Digitalis, 1/4 gr.; Cochium [colchicum?] Seed, 1/4 gr.; Squill,
1/4 gr.; Cascarin, 1/16 gr. with aromatics.”
“Pulvoids Calcylates Compound (Sugar coated orange color)”
is advertised (_Medical Times_, January, 1919) as being
“Analgesic-Antipyretic and Diuretic,” and is included in the
preparations designated by the advertiser as “Approved Remedies for
LaGrippe and ‘Flu.’” The claim that “Their tolerance is remarkable”
refers not to the physicians who tolerate such products, but to the
alleged fact that Pulvoids Calcylates are tolerated remarkably well.
The advertisement continues:
“May be given persistently and continuously without gastric
disturbances.”
“They are uniformly efficient. More certain in effect than the
ordinary Salicylates.”
It would be difficult to find an advertisement of equal length
containing a greater number of misleading or directly false statements
than are found in this one. The Journal (April 22, 1916, p. 1307) has
called attention to the lack of justification for this absurd mixture
of drugs and has discussed the preparation with especial reference to
its use in acute rheumatism, in which the salicylates occupy a special
field. The advertisement just quoted mentions La Grippe and “Flu” (or
Influenza) as special fields of usefulness for this preparation. This,
apparently, is merely an attempt to spread the sail for any breeze.
Salicylates have a field of usefulness in influenza in that they
often afford relief from pain. There is no reason to suppose that a
mixture containing calcium and strontium salicylates--the “Calcium and
Strontium Disalicylate” of Pulvoids Calcylates is probably a mixture
of calcium and strontium salicylate[127]--has any greater salicylic
effect than an equal amount of sodium salicylate. On the other hand, it
is worse than useless to give colchicum, squill and digitalis for the
relief of such pains.
[127] See report, The Journal, Sept. 9, 1916, p. 827.
Should cardiac dilatation develop, and digitalis medication be
required it would be impossible to adjust the dose of such a mixture
with special reference to the digitalis action, which alone would be
indicated for that condition. No educated physician at present would
think of giving resin of guaiac merely because his patient required
digitalis, nor would he administer “cascarin,” whatever that may be, in
fixed doses, every time he gave a dose of salicylate.
It is impossible to recognize the several effects induced by this
therapeutic omneity, and the medical profession should consider it an
insult to be offered mixtures such as Pulvoids Calcylates Compound.
Pulvoids Calcylates Compound is, per se, of no great importance; it is
one of a type. It has been selected as one of the utterly irrational
and therefore potentially dangerous mixtures, that may be found by
the score or the hundred in the catalogues of practically every
pharmaceutical manufacturing firm in the United States.--(_From The
Journal A. M. A., June 14, 1919._)
PROTEOGENS OF THE WM. S. MERRELL COMPANY
Report of the Council on Pharmacy and Chemistry
The Council has adopted and authorized publication of the statement
which appears below, declaring Proteogen No. 1 (Plantex) for Cancer,
Proteogen No. 2 for Rheumatism, Proteogen No. 3 for Tuberculosis,
Proteogen No. 4 for Hay Fever and Bronchial Asthma, Proteogen No. 5
for Dermatoses, Proteogen No. 6 for Chlorosis, Proteogen No. 7 for
Secondary Anemia, Proteogen No. 8 for Pernicious Anemia, Proteogen
No. 9 for Goitre, Proteogen No. 10 for Syphilis, Proteogen No. 11
for Gonorrhea, and Proteogen No. 12 for Influenza and Pneumonia
inadmissible to New and Nonofficial Remedies because their
composition is secret; because the therapeutic claims made for them
are unwarranted; and because the secrecy and complexity of their
composition makes the use of these preparations irrational.
The Council took up the consideration of the Merrell Proteogens because
of inquiries received, and on January 27 invited the Merrell Company
to aid in the proposed investigation by submitting information in
regard to the composition of the preparations, submitting the current
advertising, and presenting evidence for the claims that were made
for the preparations. While the Merrell Company agreed to submit the
requested information, this had not been received at the time the
report of the referee to whom the products had been assigned (Referee
1), was adopted. This report was sent to the company on April 4. In
reply the Merrell Company protested against the conclusions of the
report and submitted considerable material in an attempt to support
the claims made for the products. This material was examined by the
first referee and then transmitted to a second referee (Referee 2) for
consideration. The second referee concluded that the matter submitted
offered no evidence that would justify the Council in modifying the
report first adopted, and hence recommended that its publication be
authorized.
In accordance with this recommendation (report of Referee 2) the
Council authorized the publication of the reports of both the first and
second referees.
W. A. Puckner, Secretary.
Report of First Referee on Proteogens
“Proteogens,” according to the William S. Merrell Co., are “Polyvalent
Proteins of Non-Toxic Plant Origin.” The subject of Proteogens can
best be approached by recalling the history of “Autolysin,” an
alleged remedy for cancer, originated by A. S. Horowitz, Ph.D. This
was exploited some years ago, and was finally shown to be worthless.
Proteogens are said to be prepared “under the personal supervision of
the originator, Dr. A. S. Horowitz.” The composition of the different
Proteogens is essentially secret. The assertion was made at one time,
but is not found in the present advertising matter, that Plantex--now
called “Proteogen No. 1”--is similar to Autolysin. Now the Proteogens
are said to be “prepared by a special process employing various
combinations of plants.” Further:
The biologic principles present are chlorophyll, chromoplast,
lipoids and vitamines; these are ferments or enzymes. The vegetable
acids, metalloids and metals present in all plants in colloid form
act biochemically. Among the metalloids are hydrogen, carbon,
manganese, oxygen, sulphur, phosphorus and chlorine; the heavy
metals are iron, potassium, sodium, magnesium and copper. These
biochemic principles are always present in plants as colloids.”
It is claimed by the Merrell Company that:
“Proteogens stimulate the cytogenic mechanism to higher activity;
therefore, indirectly cleave the invading microorganism and
eliminate their special toxins. Proteogens swing the disturbed
metabolism back to normal and, by natural processes, build up
effective defenses against recurrent bacterial attacks.”
Proteogen No. 1 was first introduced as “Plantex,” and at that time the
Merrell Company referred to a preparation that was the result of “a
series of studies” carried out by a “noted biologist” with a view of
“evolving a Cancer remedy” that was “to be autolytic in character,” and
announced:
“The House of Merrell always interested in the progress of plant
therapy, began pharmacological experimentations to reproduce this
same substance. The qualitative and quantitative analysis of the
substance as used in New York having been published simplified
matters. A somewhat similar remedy has now been prepared. It
consists of the following substances--Menyanthes trifoliata
[Buckbean], Melilotus officinalis [Yellow sweet clover], Mentha
crispa [Curled mint], Brassica alba [White mustard], Anemone
hepatica [Liver leaf], Viola tricolor [Pansy], Anthemis [Roman
chamomile], Fructus colocynthidis [Colocynth], Lignum quassiæ
[Quassia], Urtica dioica [Nettle], Radix rhei [Rhubarb root], Hedge
hyssop. These substances are in approximately equal proportions
with the exception of the mustard which forms 20 per cent. of the
mixture, and the colocynth fruit which is 5 per cent.”
With respect also to the other Proteogens listed above, study of
medical literature revealed no evidence establishing their therapeutic
value; in fact, no evidence was found other than that appearing in
the advertising matter of the manufacturer. The range of diseases in
which Proteogens are recommended is so wide as to make obvious the
lack of scientific judgment which characterizes their exploitation. A
circular letter, received January, 1919, reminded the physician that
about a year ago his attention had been directed to Proteogen No. 1
for cancer, that later developments enabled the firm to recommend for
his consideration “a series of Proteogens (Nos. 2 to 9),” and that now
“In response to an insistent demand, Dr. A. S. Horowitz has prepared
two new Proteogens--No. 10 for Syphilis and No. 11 for Gonorrhea.”
A postscript to this circular letter announced another preparation,
“Proteogen No. 12 for Influenza and Pneumonia,” a “development out of
the present influenza epidemic,” and admitted that “It has not had
the clinical experimentation that precedes our introduction of a new
product.”
The introduction of No. 12 was effected by means of a special bulletin
which consists exclusively of clinical reports from seven physicians,
all from Chicago save one, and all purporting to show most favorable
results from No. 12. They describe cases which any physician with
experience with influenza can duplicate without any special treatment.
It is difficult to give serious consideration to a set of alleged
remedies when the only evidence is that furnished by the proponents of
the alleged remedies. This is particularly true when the alleged remedy
does not make a sufficient appeal to one’s sense of the rational in
therapeutics to lead one to feel justified in asking a trial at the
hands of careful clinical observers. Considering the grave nature of
the diseases for which Proteogens are recommended, particularly cancer,
tuberculosis, and pernicious anemia, the want of a rational basis
for the method of treatment and the general tenor of the advertising
matter, it appears safe to conclude that these agents do not represent
any definite advance in therapeutics.
As the use of preparations, secret in composition, and of no
established value, is contrary to rational therapy, it is recommended
that the Proteogen preparations be declared in conflict with Rules 1, 6
and 10.
Report of Second Referee Reviewing Manufacturers’ Reply
The report declaring the Proteogens of the William S. Merrell Company
inadmissible to New and Nonofficial Remedies was adopted by the
Council, but before publication it was sent to the Merrell Company
for such comments as it might desire to make. In due time the reply
of the firm was received. It consisted of two volumes bound in limp
morocco, each stamped in gold: “Report Proteogen Therapy Requested by
the American Medical Association, 1919; The Wm. S. Merrell Company.”
The first volume contained 79 pages of typewritten material; the second
volume contained 76 pages of typewritten material and a number of
advertising booklets put out by the Wm. S. Merrell Company, exploiting
the Proteogens.
Among the typewritten material was a 14-page report on “Proteogen
Therapy” by its originator, A. S. Horowitz. Following this there
are several pages devoted to what is termed “a short qualitative
description of the ingredients of major importance in Proteogens.”
Then follows a page describing the advertising of Proteogens, and
the remainder of the two books is devoted to testimonials, lauding
the benefit of Proteogens in diseases such as cancer, tuberculosis,
rheumatism, asthma, influenza, enlarged prostate, rheumatic
endocarditis, syphilis, eczema, psoriasis, diabetes, secondary anemia,
gonococcic infections, etc. Finally, there are attached samples of
advertising pamphlets.
The dissertation by A. S. Horowitz contains little actual information
concerning these substances, but is concerned principally with
discussion of foreign proteins, “antiferments,” “non-specific
proteins,” “anti-virolins” and speculations on their hypothetical
actions and interactions on each other and on the organs of the body
and on bacteria. The report contains many questionable statements.
One finds in this report but few definite statements of facts which
are known to be accurate or which could be accepted without question.
The qualitative description of the proteins and their components is
as vague as the previous discussion. The differentiation between the
various Proteogens is extremely indefinite; that for Tuberculosis,
No. 3 is described as “polyvalent, non-specific protein which rapidly
attacks the acid-fast, encapsulated tubercle bacilli”; Proteogen No.
10 for syphilis is said to be a combination of “non-specific plant
proteins and different chemicals which has the power to paralyze and
destroy living spirochete.” It is stated that Proteogens are scientific
preparations based on standard ingredients and that the standardization
is more accurate than in serums, vaccines or toxins, etc. The report
gives no proof of such statements.
The testimonials that are submitted are typical of “reports” that
manufacturers are able to obtain from some physicians, to prove the
efficacy of almost any preparation in any disease. Each consists,
practically, of the opinion of the individual who has employed the
Proteogens or the opinion of the patient who has been treated. Few data
are given in these reports from which an impartial conclusion might be
drawn. A few of the testimonials presented by the William S. Merrell
Company follow. The valuelessness of such material as scientific
evidence is obvious:
RHEUMATISM:--_Proteogen No. 2._--The Doctor has one case being
treated with No. 2. She has improved so rapidly she cannot express
her pleasure, and will continue for some time on the treatments.
She is a patient who was confined during the time she suffered from
a rheumatic illness, and it seemed to affect her mental condition.
This condition is clearing up also, very much to the pleasure of
both patient and doctor.--November 27, 1918.
INFLUENZA:--_Proteogen No. 12._--First day, temperature 102,
gave 1 c.c. Proteogen No. 12; second day, temperature 100,
gave 1 c.c. Proteogen No. 12; third day, temperature 98.8,
gave 1 c.c. Proteogen No. 12, and then discharged the case as
recovered.--October 31, 1918.
ASTHMA:--_Proteogen No. 4._--Splendid results obtained from a
sample of Proteogen No. 4. Three ampoules affected [effected?]
complete recovery.--October 9, 1918.
CANCER:--_Proteogen No. 1._--Mrs. B. pronounced recovered from
Cancer by Dr. O. W. A., of Catlin, after having injections of
Proteogen No. 1 for some time.--October 4, 1918.
ECZEMA:--_Proteogen No. 5._--Tried No. 5 on a patient with
eczema, and with happy results. Have not done anything for him
for about five months--and he is now at his business. Proteogen
No. 5 also RELIEVED HIM OF CONSTIPATION AND WHAT HE CLAIMED A
TRAUMATIC STRICTURE OF THE LOWER PORTION OF SIGMOID FLEXURE.
He is sure pleased and recommending them to his friends.
