Transcriber’s notes:
In this transcription, paired _underscores_ denote _italicised
text_ and a ^ indicates a superscripted character. A downward arrow
preceding curly brackets indicates that the bracketed character(s) are
subscripted, e.g. ↓{H}.
The text contains some uncommon characters that will not necessarily
display correctly with all viewing devices. If some of the characters
look abnormal, first ensure that the device’s character encoding is
set to Unicode (UTF-8). The default font might also need to be changed
to a Unicode font such as Arial Unicode MS, DejaVu, Segoe UI Symbol or
FreeSerif. Symbols representing male and female have been replaced by M
and F in the handheld version. Subscripted and superscripted characters
do not always display correctly on handheld devices.
The book contained innumerable typographical errors affecting spelling,
punctuation and formatting. Most spelling errors have been corrected
silently, but spelling variants that mainly reflect contemporary
spellings in the original quoted sources, have been left unchanged. A
list of the corrections and variations can be seen at the end of the
transcription. Punctuation anomalies (errors, omissions, duplications)
have mostly been corrected silently, but missing apostrophes have not
been corrected because of uncertainty about intended meaning. A few
missing quotation marks have been inserted within curly brackets {"}
and missing words inserted by the transcriber, e.g. {sic} {and} have
also been enclosed within curly brackets to differentiate them from
the numerous words and phrases inserted by the authors. Redundant
duplicated words have been deleted. Astute readers will probably note
persisting inconsistencies involving italics, fonts, hyphenation,
ellipses, accents, and ligatures (ae/æ, oe/œ) that have been left
unchanged because they have no impact on interpretation of the text.
The Table of Contents does not correspond accurately with headings used
in the text.
Footnotes are generally located below the relevant paragraphs;
however, footnotes that are cross-referenced multiple times
have not been duplicated. An error in footnote numbering
was corrected silently, and a missing footnote [120] was
inserted after being identified in the original source.
Over-sized tables have been compressed and where appropriate a key has
been inserted to assist the reader.
THE PROPAGANDA FOR REFORM
IN
Proprietary Medicines
VOLUME 2
Part I Reports of the Council
Part II Contributions from the Laboratory
Part III Journal Contributions: Proprietary Products
Part IV Journal Contributions: Miscellany
PRESS OF AMERICAN MEDICAL ASSOCIATION, FIVE HUNDRED AND THIRTY-FIVE
NORTH DEARBORN STREET,--CHICAGO
1922
COPYRIGHT, 1922 BY THE AMERICAN MEDICAL ASSOCIATION
PREFACE TO VOLUME 2
There were nine editions of the first volume of The Propaganda for
Reform in Proprietary Medicines. The ninth edition contained the most
important reports of the Council on Pharmacy and Chemistry and of the
Chemical Laboratory. It contained also those articles from _The Journal
of the American Medical Association_ (up to, and including, 1916)
which dealt with the problems of proprietaryship in medicine and the
furtherance of rational drug therapy.
The present volume contains similar material covering the period from
January, 1917, to April, 1922, inclusive. Like Volume 1, this volume is
divided into four parts:
Part I. THE COUNCIL ON PHARMACY AND CHEMISTRY: This section presents
the principles and rules which govern the Council in the examination of
medicaments, together with articles and reports bearing on the work of
the Council, and the most important reports of the Council from 1917 to
April, 1922, inclusive.
Part II. THE A. M. A. CHEMICAL LABORATORY: This section, besides
presenting the aims and objects of the Association’s Chemical
Laboratory, also outlines some of the Laboratory’s work which is of
particular interest to physicians.
Part III. CONTRIBUTIONS FROM THE JOURNAL: Proprietary Products: This
part contains articles on proprietary medicinal preparations and the
methods by which they are exploited, which have appeared in _The
Journal A. M. A._
Part IV. CONTRIBUTIONS FROM THE JOURNAL: MISCELLANY: In this section
are articles dealing with matters of interest to the medical profession
but not coming strictly under the classification of proprietary
medicinal preparations.
A comparison of the material that has appeared in Volume 1 of The
Propaganda for Reform with that which appears in this volume will
reveal the changing conditions in the proprietary medicine field. Many
of the reports in the first volume brought out the fact that medicinal
preparations were at that time foisted on the profession with false
claims of composition; reports of this character are less conspicuous
in the present volume. Many of the reports in Volume 2 deal with
unwarranted therapeutic claims, especially those advanced for animal
organ preparations, serums, vaccines, preparations for intravenous
medication, etc. The present volume will also be found of interest in
its portrayal of the changed conditions in the proprietary medicine
business brought about by the World War.
Special attention is directed to the index in this volume. It is, in
effect, a bibliography, including references not only to articles
in this book but also (1) to articles which appeared in Volume 1;
(2) to articles on the same general subject in _The Journal of the
American Medical Association_, and (3) to the articles appearing in
the annual reports of the Council on Pharmacy and Chemistry and of the
A. M. A. Chemical Laboratory, but not reprinted in either volume of the
Propaganda for Reform in Proprietary Medicines.
PREFACE TO VOLUME 1: NINTH EDITION
From time to time _The Journal of the American Medical Association_ has
published the reports of the Council on Pharmacy and Chemistry and the
Chemical Laboratory, as well as other matter on proprietary medicines.
Repeated requests for some of the matter have led to the compilation
of “The Propaganda for Reform in Proprietary Medicines,” which, in the
present volume, attains its ninth edition.
The seventh, eighth and ninth editions have been compiled on slightly
different principles from their predecessors. The therapeutic reform
work of _The Journal_ and of the Association’s Chemical Laboratory was
at first confined almost entirely to the criticism and analysis of the
so-called ethical proprietaries. This was right; the medical profession
owed it to the public to combat the nostrum evil within its own ranks.
As the more flagrant evils of the “ethical proprietary” question were
mitigated, the Association has turned the light on the more widespread
and dangerous “patent medicine” evil. The articles devoted to “patent
medicines” or quackery being naturally of greater interest to the
general public than to the medical profession, the number of inquiries
from laymen regarding various quacks and nostrums has steadily
increased. It has been thought best, therefore, to publish separately
all of the matter from _The Journal_ relative to quackery and to those
nostrums exploited only or chiefly to the public, and to include in the
Propaganda for Reform practically none of the matter that is of direct
interest primarily to laymen. In one or two instances in which the
subjects were of equal interest to the profession and to the public,
matter that has already appeared in “Nostrums and Quackery” is also
given here; but as a general rule the contents of the ninth edition
of “The Propaganda for Reform” are of strictly professional interest.
Those physicians who are desirous of obtaining in convenient form the
matter dealing with “patent medicines” should order the book “Nostrums
and Quackery” or the various pamphlets on the same subjects that have
been issued since “Nostrums and Quackery” came from the press.
The ninth edition of “Propaganda for Reform” contains a number of new
articles, greatly increasing the size of the book. It also contains
one novel feature which greatly enhances its value. The index includes
references not only to articles in the book, but also to matter on
proprietaries not accepted by the Council on Pharmacy and Chemistry
which appeared in _The Journal of the American Medical Association_ and
elsewhere. This index makes of this edition of “Propaganda for Reform”
a very full work of reference on proprietaries which are undeserving of
recognition. It should be understood, however, that not all articles
indexed are condemned; some are merely discussed and compared.
