Ipecac Tablets (Eli Lilly and Co.) were admitted
to New and Nonofficial Remedies as a preparation of ipecac that
is insoluble in the stomach but soluble in the intestines. It was
supposed that this property would permit the administration of ipecac
without the accompanying nausea and vomiting, and that this would be
of especial advantage when using the drug in amebic dysentery. The
systemic effects, of course, would be those of ipecac.
More recently, the manufacturers of Alcresta Ipecac have been advising
its use in conditions which were not contemplated by the Council when
the preparation was accepted for New and Nonofficial Remedies. They
now claim that ipecac alkaloids have been shown to be useful in the
treatment of typhoid fever, flatulence, diarrhea and constipation
and that Alcresta Ipecac has these properties. Such a statement
is misleading. While it is true that at one time ipecac was used
promiscuously against “flatulence, diarrhea and constipation” there
never has been and is not now any scientific evidence of its efficiency
in such conditions except, of course, in diarrhea of the amebic type.
As to the alleged usefulness of ipecac in typhoid fever: This has not
even the sanction of tradition and the claim certainly should not be
accepted until there is strong evidence to support it.
The advertising matter on Alcresta Ipecac also contained statements
to the effect that ipecac alkaloids have a demonstrated usefulness
in pyorrhea. Such an unequivocal statement is unwarranted. In spite
of the enthusiastic advocacy, in the past, of ipecac alkaloids as
a specific in pyorrhea alveolaris the preponderance of scientific
evidence indicates that ipecac is of questionable value in this
condition. Neither is there any substantial evidence to warrant the
claim that ipecac alkaloids, when absorbed through the intestines, are
demonstrably useful in amebic infections of the tonsils.
The reputation of the best drugs, whether unofficial or official,
is bound to suffer if extravagant claims for them are permitted to
go unchallenged. The referee of the Council, therefore, believed it
necessary to call the attention of the manufacturers of Alcresta Ipecac
Tablets to the statements made for the product and suggested that they
submit evidence to substantiate the claims. This the manufacturers have
refused to do. Their attitude in the matter, as well as their attitude
toward the Council’s work is expressed in the following letter:
“Responding to your letter of March 10th, we beg to suggest that
literature covering the different matters at issue are readily
available to your referee, and all statements emanating from us are
made advisedly.
“If you cannot satisfy yourselves that this preparation is a
scientific product, ethically advertised, and a desirable advance
in therapeutics, you can only delete it from your next issue of New
and Nonofficial Remedies.”
It is to be regretted that Eli Lilly and Co. refuse either to withdraw
or modify their claims or to substantiate these claims by scientific
evidence. The statements as they stand are exaggerated, misleading
and harmful. As such they conflict with Rule 6 of the Council and
necessitate the omission of Alcresta Ipecac from New and Nonofficial
Remedies. The referee recommended the adoption and publication of this
report.--(_From The Journal A. M. A., Oct. 20, 1917._)
IODEOL AND IODAGOL
Report of the Council on Pharmacy and Chemistry
Iodeol and Iodagol (formerly called Iodargol) are products of Viel and
Company, Rennes, France, widely advertised in this country by David B.
Levy, Incorporated, New York. The claim made for both preparations is
that they depend on “colloidal iodin” for their action. They are put up
in a number of forms, for instance:
“Iodeol Ampoules each containing 1 c.c. (20 centigrammes colloidal
iodin in an oily vehicle).”
“Iodeol External, containing 50 per cent. colloidal iodine.”
“Iodagol Ampoules, each containing 2 c.c. (50 centigrammes
colloidal iodine in an oily vehicle).”
The claim is, that, the iodin being in the colloidal state, it has the
properties of elementary iodin and thus the preparations may be used in
concentrations and under conditions which would make the use of free
iodin impossible. The products have been extensively and extravagantly
advertised for use in a wide range of conditions. Thus Iodeol has been
proposed in the treatment of:
“Pulmonary Tuberculosis”
“Laryngeal Tuberculosis,”
“Glandular Tuberculosis”
“Tuberculosis of the Bones”
“Pneumonia, Broncho-pneumonia, and Congestive Conditions”
“Whooping Cough, Influenza, Asthma”
“Typhoid Fever”
“Syphilis”
“Obesity.”