(Proteogens).--February 17, 1919.
SYPHILIS:--_Proteogen No. 10._--I am getting such excellent results
with the No. 10 Proteogen for Syphilis that I am badly in need of
more, as I am treating so many cases. Please send me four dozen
C. O. D.--October 9, 1918.
ENLARGED PROSTATE:--_Proteogen No. 1._--Have used Plantex in four
cases, with good results in each case. One of them his father, an
elderly man.--April 25, 1918.
LOBAR PNEUMONIA:--_Proteogen No. 12._--The only case I have used
Proteogen No. 12, was a man who had Lobar Pneumonia of left lung
following Influenza. After crisis came, patient continued to have
slight rise in temperature, cough, and after using 10 doses of your
Proteogen No. 12, temperature was normal, cough very much better,
patient began to take on flesh and is still improving.--December
26, 1918.
TUBERCULOSIS:--_Proteogen No. 3._--The Doctor writes: The Proteogen
No. 3 sent me worked wonders in my patient. The case came under my
care when he was too far gone for anything to benefit him a great
deal, but the Proteogen did for him more than anyone could have
expected, yet he died leaving me with a few ampoules to try on the
next patient.--September 20, 1918.
GONORRHEAL CYSTITIS:--_Proteogen No. 11._--My patient has taken
two boxes of your Proteogen No. 11 given for gonorrheal cystitis
of probably two years’ standing and at this writing I consider
her almost, if not entirely, cured which I think speaks very
highly of your remedy. I expect to use more of your preparations
in the future.--April 12, 1919. [This testimonial, either by
clerical error, or because the results were considered remarkable,
was repeated elsewhere in the material submitted by the Merrell
Company.]
ACUTE GONORRHEA:--_Proteogen No. 11._--Mr. A. E. R., age 65, weight
140 pounds. First attack. Had had no previous treatment. Came to me
January 2, 1919. Had discharge, all acute symptoms, burning, etc.
Gave seventeen injections of Proteogen No. 11, also mild antiseptic
urethral wash. Discharged on February 15, 1919, clinically
cured.--April 11, 1919.
EPITHELIOMA OF BUTTOCK.--_Proteogen No. 1._--I used Proteogen No.
1 on an epithelioma of buttock some six months ago with favorable
results and no return of symptoms as yet.--April 13, 1919.
It is obvious that the Proteogen preparations are in conflict with
Rules 1, 6 and 10, and should not be admitted to “New and Nonofficial
Remedies.” It is recommended that the previous action of the
Council be allowed to stand and that publication of both reports be
authorized.--(_From The Journal A. M. A., July 12, 1919_)
“ARSENOVEN S. S.” AND “ARSENO-METH-HYD”
Report of the Council on Pharmacy and Chemistry
The Council authorizes publication of the following report. This report
declares Arsenoven S. S. of the S. S. Products Company and Solution of
Arsenic and Mercury (formerly called Arseno-Meth-Hyd) of the New York
Intravenous Laboratory, inadmissible to New and Nonofficial Remedies.
The Council takes this opportunity to repeat its warning against the
abuses--often dangerous--to which patients are frequently subjected
when “intravenous therapy” is employed.
W. A. Puckner, Secretary.
Because of inquiries received, the Council took up the consideration of
Arsenoven S. S. and Arseno-Meth-Hyd (now sold as Solution of Arsenic
and Mercury). The preparations having been referred to a committee for
consideration, this committee reported:
ARSENOVEN S. S.
“Arsenoven S. S.” is a preparation put out by the S. S. Products
Company, Philadelphia. The claims are made that it is “a simplified
office treatment for syphilis” and is “a combination of arsenic and
mercury for office use, offering maximum efficiency, safety and
convenience.” According to the company, “Arsenoven S. S.” contains
Dimethylarsenin 15.4 grains, Mercury biniodid 1/10 grain, Sodium iodid
1/2 grain. With regard to the identity of “dimethylarsenin” the company
claims: “This product is a compound of cacodylic acid similar to
sodium cacodylate but with a more pronounced therapeutic action.” The
committee recommends to the Council that “Arsenoven S. S.” be declared
inadmissible to New and Nonofficial Remedies because of unwarranted
therapeutic claims.
ARSENO-METH-HYD
“Arseno-Meth-Hyd,” is sold by the New York Intravenous Laboratory,
New York City, for the treatment of syphilis. It comes in three
dosages, 2 gm., 1.5 gm., and 0.7 gm., respectively. The claim is made
that “Arseno-Meth-Hyd 2 gm.” contains “2 gm. (31 grains) of Sodium
Dimethylarsenate (Cacodylate), U. S. P.. and Mercury Iodid 5 mg. (1/12
grain)” in 5 c.c. of solution. Physicians are told:
“In primary and early secondary case administer Arseno-Meth-Hyd
2 gm. every sixth day and Mercury Oxycyanide .008 (1/8 grain)
intravenously between each injection.”
“In Tertiary cases and those of long standing alternate with
intravenous injection of Sodium Iodid 2 gm.”
The following claims are made for the alleged effectiveness and safety
of the cacodylate:
“This methyl compound of arsenic has come into almost universal use
for syphilis. On account of lack of toxicity an aggressive routine
can be carried on. The simple technic and absence of reactions
make it most desirable for the regular practitioner. This large
dose gives more uniform results both as healing manifestations and
negative Wassermann’s.”
“Much discussion has surrounded the use of Methyl Compounds of
Arsenic and it has been demonstrated beyond doubt that Cacodylate
of Soda proves an effective remedy for syphilis provided that it is
properly administered.” [sic]
“The low toxicity of this Methyl compound of arsenic is remarkable.
It is contraindicated only where a decided idiosyncrasy for even
small doses of arsenic exists.”
These statements are essentially false and misleading. Cacodylate has
_not_ come into universal use in the treatment of syphilis, nor has
its usefulness been “demonstrated beyond doubt.” On the contrary,
H. N. Cole (The Journal, Dec. 30, 1916, p. 2012) has shown that doses
so large as to produce renal injury were almost totally ineffective
against syphilis. Obviously, “effective doses” if such exist, are not
harmless. The dosage advised for Arseno-Meth-Hyd may not produce acute
toxic symptoms; nevertheless smaller doses have produced nephritic
phenomena. The “Arseno-Meth-Hyd” treatment includes the intravenous
injection of about 1/4 grain of a mercury salt. Although this is less
than the usual dose (about 1 grain per week), the mercury is probably
more effective than the cacodylate.
The committee recommends to the Council that, because of the
unwarranted therapeutic claims, “Arseno-Meth-Hyd” be held inadmissible
to New and Nonofficial Remedies.
The Council adopted both reports of the committee and declared
“Arsenoven S. S.” and “Solution of Arsenic and Mercury”
(“Arseno-Meth-Hyd”) inadmissible to New and Nonofficial Remedies.
The committee’s reports on these two products impel the Council
again to call attention to the undesirable and dangerous abuses to
which “Intravenous Therapy” lends itself. There is a distinct field
for the intravenous administration of drugs in those cases in which
immediate drug action is necessary, or when the medicament is likely
to be changed if absorbed through the ordinary channels. Unless such
indications exist, however, intravenous administration involves not
only inconvenience and expense to the patient, but what is more
important, unnecessary danger. The fact that indiscriminate intravenous
administration is peculiarly profitable to certain manufacturing houses
makes it all the more necessary for the medical profession to be on its
guard in this matter.
In this connection it is well worth while to quote the closing
paragraph from an editorial on “Intravenous Therapy” that appeared in
The Journal, Nov. 11, 1916. It is as true today as when it appeared:
“Intravenous therapy will be most securely advanced if its employment
is restricted to such well defined fields. [As those mentioned above.]
These fields can be satisfactorily determined only by a scientific
pharmacologic study of the action of these drugs when so administered
in animals, as well as in man, under conditions in which the results
are carefully controlled. The intravenous method is an impressive one,
approaching in preparation almost to that which goes with a surgical
operation. The patient is usually interested and impressed by this
new, and, to him, mysterious method. There is a psychic element in his
reaction to the injection which is not a factor in his reaction to the
same drug when given by mouth. The intravenous injection of a complex
mixture would appear to be particularly reprehensible. Little is known,
as has been stated, of the results to be expected from intravenous
therapy, even with simple substances. The use of complex mixtures will
without doubt react against the proper use of the method.”
After the report on Arseno-Meth-Hyd had been presented to the Council,
a letter was received from the New York Intravenous Laboratory
announcing that the preparation “Arseno-Meth-Hyd” was now called
“Solution of Arsenic and Mercury” and expressing a desire to have its
products accepted for inclusion in New and Nonofficial Remedies. In
view of this letter, the committee’s report on “Arseno-Meth-Hyd” and
the Council’s protest against promiscuous intravenous therapy were
sent the New York Intravenous Laboratory for consideration.
The reply of the New York Intravenous Laboratory contained nothing
which permitted a revision of the preceding report. The change of the
name of “Arseno-Meth-Hyd” to “Solution of Arsenic and Mercury” means
little as the name still does not disclose the important fact that the
arsenic is present as sodium cacodylate, nor does it tell the character
of the mercury compound. The Council voted that “Solution of Arsenic
and Mercury” and “Arsenoven S. S.” be declared inadmissible to New and
Nonofficial Remedies because the therapeutic claims advanced for them
are unwarranted (Rule 6) and because the names of these pharmaceutical
preparations are not descriptive of their composition (Rule 8).
In filing its reply with the Council, the New York Intravenous
Laboratory announced that that document would be circulated to the
medical profession. This is of course the firm’s privilege. The Council
notes, however, with interest, that the reply is devoted almost
entirely to points which were not raised by the Council and that it
fails to discuss the objections which were actually made.
The reply constantly confuses the efficiency of cacodylate in anemia
and in syphilis. The Council’s report on “Arseno-Meth-Hyd” does not
discuss or even touch on the question of cacodylates in anemia. It
is confined to a discussion of the disappointing results obtained
with cacodylates as such (i. e., without mercury) in the treatment
of syphilis. This attempt on the part of the New York Intravenous
Laboratory to confuse the issue and to attribute to the Council
an opinion that it has never stated or held is an inexcusable
misrepresentation. The company in its reply said:
“We believe that you have previously stated that a solution
cacodylate of soda possesses no more action than so much water. In
other words, it was inert. Now you try to show that it produces
renal injury.”
The Council has never declared that cacodylates are inert. In the
report it is merely stated “that doses so large as to produce renal
injury were almost totally ineffective against syphilis.” Neither
has the Council stated that cacodylate is “peculiarly dangerous.” In
fact the absolute toxicity of cacodylates is low but Cole’s results
were quoted as a caution that “effective” doses are not harmless. A
great portion of the remainder of the reply is devoted to disparaging
arsphenamin--a product that is not involved in this action of the
Council, and one about which the physician is amply informed.
Amongst other wholly extraneous matters, the firm’s “reply” tried to
resurrect the pepsin pancreatin controversy. This also has nothing
to do with the efficiency or harmlessness of sodium cacodylate. In
order to dispose of the matter, however, it may be pointed out that
the implications are entirely misleading. The work which is quoted
against the Council was undertaken by the Council itself, to clarify
obscurities in the older data. The outcome of these new investigations
showed the essential correctness of the deductions from the older work,
namely, that pancreatin is destroyed by pepsin-hydrochloric acid. Dr.
Long’s work to which the firm’s reply evidently refers, showed that
under favorable conditions, namely, when protected by an excess of
protein, some trypsin may escape destruction in the stomach; but it
fully confirmed the original conclusion that pepsin and pancreatin
mixtures as ordinarily administered are practically worthless (J. H.
Long, _Jour. Amer. Pharmaco. Assoc._, Sept. 19, 1917).
As regards the editorial on intravenous therapy, a concession may be
made the New York Intravenous Laboratory: intravenous injections are no
longer quite as “impressive” as in 1916, but that does not alter the
fact that they should be used only when a distinct advantage is to be
gained.--(_From The Journal A. M. A., Aug. 2, 1919_)
HORMOTONE AND HORMOTONE WITHOUT POST-PITUITARY
Report of the Council on Pharmacy and Chemistry.
“Hormotone,” of the G. W. Carnrick Company, is advertised as “A
pluriglandular tonic for asthenic conditions.” “Hormotone Without
Post-Pituitary” is recommended for use “in neurasthenic conditions
associated with high blood pressure.” These preparations are sold in
the form of tablets for oral administration. The Council declares these
preparations inadmissible to New and Nonofficial Remedies because: (1)
Their composition is semisecret (Rule 1); (2) the therapeutic claims
are unwarranted (Rule 6); (3) they are sold under names not descriptive
of their composition but suggestive of indiscriminate use as “tonics”
(Rule 8); (4) in the light of our present knowledge the routine
administration of polyglandular mixtures is irrational (Rule 10). In
explanation of this action, the Council authorized publication of the
report which appears below.
W. A. Puckner, Secretary.
Each tablet of “Hormotone” (G. W. Carnrick Co., New York City) is said
to contain 1/10 grain of desiccated thyroid and 1/20 grain of entire
pituitary, together with the hormones of the ovary and testes--the
amounts and the form in which the latter are supposed to be present are
not given. From this it will be seen that the only definite information
given to the medical profession regarding the composition of Hormotone
is that it is a weak thyroid and a still weaker pituitary preparation.