RESOLUTION ENDORSING THE WORK OF THE COUNCIL
ON PHARMACY AND CHEMISTRY
Presented at the San Francisco Session and Signed by All the Members
of the House of Delegates in Attendance
+-------------------------------------------------------------------+
| _Resolved_, We, Members of the House of Delegates of the American |
| Medical Association, believe that every effort must be made to |
| do away with the evils which result from the exploitation of the |
| sick for the sake of gain. Earnestly believing that the continued |
| toleration of secret, semisecret, unscientific or untruthfully |
| advertised proprietary medicines is an evil that is inimical to |
| medical progress and to the best interest of the public, we |
| declare ourselves in sympathy with, endorse and by our best |
| efforts will further, the work which has been, and is being, done |
| by the Council on Pharmacy and Chemistry of the American Medical |
| Association in the attempt to eliminate this evil. |
+-------------------------------------------------------------------+
TABLE OF CONTENTS
PART I: COUNCIL REPORTS
PAGE
Foreword 1
Official Rules of the Council on Pharmacy and Chemistry 3
The Council on Pharmacy and Chemistry, Present and Future 12
“Accepted by the Council on Pharmacy and Chemistry” 19
Helping the Council 20
Delays in Passing on Products 20
Cooperation of the Pharmaceutical Houses 21
Budwell’s Emulsion of Cod-Liver Oil, Nos. 1 and 2 22
Rheumalgine 23
Gray’s Glycerine Tonic 24
Tongaline and Ponca Compound 26
Alfatone 28
Uricsol 30
Jubol 31
Urodonal 32
Formamint 33
Hydragogin 41
Filudine 41
Lactopeptine and Elixir Lactopeptine 43
Iodum-Miller and Iod-Izd-Oil (Miller’s) 49
Elixir Iodo-Bromide of Calcium Comp. “Without Mercury” and
“With Mercury” 52
Lecithin Preparations Omitted from N. N. R. 53
Proprietary Names for Liquid Petrolatum 55
Seng 55
Frosst’s Blaud Capsules 56
Tyree’s Elixir of Buchu and Hyoscyamus Compound 57
Hydroleine 58
Curative Vaccine, Bruschettini 58
Stearn’s Wine 59
Protonuclein and Protonuclein Beta 59
Hydropsin 61
Digitalysatum 63
So-Called Secretin Preparations 64
Has Secretin a Therapeutic Value? 65
Radio-Rem 79
Olio-Phlogosis 79
The Hypophosphite Fallacy 80
Pulvoids Calcylates 85
Sulfuryl Monal 86
Mark White Goiter Serum and Mark White Iodinized Oil 87
Kora-Konia 92
The Therapeutic Value of the Glycerophosphates 93
Hydras 96
Bromin-Iodin Compound 97
Ammonium Hypophosphite Omitted from N. N. R. 98
Alphozone Omitted from N. N. R. 99
Calcium Glycerophosphate and Sodium Glycerophosphate Omitted
from N. N. R. 99
Gardner’s Syrup of Ammonium Hypophosphite Omitted
from N. N. R. 100
Gluten Products Made by the Kellogg Food Company 100
Iodo-Mangan Omitted from N. N. R. 106
Liquid Albolene 106
Naphey’s Medicated Uterine Wafers 107
Nujol 108
Pulvoids Natrium Compound 108
Saloform 110
Secretogen 110
Iron Citrate Green 115
Aspirin 116
Pil. Cascara Compound-Robins 117
Casta-Flora 118
Firwein 119
Firolyptol Plain and Firolyptol with Kreosote 120
Biniodol 121
Comparative Symptoms Resulting from the Use of Several Oily
Suspensions of Red Mercuric Iodid (Mercury Biniodid) 123
Corpora Lutea (Soluble Extract), Parke, Davis & Co. 128
Wheeler’s Tissue Phosphates 129
The Claimed Galactagogue Effects of Nutrolactis and
Goat’s Rue Not Substantiated 131
The Alleged Galactagogue Action of Galega and Nutrolactis 131
The Russell Emulsion and the Russell Prepared Green Bone 134
Brom-I-Phos 136
Creosote-Delson and Creofos 137
Triner’s American Elixir of Bitter Wine 139
Trimethol 140
Ferrivine, Intramine and Collosol Iodine 144
Eskay’s Neuro Phosphates 146
K-Y Lubricating Jelly 147
Ziratol 148
Gonosan 150
Alcresta Ipecac 153
Iodeol and Iodagol 154
Capsules Bismuth Resorcinol Compound Not Admitted to N. N. R. 157
Dixon’s Tubercle Bacilli Extract and Dixon’s Suspension of
Dead Tubercle Bacilli 158
Formosol 158
Iodolene, a Solution of Iodin in Liquid Petrolatum,
Inadmissible to N. N. R. 159
Kalak Water 160
Minson’s Soluble Iodin “Kelpidine” Not Admitted to N. N. R. 161
Nutone 162
Tri-Arsenole, L. O. Compound No. 1 and L. O. Compound No. 2 163
Unctol 166
V-E-M (Schoonmaker Laboratories, Inc.) 166
Hemo-Therapin 168
Venosal 169
Secretin-Beveridge and the U. S. Patent Law 170
The Question of the Stability of Secretin 171
Need for Patent Law Revision 177
Surgodine 180
Medeol Suppositories 181
Guaiodine 183
Several “Mixed” Vaccines Not Admitted to N. N. R. 184
Ophthalmol-Lindemann 189
Silvol Ineligible for N.N.R 189
Katharmon 191
Iodinized Emulsion (Scott) and Creosotonic (Scott) 192
Campetrodin and Campetrodin No. 2 193
Carminzym 194
Phillips’ Phospho-Muriate of Quinine Comp 197
B. Iodine and B. Oleum Iodine 198
B. Iodine Products 199
Antithyroid Preparations (Antithyroidin-Moebius and
Thyreoidectin) Omitted from N. N. R. 202
Cephaelin and Syrup Cephaelin-Lilly Omitted from N. N. R.
and Syrup Emetic-Lilly Not Accepted 203
Colalin Omitted from N. N. R. 203
Foral 204
Granular Effervescent Bromide and Acetanilid Compound-Mulford 206
Holadin and Bile Salt Mixtures 207
Liquor Santaiva, S. & D., Omitted from N. N. R. 211
Maltzyme, Maltzyme with Cascara Sagrada, Maltzyme with Cod
Liver Oil, Maltzyme Ferrated and Maltzyme with Yerba Santa
Omitted from N. N. R. 211
Methaform Omitted from N. N. R. 212
Pineal Gland, Red Bone-Marrow and Thymus Gland and Their
Preparations Omitted from N. N. R. 213
Piperazine and Lycetol Omitted from N. N. R. 214
Stanolind Liquid Paraffin Omitted from N. N. R. 214
Westerfield’s Digitalis Tablets 215
Xeroform-Heyden and Bismuth Tribromphenate-Merck Omitted
from N. N. R. 216
Cream of Mustard Refused Recognition 218
“Pluriglandular” Mixtures 218
Cerelene Not Admitted to N. N. R. 219
Collosol Cocaine Not Admitted to N. N. R. 221
Cuprase Not Admitted to N. N. R. 222
Collosol Preparations 223
Pulvoids Calcylates Compound 226
Proteogens of the Wm. S. Merrell Company 227
“Arsenoven S. S.” and “Arseno-Meth-Hyd” 231
Hormotone and Hormotone Without Post-Pituitary 234
Formaldehyde Lozenges 235
Lavoris 237
Medinal 239
Omission of Cotarnin Salts (Stypticin and Styptol)
from N. N. R. 240
Micajah’s Wafers and Micajah’s Suppositories 241
Alkalithia 242
Arhovin Omitted from N. N. R. 243
Chloron, Chlorax and Number “3” 244
Elarson Omitted from N. N. R. 248
Iodiphos 249
Mervenol and Armervenol Not Admitted to N. N. R. 249
Normal Phenol Serum (Cano) and Methyl-Phenol Serum (Cano)
Not Accepted for N. N. R. 251
Soamin Omitted from N. N. R. 253
Some Mixed Vaccines Not Admitted to N. N. R. 254
Somnoform 255
Tablets Formothalates 256
Triple Arsenates with Nuclein 256
“Anti-Pneumococcic Oil” and the Use of Camphor in Pneumonia 257
Dial “Ciba” 259
Apothesine 260
Eumictine 262
Platt’s Chlorides 263
Anti-Tuberculous Lymph Compound (Sweeny) and Anti-Syphilitic
Compound (Sweeny) 266
Syrup Leptinol (Formerly Syrup Balsamea) 268
Formitol Tablets, II 271
Sukro-Serum and Aphlegmatol 273
Supsalvs Not Admitted to N. N. R. 274
Hypodermic Solution No. 13, Iron, Arsenic and Phosphorus
Compound Not Accepted for N. N. R. 275
Parathesin Not Admitted to N. N. R. 276
Chlorlyptus 277
Aquazone (Oxygen Water) 290
Coagulen-Ciba Omitted from N. N. R. 290
Ferric Cacodylate Omitted from New and Non-Official Remedies 292
Libradol 293
Helmitol Omitted from N. N. R. 295
Spirocide Not Admitted to N. N. R. 296
Digifolin-Ciba Not Admitted to N. N. R. 298
Some of Loesser’s Intravenous Solutions 299
“National Iodine Solution” Not Admitted to N. N. R. 300
Mon-Arsone Not Admitted to N. N. R. 302
Oxyl-Iodide Not Admitted to N. N. R. 304
Quassia Compound Tablets 306
Toxicide 307
Pil. Mixed Treatment (Chichester) 310
Atophan Omitted from N. N. R. 313
Urotropin Omitted from N. N. R. 316
Styptysate Not Admitted to N. N. R. 318
Lipoidal Substances (Horovitz) Not Admitted to N. N. R. 320
Yeast Preparations and Vitamin B Concentrates 321
PART II: CONTRIBUTIONS FROM THE A. M. A. CHEMICAL LABORATORY
The Chemical Laboratory of the American Medical Association 322
The Work of the American Medical Association Chemical
Laboratory 322
Lead in “Akoz” 328
Sodium Acetate in Warming Bottles 329
Anti-Syphilitic Compound (Sweeny) 330
“Ambrine” and Paraffin Films 330
The Stability of Iodine Ointments 337
Iodolene and the Solubility of Iodin in Liquid Petrolatum 344
American-Made Synthetic Drugs--I 344
Standardization of Commercial Bismuth Tribromphenate 348
Standardization of Procain and Examination of the
Market Supply 355
Deterioration of Sodium Hypochlorite Solutions 358
Syphilodol 359
Cerelene 362
Dr. De Sanctis’ Rheumatic and Gout Pills 363
Iodex and Liquid Iodex 365
PART III: CONTRIBUTIONS FROM THE JOURNAL: PROPRIETARY PRODUCTS
Iodin in Liquid Petrolatum 367
American-Made Synthetic Drugs--II 369
Nostrums in Retrospect 379
Bell-Ans (Pa-Pay-Ans Bell) 380
Anasarcin and Anedemin 383
Pepto-Mangan 387
Cactina Pillets 391
Ammonol and Phenalgin 393
Fellows’ Syrup, and Other Preparations of the Hypophosphites 395
Shotgun Nostrums 398
Tyree’s Antiseptic and Aseptinol 401
Neurosine and the Original Package Evil 404
Anasarcin Advertising 407
Antimeristem-Schmidt 408
Antiphlogistine 409
“Auto-Hemic Serum” 409
“Autolysin” Advertising 413
“Basic Cancer Research” and “Cosmopolitan Cancer Research
Society” 414
Seleni-Bascca 416
Bell-Ans (Papayans, Bell) 418
Campho-Phenique 418
“Cinchophen”: Formerly “Atophan” 419
“Collosols”: An Uncritical English Endorsement 420
Cotton Process Ether 421
Dionol 422
The Eli Products of Eli H. Dunn 424
Glover’s Cancer Serum 425
Glyco-Thymoline and Poliomyelitis 427
Glykeron: Cold Storage Testimonials 428
Gray’s Glycerine Tonic: “Whose Bread I Eat His Song I Sing” 429
Hagee’s Cordial of Cod Liver Oil 429
Hypno-Bromic Compound 430
Intravenous Compound (Loffler) 430
Intravenous Specialties 435
Iodex 436
The William F. Koch Cancer Remedy 437
The Lucas Laboratories’ Products 440
“Phylacogens” 441
Pineoleum Advertising Methods 442
“Proteal Therapy” and Henry Smith Williams 443
Proteogens 445
Pulvane 450
Sal Hepatica 451
Salicon 453
So-Called Secretin Preparations 454
Succus Cineraria Maritima 455
Tekarkin 458
Tyree’s Antiseptic Powder Again 462
Wheeler’s Tissue Phosphates 463
Briefer Paragraphs 465
PART IV: CONTRIBUTIONS FROM THE JOURNAL: MISCELLANY
Albert Abrams, A.M., M.D., LL.D., F.R.M.S. 472
Acetylsalicylic Acid, Not Aspirin 480
The Allied Medical Associations of America 486
“Arsenicals” 491
Beer and Cancer Cures 494
Biologic Therapeutics and Its Commercial Domination 496
Capell’s Uroluetic Test 497
Chemotherapy and Tumors 499
The Direct Sales Company 510
Discoveries and Discoverers 511
“Drug Reform” 513
Drug Therapy: The Fallibility of Textbooks 515
Thomas Webster Edgar 515
Glycerophosphates 520
Influenza Vaccine 520
Intravenous Therapy 522
Iodin Fumes 523
Italian Physico-Chemical Company 524
What is Liquid Petrolatum? 526
The Lowenthal Postgraduate Course 527
Medical Society of the United States 531
The National Formulary--A Review of the Fourth Edition 535
Nonspecific Protein Therapy 536
Willard Ealon Ogden 538
“Patents” 542
Pharmaceutical Barnums 545
The Pharmacopeia 546
Physician’s Stock in Prescription Products 548
Pituitary Gland Preparations 549
Proprietorship in Medicine 550
Philip Rahtjen and His Discoveries 553
Sodium Cacodylate in Syphilis 555
Tablets: Dependability of Dosage 556
Therapeutic Evidence: Its Crucial Test 557
“Vaccines in Toxic Conditions” 560
Vitamins: Their Distribution 561
The William A. Webster Co. and the Direct Pharmaceutical Co. 564
Yeast 566
Briefer Paragraphs 570
THE PROPAGANDA FOR REFORM IN PROPRIETARY MEDICINES
PART I
REPORTS OF THE COUNCIL ON PHARMACY AND CHEMISTRY
FOREWORD
THE COUNCIL ON PHARMACY AND CHEMISTRY
The Council on Pharmacy and Chemistry was established by the
American Medical Association primarily for the purpose of gathering
and disseminating such information as would protect the medical
profession--and thus the public--in the prescribing of proprietary
medicinal articles.