Iodagol, which is for external use, has been advised in the treatment
of:
“Gonorrhea and its Sequelæ”
“Cystitis”
“Tetanus”
“Wounds complicated by gaseous gangrene”
“Burns”
“Old Suppurations, ulcers, abscesses, etc.”
“Articular rheumatism”
“Abscess Alveolar”
“Pyorrhea Alveolaris”
“Stomatitis (Canker-Sores).”
Nearly two years ago the American agents requested the Council to
consider Iodeol and Iodagol for admission to New and Nonofficial
Remedies. The information submitted in regard to their character and
composition was vague and indefinite, the pharmacologic information
practically nil and the clinical data as voluminous as it was
unconvincing.
On the basis of chemical, pharmacologic, bacteriologic and clinical
investigation carried out under the direction of the referee and a
study of the submitted evidence, the referee reported:
1. Iodeol and Iodagol do not contain the amount of iodin claimed.
2. The iodin is not present as elementary iodin, but instead the
preparations behave similarly to the well-known organic iodin compounds
such as iodized fats.
3. The therapeutic claims made for the preparations are exaggerated and
unwarranted.
In view of his findings he recommended that Iodeol and Iodagol be
declared inadmissible to New and Nonofficial Remedies for conflict
with Rules 1 and 2 (misleading statements regarding composition and
identification) and Rule 6 (unwarranted therapeutic claims). The
Council adopted the recommendation of the referee, directing inclusion
of the full report in the annual Council reports after submission to
the manufacturer, and recommending publication of an abstract of this
report in The Journal.
This report was brought to the attention of the American agent, David
B. Levy, Inc., and through them to the French manufacturers, E. Viel
and Company. The manufacturers have intimated that they will not file
a reply to the report. The firm of David B. Levy, Inc., has decided to
sever its connection with these products and to discontinue their sale.
W. A. Puckner, Secretary.
Summary of Referee’s Report
Iodeol and Iodagol were submitted to the Council nearly two years ago
as “electro-colloidal iodine” and with the claim that they produced
all the antiseptic and other effects of ordinary iodin without any
of its side actions. The referee has done much work on the subject,
conducted a large amount of correspondence and has contended with
long delays. He feels that the consideration of these products should
be brought to a conclusion and accordingly he submits this report of
their consideration. The following is a summary of the report, which is
appended:
_I. Discrepancy in Iodin Percentage._--The examination at the Chemical
Laboratory of the American Medical Association, as well as that of the
referee, shows that the various samples of Iodeol and Iodagol examined
contained a little less than one-half of the total iodin claimed. These
facts were reported to the American agent. After a lengthy delay a
reply was received which presented a double excuse: (1) that the full
amount of iodin had been added, whatever had become of it later; (2)
that the claims were made for “colloidal iodin” and that this is not
elementary iodin in the colloidal state, but a preparation of iodin
containing only 50 per cent. of real iodin. Neither explanation can be
taken seriously, as they are obvious quibblings. The referee concludes
that the preparations are falsely labeled as to iodin content.
_II. Nature of the Iodin Compound in Iodeol and Iodagol._--In the
information sent the Council, Iodeol and Iodagol were defined as
“A suspension of electro-chemical colloidal iodin in a vehicle of
purified oil.” Numerous inquiries have failed to elicit more specific
information from the manufacturer or his agent. The statement of
composition can mean only that the preparations contain free iodin (but
in colloidal form) suspended in oil. No evidence to substantiate this
claim has been submitted. (There is evidence that the preparations
contain colloidal particles, but it does not indicate if this colloidal
material is iodin, or a combination of iodin or indeed whether the
colloidal component contains any iodin.) The recent statements of the
agent seem to concede that what they call “electro-colloidal iodin”
contains only about 50 per cent. of real iodin, in other words that it
is not “colloidal iodin” at all, but a mixture or combination of iodin
with some other unnamed substance. This, of course, is something very
different.