What results can be anticipated from one or two tablets three times
daily (the recommended dose of Hormotone) each containing 1/10 grain
of thyroid and 1/20 grain entire pituitary? Such doses of thyroid
may, of course, have a beneficial action in a limited number of cases
of myxedema and cretinism. An extract of the posterior lobe of the
pituitary (Liquor Hypophysis, U. S. P., for example) will, _when
injected subcutaneously or intramuscularly_, have a pronounced effect
on the parturient uterus; its action on certain other forms of smooth
muscle will be much less certain. But the _oral administration_ (for
which Hormotone is recommended) of the posterior lobe of the pituitary
has not been shown to have any such effect. The use of the anterior
lobe in doses of 1 to 4 grains (doses very many times larger than those
recommended for the entire gland in Hormotone) is in the experimental
stage and its only probable value seems to be in those cases of known
gland deficiency.
As to the other alleged ingredients of Hormotone--hormones of the ovary
and testes, amounts not stated: all physicians know the uncertainties
attending the use of ovarian preparations and the serious question as
to whether testicular extracts have any therapeutic value. Whatever may
be the physicians views as to the probable therapeutic value of these
organs, the first thing he desires to know is how much of the substance
he is giving and from what part of the gland it is obtained.
So much for the facts; yet the physician is asked to jump from this
region of solid fact into a sea of hypothesis; to believe that
small amounts of the well-known drugs thyroid and pituitary, plus
an unknown amount of unknown hormones of the testes and ovary are
of great value in conditions that in themselves are often purely
hypothetical. He is asked to believe that this combination has
virtues in such conditions as “hypofunction of the adrenal system,”
neurasthenia, the “fatigue syndrome,” amenorrhea, dysmenorrhea,
“natural and artificial menopause,” sexual neuroses, cold extremities,
cardiac asthenia, low blood pressure, infantilism, sterility,
melancholic conditions, obesity, anorexia, anemia, slow metabolism,
constipation, psychasthenia, lowered virility and the sexual neuroses
of the unmarried, hysteria following functional exhaustion of the
nerve centers, frigidity, etc., etc., especially if he guesses that
the trouble is due to a “pluriglandular disturbance,” “glandular
hypofunction,” an “adreno-pituitary deficiency,” suboxidation, etc.
The physician is invited to use Hormotone because, among other reasons,
each alleged constituent is said to be “in physiologic sympathy and
therapeutic harmony with the others,” and further, because:
“Pluriglandular therapy has the endorsement of high authorities,
is both logical and effective and Hormotone is a splendid example
of it. It will be seen at its best where the patient lacks snap
and vim and vigor. Asthenic conditions necessarily indicate
hypofunction of the adrenal system ...” etc.
“The use of gland extracts in the treatment of aplasias of the
pluriglandular system has become an established therapeutic measure
of miraculous potency (Bayard Holmes: The Internal Secretory
Glands, _Lancet-Clinic_, Sept. 19, 1914).”
The G. W. Carnrick Company also advertises a “Hormotone Without
Post-Pituitary,” each tablet of which is said to contain 1/10 grain
desiccated thyroid, and to “present” “hormone bearing extracts of
thyroid, anterior pituitary, ovary, and testes.” This product is just
as irrational as “Hormotone.”--(_From The Journal A. M. A., Aug. 16,
1919_)
FORMALDEHYDE LOZENGES
Report of the Council on Pharmacy and Chemistry
The Council has voted Hex-Iodin (Daggett and Miller Co., Inc.,
Providence, R. I.), Formitol Tablets (E. L. Patch Co., Boston), and
Cin-U-Form Lozenges (McKesson and Robbins, New York City) inadmissible
to New and Nonofficial Remedies, and authorized publication of the
report which appears below.
W. A. Puckner, Secretary.
Some years ago, the Council published (The Journal A. M. A., Aug.
28, 1915, p. 816) a report on Formamint, a proprietary medicine
widely exploited as a peculiar chemical compound of sugar of milk and
formaldehyde. The formaldehyde was said to be liberated slowly by the
action of the saliva, and because of this liberation of formaldehyde,
Formamint was claimed to be a powerful germicide. Extravagant claims
were made for its curative and prophylactic effects. The Council found
that the therapeutic claims were grossly unwarranted and that its
exploitation to the public was a public danger.
During the recent epidemic of influenza, a variety of tablets or
lozenges were advertised, and are still being advertised, having
formaldehyde, in some form or other, as the nucleus around which
revolve the therapeutic claims. In some cases, the advertising clearly
indicates the character of the formaldehyde compound that is claimed
to be present; in others the statements are vague and indefinite or
misleading.
It is hardly necessary to remind physicians that the use of tablets
containing hexamethylenamin or other formaldehyde compounds can neither
cure respiratory infections, nor even confer protection against such
infections. To be effective, formaldehyde would need to be supplied
to the entire respiratory tract continuously for some time or else in
concentrations that would be distinctly irritant and damaging to the
tissues. Saliva-dissolved tablets, obviously cannot reach the nasal
or tracheal mucosae directly; and the application of quickly acting
concentrations of formaldehyde is out of the question. This altogether
aside from the fact that hexamethylenamin, the basis of some of these
tablets, does not liberate formaldehyde in the mouth, and for this
reason alone would be quite useless for this purpose! (See Hanzlik and
Collins, _Archives of Internal Medicine_, November, 1913.)
An inefficient antiseptic is more than merely useless; it is a menace
to public safety, in that it tends to lead to the neglect of rational
and effective protective measures. It therefore seems advisable for
the Council again to call the attention of physicians to the subject.
Accordingly, three specimens of these products were purchased and
examined in the Association’s Chemical Laboratory.
Hex-Iodin
Hex-Iodin (Hexamethylenetetramine and Iodum) Lozenges are manufactured
by Daggett and Miller Company, Inc., Providence, R. I. They weigh
15-1/2 grs. each, are sweetened and are flavored with mint or menthol.
The package and circulars do not contain a definite statement of
composition. The rather indefinite synonyms “Hexameth. and Iodine
Comp.” and “Hexamethylenetetramine and Iodum” suggest that the lozenges
contain hexamethylenamin and free iodin. The further statement that
they “contain the combined medicinal antiseptic and prophylactic
properties of Hexamethylenetetramine and Iodum” is also rather
indefinite. The therapeutic action claimed for the lozenges, however,
could only be produced by free iodin and by liberated formaldehyde.
It is unnecessary to discuss in detail the extravagant claims made
for these lozenges. The inefficiency of hexamethylenamin has already
been referred to; the limitations of iodin, free or combined, in
lozenge form, need not be discussed because the examination made in the
A. M. A. Chemical Laboratory showed that Hex-Iodin lozenges contained
no free iodin, and only traces of combined iodin. Neither formaldehyde
nor paraformaldehyde was present; hexamethylenamin was present but, the
lozenges being neutral no formaldehyde is generated in contact with
water or with the alkaline saliva.
Thus Hex-Iodin is shown to be worthless for the purpose for which it is
advertised. Of the two important ingredients said to be present, iodin
and hexamethylenamin, only traces could be found of the former while
the latter, as has been shown, is incapable of exerting any effect when
used as the manufacturers direct.
Formitol Tablets
These tablets are prepared by the E. L. Patch Co., Boston. Each tablet
weighs 13-1/2 grs. They have the odor of thymol or menthol and an acid
taste and reaction. They are, according to the label:
“For the throat and mouth. Soothing, Astringent, Antiseptic.
Rapidly destroys germs of infection, preventing and relieving sore
throat and mouth.”
In a circular, it is stated, that one of the qualities of Formitol:
“... is the generation of formaldehyde when in contact with water
or the saliva.”
“Besides generating formaldehyde, Formitol, Patch contains
astringent, demulcent and soothing ingredients which render the
combination unusually effective.”
A bacteriologic report is given in this circular in which it is stated
that, in 2-1/2 minutes one Formitol Tablet rendered sterile a plate
culture of a “characteristic throat micrococci.” The instructions
are to dissolve a tablet in the mouth, slowly, once an hour or a
half-tablet every half hour.
The A. M. A. Chemical Laboratory reported that Formitol Tablets
contained formaldehyde (or paraformaldehyde), and ammonium compound,
and some hexamethylenamin. It is probable that the formaldehyde (or
paraformaldehyde) was produced by the decomposition of hexamethylenamin
originally present in the tablets but decomposed by long contact with
the acid.[128]
[128] The E. L. Patch Company declares that “no hexamethylenamine
has ever been used in the manufacture of Formitol tablets,” and that
ammonium chloride and paraformaldehyde are among the ingredients used
in the manufacture of these tablets. The hexamethylenamine present
in the tablets, therefore, must have been produced by interaction of
the paraformaldehyde and ammonium chloride. This does not alter the
laboratory findings regarding the composition of the tablets, namely,
that they “contain formaldehyde (or paraformaldehyde), an ammonium
compound and some hexamethylenamine.”
These tablets differ from Hex-Iodin in that they really contain active
formaldehyde and, therefore, possibly produce antiseptic effect
in test-tube cultures. The conditions in the mouth, however, are
very different from those in the test-tube, since in the mouth the
formaldehyde would be immediately “bound” or absorbed. The claimed
absence of irritation indicates sufficiently the absence of efficient
quantities of formaldehyde under clinical conditions.
Cin-U-Form Lozenges
Cin-U-Form Lozenges, manufactured by McKesson and Robbins, New York
City, are marketed in bottles of 24 for 25 cents. They have a strong
odor of cinnamon, weigh 15-1/2 grs. each, and are acid in taste and
reaction. The label states that they contain:
“Cinnamon, Eucalyptus, Formaldehyde and Menthol--all powerful
germicides against Influenzal bacilli, but not injurious to the
system in this palatable form.”
A circular contains the same statement as to composition and claims
further that they:
“... help to prevent the infection of Spanish Influenza, Pneumonia,
Grip Colds and to guard against Sore Throat, Tonsillitis,
Pharyngitis, etc.”
The A. M. A. Chemical Laboratory reported that Cin-U-Form
Lozenges contained some formaldehyde (or paraformaldehyde) and no
hexamethylenamin. It is obvious that the mouth and throat cannot be
“disinfected” by these lozenges. They would be totally ineffective
against bacteria that enter through the nose; they cannot prevent
influenza, pneumonia, etc.--(_From The Journal A. M. A., Oct. 4, 1919_)
LAVORIS
Report of the Council on Pharmacy and Chemistry
Lavoris was considered by the Council in 1913, and its proprietors--the
Lavoris Chemical Company--were advised that the preparation was
inadmissible to New and Nonofficial Remedies because of conflict with
Rules 1, 4, 6, 8 and 10. No report was published at that time. As the
preparation is still widely advertised to physicians, the Council has
again examined Lavoris and authorized publication of the following
report.
W. A. Puckner, Secretary.
In recent years Lavoris has been widely advertised as “THE IDEAL ORAL
ANTISEPTIC,” particularly to the dental profession. A printed card
sent out by the Lavoris Chemical Company in 1913 read: “LAVORIS, the
Pyorrhea Remedy. The Original ZINC CHLORIDE Mouth Wash. One grain zinc
to each ounce.” The card also gave a “formula” to the effect that each
pint of Lavoris contained:
Zinc Chloride 1.040
Resorcin 0.520
Menthol 0.400
Saccharin 0.195
Formalin 0.195
Ol. Cassia Zeyl 0.780
Ol. Caryophyl 0.195
Advertisements now appearing in medical journals repeat the older
“formula” except that resorcin is omitted. The formula while seemingly
frank and open is in reality indefinite and misleading in that no
denomination of weight is given for the various constituents. It is
uncertain, for example, if the figures in the formula are intended to
represent grains, grams or percentages of the several constituents.
In view of the indefinite statement of composition, a chemical
examination of Lavoris was undertaken in the A. M. A. Chemical
Laboratory. The report of the laboratory follows:
_Zinc._--This was determined electrolytically. Fifty c.c. gave
0.026 gm. zinc and 100 c.c. gave 0.0531 gm. zinc. The average is
0.0526 gm. zinc in 100 c.c. This is equivalent to 0.1102 gm. anhydrous
zinc chlorid in 100 c.c.
_Chlorid._--After decolorizing some of Lavoris with chlorid-free animal
charcoal, the chlorid was determined by the Volhard method. Twenty-five
c.c. Lavoris required 4.328 c.c. tenth-normal silver nitrate solution
equivalent to 0.01535 gm. chlorid (chloridion) or 0.0614 gm. in
100 c.c. A second 25 c.c. of Lavoris required 4.112 gm. tenth-normal
silver nitrate solution equivalent to 0.01458 gm. chlorid (chloridion)
or 0.05832 gm. in 100 c.c. Average is 0.05985 gm. This is equivalent
to 0.1150 gm. zinc chlorid in 100 c.c. This agrees closely with the
foregoing zinc determination.
_Resorcin._--The method of the U. S. Pharmacopeia was used. The total
bromin absorption of 25 c.c. Lavoris was 3.68 c.c. tenth-normal
bromin solution. This would be equivalent to 0.00675 gm. resorcin
in 25 c.c. or 0.02700 gm. in 100 c.c. In a duplicate test, 25 c.c.