The Council consists of sixteen members, fifteen appointed for a term
of five years without pay, and the sixteenth, a secretary, who is
also the director of the Chemical Laboratory of the American Medical
Association (see Part II).
At the present time (1921) the membership is:
C. L. Alsberg, A.M., M.D., Chief of the Bureau of Chemistry, U. S.
Department of Agriculture, Washington, D. C.
C. W. Edmunds, M.D., Professor of Materia Medica and Therapeutics,
University of Michigan Medical School, Ann Arbor.
R. A. Hatcher, Ph.G., M.D., Professor of Pharmacology, Cornell
University Medical College, New York City.
A. W. Hewlett, M.D., Professor of Medicine, Leland Stanford Junior
University School of Medicine, San Francisco.
John Howland, M.D., Professor of Pediatrics, Johns Hopkins University
Medical Department, Baltimore.
Reid Hunt, M.D., Professor of Pharmacology, Medical School, Harvard
University, Boston.
W. T. Longcope, A.B., M.D., New York.
G. W. McCoy, M.D., Director of the Hygienic Laboratory, U. S. Public
Health Service, Washington, D. C.
Lafayette B. Mendel, Ph.D., Sc.D., Professor of Physiological
Chemistry, Sheffield Scientific School, Yale University, New Haven.
F. G. Novy, Sc.D., M.D., Professor of Bacteriology, University of
Michigan Medical School, Ann Arbor.
W. W. Palmer, B.S., M.D., Bard Professor of Medicine, Columbia
University College of Physicians and Surgeons, New York.
W. A. Puckner, Phar.D., Secretary of the Council, Director of the
Chemical Laboratory of the American Medical Association, Chicago.
L. G. Rowntree, M.D., Sc.D., Professor of Medicine, Mayo Foundation,
Rochester.
G. H. Simmons, M.D., LL.D., Chairman of the Council, Editor of The
Journal of the American Medical Association, Chicago.
Torald Sollmann, M.D., Professor of Pharmacology and Materia Medica,
Western Reserve University School of Medicine, Cleveland.
Julius Stieglitz, Ph.D., Sc.D., Chem.D., Professor of Chemistry,
University of Chicago, Vice-Chairman of the Council, Chicago.
At its first meeting in 1905, the Council began examining the
proprietary and nonofficial medicinal preparations offered to
physicians of the United States, and authorized the publication of
a book (New and Nonofficial Remedies) containing descriptions of
those preparations which were deemed worthy of the consideration of
physicians. It also issued reports (Reports of the Council on Pharmacy
and Chemistry) to the medical profession on those preparations which
were not eligible. The Council adopted a set of rules by which to
measure the eligibility of each preparation for admission to New and
Nonofficial Remedies. These rules were designed primarily to protect
the public--through the medical profession--against fraud, undesirable
secrecy and objectionable advertising in connection with proprietary
medicinal articles. The rules originally adopted have been subjected
to revision from time to time to meet changing conditions. For the
information of those who wish to familiarize themselves with the work
of the Council the rules which are now in force (1921) follow this
introduction. A summary is also to be found in the article, “The Work
of the Council on Pharmacy and Chemistry, Present and Future,” page 12.
Since 1906, the Council has issued New and Nonofficial Remedies
annually. In each issue are listed and described the articles that
stand accepted on January 1 of the year of publication. The book
describes proprietary medicinal articles on the American market that
are found eligible under the rules, and also such nonproprietary,
nonofficial articles as give promise of therapeutic usefulness, listing
the acceptable brands. Articles of a similar character are grouped
together, and each group is preceded by a general discussion for the
purpose of comparison.
Since 1908, the Council has also issued an annual volume, “Reports
of the Council on Pharmacy and Chemistry,” which contains reports
on proprietary medicines that were found inadmissible to New and
Nonofficial Remedies. The reports issued prior to 1916--and deemed of
sufficient interest to physicians--were reprinted in the Propaganda
for Reform in Proprietary Medicines, ninth edition (1916). The more
important reports issued from 1916 to 1921, inclusive, are in this
volume.
While it is the chief function of the Council to investigate and report
on proprietary medicinal preparations, its work has broadened so that
the Council’s work may now be characterized as a propaganda for the
rational use of drugs. Thus, its Committee on Therapeutic Research
encourages the investigation of questions concerning the actions
of drugs. These investigations are brought together in the “Annual
Reports of the Therapeutic Research Committee.” The Council also has a
committee on medical teaching which has issued the publication “Useful
Drugs,” a concise, but thorough and up-to-date, discussion of the more
important drugs. In addition, the Council appointed a committee to
prepare an “Epitome of the U. S. Pharmacopeia and National Formulary,”
in which are presented those portions of the United States Pharmacopeia
and the National Formulary that are of interest to physicians and in
which is given a concise statement of the therapeutic usefulness of
such drugs and preparations.
OFFICIAL RULES OF THE COUNCIL ON PHARMACY AND CHEMISTRY
[May 1, 1921]
Introduction
The following rules have been adopted by the Council primarily with
the object of protecting the medical profession and the public against
fraud, undesirable secrecy and objectionable advertising in connection
with proprietary medicinal articles.
NEW AND NONOFFICIAL REMEDIES.--The book New and Nonofficial Remedies
contains a description of proprietary articles which have been
accepted as conforming to the rules of the Council; and of such simple
nonproprietary and nonofficial substances as seem of sufficient
importance to warrant their inclusion.
MIXTURES.--For admission to N. N. R., proprietary pharmaceutical
mixtures must comply with the rules; and, to determine such compliance,
they will be investigated by the Council. The Council, however,
endorses the principle that prescriptions should be written on the
basis of the therapeutic effects of the individual ingredients. For
this reason, it includes in this book only those mixtures that present
some real advantage. There is also an appendix in which are included
those proprietary articles which, so far as known to the Council,
comply with the rules, but which do not possess sufficient originality
to be admitted to the body of the book.
Rules Governing the Admission of Proprietary Articles to the Book
New and Nonofficial Remedies
DEFINITION OF PROPRIETARY ARTICLES.--The term “proprietary article,”
in this place, shall mean any chemical, drug or similar preparation
used in the treatment of diseases, if such article is protected against
free competition, as to name, product, composition or process of
manufacture, by secrecy, patent, copyright, or by any other means.
_Rule 1._--COMPOSITION.--No article will be accepted for inclusion in
the book New and Nonofficial Remedies, or retained therein, unless its
composition be furnished to the Council for publication. For simple
substances, the scientific name and the chemical formula, rational or
structural, if known, should be supplied. For mixtures, the amount of
each active medicinal ingredient in a given quantity of the article
must be stated. The general composition of the vehicle, its alcoholic
percentage, and the identity of the preservatives must be furnished.
_Rule 2._--IDENTIFICATION.--No article will be accepted or retained
unless suitable tests for determining its composition are furnished to
the Council. In the case of chemical compounds, these shall consist of
tests for identity and purity. In the case of mixtures, description of
methods for determining the amount and active strength of the potent
ingredients shall be furnished, if practicable.
_Rule 3._--DIRECT ADVERTISING.--No article that is advertised to the
public will be accepted or retained; but this rule shall not apply
to: (_a_) disinfectants, germicides and antiseptics, provided the
advertising is limited to conservative recommendations for their use as
prophylactic applications to superficial cuts and abrasions of the skin
and to the mucous surfaces of the mouth, pharynx and nose (but not to
those of the eye, and the gastro-intestinal and genito-urinary tracts)
and provided they are not advertised as curative agents (see comments
to Rule 3); and (_b_) nonmedicinal food preparations, except when
advertised in an objectionable manner.
_Rule 4._--INDIRECT ADVERTISING.--No article will be accepted or
retained if the label, package or circular accompanying the package
contains the names of diseases in the treatment of which the article is
said to be indicated. The therapeutic indications and properties may be
stated, provided such statements do not suggest self-medication. Dosage
may be indicated. (This rule shall not apply to remedies with which
self-medication is altogether improbable, to vaccines and antitoxins
or to directions for administering or applying remedies when similar
immediate, heroic treatment is indicated.)