Certain results reported from the American Medical Association’s
Chemical Laboratory suggest that the so-called “colloidal iodin”
of Iodeol may be a combination of iodin with a volatile oil. The
investigations of the referee indicate that the iodin exists in a
rather resistant form or combination behaving altogether differently
from ordinary free iodin, and rather resembling the behavior of iodin
substitution products, such as iodized fats or phenols. Briefly
then the recent admissions of the agents indicate that Iodeol does
not contain “colloidal iodin” in a chemical sense, and there are
indications that it does contain its iodin in a rather firm (chemical)
combination.
_III. Chemical Properties of Iodeol._--From a study of different
specimens of Iodeol, the referee concludes that fresh specimens contain
no free iodin and that old ones contain small amounts as a result of
decomposition. Iodeol has the solubility characteristics of fats and
fat-like compounds. The examination, as a whole, shows that Iodeol
contains a peculiar and rather resistant form or combination of iodin.
There is nothing in the chemical data that suggests that it could act
differently from ordinary iodin compounds, such as iodized fats. It
would not act as ordinary iodin.
_IV. Pharmacologic Data._--The pharmacologic statements which were
submitted were loose and apparently meaningless or misleading. In
reply to questions submitted by the referee, the manufacturer finally
had some work done and submitted a report by Jean Laumonnier. The
referee was unable to confirm some of this work, and as a whole it
does not appear materially to elucidate the action of Iodeol. From a
consideration of the submitted evidence, and as a result of his own
work, the referee concludes that Iodeol does not behave like elementary
iodin; it does not coagulate proteins and therefore is not irritant. It
is presumably absorbed, but quite probably after chemical change; it is
changed into iodid and, like organic iodids, is excreted somewhat more
slowly than when inorganic iodids are administered, but the difference
does not appear important.
_V. Antiseptic and Bactericidal Action._--Elementary iodin is
considered a fairly powerful agent in these respects. The activity
is presumably due to changes in the proteins, etc., of the bacteria,
analogous to the effects which produce pain, irritation and necrosis of
the tissue cells. Since the latter effect is not produced by Iodeol,
it seems highly improbable, if not impossible, that it should act on
bacteria like elementary iodin. It is entirely unjustifiable to credit
the known antibacterial qualities of ordinary iodin to “colloid” iodin.
This misrepresentation is especially prominent in the circular “Notable
New Therapeutic Agents,” as will be seen, for instance, from the
following citations:
“Iodine has long been universally recognized as an antiseptic of
extraordinary potency. Not only is it rapid and certain in its
germ-destroying action, but it also possesses an attribute denied
many other antiseptic agents, namely, the power to penetrate and
impregnate the tissues. Other antiseptics, as is well known, act on
the surface epithelium only.”
“According to Kinnaman (J. A. M. A., Aug. 26, 1905), iodine is far
superior to bichloride of mercury, a two per cent. solution killing
streptococcus pyogenes in two minutes. Iodine does not coagulate
albumin, and is very penetrating.”
The citations imply that this “colloidal iodin” of Iodeol and
Iodagol acts as an antiseptic like ordinary iodin, except that it is
claimed to be more efficient by “diffusing” more readily. This is
entirely unjustified and misleading. If Iodeol and Iodagol are really
antiseptic, they must act by some other mechanism than that through
which elementary iodin acts, and such antiseptic action would have to
be demonstrated by direct observation and not assumed from the known
action of free iodin.
Antiseptic and bactericidal effects are easily estimated by laboratory
methods. Yet no evidence on this point appeared to have been available
until the Council called for this. Laumonnier then carried out some
experiments which were in turn submitted to bacteriologic control. The
bacteriologist failed to obtain any results with some of the tests, and
considered the other data of little value.
The claim that Iodeol and Iodagol have the antiseptic and bactericidal
action of free iodin lacks proof and must be considered unwarranted and
misleading in the extreme.
_VI. Clinical Trials._--The manufacturers and agents of Iodeol
presented many letters from physicians; but few, if any, of these gave
evidence of careful, critical, controlled observations. They could not,
therefore, be considered as acceptable evidence. The more important
claims, letters and published papers, however, were submitted to
clinical specialists collaborating with the Council, with the request
that they examine these and conduct some clinical trials, if they
considered it advisable. The results obtained in these preliminary
trials did not appear sufficient to warrant further experimentation.