Lavoris required 3.8 c.c. tenth-normal bromin solution equivalent to
0.00697 gm. resorcin or 0.02788 gm. in 100 c.c. Since oil of cinnamon
absorbs bromin, 50 c.c. of Lavoris was boiled until very little or
no odor of the oil was noted, keeping the volume nearly constant by
adding a little water from time to time, and the bromin absorption then
taken. In one experiment, 0.36 c.c. of tenth-normal bromin solution was
consumed, and in a duplicate no bromin was absorbed. This shows the
absence of resorcin.
_Residue._--On evaporating 25 c.c. Lavoris on a steam bath and
subsequent drying of the residue at 100 C., 0.0455 gm. of residue was
obtained. This is equivalent to 0.1820 gm. in 100 c.c.
_Saccharin._--Saccharin was detected in the residue and ether-extract
of the residue by its intense sweet taste when a little sodium
bicarbonate was added to it.
_Formaldehyd._--This could be detected by the Jarrison test. The color
was not very pronounced and the quantity of formaldehyd was small.
_Oil of Cinnamon._--The odor and taste of Lavoris is characteristic of
cinnamon.
_Menthol and Oil of Cloves._--The odor of menthol and of oil of cloves
could not be detected, but no tests were made to demonstrate their
presence.
The analysis thus indicates that the Lavoris of today contains no
resorcin but does contain a small amount of formaldehyd, a little
saccharin, and oil of cinnamon (menthol and oil of cloves could not be
detected by the odor, but were not tested for). The analysis showed
that the principal constituent of Lavoris is zinc chlorid, of which
there is about 0.1 gm. per 100 c.c. (about 1/2 grain to the ounce).
The amount of zinc chlorid given in the published formula, i. e.,
1.04, is meaningless because the unit of weight or measure is not
given; furthermore, the analysis shows that it is inaccurate for any
unit of weight that might be assumed from the published figures. Since
the amount of the most active medicinal ingredient is both indefinite
and inaccurate, the composition of the preparation is essentially
secret. Lavoris is indirectly advertised to the public by having
included in the package a circular giving a list of diseases for which
the preparation was recommended. The combination of zinc chlorid,
formaldehyd and oil of cinnamon (assuming the menthol and oil of cloves
to be present as flavors) in a mixture is irrational and likely to lead
its users to ascribe a false and exaggerated value to the preparation.
The name is objectionable in that it does not indicate the composition
of the potent ingredients of the mixture, but instead suggests its use
as a mouth wash.
From a standpoint of public safety, the most serious objection to
Lavoris, however, lies in the many unwarranted therapeutic claims
and suggestions. It is generally held that zinc chlorid solutions
which possess a strength of from 1 to 200 up to 1 to 500 exercise a
weak antiseptic action. The strength of zinc chlorid in Lavoris is
approximately 1 to 1,000. The directions for its use recommend that
Lavoris should be diluted. A dilution of 1 to 4 is recommended for a
variety of mouth conditions while for cystitis irrigations and as a
vaginal douche, it is recommended that one tablespoonful be added to
a quart of warm water or salt solution. The strength of zinc chlorid
in the last suggested dilution would approximate 1 to 64,000. It is
evident that no antiseptic action could be expected from such dilutions.
The recommendation that diluted Lavoris be used for the treatment
of coryza, nasal catarrh, hay fever, inflamed eyes, hemorrhoids and
leucorrhea is objectionable and irrational. Especially dangerous is
the recommendation that members of a family exposed to diphtheria
or scarlet fever should use Lavoris freely as a preventive. Such
recommendations can but give a false sense of security and lead to the
neglect of proved methods for preventing the spread of these diseases.
Equally unwarranted is the recommendation that in gonorrhea one
teaspoonful of Lavoris to eight of warm water be used with a blunt end
syringe.
The use of Lavoris as recommended would not only prove valueless in
many instances but might lead to serious consequences because really
valuable methods of prevention or treatment might be neglected. For
these reasons the preparation is in conflict with Rule 6.
The Council declared Lavoris ineligible for New and Nonofficial
Remedies.--(_From The Journal A. M. A., Nov. 1, 1919_)
MEDINAL
Report of the Council on Pharmacy and Chemistry
The Council has authorized publication of the following report on
Medinal (Schering and Glatz, Inc.).
W. A. Puckner, Secretary.
Medinal is a proprietary name applied to barbital sodium (sodium
diethylbarbiturate) the sodium salt of barbital (diethylbarbituric
acid). The latter was first introduced as Veronal.
Medinal was deleted from New and Nonofficial Remedies in 1916 because
the advertising issued by Schering and Glatz (who then acted as
agents for Chemische Fabrik auf Actien vorm. E. Schering, the German
manufacturer) contained misleading and unwarranted therapeutic claims.
The Council did not publish its report because by the time the report
was ready for publication the product was practically off the American
market, and it was hoped that when Medinal again became available,
Schering and Glatz would revise the claims and thus permit its
reacceptance.
Medinal, said to be manufactured in the United States, is now marketed
by Schering and Glatz, Inc. In October, 1918, the firm sent to the
Council a typewritten copy of a proposed circular for Medinal. The firm
was informed that this leaflet was subject to the objections that had
been raised when Medinal was deleted from New and Nonofficial Remedies.
In April, 1919, the firm submitted a printed circular which it was
sending out. This contained numerous misleading statements, among them,
these:
“MEDINAL removes its [Diethylbarbituric acid] one objectionable
feature--insufficient solubility--and thus fulfills the three
prerequisites of a truly rational hypnotic: Quick absorption,
insuring prompt action, rapid and complete excretion, affording
protection from cumulative toxic after effects, and the choice of
rectal and subcutaneous administration.”
There is no justification for the claim that diethylbarbituric acid
(barbital) has only one objectionable feature and that a minor matter
of “insufficient solubility.” The Council has called the attention of
Schering and Glatz, Inc., to the fact that the difference in the time
of absorption between Medinal (barbital sodium) and barbital is, at the
most, but one of minutes and that there is no evidence that Medinal is
excreted more rapidly than barbital. Hence the claims that the danger
of toxic side-actions and that cumulative after-effects are avoided in
this product, are wholly unwarranted.
It is also claimed, and the claim is unsupported by satisfactory
evidence, that Medinal is useful in the insomnia of tuberculosis in
which condition it is said to have a double advantage owing to its
favorable effects on the night-sweats. It is claimed that Medinal
is used in the withdrawal treatment of morphin addiction with great
success; there is no evidence that Medinal has any special usefulness
in this treatment of the morphin habit. It is claimed further that
success has been reported with Medinal in the treatment of whooping
cough. The Council knows of no satisfactory evidence to show that
Medinal is of special value in whooping cough; on the contrary, it is
capable of doing a great deal of harm. The recommendations that Medinal
be used for the control of labor pains and in acute neuralgic pains
that resist other forms of treatment are wholly unwarranted as the
value of the drug in such conditions is inherently improbable and until
satisfactory evidence in support of them is forthcoming, must be deemed
misleading.--(_From The Journal A. M. A., Nov. 15, 1919_)
OMISSION OF COTARNIN SALTS (STYPTICIN AND STYPTOL) FROM N. N. R.
Report of the Council on Pharmacy and Chemistry
The Council has authorized publication of the following report.
W. A. Puckner, Secretary.
Salts of the base cotarnin have been used as local and systemic
hemostatics. The hydrochlorid was first introduced as “Stypticin,”
and is now in the pharmacopeia as cotarnin hydrochlorid
(_Cotarninae Hydrochloridum, U. S. P._). The phthallic acid salt of
cotarnin--cotarnin phthallate--was introduced as “Styptol.” Both
Stypticin and Styptol were admitted to New and Nonofficial Remedies. In
1918 the Council voted to omit Stypticin because the former American
agents were no longer offering it for sale. Styptol was retained and is
described in N. N. R., 1919.
As was pointed out in the description (N. N. R., 1918), the evidence
for the usefulness of the cotarnin salts has been contradictory and
unsatisfactory; but since the available data against the efficiency
were at least equally unreliable, the Council deemed it best to retain
them in N. N. R. pending a thorough investigation of the subject. This
was undertaken by P. J. Hanzlik, at the suggestion of the Therapeutic
Research Committee of the Council.
A reliable judgment of hemostatic efficiency can be formed only on a
basis of strictly controlled conditions, which can best be furnished in
the laboratory. Hanzlik repeated the principal experiments published
by previous investigators, and applied a number of new or improved
methods. The results (published in the _Journal of Pharmacology
and Experimental Therapeutics_ =10=:523, 1918; =12=:71, 1919) show the
following:
_Direct Application to Wounds._--The widely quoted results of the
gynecologist K. Abel, on the footpad of cats, were found to be quite
unreliable. When the experiment is properly controlled, the results
are either negative or the bleeding may be increased. Quantitative
experiments on wounds of the footpad of dogs showed that cotarnin
invariably _increased_ the bleeding. Equally negative or unfavorable
results were obtained with wounds to the comb of roosters, and to the
liver and spleen.
_Direct Action on Vessels._--The results of perfusion experiments were
variable, but, in general, showed a vasodilation action instead of
constriction. This holds true also of the uterine vessels. The vessels
in the living animal (rabbit’s ear) were also unaffected.
_Systemic Administration._--The bleeding from an irrigated wound was
not modified directly by intravenous injection of cotarnin salts, but
varied merely with the state of the blood pressure.
The evidence for the inefficiency of cotarnin salts as hemostatics
seemed so conclusive as to warrant the Council in rescinding the
acceptance of Styptol, and directing the omission of the general
article on cotarnin salts and the description of Styptol from New and
Nonofficial Remedies.--(_From The Journal A. M. A., Nov. 22, 1919_)
MICAJAH’S WAFERS AND MICAJAH’S SUPPOSITORIES
Report of the Council on Pharmacy and Chemistry
“Micajah’s Medicated Wafers” and “Micajah’s Suppositories,” sold by
Micajah & Co., Warren, Pa., are declared inadmissible to “New and
Nonofficial Remedies” because (1) their composition is essentially
secret (Rule 1); (2) name of neither of these mixtures is indicative
of its composition (Rule 8); (3) of exaggerated and unwarranted
therapeutic claims (Rule 6), and (4) the therapeutic advice which
accompanies the trade packages constitutes an indirect advertisement to
the public (Rule 4).
W. A. Puckner, Secretary.
Micajah’s Medicated Wafers (formerly called “Micajah’s Medicated
Uterine Wafers”) were analyzed in the A. M. A. Chemical Laboratory in
1910. They were found to consist essentially of dried (“burnt”) alum,
boric acid and borax, in approximately the following proportions:
Alum, dried 59.86 per cent.
Borax, dried 15.62 per cent.
Boric acid 5.67 per cent.
Water of hydration 18.85 per cent.
There are a number of drugs that are more or less effective in the
treatment of local lesions of mucous membranes and the skin. They
are classed as astringents. Among these are included alum, borax
and boric acid. Every physician has used them. To say that a wafer
consists of alum, borax and boric acid inspires but little awe. But
there is something much more mysterious and impressive in declaring
that a wafer “consists of an astringent and antiseptic base, in which
are incorporated certain medicaments which both locally and after
absorption, contribute to the astringent, antiphlogistic, depletive,
soothing and healing action of the product.” This gives the impression
that some powerful and almost incomprehensible factors are at work.
Yet, after all is said and done, the substances contained in Micajah’s
Medicated Wafers are just the homely old alum, boric acid and borax.
In addition to “Micajah’s Medicated Wafers,” Micajah & Co. also put out
“Micajah’s Suppositories for Hemorrhoids.” These have been examined in
the A. M. A. Chemical Laboratory and, like the “Medicated Wafers” have
been found to contain alum, boric acid and borax--and these substances
practically alone--incorporated in cocoa butter. The company claims
that “to these have been added Ammonii Ichthyosulphonate, Balsam of
Peru, Ext. Belladonae.” The A. M. A. chemists report, however, that if
extract of belladonna is present at all it is in amounts too small to
be detected by the method commonly employed in the chemical examination
of alkaloidal drugs. The chemists report further that while ammonium
ichthyosulphonate and balsam of Peru both have a decided odor and are
dark in color, the suppositories have but little color and the odor of
the cocoa butter that forms their base is not covered by these drugs;
obviously, therefore, if ammonium ichthyosulphonate and balsam of Peru
are present at all it is in amounts utterly insufficient to exert any
therapeutic effect.
It would be hard to find better examples of mischievous proprietary
medicines than these two products of the Micajah Company. “Twins
of Efficiency,” they are called in an advertising pamphlet. The
composition is not stated. A physician using the “twins” does so
absolutely in the dark. To him they are secret preparations. He is
encouraged to use them in a great variety of conditions in which other
drugs are much more useful. Inevitably, physicians using them will be
likely to overlook, or pass over, new growths, specific infections and
diseases that require radical remedial measures.
In addition to misleading and exaggerated claims, there is a reference
to a report from the usual “well-known and reliable bacteriological
laboratory.” The excerpts published from this report of an unnamed
laboratory are sufficiently vague to incriminate no one.