_Rule 5._--FALSE CLAIMS AS TO ORIGIN.--No article will be accepted or
retained concerning which the manufacturer or his agents make false or
misleading statements as to source, raw material from which made, or
method of collection or preparation.
_Rule 6._--UNWARRANTED THERAPEUTIC CLAIMS.--No article will be accepted
or retained concerning which the manufacturer or his agents make
unwarranted, exaggerated or misleading statements as to the therapeutic
value.
_Rule 7._--POISONOUS SUBSTANCES.--The principal label on an article
containing “poisonous” or “potent” substances must state plainly the
amount of each of such ingredients in a given quantity of the product.
_Rule 8._--OBJECTIONABLE NAMES.--Proprietary names for medicinal
articles will be recognized only when the Council shall deem the use
of such exclusive names to be in the interest of public welfare. Names
which are misleading or which suggest diseases, pathologic conditions
or therapeutic indications will not be recognized (the provision
against therapeutically suggestive names does not apply to serums,
vaccines and antitoxins, or to foods). In the case of pharmaceutical
preparations or mixtures, the name must be so framed as to indicate the
most potent ingredients.
_Rule 9._--PATENTED PRODUCTS AND PROTECTED NAMES.--If the article is
patented--either process or product, or both--the number of such patent
or patents must be furnished to the Council. Furthermore, if the name
of an article is registered, or the label copyrighted, the registration
(trademark) number and a copy of the protected label should be
furnished the Council. In case of registration in foreign countries,
the name under which the article is registered should be supplied.
_Rule 10._--UNSCIENTIFIC AND USELESS ARTICLES.--No article will be
accepted or retained which, because of its unscientific composition,
is useless or inimical to the best interests of the public or of the
medical profession.
Explanatory Comments on the Rules
INTRODUCTION.--The Council on Pharmacy and Chemistry was established
in February, 1905, by the American Medical Association, primarily
for the purpose of gathering and disseminating such information as
will protect the medical profession in the prescribing of proprietary
medicinal articles. In pursuance of this object, the Council examines
the articles on the market as to their compliance with definite rules
designed to prevent fraud, undesirable secrecy and the abuses which
arise from advertising directly or indirectly to the laity. Such
articles as appear to conform to the rules are accepted; and their
essential features are described in the annual publication of the
Council, New and Nonofficial Remedies, if they come within the scope
of this book. These descriptions are based in part on investigations
made by, or under, the direction of the Council, but in part also on
evidence or information supplied by the manufacturer or his agents.
Such interested statements are examined critically, and are admitted
only if they appear to be in conformity with the evidence. It is,
however, manifestly impossible for the Council to investigate the
composition of every complex pharmaceutical mixture, or to check
thoroughly every therapeutic claim; it can give only an unbiased
judgment on the available evidence. Criticisms and corrections of
the descriptions which may aid in the revision of the matter will be
appreciated. The Council judges an article entirely by the facts in
evidence at the time of its admission. Previous noncompliance with the
rules (short of _intentional_ fraud) does not prevent the favorable
consideration of an article which is in accord with existing rules.
Infringements of the rules after acceptance of an article for New and
Nonofficial Remedies, or the discovery that the Council’s information
was incorrect, will cause the acceptance to be reconsidered. An article
is accepted for New and Nonofficial Remedies, and will continue to be
included in the book, with the understanding that serious violations of
the rules, after acceptance, will be followed by the omission of the
article and publication of the reasons for such omission. The Council
desires physicians to understand that the admission of an article does
not imply a recommendation. Acceptance simply means that no conflict
with the rules has been found by the Council.
DURATION OF ACCEPTANCE.--Unless an agreement to the contrary is made
at the time of acceptance, articles admitted to New and Nonofficial
Remedies will be retained for a period of three years, provided that
during that period they comply with the rules and regulations which
were in force at the time of their acceptance. At the end of this
period all articles will be carefully reexamined for compliance with
existing rules. Particular weight will be given to the question as to
whether recent evidence has substantiated claims as to the therapeutic
value of any preparation, this evidence to consist partly of recent
statements in the literature and partly of the general esteem in which
the preparation is held by clinical consultants of the Council. The
reacceptance of articles after such reexamination shall be for three
years unless a shorter period is specified. Any amendments to the
rules, by specific requirements or by interpretation, which may be made
after the acceptance of an article, shall not apply to such article
until the period of acceptance has elapsed. At the end of this period
the article, if it is not eligible under the amended rules, will be
omitted.
THE SCOPE OF NEW AND NONOFFICIAL REMEDIES AND APPENDIX.--To aid
physicians and manufacturers in deciding what articles come within
the scope of this book, or, in other words, to enable physicians
to recognize whether an article which is not described in New and
Nonofficial Remedies has been omitted because it does not need
admission or because it has been rejected, the Council furnishes the
following more detailed definitions:
OFFICIAL ARTICLES.--_Articles official in the U. S. P. or N. F. do not
require consideration by the Council if they are marketed under the
official name and if no unestablished therapeutic claims are made for
them._
These do not require consideration by the Council, since standards for
them are provided in these books, and enforced under the provisions
of the federal Food and Drugs Act, except that they may be mentioned
for information. Consideration by the Council becomes necessary if a
U. S. P. or N. F. product is offered for sale under a name other than
that, or the synonyms, under which the product is described in one of
these books of standards, or if the proprietors or their agents advance
claims that the product possesses therapeutic properties other than
those commonly accredited to it.
MODIFICATIONS OF U. S. P. AND N. F. PRODUCTS.--A pharmacopeial or
National Formulary product which is marketed under the official title
or synonym, but with well-founded claims that its purity, permanence,
palatability or other physical properties excel the official standard,
may, if no extraordinary therapeutic properties are asserted, be
considered as an official article and held not to be within the scope
of New and Nonofficial Remedies. When such products are marketed under
the claim that they possess therapeutic properties other than those
commonly accredited to the U. S. P. or N. F. products of which they
are modifications, they shall be subject to the consideration of the
Council.
SPECIFICALLY EXEMPTED PREPARATIONS.--Foods, in general, unless marketed
with the claim that they possess therapeutic properties shall not, at
the present time, be considered by the Council. Mechanical appliances,
at the present time, shall not be considered by the Council. Mineral
waters (natural), at the present time, shall not be considered by the
Council. With these exceptions, products which in the judgment of the
Council are manufactured and marketed in conformity to the principles
underlying the rules of the Council may be accepted for N. N. R.
Products which are manufactured and marketed in a manner which does not
conform to the principles underlying the rules of the Council shall not
be accepted for N. N. R. The burden of proof in establishing claims
for therapeutic properties of products considered by the Council shall
lie with the proprietor or, when a foreign made product, with the
agent who markets the product in the United States. To avoid confusion
with nonofficial substances marketed under similar names, the Council
recommends that official substances be prescribed by their official
titles, followed by the abbreviation “U. S. P.” or “N. F.”; thus:
Tinctura Nucis Vomicae, U. S. P.; Elixir Gentianae, N. F.
SUBSTANCES DESCRIBED IN NEW AND NONOFFICIAL REMEDIES.--In the body of
the book will be described simple proprietary substances and their
preparations; proprietary mixtures if they have originality or other
important qualities which, in the judgment of the Council, entitle them
to such place, and important, nonproprietary, unofficial articles.
The Council recommends that when the latter are prescribed, they
be indicated by the abbreviation, “N. N. R.,” thus insuring to the
prescriber the quality of these articles laid down in the book.
PROPRIETARY MIXTURES.--A mixture will be considered as proprietary,
and therefore requiring consideration by the Council for admission
to the book or appendix, if it contains any proprietary article; if
it is marketed under a name which is in any way protected, or if
its manufacturer claims for it any unusual therapeutic qualities.
Proprietary mixtures which are marketed in conformity with the
rules are listed in the appendix of the book under the names of the
respective manufacturers. Such proprietary mixtures are not admitted
to the body of the book, save in the exceptional cases cited in the
preceding paragraph.
NONPROPRIETARY MIXTURES OF OFFICIAL SUBSTANCES.--Since the ingredients
of such mixtures do not require consideration by the Council, and
since the mixtures are not open to the proprietary abuses which call
for the work of the Council, it is not necessary that they should be
investigated by the Council. The physician must judge whether such
mixtures should be directed to be prepared by the pharmacist, or
whether he is justified in ordering a ready-made preparation. If he
decides to use a ready-made, nonproprietary preparation, he must judge
for himself whether it is marketed in accordance with the rules. It
should, however, be remembered that the application of a trade name to
any substance makes it proprietary.
Explanation of Rule 1: Composition
_Secrecy Objectionable._--It is not only the right but also the duty of
the physician to know the essential composition of what he prescribes;
the Council cannot compromise on this proposition.
_Vehicles and Preservatives._--In the case of mixtures, not only the
potent ingredient, but also the general character of the vehicle, the
presence of alcohol, and the identity of preservatives, or of any other
substance, whether added or present as an impurity, must be stated if
these can under any circumstances affect the therapeutic action of
the article. This, as a rule, does not mean the publication of trade
secrets, such as flavors or the details of the working formula.
_Trade Secrets._--Furthermore, trade secrets will not be received as
confidential by the Council, since it accepts information only with
the distinct understanding that this may be freely published, at its
discretion.
_Inspection of Factories._--The Council does not accept invitations to
inspect factories; its concern is with the finished products.
On the other hand, the Council requires that the information be
complete and accurate as to medicinal ingredients.
_Unofficial Constituents._--Unofficial constituents of proprietary
mixtures must be presented by the manufacturer in the regular way and
must be acted on by the Council before the preparations containing them
can be accepted.
_Fraud._--When it appears that a manufacturer has made a _deliberately_
false statement concerning a product, he is asked to furnish an
explanation; and if this is not satisfactory, the product will not be
accepted, even if the false statement is subsequently corrected or
omitted.
_Testimonials._--The foregoing paragraph applies not only to statements
made to the Council, but also to statements furnished to physicians by
the manufacturer or his agents, even when these statements are in the
guise of testimonials.
Explanation of Rule 2: Identification
In order to avoid errors in the case of chemical compounds, and to
guard against adulterations, lack of potency or strength, and the
mistaking of one chemical for another, it is necessary to have at hand
suitable tests.