From a consideration of the evidence presented, the referee concludes
that the claims made for Iodeol and Iodagol are unwarranted,
exaggerated and misleading. He recommends that Iodeol and Iodagol be
declared ineligible for New and Nonofficial Remedies for conflict
with Rules 1 and 2 (misleading statements as to composition and
identification) and with Rule 6 (unwarranted and misleading therapeutic
claims). He further recommends that the Council authorize publication
of the preceding summary of the consideration of Iodeol and Iodagol
in The Journal and inclusion of the full report in the annual Council
reports after submission to the manufacturer.--(_From The Journal
A. M. A., Nov. 17, 1917._)
CAPSULES BISMUTH RESORCINOL COMPOUND NOT ADMITTED TO N. N. R.
Report of the Council on Pharmacy and Chemistry
In response to inquiries received, the Council took up the
consideration of Capsules Bismuth Resorcinol Compound (The Gross Drug
Company, Inc., New York City). The label, sent by the Gross Drug
Company, bore the following:
CAPSULES
BISMUTH RESORCINOL COMPOUND
Bismuth Subgallate 2 grs.
Resorcinol 1 gr.
Beta Naphthol 1/2 gr.
Creosote (Beechwood) 1 m.
This combination is of acknowledged value
in reducing the value in reducing the intes-
tinal putrefaction and fermentation, allaying
the pain and discomfort of flatulent conditions
in the intestinal tract.
DOSE.--One or two capsules before or after meals
repeated in two hours if necessary.
The Gross Drug Company, Inc.
20 Laight Street, New York
The Council held this preparation inadmissible to New and Nonofficial
Remedies or the Appendix, because (1) the claim “acknowledged value in
reducing the intestinal putrefaction and fermentation, allaying the
pain and discomfort of flatulent conditions in the intestinal tract” is
an unwarranted, exaggerated and misleading claim of therapeutic value
(Rule 6); because (2) the name does not indicate the identity of the
bismuth salt contained in the capsules, nor declare the presence of
betanaphthol and creosote (Rule 8); and because (3) the combination
of bismuth subgallate, resorcinol, betanaphthol and creosote in fixed
proportions is irrational (Rule 10).--(_From Reports of Council on
Pharmacy and Chemistry, 1917, p. 139._)
DIXON’S TUBERCLE BACILLI EXTRACT AND DIXON’S SUSPENSION
OF DEAD TUBERCLE BACILLI
Report of the Council on Pharmacy and Chemistry
New and Nonofficial Remedies, 1917, contains general descriptions
of Dixon’s Tubercle Bacilli Extract and Dixon’s Suspension of Dead
Tubercle Bacilli; the products of these manufactured by the H. M.
Alexander Company being listed as dosage forms. It having become
necessary to omit the preparations of the Alexander Company (see page
138) the referee recommended that the general articles of “Dixon’s
Tubercle Bacilli Extract” and “Dixon’s Suspension of Dead Tubercle
Bacilli” also be omitted. He reported that no other firm appears to
be marketing these products and that they had not been shown to be of
special value.
The Council accepted the recommendation and directed the omission as
proposed. In accordance with the procedure of the Council, these have
been transferred to the annual Council Reports for reference and appear
below.
W. A. Puckner, Secretary.
=Dixon’s Tubercle Bacilli Extract.=--An extract of tubercle bacilli
dissolved in normal saline solution. (See “Fluid of Dixon,” _Medical
News_, Jan. 17, 1891.)