From time to time it is worth while to emphasize facts regarding
proprietary medicines that while obvious are sometimes forgotten. For
this reason attention is directed to Micajah’s Uterine Wafers and
Micajah’s Suppositories.--(_From The Journal A. M. A., Nov. 29, 1919_)
ALKALITHIA
Report of the Council on Pharmacy and Chemistry
Alkalithia was introduced at a time when it was believed that the
administration of lithium salts served to remove uric acid from the
system. The product was considered by the Council in 1906, and found
ineligible for New and Nonofficial Remedies. No report, however, was
published at that time.
Because of inquiries received, the Council examined the current claims
for Alkalithia, and authorized publication of the report which appears
below.
W. A. Puckner, Secretary.
Keasbey and Mattison Company’s Effervescent Alkalithia is sold with the
following statement of composition:
“Each dose or heaping teaspoonful contains 1 grain of Caffeine, 10
grains each of Bi-carbonates of soda and potash, and 5 grains of
Carbonate of Lithia.”
The A. M. A. Chemical Laboratory reports that Alkalithia is an
effervescent mixture which contains alkaline carbonates and
bicarbonates together with caffein, free tartaric acid and free citric
acid. The major portion of the alkali carbonates and bicarbonates
is converted into citrates and tartrates when the preparation is
dissolved in water--as is done before it is taken. An excess of alkali
is present, however, as the solution has an alkaline reaction. Each
“heaping teaspoonful” (which was found to be about 4.85 Gm.) contains
about 0.044 Gm. of caffein (the manufacturers claim 0.0648 Gm. per
heaping teaspoonful). As taken, Alkalithia, therefore, represents
caffein in a solution of alkali tartrate, citrate and bicarbonate
containing free carbonic acid. If it is assumed that all of the
tartrate and citrate in Alkalithia is converted into carbonate in
the organism, a “heaping teaspoonful” of Alkalithia would represent
about 2.9 Gm. of sodium bicarbonate. This assumption is, however, not
correct, for it is known that tartrates are not completely converted
into carbonates in the organism.
According to the label on the bottle, this mixture of caffein and
alkali salts is “a common sense remedy for the relief and treatment
of conditions dependent upon perverted metabolism as manifested by
neuralgic, rheumatic, cardiac and renal symptoms.” Wrapped with a trade
package is a circular in which is discussed the “uric acid diathesis”
as “a cause of Rheumatism in its various forms, Calculus, Gravel and
Inflammation of the Bladder and Kidneys, Asthma, Hay Fever, Catarrh,
Quinsy and Bronchitis, Eczema, Hives, Itching and Burning of the Skin,
Palpitation of the Heart and Cold Hands and Feet, Dizziness, Mental
Depression, Melancholia, Neuralgia, Chorea, Hysteria, Numbness and a
great variety of purely nervous symptoms.” The arguments for the use
of Alkalithia as “a safe and scientific treatment for the uric acid
diathesis” found in the circular constitute an indirect appeal to the
laity (conflict with Rule 4).
In the circular matter sent direct to the physicians, Keasbey and
Mattison claim that in rheumatism, Alkalithia is prescribed by the
medical profession more often than any other remedy. The claim is made
that, “In five minutes the urine will be discolorized and analysis will
show it to be loaded with urates.” The manufacturers further assert:
“You can change the character of the urinary secretion in a few
minutes completely” by Alkalithia, and “In nine cases out of
ten, when the doctor prescribes ‘Alkalithia’ his patient greatly
improves, or gets well.”
The firm advises that “Renal Insufficiency” be determined by the old
method of multiplying the ounces of urine in twenty-four hours by the
last two numbers of the specific gravity, adding 10, which gives the
number of grains of solids excreted in the twenty-four hours. If this
is low, no matter what the cause, they advise Alkalithia, “that ideal
eliminant.”
The Council declared Alkalithia inadmissible to New and Nonofficial
Remedies because the claims made on the label and the circular
accompanying the trade package lead the public to its detriment to
depend on this preparation (Rule 4); and because the therapeutic claims
are unwarranted (Rule 6).--(_From Reports of Council on Pharmacy and
Chemistry, 1919, p. 65_)
ARHOVIN OMITTED FROM N. N. R.
Report of the Council on Pharmacy and Chemistry
Arhovin is a solution of dephenylamine, thymol benzoate and ethyl
benzoate, marketed by Schering and Glatz, Inc. It was omitted from
New and Nonofficial Remedies because the therapeutic claims made for
the preparation were unwarranted and because the firm had refused to
discontinue the distribution of the advertising which contained the
objectionable claims prior to Jan. 1, 1919. When the report which
appears below explaining the dismissal was submitted to Schering and
Glatz, Inc., the firm again promised a revision of its advertising,
but refused discontinuance of the objectionable circular before Jan.
1, 1920. Since Arhovin is still marketed with unwarranted therapeutic
claims, the Council has authorized publication of this report.
W. A. Puckner, Secretary.
The attention of the firm Schering and Glatz, Inc., was called to
misleading statements in its booklet for Arhovin in 1915, and in 1918
the firm was informed that unless the misleading statements were
withdrawn before Jan. 1, 1919, Arhovin would be omitted from New and
Nonofficial Remedies.
The following quotations are taken from the circular in question, and
illustrate the character of the claims to which objection was made:
“Striking also is the antiphlogistic and anesthetic effect
of Arhovin on the inflamed mucosae, an effect which, as all
authorities agree, is far greater than that of all other internal
anti-gonorrheaics.”
“Under its influence vesical and prostatic complications,
gonorrheal arthritis, endocarditis, etc., are rarely incurred.”
References to the indexes of leading textbooks, including those
of Meyer and Gottlieb, Cushny, Sollman and Bastedo, fails to show
that Arhovin is so much as mentioned by those authors; hence, it is
obviously false to state, as is done in the first of the quotations
above, that all authors agree concerning the striking effects of
Arhovin.
Many of the statements are objectionable by reason of the actions
implied, rather than stated directly. The following are examples:
“Arhovin in Gonorrheal Infections of the Male Genito-Urinary
Organs. Anterior Urethritis. This is the class of cases in which
the most favorable results from Arhovin have been reported.”
“Posterior Urethritis.
“Here also the striking effects from Arhovin medication, both
in acute and chronic cases, are rapid decrease of discharge,
disappearance of gonococci from the secretion, and cessation of
subjective difficulties, such as strangury.”
While the firm did not agree to withdraw the objectionable advertising
before Jan. 1, 1919, which made necessary the omission of Arhovin from
New and Nonofficial Remedies, 1919, it did submit a proposed folder in
which the most objectionable of the claims are still made.
The following statement, which was in the proposed “folder” and is
included in an advertising pamphlet sent out during 1919, serves to
illustrate those points:
“Its action is three-fold:
“Strong antiseptic and bactericidal effect upon the urethral and
vesical mucosae, highly conducive to shortening and palliation of
the acute disease course.”
No evidence has been presented that Arhovin is capable of destroying
the gonococcus in the urethra, and consequently, the Council
declared the recommendation for the use of Arhovin in the treatment
of gonorrhea, by means of claims such as those just cited, is both
misleading and dangerous.--(_From Reports of Council on Pharmacy and
Chemistry, 1919, p. 66_)
CHLORON, CHLORAX AND NUMBER “3”
Report of the Council on Pharmacy and Chemistry
The report which appears below was sent to the Chlorine Products
Company, Inc., May 14, 1919. In reply to an inquiry sent the Chlorine
Products Company, July 8, the company wrote that it could send no reply
because the medical director was still in France. However, Chloron and
Chlorax are being advertised in medical journals; also essentially the
same advertising as that discussed in the report was recently received
by a physician from the Chlorine Products Company.
The preceding facts having been reported to the Council, publication of
the report was authorized.
W. A. Puckner, Secretary.
Chloron, Chlorax and Number “3” are preparations of essentially similar
composition put out by the Chlorine Products Company, Inc., New York.
Chloron
Chloron, according to the label, is “A stable CHLORINE remedy for the
reduction of inflammation, relief of pain and for all wounds, burns,
scalds and every description of sores except cancer and lupus.” Its
composition is given as:
“Free chlorine, 0.200 per cent.; calcium chloride, 0.190 per cent.;
mercurous chloride, 0.030 per cent.; lithium chloride, 0.035 per
cent.; calcium hydrate, 0.010 per cent.; water to 100 parts.”
The Council asked the manufacturers for further information in regard
to the composition or preparation of Chloron and received this reply:
“Chlorine gas is prepared in the usual way and purified and passed
into water until a saturated solution is made.
“Water to the extent of three times the volume of the chlorine
solution is used to dissolve the necessary amount of calcium
chloride, and the two solutions are mixed.
“The necessary amounts of Lithium and Mercurous Chloride are then
intimately mixed and made into solution. This solution is then
added to the above and the whole is agitated for some minutes.”
A specimen of Chloron was examined in the A. M. A. Chemical laboratory
and the chemists reported:
Qualitatively the presence of the following constituents was confirmed:
calcium, mercury, lithium, chlorid, free chlorin. The solution was
alkaline. Of course, the declaration that Chloron contains mercurous
chlorid (calomel) is obviously incorrect, as mercurous chlorid cannot
exist in a solution containing active (free) chlorin, but is oxidized
to mercuric chlorid (corrosive sublimate). As the solution was alkaline
in reaction, it seemed unlikely that all the active chlorin was present
in the free state, as declared on the label. Quantitative determination
of free chlorin and of total active (“available”) chlorin gave: free
chlorin, 0.036 gm. per hundred c.c.; total “available” chlorin,
0.330 gm. per hundred c.c., or 165 per cent. of the claimed amount.
A comparison of the information sent to the Council with the analytic
findings leads to the conclusion that Chloron is not of reliable
composition.
As evidence of the therapeutic value of Chloron, the following “case
reports” were submitted:
“In a case of second degree burn involving the most of one leg
from the middle of the calf down, CHLORON was the only dressing
used. The burn was a bad one and the patient in a rundown anaemic
condition, at no time was there any appearance of pus, the surface
looked clean and bright and the healing was accomplished with
practically no scar whatever. The burn was kept wet with the
solution by hourly applications day and night. The skin which has
grown on the wound is clear, healthy and firm.
In another case of Varicose veins of long standing, the result was
surprising. The patient told of two years vibrating from Hospital
to Hospital and getting no real relief. Each leg had large open
running sores, the only dressing used was wet compresses of this
solution. The pus disappeared at once, the wound began to cicatrise
from the edges and in two weeks the man was discharged from the
hospital practically cured.”
“CHLORON was recently tried at the ---- and ---- Hospital on cases
presenting ulcers and other sores which did not readily yield to
other methods, with good results, in fact were of an indolent type.
In these cases CHLORON proved very valuable.”
“I have used CHLORON on a series of cases (surgical) presenting pus
foci and I have found the application very beneficial and healing,
the pus early disappearing. In cases of Osteomyelitis, Suppurating
Arthritis, Cellulitis and Chronic Ulcers, CHLORON is particularly
valuable, its good effects quickly observed and the time of
restoration to health shortened.”
In the first case report, there is no evidence that Chloron is more
efficient in the treatment of burns than any other commonly used
procedure might have been. In the case of the varicose ulcers, while
there was some apparent benefit from Chloron, no credit is given to
rest and the general treatment which is known to be important in the
treatment of such conditions. The evidence in the other case reports is
quite inconclusive. Consideration of the “case reports” leads to the
conclusion that clinical evidence for the value of Chloron is lacking.
Attention should be called to the fact that the amount of active
chlorin, claimed to be present in Chloron as well as the amount found
by the association laboratory, is less than that considered effective
by Dakin, Dunham and others; seemingly in preparing Chloron no
attention has been paid to the degree of alkalinity, yet the importance
of this factor is now generally recognized.
Chloron fails to comply with the requirements for surgical solution of
chlorinated soda (N. N. R., 1919, p. 133), yet the manufacturers make
free use of the text of Dakin and Dunham’s Handbook of Antiseptics in
their advertising pamphlet. Thus:
From the Chloron pamphlet:
“This ideal antiseptic effects complete sterilization within
its sphere of action without causing any damage to the cells or
tissues. An important method of judging the injurious action of
antiseptics is to investigate their effects on the leucocytes. From
experiments _in vitro_ by Parry Morgan and _in vivo_ by Col. C. J.
Bond with the strength of antiseptics commonly used in surgery, it
has been found that Chlorine antiseptics and mercury salts have
little effect on phagocytosis in comparison with other germicides.
The activity of the leucocytes from wounds which have recently been
treated with CHLORON may be demonstrated experimentally.”
“In addition to its antiseptic action CHLORON is a strong oxidizing
agent and deodorant and possesses to a marked degree the property
of decomposing toxins. In this connection it is interesting
and pertinent to note that Dean, by the regulated action of
hypochlorous acid, has prepared a nontoxic dysentery vaccine and it
is now a common observation that the free use of CHLORON may reduce
the constitutional symptoms arising from septic processes and that
they reappear on discontinuing the antiseptic treatment.”
Dakin and Dunham Handbook of Antiseptics:
“The ideal surgical antiseptic should effect complete sterilization
within its sphere of action without causing any damage to animal
cells. At the moment such a substance does not appear likely to be
found, but on the other hand it is surprising to see how little
damage may be done to animal tissues by some active antiseptics.