_Tests, etc._--If these facts have appeared in the literature, or
in standard textbooks, reference to them will be sufficient; but
with new chemicals, especially synthetics, the manufacturer or his
representatives will be required to supply such tests for publication,
as will assure an intelligent opinion of these products.
_Physiologic Standardization._--In cases in which chemical methods of
identification are unknown or unreliable, physiologic standardization
should be employed. The Council considers the phrase “physiologically
standardized” or “assayed” as misleading unless the standard and
method are published in sufficient detail to permit of their control
by independent investigators. It is evident that when no standard is
published, it is impossible to know whether the quality is high or
low, and the conscientious manufacturer who sets for himself a high
standard is placed on a level with the dishonest or careless one who
adopts a low standard. Again, if the process of standardization is
not published, it is impossible to learn, without actual trial, the
relative value of one preparation as compared with that of another
manufacturer, or to confirm or disprove the statements of the
manufacturer as to the quality of his product.
_Standardization of Disinfectants and Germicides._--No disinfectant or
germicide of the phenol type will be accepted for New and Nonofficial
Remedies whose phenol coefficient, determined according to the method
of the Hygienic Laboratory, U. S. P. H. S., is not stated on the label
of the preparation.
Explanation of Rule 3: Direct Advertising
_Lay Advertising._--The impossibility of controlling the irresponsible
claims which are usually made in advertisements to the public, the
well-known dangers of suggesting by descriptions of symptoms to the
minds of the people that they are suffering from the many diseases
described, the dangers of the unconscious and innocent formation of a
drug habit, and the evils of harmful self-medication, including the
dangers of the spread of many infectious and contagious diseases when
hidden from the physician, and similar well-known considerations, are
the reasons for discouraging, in the interest, and for the safety, of
the public, this reprehensible form of exploitation. Advertising in
medical journals, etc., distributed solely to physicians, does not come
within the scope of this rule.
_Exceptions._--In the case of subjects on which the public should be
instructed, as the use of disinfectants, germicides, antiseptics and
foods, advertisements to the public, if not in objectionable forms,
are considered admissible. In no case shall such advertisements
include recommendations for use as curative agents, nor shall the
names of any diseases be mentioned in exploitation. If the preparation
is sufficiently toxic to require caution in its use to prevent
poisoning, this fact shall be stated on the label. On account of the
deplorable results which would follow any abuse of this privilege, the
conscientious cooperation of manufacturers and their agents in adhering
strictly to the limitations laid down is asked; and for the same reason
the acceptance of an article which is so advertised as to infringe on
these limitations in any essential way (as by naming diseases or by
making false and exaggerated claims) shall be summarily rescinded,
and the reasons for such action may be published without notice to
manufacturer or agent. A disinfectant, germicide or antiseptic will
be accepted for description in New and Nonofficial Remedies, and an
article of this class which has already been accepted will continue
to be included in New and Nonofficial Remedies only on the explicit
understanding by the manufacturer and agent that such infringements of
the rule will be followed by deletion of the article and by publication
of the facts as described.
_Foods._--We may divide the foods into three groups. The first group
contains the ordinary foods, including the well-known breakfast
foods. These do not come under the supervision of the Council in
any way. The second group includes a large and important class of
manufactured products, such as invalid and infant foods, which in a
sense stand between the first and third groups. The public has the
same interest in these foods that the physician has, and usually is
supplied with full information concerning them. While the primary
recommendation of these articles should naturally come from the
physician, it cannot be expected that their continued use should
depend on repeated prescriptions. Information concerning this group
of foods would come naturally and properly from a physician, and the
collection and dissemination of this information may very properly be
included in the work of this Council. As the products in this class
are used extensively, it is not proper to limit their advertising
to medical journals, but the advertising should be permitted in the
lay press so long as it is conducted in a manner compatible with
the rules of the Council. The third group includes medicinal foods
proper, such as predigested foods. These have a relatively low food
value and are characterized by a high alcohol or preservative
content. They frequently contain strictly medicinal substances, or
food substances for which distinct therapeutic properties are claimed.
These products should be used only on the advice of the physician, and
the advertisements should be restricted as in the case of ordinary
medicines.
_Advertisements in Foreign Countries._--The Council deals primarily, in
the interest of the public and of the medical profession, with articles
proposed for admission to New and Nonofficial Remedies, and, in
determining the status of any article, must take into consideration any
statements made regarding it or any method of advertising it employed
by the manufacturer or his authorized agents or representatives,
whether in this country or abroad. The Council will not regard as
within its scope, however, questions concerning the marketing of
articles (except the matter of direct advertising to the laity and
unwarranted claims or misrepresentations) in any country which has a
public body corresponding to this Council.
Explanation of Rule 4: Indirect Advertising
_Matter Distributed Solely to Physicians._--It should be remembered
that the sole intent of this rule is to protect the physician, so
that in prescribing a proprietary medicine he shall not unconsciously
advertise proprietary preparations. The rule imposes no restriction on
the legitimate methods of bringing a remedy to the attention of the
profession, such as advertising in medical journals, circulars and
other printed matter distributed solely to physicians. The rule applies
only to the package as it may reach the patient.
_Naming Diseases on Labels._--The naming of diseases on the label
or package is not necessary, as is shown by the very large number
of proprietary products which have been successfully introduced
without resorting to this expedient. This method of popularizing a
proprietary remedy with the laity is most objectionable, and should not
be tolerated in any form. In general, therapeutic indications should
be omitted from the label and package. The Council will not insist
on this point, however, when such indications are so given as not to
promote self-medication, particularly in diseases which require expert
diagnosis and supervision. It will be considered an infringement of
the rule if an article be marketed in bottles which have the name of
the article blown into the glass, or if otherwise the name or initials
or other distinctive mark of the article is permanently stamped on
the container, on the article itself, or is on the stoppers or seals.
Articles which are marketed in any of these ways are not accepted
for New and Nonofficial Remedies. Readily removable labels are not
objectionable, nor is the permanent affixing of the firm’s initials or
name to the trade package if such initials or name is not suggestive of
the article. The Council does not countenance the use of an accepted
article for advertising other articles which have not been accepted by
the Council.
Explanation of Rule 5: False Claims as to Origin
_Source._--No false or misleading statement in regard to an article can
be permitted concerning the source of material from which it is made,
or the persons by whom it is made. Some glaring frauds of this nature
have been perpetrated in the past, and this rule is intended to prevent
such imposition.
Explanation of Rule 6: Unwarranted Therapeutic Claims
_Therapeutic Questions._--This rule insists that the claims of
manufacturers or agents concerning the therapeutic properties of their
products must be compatible with demonstrable facts. Manufacturers
will be held responsible for all statements made or quoted in their
advertising “literature” regarding their products. Recognizing the
existence of honest differences of opinion on many therapeutic
questions, the Council desires to be liberal in the application of
this rule. It is natural that a manufacturer should be partial toward
his own product, and a moderate degree of emphasis in advertising may
not be objectionable. The Council, however, will not admit claims which
are neither in harmony with already accepted facts nor supported by
acceptable evidence. In doubtful cases the Council considers these
questions with the advice and cooperation of its staff of clinical
consultants.
_Clinical Evidence._--To be acceptable, the clinical evidence must
offer objective data with such citation of authority as will enable the
Council to confirm the facts and establish the scientific value of the
conclusions drawn. Clinical data are worthless when the author is not
cited. The facts on which claims with regard to the value of a remedy
are based must have been rendered accessible for investigation and
confirmation by disinterested observers, either through publication or
through the records of a hospital or other institution.
Explanation of Rule 7: Poisonous Substances
_Poisons._--For the information of the pharmacist or dispenser, and to
enable him to safeguard the interests of the patient and the physician,
all articles containing such potent agents as the poisonous alkaloids
and other organic substances and the salts of some of the metals should
have the exact amount of these ingredients which is contained in the
average adult dose stated on the label.
Explanation of Rule 8: Objectionable Names
_“Coined” Names._--Many of the abuses connected with proprietary
medicines arise from “coined” proprietary trade names. Such names will
not be recognized by the Council unless in particular instances the
Council shall deem their use to be in the interest of public welfare.
In every such exception the burden of proof, both for establishing and
for continuing the exception, lies with those who market the product.
_Proprietary (“Trade”) Names When Permitted._--In consideration of
the benefits which may come from the discovery of a therapeutic
agent, the Council concedes to the person or firm which, by right of
discovery, controls such a product the right to name it. The Council
will offer no opposition to an arbitrary name for such a new product,
provided it is not misleading, therapeutically suggestive, or otherwise
subversive of scientific pharmacy and therapeutics. If the discovery
that a previously known substance has therapeutic value is deemed of
sufficient importance, the Council may recognize a name for such a
substance if the name is applied by the person who makes the discovery;
or, with the consent of the discoverer or in the absence of any protest
on his part, the Council may recognize a name applied by the firm which
first makes such a product available to physicians. In the interest
of rational drug therapy, the Council recommends that trade names be
coined so as to indicate the potent element or constituent.
_Scientific Names._--When the proprietary or trade name for an article
is considered insufficiently descriptive of its chemical composition
or pharmaceutical character, the Council may require as a condition
for the acceptance of such articles that a descriptive scientific
name satisfactory to the Council appear on the labels, circulars
and advertisements for such an article. For all definite chemical
substances it is required that the scientific name be given prominence
on the labels, in circulars and advertisements.
_Proprietary Names for Unoriginal Articles._--Proprietary names
will not be recognized for articles which are included in the U. S.
Pharmacopeia or National Formulary or for unessential modifications
of such articles. Neither will proprietary names be recognized for
substances or mixtures which are described in medical or pharmaceutical
publications. In the marketing of unoriginal articles, the legitimate
interests of the producer are fully served by identifying such products
by appending the name or initials of the manufacturer or agent, or
by the use of a general brand mark. No objection will be made by the
Council to the use of such brand marks, provided that in no case shall
such mark be used as a designation for an individual article.
For any product which, by reason of the absence or lapse of patent
rights or for other reasons, is open to manufacture by more than one
firm, the Council reserves the right to select a common name and to
provide standards of identity, purity and strength, and then will
accept such article only if it is marketed under the title adopted as
the N. N. R. name or the name under which such article was introduced
(to which may be appended the firm’s identifying mark).