=Dixon’s Suspension of Dead Tubercle Bacilli.=--A suspension in
physiologic salt solution of dead tubercle bacilli which have
been defatted by prolonged treatment with alcohol and ether. (See
“Possibility of Establishing Tolerance for Tubercle Bacilli,” _Medical
News_, Oct. 19, 1889.)--(_From Reports of Council on Pharmacy and
Chemistry, 1917, p. 140._)
FORMOSOL
Report of the Council on Pharmacy and Chemistry
Sunshine’s Formosol (The Formosol Chemical Company, formerly the
Sunshine Chemical Company, Cleveland, Ohio) is claimed to contain
18 per cent. formaldehyd in a solution of soap. It is therefore
very similar to Veroform Germicide which was deleted from New and
Nonofficial Remedies because of the low phenol coefficient reported by
the Hygienic Laboratory of the United States Public Health Service (The
Journal, Nov. 22, 1913, p. 1920.) The Council voted that in view of the
Hygienic Laboratory’s finding that formaldehyd has a low germicidal
value, the manufacturers of Formosol be required to produce definite
evidence of the degree of germicidal value for this product.
In submitting the preparation to the Council, it was claimed that
Formosol had “all properties peculiar to Formaldehyde.” This
conservative tone was, however, not maintained in the form-letters
submitted. These contain the following unwarranted statements:
“As the name implies, FORMOSOL is a formaldehyde preparation, which
embodies all the innate antiseptic merits and eliminates all the
ill features of the world’s greatest disinfectant.”
“The elimination of all the destructive elements and the
incorporation of all the established therapeutic virtues of
formaldehyde, have been scientifically blended in FORMOSOL.”
“FORMOSOL is unique in the sphere of antisepsis because of its
peculiar healing properties as diametrically opposed to irritation
to the tissue of mucous membrane.”
“FORMOSOL may be used for the thousand niceties of modern
antisepsis, but is _specific_ in Gynecology and Obstetrics and is
indicated in Dermatology.” [Italics not in original.]
“The constant use of FORMOSOL is to develop a habit sympathetic to
ethics.”
“To prescribe FORMOSOL is a great step toward Personal Hygiene, a
_duty of the medical fraternity_ to the laity.” [Italics not in
original.]
The trade package recommends the use of Formosol “for cuts, wounds,
ulcers, abscesses ...” This is a conflict with Rule 4. The Council held
Formosol in conflict with Rules 4 and 6, and advised the manufacturers
that Formosol is refused admission to New and Nonofficial Remedies
until they submit evidence establishing the degree of antiseptic and
germicidal efficiency, and justify the quotations listed above; or
until these and any other existing conflicts with the Rules have been
removed.
After submission of this report to The Formosol Chemical Company the
Council authorized its publication.--(_From Reports of Council on
Pharmacy and Chemistry, 1917, p. 145._)
IODOLENE, A SOLUTION OF IODIN IN LIQUID PETROLATUM,
INADMISSIBLE TO N. N. R.
Report of the Council on Pharmacy and Chemistry
The Council was asked to consider a solution of iodin in liquid
petrolatum, said to be prepared from Gulf Coast petroleum by a special
process. It was to be marketed as “Iodolen” provided the Council
found the preparation admissible to New and Nonofficial Remedies. The
preparation was claimed to contain over 1.5 per cent. free iodin. The
following claims were made:
“It is less irritating in its use on the skin, or in wounds.” “Will
kill pathogenic micro-organisms present.” “Is a suitable medium for
cell proliferation.” “Will penetrate a useful distance into the
walls of a wound.” “Facilitates an easier, less painful and better
method of dressing wounds or ulcers.”
Examination in the American Medical Association Chemical Laboratory
showed a submitted sample to contain 1.32 per cent. free iodin and
to emit a strong odor of hydrogen sulphid. A specimen of liquid
petrolatum, said to be composed chiefly of hydrocarbons of the
naphthene series, after saturation with iodin at room temperature was
found to contain 1.42 per cent. free iodin. Another specimen of liquid
petrolatum, said to be composed chiefly of saturated hydrocarbons,
after saturation at room temperature was found to contain 1.30 per
cent. free iodin.