An important method of judging of the injurious action of
antiseptics is to investigate the condition of the leucocytes in
wounds recently treated with the substance under consideration.
In general it appears from experiments _in vitro_ that, with the
strength of antiseptics commonly used in surgery, mercury salts
and hypochlorites have relatively little effect on phagocytosis as
compared with phenol (Parry Morgan). It is a regular phenomenon to
observe activity of the leucocytes obtained from wounds which have
been recently treated with hypochlorites.
Ingenious methods for determining the influence _in vivo_ of
antiseptics on the activities of leucocytes have been worked out by
Col. C. J. Bond.
“In addition to their disinfecting action, the Chlorine antiseptics
are strong oxidizing agents and deodorants and moreover possess in
high degree the property of decomposing toxins. By the regulated
action of hypochlorous acid, Dean has prepared a nontoxic dysentery
vaccine and it is a common observation that the free use of
hypochlorites may reduce the constitutional symptoms arising from
septic processes and that they reappear on discontinuing the
antiseptic treatment.”
Chlorax
Chlorax is said to be “A stable CHLORINE solution for internal use,” in
“Kidney Conditions,” “Diabetes,” “Acute Infections,” “Blood Dicrasias,”
“Lithemias and Rheumatism,” and “Nervous Conditions.” It is claimed to
have the same composition as that of Chloron with the addition of 0.016
per cent. of tincture of opium.
The A. M. A. Chemical Laboratory reported that the free chlorin in
Chlorax was 0.01 gm. per hundred c.c. and the total amount of active
(“available”) chlorin was 0.25 gm. per hundred c.c., or 125 per cent.
of the amount claimed. The laboratory notes that though the chlorin
content of Chloron and Chlorax is claimed to be the same, that of
Chlorax actually is less. This is not surprising when the presence in
Chlorax of reducing substances such as alcohol is borne in mind. The
laboratory concludes that Chlorax is not of reliable composition.
The following is typical of the “case reports” submitted to show the
value of Chlorax:
“In January last I used Chlorax on a case of Diabetes Mellitus and
with excellent results.
“The patient had been suffering for about nine years and when first
brought to my care Toxemia had set in, he was drowsy, irritable
and unable to leave the house. I prescribed Chlorax in teaspoonful
doses four times a day and am pleased to say that in one week he
showed marked improvement. Soon after he was able to leave the
house and attend to his business and after two months’ treatment
resumed a normal diet and habits apparently without injurious
effects.
“I believe that in this case Chlorax undoubtedly prolonged life.”
No mention is made of the dietary or other measures used. The wide
variation in diabetes and its response to proper diet is so well known
that the noncommittal statement concerning the beneficial effects of
Chlorax amounts to no evidence at all in favor of the preparation.
The other “case reports” furnished by the Chlorine Products Company,
Inc., which concern the treatment of gastric ulcers, acute alcoholic
gastritis, tonsillitis, etc., are equally unconvincing. In fact, no
satisfactory evidence for the clinical value of Chlorax has been
presented.
The following from the advertising for Chlorax is unwarranted and
absurd:
“Mercurous chloride (calomel) is perhaps the most widely used
internal antiseptic and alterative and has established itself in
the therapy of constipation, cholera, dysentery, cardiac dropsy,
pleurisy, malignant fever, malaria, syphilis, worms, infectious
diseases, gout and rheumatism; lithium chloride is particularly
efficacious in acute and chronic parenchymatous nephritis and in
various lithemic conditions; while Opium has no rival as an anodyne
and can be used to stabilize and conserve the alkaline reserve of
the body against the acidosing influence of infections.”
Further, on page 14 we find:
“In chills and fever malaria and other blood dicrasias, CHLORAX
is indicated as an internal antiseptic and it exerts a beneficial
effect on the course of these diseases.”
The claims made for Chlorax are exaggerated and misleading.
Number “3”
According to the label, Number “3” is “A STABLE CHLORINE remedy for the
purification of the blood,” with the composition:
“Free Chlorine, 0.35 per cent.; Calcium Chloride, 0.30 per cent.;
Mercurous Chloride, 0.03 per cent.; Lithium Chloride, 0.04 per
cent.; Calcium Hydrate, 0.01 per cent.; Opium, 0.02 per cent.;
Ethyl Alcohol, 0.10 per cent.; water to 100 parts.”
It will be noticed that the composition claimed for Number “3” is
essentially similar to that claimed for Chloron. It differs from
Chloron in that the amounts of some of the constituents are somewhat
greater, and in that, like Chlorax, it contains some tincture of opium.
The A. M. A. Chemical Laboratory reports that the free chlorin in a
specimen of Number “3” was 0.024 gm. in 100 c.c. and the total active
(“available”) chlorin 0.173 gm. per hundred c.c., or about 50 per cent.
of the claimed amount. The examination indicates that Number “3” is of
unreliable composition. The Chlorine Products Company, Inc., submitted
no clinical evidence for Number “3” to which it refers as “our Syphilis
remedy.” It stated that two physicians had used the preparation “with
good results,” and admitted that “the company requires further evidence
before pushing it.”
The Council declared “Chloron,” “Chlorax” and “Number ‘3’” in conflict
with the rules governing admission to New and Nonofficial Remedies. All
are of unreliable composition (conflict with Rule 1). The therapeutic
claims made for the preparations are not substantiated by acceptable
evidence and are unwarranted and misleading. Chloron is inferior as an
antiseptic to the well-known surgical solution of chlorinated soda on
account of its low chlorin content and uncontrolled reaction. There
is no warrant for the claim that Chlorax is useful in the treatment
of “Kidney Conditions,” “Diabetes,” “Acute Infections,” “Blood
Dicrasias,” “Lithemias and Rheumatism,” and “Nervous Conditions,” nor
is there warrant for the claim that “Number ‘3’” is a remedy for the
purification of the blood or a “Syphilis remedy” (conflict with Rule 6).
The names of these pharmaceutical mixtures are not descriptive of their
composition (conflict with Rule 8).
All three preparations are irrational. No evidence has been furnished
that the lithium salt is of value in the mixtures. It is not rational
to combine an active chlorin preparation and a mercury salt in one
mixture, nor is there evidence that the addition of opium to the
preparations proposed for internal use is of value or rational.
Experimentation with Number “3” as a “Syphilis remedy” is to be
severely condemned in that those on whom it is used will in the
meantime be deprived of efficient medication (conflict with Rule
10).--(_From Reports of Council on Pharmacy and Chemistry, 1919, p. 70_)
ELARSON OMITTED FROM N. N. R.
Report of the Council on Pharmacy and Chemistry
The Council has authorized publication of the following report
announcing the omission of Elarson from New and Nonofficial Remedies.
W. A. Puckner, Secretary.
Elarson, now sold by the Winthrop Chemical Company, Inc., was formerly
sold in the United States by the Bayer Co., Inc. It was admitted to New
and Nonofficial Remedies in 1914.
The circular issued by the Winthrop Chemical Co. contains several
statements markedly at variance with the results of an investigation
made, at the request of Fischer, by Joachimoglu (_Arch. f. exper. Path.
u. Pharmakol._ 78:1914). The circular states that Elarson contains
about 13 per cent. arsenic. Joachimoglu found from 10.8 to 11.1 per
cent. to be present. The circular states further:
“The fact that Elarson represents a lipoid-like chemical
combination of arsenic has an important bearing upon its absorption
and utilization in the system ... there is good reason to believe
that when arsenic is administered in a stable, lipoid-like
combination, as in Elarson, it is more readily taken up by the
cells and more completely utilized than when given in the customary
manner.”
“As regards the behavior of Elarson in the system, it has been
shown that its active constituent, chlorarseno-behenol, is almost
completely absorbed in this form, probably as a chlor-behenolate of
sodium or potassium.”
As a matter of fact, Joachimoglu found that very little arsenic was
absorbed when Elarson was given to dogs and rabbits; most of it was
recovered from the feces; only traces were found in the liver and
kidneys and none in the blood and brain. The absence from the latter
organs shows that the lipoid solubility does not obtain in the body. It
is claimed in the circular that Elarson has the advantage over Fowler’s
solution “in that it is free from any irritating action upon the
gastro-intestinal tract”; it is stated that as many as sixty tablets
have been given to dogs daily without any toxic effects. Joachimoglu,
on the other hand, found powdered Elarson to be very irritating to
the gastro-intestinal tract; also that the dog could not stand sixty
tablets at all (_gar nicht vertragen_), such doses causing vomiting,
diarrhea and intestinal hemorrhages; on repeated administration the
symptoms became progressively more severe. Joachimoglu also found that,
compared on the basis of arsenic content, Elarson, given intravenously,
is from ten to twelve times as poisonous as arsenic trioxid. Elarson
is recommended for the class of cases in which Fowler’s solution is
used.
To sum up: None of the special claims made for Elarson--the arsenic
content, ready absorbability, freedom from irritating action on the
gastro-intestinal tract and its alleged better adaptation for continued
administration--have been substantiated; on the contrary, they have
been disproved as well as the theory of its mode of absorption proposed
by Fischer and Klemperer. Furthermore, Joachimoglu found that when it
actually got into the circulation (intravenous injection) in the form
in which Fischer and Klemperer supposed it to be absorbed, it was from
ten to twelve times as toxic as arsenic trioxid.
The Council voted to omit Elarson from New and Nonofficial Remedies
because it is sold under unproved and consequently unwarranted claims
and because it is an unscientific and relatively useless article.
Elarson has not been shown to have advantages over Fowler’s solution;
on the contrary, in some respects at least, it is inferior.--(_From
Reports of Council on Pharmacy and Chemistry, 1919, p. 75._)
IODIPHOS
Report of the Council on Pharmacy and Chemistry
A report which appears below was sent Charles L. Heffner for
consideration. No reply having been received, the Council authorized
its publication.
W. A. Puckner, Secretary.
Iodiphos, marketed by Charles L. Heffner, Brooklyn, N. Y., is declared
to contain ferric citro-iodine, 6 grains; calcium glycerophosphate,
8 grains; sodium glycerophosphate, 8 grains, and hypophosphorous
acid, 2 minims in each fluidounce, and to present “the Metallic and
Non-Metallic elements: Iron, Iodine, Phosphorous, Calcium and Sodium
(each in separate Basic combination).”
According to the label, Iodiphos is “ALTERATIVE, TONIC, NERVINE and
ANTI-TUBERCULAR” and is “For Treatment of BLOOD, NERVES and PULMONARY
ORGANS.” An advertising circular[129] asserts that “Iodiphos exerts its
Physiological action rapidly in hardening of the Arteries, High Blood
Pressure, Anaemia, Glandular Swelling, Neurasthenia, Hypochondria,
Phthisis, Bronchitis, Asthma, Pneumonia and as an Intestinal Antiseptic
and Appetizer,” and declares it to be “Indispensable as a Tonic and
Restorative.”
[129] After publication of the foregoing report had been authorized by
the Council, a letter was received from Charles L. Heffner, advising
that the distribution of the circulars has been discontinued.
In the advertising circular it is averred that in the production of
Iodiphos “Chemistry Again Aids the Modern Physician.” Iodiphos is
another instance when a decadent polypharmacy proposes haphazard
medication and so obstructs the efforts of modern medicine to establish
the use of single drugs to meet definite indications.
Iodiphos is inadmissible to New and Nonofficial Remedies because it
is an irrational mixture of drugs sold with therapeutic claims that
are unwarranted, and under a name which is not descriptive of its
composition.--(_From Reports of Council on Pharmacy and Chemistry,
1919, p. 81._)
MERVENOL AND ARMERVENOL NOT ADMITTED TO N. N. R.
Report of the Council on Pharmacy and Chemistry
The Council has authorized publication of the report which appears
below declaring Mervenol and Armervenol, marketed by the Hille
Laboratories, inadmissible to New and Nonofficial Remedies.
W. A. Puckner, Secretary.
Mervenol is stated by the proprietors--The Hille Laboratories,
Chicago--to be a hydrosol (colloidal suspension) of the sulphides of
mercury and copper, containing sufficient sodium chloride to make it
isotonic with blood serum, and “inert proteid” and “carbohydrate” to
stabilize the colloidal suspension: each cubic centimeter is stated to
contain 0.005 gm. mercury, 0.0016 gm. copper, and 0.0016 gm. sulphur.
It is claimed that this preparation is of value in pneumonia,
influenza, and other conditions and diseases requiring increased
leukocytosis.
It is further claimed that the properties and therapeutic effects of
this preparation are as follows: “Practically non-irritant; practically
non-toxic; lower temperature, often crisis like; lower pulse, with
better elimination; greatly accelerated recovery from Influenza;
fewer Pneumonia complications; lower mortality rate in Influenza and
Pneumonia; remarkable Leucocyte stimulation.” Administration by mouth
and by intramuscular and intravenous injection are advocated.
In the recent influenza epidemic, it is reported that therapeutic
results of some value were obtained at the Great Lakes Training
Station and at Fort Sheridan. The reports of certain medical officers
indicate that this preparation seemed to have some effect on the
course of pneumonia and influenza, on the temperature, and on the
leukocyte count. But those conducting the experiments state that it was
“absolutely impossible” to fulfil ideal conditions as to controls and
other observations at the time the experiments were conducted.