_N. N. R. to U. S. P._--When an article which has been accepted for
New and Nonofficial Remedies is admitted to the U. S. Pharmacopeia
or National Formulary, it will be omitted from New and Nonofficial
Remedies one year after such standardization if the name of such
article is used in these standards either as the main title for the
product or as a synonym. If the name under which the article is
described in New and Nonofficial Remedies is not used in these books of
standards, the proprietary preparation will be retained provided the
official name is given prominence on the labels and in the circulars
and advertisements of such article. When the Council adopts a common
name for an article that has been admitted under another name, it
will be continued under the older name only on condition that the
Council name be given prominence on the label and in the circulars and
advertisements for such article.
_Pharmaceutical Preparations and Mixtures._--These, with rare
exceptions, are not original in composition and there is seldom
any reason why they should be endowed with arbitrary names. On the
contrary, it is important that the prescriber should be reminded
constantly of their potent ingredients.
_Therapeutically Suggestive Names._--Articles bearing therapeutically
suggestive names will not be accepted for New and Nonofficial Remedies,
first, because they are likely to lead physicians into prescribing
names instead of remedies, and second, because they tend to encourage
unwarranted self-medication by the laity. Even if the name is at
first apparently meaningless to the public, its meaning will soon be
understood because patients soon learn the technical names applied to
their diseases and symptoms. The prohibition against therapeutically
suggestive names is not applied to serums, vaccines and antitoxins,
because the accepted nomenclature of the specific organisms used in
their preparation makes this unavoidable and because self-medication
with them is improbable.
Explanation of Rule 9: Patents, Trademarks, Copyrights, Etc.
_Protection._--This information is important as a means of determining
the legal status of medicinal articles and as an aid to their ready
recognition in current publications.
Explanation of Rule 10: Unscientific and Useless Articles
_Unscientific Compounds._--The use of articles which are unessential
modifications of official or established nonproprietary articles is
unscientific and serves no useful purpose. The Council will not accept
products which are scientifically unsound and which, therefore, must
be considered useless or inimical to the best interest of the medical
profession and the public. This class includes compounds or mixtures
containing an excessive number of active ingredients; those compounds
or mixtures the components of which are of no probable assistance to
one another, and those articles which are of no therapeutic value.
_Unessential Modifications of Official Substances._--The subterfuge
of obtaining proprietary rights over an official or established
nonproprietary product, by introducing unessential modifications, also
tends to confusion and abuses, and such articles will not be admitted
by the Council. Essential and important modifications, however, will
receive recognition. (The Council interprets the term “established
nonproprietary product” as applying to a preparation of any formula
which has been published through any recognized or reasonably
accessible channel of publication, prior to its appropriation or
modification by a manufacturer.) Duplicates of biologic products
accepted under the name of the manufacturers will not be accepted under
the names of the distributors.
THE COUNCIL ON PHARMACY AND CHEMISTRY, PRESENT AND FUTURE[A]
W. A. Puckner, Phar.D.
Secretary, Council on Pharmacy and Chemistry
[A] Read before the Chicago Medical Society, March 26, 1919.
The World War marked an epoch in the existence of the Council on
Pharmacy and Chemistry, as it did in all human endeavors. The
information and experience which had been accumulated by the Council
during its thirteen years’ existence was drawn on by our government,
directly or indirectly, and it also received consideration in England,
France,[1] Belgium, Holland,[2] Italy,[3] Sweden and elsewhere. In the
world wide readjustment that has begun, the efforts of the Council,
past and present, will influence the plans of those who engage in
the manufacture or sale of medicines, and, undoubtedly, will be the
incentive to the establishment of similar bodies in other countries.
[1] “New and Nonofficial Remedies” in France, Foreign News, J. A. M. A.
=71=:1331 (Oct. 19) 1918; =70=:1783 (June 8) 1918.
[2] Nederl. Tjdschr. v. Geneesk. Oct. 5, 1918, p. 1201.
[3] An Italian View of the Proprietary Evil, Foreign News, J. A. M. A.
=71=:840 (Sept. 7) 1918; The Council on Pharmacy and Chemistry and the
Patriotic Medical League in Italy, ibid. =71=:918 (Sept. 14) 1918.
As secretary of the Council almost from the time of its organization
in 1905,[4] and knowing the work of its members and its collaborators,
I am firmly convinced that this body has deserved the endorsement and
support given it by the American medical profession. I welcome this
opportunity to present an outline of the Council’s past activities and
to speak of some of the problems of the future, because I feel assured
that a knowledge of its endeavor to improve drug therapy will increase
the profession’s confidence in the Council and add to the number of its
supporters.
[4] Although the Council on Pharmacy and Chemistry was established in
1905, it is likely that only a small percentage of physicians know
just what the Council is, or have any conception as to its personnel
and its ability to judge the available evidence for proprietary
medicaments. The personnel has changed from time to time since 1905.
At present its membership is: C. L. Alsberg, A.M., M.D., chief of the
Bureau of Chemistry, U. S. Department of Agriculture, Washington,
D. C.; R. A. Hatcher, Ph.G., M.D., professor of pharmacology, Cornell
University Medical College, New York City; A. W. Hewlett, M.D.,
professor of medicine, Leland Stanford Junior University Medical
School, San Francisco; John Howland, M.D., professor of pediatrics,
Johns Hopkins University Department of Medicine, Baltimore; Reid
Hunt, M.D., professor of pharmacology, Harvard University Medical
School, Boston; Henry Kraemer, Ph.D., professor of pharmacognosy,
University of Michigan College of Pharmacy, Ann Arbor, Mich.; W. T.
Longcope, A.B., M.D., Bard Professor of the Practice of Medicine,
College of Physicians and Surgeons of Columbia University, New York
City; G. W. McCoy, M.D., director of the Hygienic Laboratory, United
States Public Health Service, Washington, D. C.; Lafayette B. Mendel,
Ph.D., Sc.D., professor of physiologic chemistry, Sheffield Scientific
School, Yale University, New Haven, Conn.; F. G. Novy, M.D., Sc.D.,
professor of bacteriology, University of Michigan, Ann Arbor, Mich.;
W. W. Palmer, B.S., M.D., associate professor of medicine, College of
Physicians and Surgeons of Columbia University, New York City; L. G.
Rowntree, M.D., professor of medicine, University of Minnesota Medical
School, Minneapolis; Torald Sollmann, M.D., professor of pharmacology
and materia medica, Medical Department, Western Reserve University,
Cleveland; Julius Stieglitz, Ph.D., Sc.D., Chem.D., vice chairman of
the Council, professor of chemistry, University of Chicago, Chicago;
G. H. Simmons, M.D., LL.D., chairman of the Council, editor of The
Journal of the American Medical Association, Chicago, and W. A.
Puckner, Phar.D., secretary of the Council, director of the Chemical
Laboratory of the American Medical Association, Chicago.
THE COUNCIL’S ACTIVITIES
Organized primarily for the purpose of putting a stop to false
declarations with regard to the composition of proprietary medicines,
the Council’s activities have broadened until its work may be
characterized as “a propaganda for the rational use of drugs.” The
following are some of its activities:
1. _New and Nonofficial Remedies._--This is an annual volume, issued
by the Council. It describes both proprietary and nonofficial,
nonproprietary drugs which are deemed worthy of consideration by the
medical profession. To be admitted to this book, a preparation must
comply with certain definite rules which stipulate, in effect, that its
composition be declared, that no untrue or grossly exaggerated claims
be made for it, and that it shall give promise of having therapeutic
value.
With the exception of a few which are still under consideration, the
Council has considered all proprietaries whose owners or accredited
agents have requested that an examination of the products be made,
and it has admitted to the book those which were found eligible. In
addition, the Council has examined all of the more important or widely
exploited proprietaries, even when no examination was requested,
and it has admitted those of this group which were found eligible.
Further, the Council has admitted to the book certain nonofficial,
nonproprietary articles which seemed to give promise of therapeutic
usefulness, and it has established standards for the control of their
identity and purity, and listed those brands which complied with these
standards.
As most proprietary medicines are of a more or less experimental
nature, they are accepted for inclusion in New and Nonofficial Remedies
only for a limited time--usually a period of three years. At the
expiration of the period of acceptance, each preparation is reexamined
and retained only if the claims made for it and the present day
knowledge of its value permit this action.
Since manufacturers give information only in regard to their own
products, New and Nonofficial Remedies groups together articles of a
similar character, and includes in each case a general discussion of
the group for the purpose of comparison, not only with each other, but
also with the established or pharmacopeial drugs which members of the
group are intended to supplant.
In brief, New and Nonofficial Remedies is a book in which are described
preparations that have been accepted by the Council. The description
includes facts that the physician should have. It is a book that should
be in the hands of every physician who prescribes medicines, and who
wishes to know the facts regarding the newest remedies. It is the only
book in which he can find information relative to proprietary medicines
that are worthy of his patronage. It will protect the physician who
makes use of it against the wiles of the promoters of products not
worthy of his patronage. It would certainly be of use to the physician
when the detail man calls on him, for if he were being importuned to
prescribe or use samples of something which he had not heretofore used
and which he was unable to find in N. N. R., he might ask the detail
man why. In the nature of things few physicians are sufficiently expert
in chemistry and allied sciences to be able unerringly to discriminate
between the true and the false as regards many preparations that he is
asked to prescribe.
2. _The Reports of the Council on Pharmacy and Chemistry._--A
medicament may be inadmissible to New and Nonofficial Remedies for
various reasons; it may be worthless or irrational, its composition
may be secret or indefinite, or it may be exploited under exaggerated
or unwarranted claims or in a way otherwise detrimental to the public
health and scientific medicine. Of these various reasons which make
an article unacceptable, the manufacturer obviously may remove all
except the first, viz., worthlessness or irrationality. Consequently,
a preparation which has been presented for admission is not definitely
rejected until after its proprietor has been informed of the objections
to his product and has failed to bring the preparation in conformity
with the Council’s rules. When a preparation is found definitely
inadmissible to New and Nonofficial Remedies, that is, when the
proprietor cannot or will not make it acceptable, the Council prepares
a report for publication. These reports are sent for publication to The
Journal of the American Medical Association, and later published in the
annual “Reports of the Council on Pharmacy and Chemistry.” The more
important of these are also published in the book, “The Propaganda for
Reform in Proprietary Medicines.”