The preparation having been shown to be an unoriginal, simple
solution of iodin in liquid petrolatum, the Council declared the name
“Iodolene” unacceptable (Rule 8) and the therapeutic claims made for
the preparation unwarranted (Rule 6).--(_From Reports of Council on
Pharmacy and Chemistry, 1917, p. 148._)
KALAK WATER
Report of the Council on Pharmacy and Chemistry
The following report, submitted by a member of the Council’s committee
on chemistry, was endorsed by the committee and adopted by the Council:
Kalak Water, sold by the Kalak Water Company, Inc., New York, is an
artificial mineral water said to be made by adding certain salts to
carbonated, distilled water and supersaturating with the gas under
pressure. Such merit as it may possess by virtue of sodium bicarbonate
and sodium phosphate is quite insufficient to warrant the extravagant
claims made in the advertising pamphlets.
According to the analysis furnished, the water contains, in 1,000,000
parts (milligrams per liter) the following:
Sodium carbonate 4049.0
Sodium phosphate 238.5
Sodium chloride 806.3
Calcium carbonate 578.2
Magnesium carbonate 48.9
Potassium chloride 47.9
Among the many misleading statements found in the advertising pamphlet
bearing the title “A Brief for Physiological Alkalescence” these may be
quoted:
“The calcium content of Kalak is over 100% greater than ever before
placed in solution in any vehicle, a fact of supreme importance
when the unique alkalinizing power of the alkaline salts of this
metal is considered; the ratio of calcium metabolism to its
enormous waste in pregnancy, the diseases of infancy and childhood
and the rapidly growing group of ‘acidoses’ make its availability
in Kalak of double value.”
The first part of this statement is untrue; the last part is muddled
and without much meaning. Evidently the “acidosis” fad is to be
overworked as was the old “uric acid diathesis,” of unsavory memory.
Again this:
“One of the most important characteristics of Kalak is the close
approximation of its formula to the correlation of the contained
salts as they occur in the human body, together with its freedom
from salts foreign to the human economy. Another is its almost
unbelievable palatability, considering its high degree of
alkalinity, it being eleven times greater than any other known
mineral water, artificial or natural.”
These statements are false. The salts dissolved here bear no
discernible relation to the needs of the body, as disclosed by the
composition of the blood or solid tissues or as shown by the character
of the urinary excretion. The last statement concerning the high
alkalinity is neither clear nor accurate. Then, this warning and remedy:
“It seems to be an unappreciated fact that the degree of urinary
acidity, checked with the acidity of the saliva, is in direct ratio
to the existing acid toxemia, and a urine acid to methyl red should
be the signal for immediate and adequate alkalinizing treatment....
“Startling clinical results have been observed by physicians who
have used Kalak thoughtfully and sufficiently in the more serious
types of acidosis associated with diabetes, nephritis, rheumatism,
gout and the acute infections. There is also evidence of its good
effect in acute alcoholism and the respiratory edemas; in fact a
certain few have hailed Kalak as a possible solution of the annual
hay fever problem. Of perhaps supreme importance, however, is the
use of Kalak throughout pregnancy as preventive medicine against
the inevitable ‘toxemia of pregnancy.’”
Also this:
“Kalak has accomplished certain unexplainable things for the
diabetic and nephritic, and if, in future years, diabetes and
nephritis should prove to be constitutional diseases, based upon
functionation or its lack, Kalak therapy, the embodiment of
physiological alkalescence may come into its own, for if acidity
retards, alkalinity must normalize functionation.”
It is not necessary to quote further. In order to insure that everyone
will recognize the great need of Kalak it is advised to test the urine
for acidity by means of a group of indicator solutions sent out to the
physicians. Methyl red is one of these and any urine showing an acid
reaction with this is said to be open to suspicion. Paranitrophenol is
another of the indicators and the explanations given of the behavior of
the two and the conclusions to be drawn are questionable. The methyl
red solution furnished is too concentrated for proper use and perfectly
normal urines from normal individuals have given a rather marked color
with it. This indicator gives some color at [H+] = 1.2 × 10^{-6} and a
strong reaction at 3 × 10^{-3}. To condemn a urine on such a finding is
entirely unwarranted.
Sodium bicarbonate is the main constituent of the water. The value
of the phosphate in such a combination, with so much calcium, is
problematical. In case an alkaline reaction in the intestine is reached
some of it would be left as insoluble phosphate. A few grams of
bicarbonate daily would have equal therapeutic value with this water.
The advice based on the indications of methyl red and the urine is bad.