So far as the Council knows, no effort has been made to determine the
potent constituent, or constituents, of this preparation; whether the
mercury, the copper, or the protein in the mixture was responsible for
the claimed benefits is an open question.
These reports were given careful consideration, but it was decided
not to accept this preparation because of (1) exaggerated therapeutic
claims, conflicting with Rule 6 (aside from the report of its use
in influenza and pneumonia at the Great Lakes Training Station and
the Post Hospital at Fort Sheridan, which reports are of work done
and observations made under conditions which did not permit careful
controls, no evidence has been presented to the Council supporting the
therapeutic claims) and (2) being an irrational mixture, conflicting
with Rule 10--a mixture containing colloidal mercury, copper and
sulphur with proteins and carbohydrates in addition, it is difficult to
predict the changes which occur in such mixtures on standing.
Samples of Mervenol (two 1-ounce bottles) submitted by the
manufacturer, June 5, 1919, were found when opened, Aug. 18, 1919, to
have undergone decomposition. A very disagreeable odor had developed,
the liquid was turbid, and a large amount of precipitate had formed.
Armervenol is stated by the proprietors--The Hille Laboratories,
Chicago--to be a hydrosol (colloidal suspension) of
“mercury-copper-sulpharsenite” containing sufficient sodium chlorid
to make it isotonic with blood serum and “inert proteid” and
“carbohydrate” to stabilize the solution: each cubic centimeter is
declared to contain 0.0025 gm. arsenic, 0.005 gm. mercury, 0.0016 gm.
copper, and 0.0032 gm. sulphur.
The use of Armervenol as advised by the Hille Laboratories is the same
as that of Mervenol, and in addition its use in syphilis is emphasized.
The criticisms of this mixture are similar in every respect to those
directed against Mervenol--the addition of arsenic introduces still
another factor of uncertainty.
After investigating these claims, it was decided not to accept this
preparation on the ground (1) that the therapeutic claims are unproved
and unwarranted, conflicting with Rule 6, and (2) that the mixture is
an irrational one, conflicting with Rule 10.--(_From Reports of Council
on Pharmacy and Chemistry, 1919, p. 82._)
NORMAL PHENOL SERUM (CANO) AND METHYL-PHENOL SERUM (CANO)
NOT ACCEPTED FOR N. N. R.
Report of the Council on Pharmacy and Chemistry
The Council has adopted the following statement declaring Normal Phenol
Serum (Cano) and Methyl-Phenol Serum (Cano) ineligible to New and
Nonofficial Remedies.
W. A. Puckner, Secretary.
No statement of the composition of these preparations was submitted
to the Council and none appears on the labels of the trade packages.
However, the advertising circular contains statements such as:
“... normal phenol serum--phenol with methyl blue dissolved in
anaphylactic serum ...”
“... a combination of human or horse serum with Phenol and
Methylene-blue, thereby forming a new chemico-biologic product
which he termed Methyl-phenol Serum or, chemically, Chloride of
Phenol Thionin Tetramethylene-Seric.”
“Methyl-phenol Serum is a chemico-biological product in which
Phenol is the chief factor. Each ampule of 10 c.c. contains the
therapeutic equivalent of 0.5 gm. (7.5 grains) of Phenol.”
From the foregoing it appears that both preparations contain phenol and
methylthionine chloride (methylene blue) and that the second does not
contain methyl phenol (cresol) as the name would indicate.
No definite evidence for the value of these preparations is brought
forward and even the manufacturer is constrained to caution, “We assume
no responsibility for the therapeutic action of the serum....” On the
other hand there are a great many statements in the papers of Cano and
his colleagues to which exception must be taken. Of these, from among
many similar, the following statements are to be cited and commented on:
“Accepting that the gonorrheal infection gives systemic toxemia
from absorption of the toxins ...”
It is the general opinion that in the majority of instances there is no
systemic toxemia.
“The technique of intraprostatic injection, while less simple than
that of the intravenous, is by no means so difficult or complicated
as to place it exclusively in the category of the urologist.”
This obviously is an attempt to encourage the general use of these
preparations and to minimize the necessity for careful study and
special skill in their employment. It is most unwise for one to attempt
intraprostatic injections unless he is specially trained in the
technique of this procedure.
“This injection to be performed after the 5th or 6th intravenous
injection of Methyl-phenol Serum....”
Intravenous injections have a place in sane therapy only when the
medicament to be so administered is of known composition and when
evidence is available which gives assurance that definite results shall
follow its use. In the absence of these conditions it is manifestly
unwise and even unexcusable to employ any medicament in this manner,
and its repeated use is reprehensible.
“Intravenous injection of Methyl-phenol Serum alternating with
intravenous injections of mercury should be given every 48 hours
until infection is under control.”
This quotation further emphasizes that the treatment, as advised,
carries with it a certain element of danger.
“Methylene blue prevents the phenol from exerting its usual action
upon the red blood corpuscles, and ensures rapid elimination
through healthy kidneys. It preserves the antiseptic power of
the phenol and prevents the phenol from interfering with the
chemico-biological function of the white and red blood cells. The
serum component favors chemotaxis, it strengthens bodily defense,
it prevents anaphylaxis even in debilitated patients, and it
replaces the resistance which has been impaired by the demands that
have already been made upon it.”
No evidence is submitted to substantiate these claims. It seems strange
that phenol should lose its power and that this should be restored by
the methylene blue.
“It has a refractory chemico-biological action, and exercises no
vicious effect on the red blood corpuscles in the circulation, but,
on the contrary, by its inoffensive presence, it wholly preserves
all of the physiological properties of the blood.”
What “a refractory chemico-biologic action” is, is not clear, but
there is no evidence that this preparation has any action which might
be defined as “refractory chemico-biological,” that its presence is
inoffensive or that it wholly preserves all the physiologic properties
of the blood.
“The treatment of gonorrhea by Cano’s theory ... is firmly
based upon chemico-biological facts and accepted authoritative
theories and bears the same relation to gonorrhea that intravenous
injections of arsenicals bear to syphilis.”
Quite an exaggerated and unwarranted statement. In the same way,
objection is taken to the following quotations:
“Phenol administered intravenously in combination with methylene
blue, to protect the red-blood globule, undergoes no change, and
preserves all of its actual antiseptic effect on the gonococcus and
its toxins as though employed in the test tube.”
“When thus introduced into the human body its elimination is
unique, effective, antiseptic, germicidal, being completely and
exclusively thrown off through the kidneys in a period varying from
one-half to twelve hours without local injury or disturbance to the
general economy.”
“Combinations of phenol are unstable, but they do have the
advantage of mitigating direct action on the cells and globules.
It is also known that ordinary phenol has a _coagulant action_ on
the albumins and an _oxidizing power_ on the tissues, which power,
if permanent, produces gangrene. By virtue of this dual action it
therefore acts as a _modifier_; by its oxidizing power on the germ
it is germicidal, and prevents the growth of the gonococcus; and
by its coagulant power on the toxins it relieves paragonococcal
lesions (mono- and poly-arthritides) and affections of the serous
organs (endo- and pericarditis, meningitis), and some definite
systemic disturbances, the pathology of which is often confused
with that of other infections.”
“Lymphocytosis is often persistent in some individuals in whom
the internal secretions and the processes of assimilation and
disassimilation are deficient; and because of the lack of these the
organic physiological ferments are insufficient for the mechanism
of nutrition and the phenomena of hematopoiesis.”
Until proof is available showing that phenol, administered
intravenously in the quantities employed in Cano’s Normal Phenol Serum
and Cano’s Methyl-Phenol Serum, acts as a germicide and methylthionine
chloride (“methylene blue”) prevents the deleterious effects of phenol
on the red blood corpuscles; that repeated intravenous injections of
phenol and mercury are without danger; that there is no danger of
anaphylaxis; that the physiologic properties of the blood are preserved
by these medicaments; and, finally, that these preparations have an
effect on gonorrhea and its complications, these substances Normal
Phenol Serum (Cano) and Methyl-Phenol (Cano), are inadmissible to New
and Nonofficial Remedies.
The following quotations taken from the circular are admissions that
these preparations are not innocuous:
“That the economy will tolerate to a surprising degree substances
directly introduced through the blood stream is now well known.
By the intravenous injection of 10 c.c. of methyl-phenol serum we
throw into the human body a massive dose of an alien substance.
The immediate effect of this injection is upon the central nervous
system. The recipient usually becomes either pale or suffused, he
has a ringing in his ears, has a sensation of great altitude, and
occasionally has a dryness of the fauces and a metallic or a garlic
taste.”
“In some patients secondary reactions occur in from one to four
hours after injection. The phenomena we have observed in these
secondary reactions are pronounced chill and rigor ...”
There is no doubt that considerable harm may be done by the intravenous
and by the intraprostatic administration of these preparations and
until there is good evidence showing the therapeutic value of the
treatment, the routine use of these preparations, except perhaps at
hospitals in selected and well controlled and carefully guarded cases,
is to be strongly discouraged.
When the foregoing statement was sent to the Mulford Company for
comment, the firm submitted a letter from Dr. Perry Townsend to the
Mulford Company in which he declared that the results obtained with the
Cano preparations had been satisfactory and without untoward results.
In this letter, Dr. Townsend proposed that a series of injections with
these preparations be carried out under the observation of members of
the Council and the supervision of Dr. Cano or himself.
The report of the Council, the letter from the Mulford Company and that
of Dr. Townsend were sent to a number of urologists for their opinion
concerning this whole matter. It was explained that the referee held
that no reason had been presented which would warrant the Council to
depart from its customary procedure, namely, to require that clinical
evidence be submitted in the form of published reports which permit
investigation and verification by independent observers but that,
before making further recommendation to the Council, he desired the
opinion of urologists of recognized standing concerning the report
submitted to the Mulford Company. All replies received approved the
Council’s position.
The following is one of the replies received:
Your letter in regard to Normal Phenol Serum (Cano) and
Methyl-Phenol Serum (Cano) received. I wish to state that I have
read the correspondence between the Council and H. K. Mulford Co.
and in my opinion the referee and the Council are quite correct in
their attitude in the matter. In my opinion I would emphasize the
following:
(1) There is absolutely nothing about the remedies directed
_specifically_ against the gonococcus and no evidence to show that
any action against them is obtained. As we know there are certain
states of normal serum which are highly toxic and any normal
serum from another animal will produce disturbances in man when
injected intravenously--particularly if repeated. The addition of
substances to serum normal or otherwise is apt to and frequently
does render that serum highly toxic! The substances added in the
instances referred to--phenol and methylene blue are not in any
way calculated to lessen the toxicity of serum. The element of
danger existing in the indiscriminate use of serums intravenously
is, in my opinion, increased by the addition of the substances
mentioned, and it would be unwise to encourage the general use of
any such remedies. Furthermore the products are condemned by the
very evidence of the originators and their admissions are quite
sufficient to deter anyone from using the products as they suggest.
As to the intraprostatic injections with the serums it does not
at all meet my views; although the introduction of serums by this
route have been frequently advocated and I have personally carried
this mode out I cannot allow the impression to go out that it
could be done in a routine manner--nor that no ill results could
follow--for I have seen otherwise. Furthermore from theoretical
standpoint serums need not be given in this way.
In consideration of the opinion expressed by the Council’s
consultants the referee recommended that Normal Phenol Serum (Cano)
and Methyl-Phenol Serum (Cano) be declared ineligible for New and
Nonofficial Remedies because of conflict with Rule 6 (unwarranted
therapeutic claims) without considering possible conflicts with other
rules, and that publication of the report be authorized.--(_From
Reports of Council on Pharmacy and Chemistry, 1919, p. 85._)
SOAMIN OMITTED FROM N. N. R.
Report of the Council on Pharmacy and Chemistry
Soamin is the name under which the firm of Burroughs Wellcome and
Company sells its brand of sodium arsanilate. The Council directed the
omission of Soamin from New and Nonofficial Remedies and authorized
publication of the report which appears below after the proprietors of
the product had declined to withdraw or suitably revise the unwarranted
therapeutic claims which it made.
W. A. Puckner, Secretary.
The proprietary brand “Soamin” of sodium arsanilate was admitted to
New and Nonofficial Remedies several years ago at a time when the
therapeutic value of arsanilic acid had not been definitely determined.
Experience with this drug has shown that it is far more dangerous
and also has a more limited field of usefulness than was at first
recognized. The proprietors of the Soamin brand have continued to
include in the list of conditions in which it “would seem” to be a
“very effective agent” cerebrospinal meningitis and pellagra; in fact,
meningitis is the first in the list of conditions mentioned, syphilis
the second and pellagra third. In support of their belief in the
efficacy of the remedy in meningitis, three reports, published from
six to nine years ago, are quoted. In one of these it is stated that
two patients “were cured”; in another report, seven of eight patients
in whom the clinical, but not the microscopic, diagnosis of meningitis
had been made were reported as having recovered; in the third report,
fifty-six of ninety cases were reported cured; in this larger series of
cases the author neglects to state the method of administration. The
firm quotes but one paper (which is a very uncritical report) in regard
to pellagra.
It seems to the Council that the evidence of value of sodium arsanilate
in these conditions (which are now treated by more rational methods) is
too slight to justify the emphasis laid on it by the firm, especially
as sodium arsanilate is admittedly a dangerous agent, several cases of
blindness having been reported from its use.