3. _Useful Drugs._--Since the domination of proprietary medicines,
which was retarding medical advance and threatening therapeutic chaos,
had been made possible only by the insufficient and inefficient
instruction given in medical schools in subjects having to do with
drugs, the Council appointed a Committee on Medical Teaching to secure
the cooperation of teachers in materia medica, pharmacology and related
branches. This committee has endeavored to effect an improvement in
these courses of instruction. One of the results of this work was the
selection of a list of drugs to serve as a basis of materia medica
instruction and thus insure that medical students shall be better
informed with regard to the therapeutic worth of a few well established
drugs, rather than, as in the past, leaving school with a smattering
of knowledge about many drugs. The outcome of these efforts is the
publication of “Useful Drugs,” a concise but thorough and up-to-date
discussion of the actions, uses and dosage of the more important
drugs. The list of drugs presented in this book is now the basis of
instruction in many schools; and many state examining boards are
confining their materia medica questions to the drugs in the list.
4. _Epitome of the U. S. P. and N. F._--To encourage the use of
official drugs and to make available an estimate of their therapeutic
value, a committee of the Council prepared an abstract of the U. S.
Pharmacopeia and the National Formulary. This booklet, the “Epitome of
the U. S. Pharmacopeia and National Formulary,” presents those portions
of these books which are of interest to physicians, and in addition,
gives a concise statement of the therapeutic usefulness of the drugs
and preparations described in them.
5. _Patent Law Reform._--Some of the worst abuses connected with the
exploitation of proprietary medicines have been made possible by our
patent and trademark laws and the method of their interpretation and
enforcement. The Council, therefore, appointed a committee to study
these laws and the various propositions advanced for their improvement.
This committee has published, from time to time, reports on various
phases of our patent and trademark laws and recently summarized these
reports in an address[5] sent to the commissioner of patents and the
interested congressional committees. It is hoped that by means of these
reports physicians will be enabled to give intelligent support to a
revision of the patent and trademark laws when legislation is proposed.
[5] Need for Patent Law Revision, A. M. A. Council on Pharmacy and
Chemistry Reports, 1917, p. 130.
6. _Therapeutic Research._--Through its Committee on Therapeutic
Research, and with the aid of funds provided by the Board of Trustees
of the American Medical Association, the Council has encouraged the
investigations of questions which might lead to a better understanding
of the action of drugs. These investigations are brought together in
the annual reports of the Committee on Therapeutic Research, and are an
important addition to our knowledge of drug action.
In the past, the Council has in particular encouraged the investigation
of the action and therapeutic value of widely used drugs regarding
which our knowledge is still unsatisfactory. These investigations
have included a study of the action of strychnin in cardiac disease,
a comparison of the action of absorption and excretion of iodid
preparations, a study of the pharmacology of the opium alkaloids,
etc. Appreciating that the available knowledge of proprietary drugs
is one sided in that it comes from investigations made by interested
pharmaceutical concerns or from investigations made at the instigation
of these firms, the Council is planning a comprehensive study of many
of the synthetic drugs that have gained some vogue during recent years.
THE FUTURE
Medical research, and efficient instruction in therapeutics and related
subjects, spell a diminishing influence of commercial medicine over
rational therapeutics. The fact that the present shortage of German
synthetics has not handicapped seriously the practice of medicine
should be a lesson to American physicians for many years to come.
On the other hand, it must be remembered that the publicity given to
the reports of the Council and to other contributions toward rational
therapeutics by The Journal of the American Medical Association,
the journals of the state organizations, and a few personally owned
publications, is as nothing when compared with the persistent and wide
publicity given to the propaganda of the proprietary houses. While a
report setting forth the objections to a proprietary is published but
once, the firm’s laudatory pronouncement goes forth again and again
until the Council’s report is completely overwhelmed and forgotten.
Manufacturers of proprietaries not only keep in close touch with the
practicing physician by means of house organs, special “literature,”
or by traveling representatives, but many of the firms, through the
meritorious lines of pills, tablets, tinctures, etc., which they put
out, also obtain and hold the good will and confidence of a large
proportion of the medical profession.
Furthermore, some of these firms may gain the confidence of the medical
profession through these high grade pharmaceuticals, and certain of
their proprietaries may be of distinct therapeutic value but may fail
to be acceptable for New and Nonofficial Remedies, because they do not
conform to the reasonable rules of the Council. These firms do not
find it profitable to force the sale of their regular nonproprietary
pharmaceuticals by unwarranted claims or objectionable methods, yet
they may consider it good business to market certain proprietary
products by means of claims which are extravagant and without warrant,
and which will lead to indiscriminate use by the profession and the
public. In a word, where there is one dollar spent on behalf of
rational medicine, thousands are spent for the purpose of increasing
the sale of preparations which directly or indirectly are a detriment
to the public health, to medicine, and to the pocketbook.
That the day of the secret nostrum of the pseudo-chemical company is
not yet past is well illustrated by the recent introduction of an
asserted arsphenamin preparation called “Syphilodol.” The A. M. A.
Chemical Laboratory proved one form of this asserted French discovery
to be essentially a pill of mercurous iodid. Another form of Syphilodol
(for intravenous administration) had all the characteristics of water,
and appeared devoid of any potent ingredient. Though the advertising
sent out by the promoters in regard to its composition was suspiciously
evasive, the _Illinois Medical Journal_ published an advertisement
of “Syphilodol,” which, possibly by a coincidence, appeared above an
appeal to “Our Readers” to use wares advertised in that journal.
While such rank deceptions as “Syphilodol” are not common, there are
more subtle deceptions that are even more dangerous. Types of widely
exploited remedies of today comprise so-called ethical specialties
composed of well known and established drugs (with “jokers” hidden
away somewhere) or preparations which have a plausibly fascinating
pseudo-scientific background of radiant energy, colloidal chemistry,
nonspecific protein reaction, or something of the sort. The latter
class of preparations in particular appeal to physicians who are
striving hard to keep pace with modern science. Exposure of their
fallacies requires most careful consideration on the part of the
Council.
Progress toward a rational and scientific drug therapy must continue,
and, therefore, it is important that the Council on Pharmacy and
Chemistry should continue to make the investigation of proprietary
medicines its chief work. Investigation of a proprietary medicine,
however, and a report of such investigation are of value in direct
ratio only to the number of physicians who read the report, endorse
it and act in accordance with its conclusions. In order that you may
determine to what extent those preparations which are admitted to New
and Nonofficial Remedies deserve your interest and confidence, it will
be worth while briefly to outline the rules which govern the Council in
the admission of articles to New and Nonofficial Remedies.
RULES GOVERNING THE ACCEPTANCE OF ARTICLES FOR N. N. R.
_Composition._--Rules 1 and 2, and in a measure 5, 7, and 9, deal with
the composition of articles. Rule 1 requires that the quantitative
composition of an article be furnished the Council for publication.
Rule 2 requires that the manufacturer furnish methods whereby the
composition of products that are definite chemicals or the potent
constituents of mixtures may be determined. The Council does not
require that the process of manufacture of an article be declared
unless this becomes necessary in order to judge its composition. Rule
5 requires that statements with regard to the origin and source of an
article shall be truthful. Rule 7 requires that for the guidance of the
dispenser, the amounts of poisonous ingredients of a preparation be
placed on the label. Rule 9 requires that if patent rights are claimed
for a product, the Council be informed on this point.
That it is not only the right but also the duty of the physician to
know the composition of what he prescribes for his patients is so
generally admitted that few have attempted to market preparations of
avowedly secret composition. When the Council first began its work,
it was common to see chemical formulas or statements of composition
published which a chemist or a pharmacist was able to pronounce
at a glance as impossible.[6] It was not unusual to find that the
promoter published “a formula” for his preparation, rather than “the
formula.”[7] Today, however, a more prudent, if not more honest, course
is pursued. This gives a “formula” which is correct so far as it goes,
but which fails to divulge the actual composition of a preparation.
When it is considered that many physicians are not any too conversant
with the chemistry and pharmacy of drugs, it is not surprising that
some administered the proprietary “Venarsen,” regarding the composition
of which they had only the vague statement that it was “... a
comparatively nontoxic organic arsenic compound, 0.6 gm. representing
247 mg. (3-3/4 grains) of metallic arsenic in chemical combination
...” in the belief that a preparation similar to that first introduced
as salvarsan was being used. That “Venarsen” contained its arsenic as
sodium cacodylate--a notoriously inactive state of combination--does
not justify the intravenous administration of a drug of unknown
composition.
[6] Puckner, W. A.: The Abuse of Chemical Formulas, Reports A. M. A.
Chemical Laboratory =3=:7, 1910.
[7] The Formula for Glyco-Thymoline, J. A. M. A. =52=:147 (Jan. 9) 1909.
While for the present it probably is not feasible to require, on the
part of those who manufacture medicinal preparations, such professional
training as is required of those who prescribe and those who dispense
them, it certainly is not too much to require, as does Rule 2, that a
manufacturer shall be able to demonstrate that his preparation has the
composition claimed for it. Nor is it sufficient for him to know that
the ingredients claimed as constituents were used in the manufacture.
The fallacy of his method of reasoning was furnished by the physician
who reported that he had personally added the required amount of
mercuric iodid for a batch of “Mercol” which, nevertheless, was devoid
of mercury.[8] Acceptance of this rule by manufacturers will permit
physicians to have a more accurate knowledge of the composition of
preparations such as “Taka-Diastase”[9] and “Iodeol”.[10]
[8] Hunt, Reid, and Seidell, Atherton: Howell’s Mercol, J. A. M. A.
=52=:225 (Jan. 16) 1909. Howell’s Mercol Again: Another Analysis Fails
to Reveal the Presence of Mercury, J. A. M. A. =52=:1595 (May 15) 1909.