The committee’s report was sent to the Kalak Water Company for comment.
The company promised to withdraw the advertising circular referred to
in the report and disclaimed responsibility for the accuracy and value
of the set of indicators which it sent out, but, on the whole, the
previous advertising claims were insisted on.
In view of the absurd and false claims made for the product the Council
declared Kalak Water inadmissible to N. N. R.--(_From Reports of
Council on Pharmacy and Chemistry, 1917, p. 148._)
MINSON’S SOLUBLE IODIN “KELPIDINE” NOT ADMITTED TO N. N. R.
Report of the Council on Pharmacy and Chemistry
Minson’s Soluble Iodin “Kelpidine” was submitted to the Council by
J. J. Minson, Washington, D. C., trading as the Kelpidine Company,
with the statement that in future “literature” it was to be known as
Minson’s Soluble Iodin, only. The following statement of composition
was furnished:
“Minson’s Soluble Iodin is somewhat of an indefinite character,
chemically. Its formula is, Iodin 4 per cent., Distilled Water
6 per cent., and Absolute Alcohol _q. s._ 100 per cent. By a
process of chilling and heating an iodid of uncertain character is
produced, and because of the extreme sensitiveness of the product
to chemical tests, it is hard to determine. So far as I have been
able to judge, however, the result is about 3 or 3-1/2 per cent.
free iodin and from 1/2 per cent. to 1 per cent. iodid, possibly
ethyl and hydrogen iodid in combination.”
The A. M. A. Chemical Laboratory reports that the preparation is an
alcoholic solution containing free iodin and iodid, probably hydrogen
iodid and ethyl iodid, but that the free iodin content was only
2.69 gm. per 100 c.c.
It is claimed that the “therapeutic indications” of Minson’s Soluble
Iodin are the “same as those of all iodin and iodid preparations,
internally, externally, hypodermically and intravenously; excepting,
however, counter irritation.” It is admitted that there are no
“clinical reports” as to the hypodermic and intravenous use, but the
belief is expressed “that in an emergency it is a safe remedy under
proper dilution.” It is further claimed that “for all practical
purposes it is nontoxic and nonirritating” and that “it has none of
the undesirable features such as is the case with the iodids and the
organic preparations of iodin, proprietary or otherwise.”
It was assigned for consideration to the Committee on Pharmacology,
whose referee reported:
“According to the information submitted, this is a tincture of iodin;
differing from the official tincture in that it is more dilute and in
that hydrogen and ethyl iodid is the solvent in place of potassium
iodid. It is practically immaterial for internal administration,
whether the cation of the solvent iodid is hydrogen, ethyl, potassium
or sodium. It would certainly be inadvisable to inject a preparation
containing free iodin hypodermically. It is not ‘a safe remedy’ for
intravenous injection and it would not be nonirritant. The statement
that ‘it has none of the undesirable features’ of other iodin compounds
is inherently impossible. Apparent freedom of any iodin preparation
from undesirable effects is generally due to the use of small doses.
Such claims are plainly therapeutic exaggerations and therefore in
conflict with Rule 6. Even should these be removed, the preparation
must be held an unessential modification of the official tincture, and
therefore in conflict with Rule 10.”
The report was agreed to by the committee and adopted by the Council
and Minson’s Soluble Iodin “Kelpidine” declared inadmissible to New
and Nonofficial Remedies.--(_From Reports of Council on Pharmacy and
Chemistry, 1917, p. 152._)
NUTONE
Report of the Council on Pharmacy and Chemistry
NuTone (NuTone Company, Lowell, Mass.) is a “nutritive tonic” said to
have the following complex composition:
Cod Liver Oil, Pure Norwegian, 25 per cent.
Malt Extract, 9-1/3 per cent.
Beef juice,
Glycerine,
Hypophosphite Lime, Hypophosphite Soda, Chemically pure,
1-1/2 grs. each to the oz.
Fl. Ext. Nux Vomica, 3/64 of a minimum in each teaspoonful.
It is advertised with claims that will lead thoughtless physicians
and a confiding public to depend on it in cases in which fresh air,
hygienic surroundings and nutritious food are of prime importance.