For these reasons it was voted to omit Soamin from New and Nonofficial
Remedies.--(_From Reports of Council on Pharmacy and Chemistry, 1919,
p. 89._)
SOME MIXED VACCINES NOT ADMITTED TO N. N. R.
Report of the Council on Pharmacy and Chemistry
The Council has authorized publication of the following report.
W. A. Puckner, Secretary.
The consideration of the following “mixed” vaccines was requested by
F. I. Lackenbach, San Francisco:
Special Bacterial Vaccine No. 2 (Staph-Strep. Bacterin) containing
killed _Staphylococcus albus_, _Staphylococcus aureus_ and
streptococcus.
Special Bacterial Vaccine No. 3 (Pneumo-Staph-Strep. Bacterin)
containing killed _Staphylococcus albus_, _Staphylococcus aureus_,
streptococcus and pneumococcus.
Special Bacterial Vaccine No. 4 (Pneumo-Staph-Strep-Coli Bacterin)
containing killed _Staphylococcus albus_, _Staphylococcus aureus_,
_Staphylococcus citreus_, _Bacillus coli_, streptococcus and
pneumococcus.
Special Bacterial Vaccine No. 5 (Influenza Combined Bacterin)
containing killed _Staphylococcus albus_, _Staphylococcus aureus_,
_Bacillus Friedländer_, _Bacillus influenzae_, _Micrococcus
catarrhalis_, streptococcus and pneumococcus.
Special Bacterial Vaccine No. 11 (Pneumo-Strep. Bacterin)
containing killed streptococcus and pneumococcus.
Special Bacterial Vaccine No. 15 (Combined Whooping Cough Bacterin)
containing killed _Bacillus pertussis_, _Staphylococcus albus_,
_Staphylococcus aureus_, _Micrococcus catarrhalis_, _Bacillus
influenzae_, streptococcus and pneumococcus.
Special Bacterial Vaccine No. 16 (Mixed Gonococcus Bacterin)
containing killed gonococcus, _Staphylococcus albus_,
_Staphylococcus aureus_, _Bacillus coli_, _diphtheroid bacillus_,
streptococcus and pneumococcus.
Mr. Lackenbach states that these bacterial mixtures were prepared
for him by E. R. Squibb & Sons. Their sale in interstate commerce is
permitted under the license granted to the latter firm by the U. S.
Treasury Department. However, no evidence of any kind was presented
to the Council proving the therapeutic efficacy of the several mixed
vaccines. As a mixture of two or more kinds of organisms is accepted
for New and Nonofficial Remedies only if there is satisfactory evidence
that its therapeutic use is rational, the Council declared the several
vaccine mixtures ineligible for New and Nonofficial Remedies (Rule
10).--(_From Reports of Council on Pharmacy and Chemistry, 1919,
p. 90._)
SOMNOFORM
Report of the Council on Pharmacy and Chemistry
The Council examined the available evidence for Somnoform, sold by
Stratford-Cookson Company, successors to E. de Trey and Sons, and found
the preparation inadmissible to New and Nonofficial Remedies. The
Council authorized publication of the report which appears below.
W. A. Puckner, Secretary.
Somnoform is sold in the United States by Stratford-Cookson Company,
successors to E. de Trey and Sons. According to the label on a package
of Somnoform sent the Council.
“This mixture contains Chloride of Ethyl, 83 per cent.; Chloride of
Methyl, 16 per cent.; Bromide of Ethyl, 1 per cent.”
Although Somnoform has been on the market for a long time, the
published reports present no proof that it is superior to ethyl
chlorid used alone. Moreover, the published reports and statistics do
not necessarily apply to the Somnoform now sold for the reason that
mixtures of varying composition have been sold as Somnoform in the
past. Thus, when Somnoform was considered by the Council in 1909, it
was claimed to be composed of chloride of ethyl, 60 per cent.; chloride
of methyl, 35 per cent., and bromide of ethyl, 5 per cent. Federal
chemists found, however, that it contained no bromide of ethyl (Notice
of Judgment No. 571). It is a question, therefore, whether a given
report applies to a mixture containing 5 per cent. bromide of ethyl, 1
per cent. of this substance, or none at all.
The present advertising booklet for Somnoform does not present
acceptable evidence of the therapeutic value of the preparation.
An ignorance concerning the elementary facts of physiology and
pharmacology is evident in the second sentence: when having stated that
“Somnoform is the result of several years of study and investigation by
Dr. George Rolland, Dean of the Bordeau Dental School,” the pamphlet
continues: “He sought an anesthetic which would enter, dwell in, and
leave the body in the same manner that oxygen does....”
The claim as to the value of the 1 per cent. of ethyl bromide in the
mixture is highly improbable; certainly no evidence in support of the
claimed value of this constituent is available to the referee.
No evidence is submitted which proves the claim of superiority of
Somnoform over similar preparations, asserted in the following:
“The peculiar manner in which the elements are combined is what
makes Somnoform at once so efficient and so safe.”
The Council declared Somnoform inadmissible to New and Nonofficial
Remedies because, in the absence of acceptable evidence showing its
exceptional safety and value, the claims are unwarranted (Rule 6), and
because the name of the mixture is not descriptive of its composition
(Rule 8).--(_From Reports of Council on Pharmacy and Chemistry, 1919,
p. 90._)
TABLETS FORMOTHALATES
Report of the Council on Pharmacy and Chemistry
The Council has authorized publication of the following report which
declares Tablets Formothalates (Tailby-Nason Company, Boston, Mass.)
ineligible for New and Nonofficial Remedies.
W. A. Puckner, Secretary.
Tablets Formothalates are sold by Tailby-Nason Company, Boston,
Mass. On the label a formula is given: “Constituents: Acetanilid
2 gr.; phenolphthalein 1/2 gr. In a balanced combination with
Hexamene [a name sometimes applied to hexamethylenamin] and Oil of
Cinnamon. Indications: Influenza, Colds, Grippe, Headache, Neuralgia,
Rheumatism.” The same formula is given in advertisements and in this
advertisement it is claimed that they are “For Influenza and Grip” and
if “given in the acute stage may avert a serious attack” (_Boston M.
& S. J._, Oct. 3, 1918). The dose is given as one to two tablets at
6 p. m. and repeat at bedtimes.
The A. M. A. Chemical Laboratory reported that the tablets weigh an
average of 0.4882 Gm., or 7-1/2 grains; that they _have_ the odor and
taste of cinnamon; and that they contain hexamethylenamin, are neutral
and therefore give up no formaldehyde in the presence of water alone.
The Laboratory further reported that they contain phenolphthalein and
acetanilid. These tablets were directed to be taken internally and
therefore their effect was not intended to be local.
The amount of hexamethylenamin was not determined, but in any case
could not exceed 5 grains per tablet. It is evident that 4 grains
of acetanilid and 10 grains of hexamethylenamin and 1 grain of
phenolphthalein (in two tablets) “if given in the acute stage” of
influenza would not “avert a serious attack,” as claimed in the
advertisements.
The Council declared Tablets Formothalates inadmissible to New and
Nonofficial Remedies.--(_From Reports of Council on Pharmacy and
Chemistry, 1919, p. 92._)
TRIPLE ARSENATES WITH NUCLEIN
Report of the Council on Pharmacy and Chemistry
The Council has declared Triple Arsenates with Nuclein No. 1 and
Triple Arsenates with Nuclein No. 2, tablets marketed by the Abbott
Laboratories, inadmissible to New and Nonofficial Remedies because
unwarranted therapeutic claims (Rule 6) are made for them and because
they present an illogical combination of drugs (Rule 10). The
publication of the following report has been authorized by the Council.
W. A. Puckner, Secretary.
The following claims are made for Triple Arsenates with Nuclein:
“Puts ‘pep’ and strength back into that patient recovering from
Spanish Influenza, pneumonia, typhoid, or surgical operation. An
extremely powerful reconstructive tonic. Try it for that ‘run down’
feeling.”
Triple Arsenates with Nuclein is said to contain “Strychnin Arsenate
gr. 1/128, Quinin Arsenate gr. 1/64, Iron Arsenate gr. 1/64, Nuclein
Solution mins. 4.” A second preparation, of double strength--Triple
Arsenates with Nuclein No. 2--is also advertised. The Council voted not
to accept these preparations for New and Nonofficial Remedies on the
following grounds:
The quantities of quinin, iron and nuclein in the doses represented in
these mixtures are negligible; thus, one tablet of Triple Arsenates
with Nuclein containing 1/64 grain of quinin arsenate contains only
about 1/90 grain of anhydrous quinin; the tablet containing 1/64
grain of iron arsenate contains 1/210 grain of iron; 4 minims of the
nuclein solution (assuming it to be the “Nuclein Solution-Abbott”)
would contain but 2/5 of a grain of nuclein--a substance which even in
large doses is of questionable therapeutic value. The amounts of iron
and nuclein contained in doses of this preparation are insignificant
in comparison with the amounts present in ordinary foods. The only
substances present in even small therapeutic doses are strychnin and
arsenic. The effects of arsenic and strychnin are very different
and there are comparatively few conditions in which they should be
prescribed at the same time. Hence a preparation containing these
two in fixed proportions is illogical.--(_From Reports of Council on
Pharmacy and Chemistry, 1919, p. 92._)
“ANTI-PNEUMOCOCCIC OIL” AND THE USE OF CAMPHOR IN PNEUMONIA
Report of the Council on Pharmacy and Chemistry
The Council has adopted and authorized publication of the report which
appears below. This report declares “Anti-Pneumococcic Oil” (a solution
of camphor in oil sold by Eimer and Amend, New York) ineligible for
New and Nonofficial Remedies because (1) the recommendations for its
use in pneumonia are not warranted by the evidence, (2) the name is
not descriptive of its composition but is therapeutically suggestive,
and (3) the sale of a solution of camphor in oil under a name
nondescriptive of its composition is unscientific and a hindrance to
therapeutic progress.
W. A. Puckner, Secretary.
The Council having decided to consider Anti-Pneumococcic Oil (Eimer
and Amend, New York), the preparation was assigned to the Committee on
Therapeutics for report. The report that follows was made by a member
of this committee:
According to the advertising, Anti-Pneumococcic Oil is a “twenty-five
per cent. solution of camphor in a thin oil” which was “originated” by
August Seibert, M.D. The following directions are given for its use:
“10 c.c. (150 minims) to every 100 pounds of body weight, to be
injected hypodermically every eight to twelve hours in pneumococcic
pneumonia, as soon after the initial chill as possible.”
It is claimed that the prescribed dose one hour before general
anesthesia begins, “safeguards against postoperative pneumonia,” and,
that “animals can so be immunized against later and otherwise fatal
intravenous pneumococcic infection (Boehnke, Institute for Experimental
Therapy, Frankfort).” The advice is given:
“In pneumococcic meningitis, endocarditis and pleuritis, 3% of
salicylic acid should be added to this oil.”
In an article by Seibert, “Camphor and Pneumococci” (_Medical
Record_, April 20, 1912), a reprint of which is used to advertise
Anti-Pneumococcic Oil, previous work (_München, med. Wchnschr._, No.
36, 1909) is mentioned as the starting point for the use of camphor in
pneumonia. In this article, the author reports his first case, that of
a young woman who entered St. Francis’ Hospital on the third day after
the initial chill “with the symptoms of severe toxemia (unconscious,
temperature 105.5 F., pulse 130, and respiration 40) and involvement of
both lower lobes.” “Large doses of camphor,” 12 c.c. of a 20 per cent.
solution, were injected hypodermically “every twelve hours, resulting
in _gradual_ improvement and recovery by the fourth day, without a
crisis.” Seibert reports success in its use in twenty-one cases, but
gives no case histories or protocols. He admits, however, that in
four out of sixteen cases, following the first twenty-one so reported
certain “limitations of this treatment were observed,” and a “sudden
rise of temperature in two patients on the second and third days of
treatment, respectively, proved to be due to pneumococcic nephritis,
promptly subdued by appropriate doses of urotropin, while the camphor
injections were continued and resulting in speedy recovery.” He further
admits that empyema occurs, and states: “This proves that the camphor
brought into the blood cannot prevent the as yet living organisms,
constantly entering the blood current from the affected alveoli, from
colonizing in the renal and pleural tissue.”
He reports, among thirty-seven patients treated in this manner,
one death, that of a man 68 years old, weighing 200 pounds, with a
fatty heart. Heart failure was the real cause of death. Seibert also
reports some very incomplete experimental work; Dr. Hensel, assistant
and pathologist of the German Hospital, found that “1/10,000 part
of camphor added to the usual culture media inhibited the growth
of pneumococci, while the controls all thrived”; Dr. J. C. Welch,
pathologist of the Lying-in Hospital, found that rabbits infected
with lethal doses of pneumococcus cultures intravenously were saved
by large doses of camphorated oil; fragmentary protocols are given.
The assistant pathologist of St. Francis’ Hospital carried on the
experimental work, adding salicylic acid to the camphor. No blood
cultures are reported. The conclusion reached by Dr. Seibert is that
salicylic acid up to 3 per cent., added to the camphorated oil, is
effective in preventing pleural infection. In the article by Dr.
Seibert, there appear most sketchy reports of cases, recovery being
reported without crisis in from three to nine days.