[9] Taka-Diastase and Liquid Taka-Diastase: Report of the Council on
Pharmacy and Chemistry, J. A. M. A. =59=:50 (July 6) 1912.
[10] Iodeol and Iodagol: Report of the Council on Pharmacy and
Chemistry, J. A. M. A. =69=:1725 (Nov. 17) 1917.
A requirement similar to that of Rule 5 is contained in the Federal
Food and Drugs Act and so no objection has been made to this rule which
requires a truthful statement of the origin and source of articles. An
illustration for the need of the rule was furnished by the one time
popular “Vin Mariani”[11] which, though very French in its makeup,
was found to be largely of the “made in the United States” variety of
tipple.
[11] Vin Mariani: Official Report of Council on Pharmacy and
Chemistry--With Comments, J. A. M. A. =47=:1751 (Nov. 24) 1906.
The issuance of a patent for a medicinal product does not prove that
such a product presents a discovery or that its owner is entitled to
a temporary monopoly, yet it is only fair to physicians and to other
manufacturers that notice of such patent claims be given. Hence, the
Council publishes in New and Nonofficial Remedies the information
bearing on this point.
_Lay Advertising._--Rules 3 and 4 provide against the recognition of
articles that are advertised to the public directly or indirectly,
exempting from this requirement preparations which the Council believes
are safe to be so advertised.
It has been held with some justice that certain shotgun proprietaries
are purchased by the public with as much circumspection as they are
ordered by those physicians who are addicted to the prescribing of
them; but even the exploiters of these mixtures have not denied that
the use of medicines by the public on its own initiative is surrounded
with many objections. Hence the practice of self medication should not
be encouraged by prescribing or using those preparations advertised for
public use.
The only objection to the rule has come from a firm which markets a
brand of liquid petrolatum, the Standard Oil Company of Indiana. The
Council has considered the question of exempting simple laxatives from
the restrictions of Rules 3 and 4 as it has exempted antiseptics and
nonmedicinal foods. The conclusion was, however, that the excessive
use of a simple laxative like a liquid petrolatum, when prompted by
newspaper exploitation, is likely to be detrimental to health by
overuse as well as by misuse.
The indirect advertisement to the public, which Rule 4 provides
against, has been the means of inducing the extensive lay use of
“Antikamnia,” “Bromidia” and “Fellows’ Syrup.” Naturally Rule 4 has
been bitterly opposed by most proprietary firms. Arguing that many
physicians dispense their own drugs, pharmaceutical firms have insisted
that every medicinal preparation should bear on its label, not only
the dose of the preparation, but also a statement of the diseases in
which the article is indicated. Whether manufacturers anticipated the
profession’s resentment toward the claim that physicians determine
the treatment and perhaps the diagnosis by means of the statements on
labels, or because the Shirley amendment to the Food and Drugs Act
makes the proprietor responsible for therapeutic claims on the label
of a medicine, it is a fact that fewer preparations than formerly need
to be refused on account of infringement on this rule. In fact, some
thoroughly objectionable proprietaries make a show of being “ethical”
by omitting all therapeutic discussion from the labels of their
preparations.
_Therapeutic Claims._--Rule 6 makes ineligible for New and Nonofficial
Remedies any articles regarding which the manufacturer or his
agents make unwarranted, exaggerated or misleading statements as to
the therapeutic value. Recognizing the long established custom of
therapeutic exaggeration, it has been most difficult to determine
the degree of conservatism which might with fairness be required
of a manufacturer. In view of the common acceptance of individual
impressions as dependable evidence, it is often almost embarrassing
to declare as incompetent the statement of some well meaning and
all-too-kind-hearted doctor. However, as the pitfalls of haphazard
clinical trials become better known and the physician’s mistrust of
glowing accounts of marvelous cures more outspoken, the manufacturers’
claims will be more moderate.
_Nomenclature._--Were it possible to enact and enforce a law which
would oblige manufacturers to sell their medicinal products under
properly descriptive names and which would make it illegal for a
physician to prescribe it unless he understood the meaning of such
properly descriptive titles, then the Council might safely disband. In
that case, physicians would discontinue the use of most proprietary
preparations in favor of established drugs, and successful newcomers
might each year be counted on the fingers of one hand. Such a rational
nomenclature is not to be thought of, at least in our generation.
Rule 8 requires that the name of an article shall not be misleading,
that it shall not be therapeutically suggestive, and that established
drugs shall not be disguised by fanciful titles. It recognizes the
right of discoverers of new drugs to name their discoveries, and
interposes no objection to arbitrary names for such products so long
as such names are not misleading or do not suggest the therapeutic
uses of the products. As the rule provides against the recognition of
coined names for established nonproprietary drugs, so it requires that
mixtures of drugs shall bear names descriptive of their composition.
It would be a long step forward if physicians would recognize more
fully the objections to the many proprietaries which have, as their
only point of originality, a non-descriptive name for an old drug or
a mixture of well known drugs. It is an encouraging sign that the
Federal Trade Commission, when issuing licenses for the manufacture of
synthetic drugs introduced under German patents, stipulated that all
manufacturers authorized to make a given drug shall use the same name
for it.
_Irrational Articles._--Rule 10 provides against the recognition of
an article which, because of its composition, is useless or inimical
to the best interests of the public and medical profession. This
rule excludes medicaments which (1) are unessential modifications of
established articles, or (2) are of no therapeutic value or (3) are
irrational. With regard to the recognition of mixtures or compounds
containing two or more active ingredients, the Council requires that
the manufacturer establish the rationality of its combination. The rule
has prevented the recognition of many unnecessary so-called ethical
specialties. Though a mass of testimonials was often to be had for
them, these contained no evidence that the mixture was superior to its
potent ingredient, or that its therapeutic effect had been determined.
That there is a healthy tendency to use single drugs for their definite
action and to discard combinations (be they shotgun proprietaries or
“mixed” vaccines) is perhaps best illustrated by the fact that at
the last revision of the U. S. Pharmacopeia a considerable number of
complex antiquities were omitted from that book.
Feeling confident that this meets with the endorsement of the
profession, the Council is examining more critically the evidence for
the value of pharmaceutical mixtures.--(_From The Journal A. M. A., May
10, 1919._)
“ACCEPTED BY THE COUNCIL ON PHARMACY AND CHEMISTRY”
Under the caption given above, the _Journal of the Missouri State
Medical Association_, in its July issue, speaks editorially as follows:
The Council on Pharmacy and Chemistry of the American Medical
Association is a department of our national organization that has
not received the plaudits and encomiums of a wildly joyous medical
profession nor the grateful praises of the enthusiastic manufacturer
of pharmaceuticals. The Council seems indeed to be the unloved child
of the entire family of subsidiary bodies of the association. Perhaps
the reason for this may be found in the character of its duties, for
the Council must expose fraud, sometimes in high places, and protect
the physician from being duped by avaricious persons and by persons
who are themselves sometimes the victims of their own credulity. It
thus happens that the sale of some proprietary article previously held
in high esteem by the practitioner proves valueless, perhaps even
fraudulent. The practitioner, however, may have credited much of his
success in treating certain conditions to that preparation and the
maker has had success in accumulating dollars from its sale and both
parties emit a loud and vicious roar against the Council, because
they both lose money. Nobody wants to be “protected” against making
money--make it honestly, if possible, but make it--but this black sheep
among the Councils of the American Medical Association insists on their
making their money honestly!
Despite many obstacles thrown into its path, the Council on Pharmacy
and Chemistry has serenely pursued its allotted tasks, corrected
its mistakes, improved its methods, and today stands as the only
medium to which the honest physician may turn for information--not
misinformation--regarding proprietary articles. During the war the
Council and the chemical laboratory were in close cooperation with
the Surgeon-General’s Office, testing and investigating every article
offered to the government for the treatment of sick soldiers. The
variety and the number of fakish and fraudulent stuff offered to the
Surgeon-General was a pitiable exhibit of the mental gymnastics of
some people. Just now the Council and the laboratory have a new and
important field before them, i. e., to protect the physicians against
worthless and useless serums, vaccines and synthetics. It will be the
Council’s unpleasant duty to expose the fraudulent and useless among
these articles and stamp truth on those found worthy.
We seem to have wandered from the topic in our caption, but not so in
reality, because the burden of our thought is to lend our influence to
the spread of the motto of the Advertising Clubs of the World, namely,
“Truth in Advertising.” It is our purpose to stimulate a larger degree
of enthusiasm for the work of the Council on Pharmacy and Chemistry
and the Chemical Laboratory, a more generous flow of inquiries
concerning articles unfamiliar to the physician, and particularly to
urge that the words “Accepted by the Council on Pharmacy and Chemistry
of the American Medical Association” be printed on the label and on
all advertising circulars of proprietary articles that have been
admitted to New and Nonofficial Remedies. Then, when pamphlets and
circulars are received by physicians they will read the statements of
manufacturers with sympathetic understanding and with full confidence
in the verity of the declarations. The importance of creating just
that sort of receptivity in the mind of the prospective buyer is so
well known to the astute publicity expert that it is needless for
us to dwell on its advantages. Every proprietary article advertised
in our journal, in The Journal of the American Medical Association,
and in the other state association journals, as well as in several
well-edited privately owned journals, does in effect say to the reader
that the articles so advertised are accepted by the Council because
only proprietary articles so accepted are accepted by us. The fact is
further acknowledged when these firms are permitted to exhibit their
goods at our annual sessions for again the rule is enforced that only
proprietary articles which have been approved by the Council may be
placed on display.
Why not complete the circle of ideas--it would not be a “vicious
circle”--by printing on labels, in advertisements and circulars, the
words: “Accepted by the Council on Pharmacy and Chemistry”?--(_From The
Journal A. M. A., Aug. 2, 1919._)
HELPING THE COUNCIL
If they were built that way, the members of the Council on Pharmacy and
Chemistry of the American Medical Association might become discouraged
at the apparent indifference of many members of the medical profession
to their efforts. There are many physicians who, while figuratively
patting the Council on the back, actually do nothing to aid its
efforts. On the other hand, there are men in the profession who give
the Council active support instead of merely passive appreciation.
The letter that follows was written by such a man to a pharmaceutical
concern:
I am receiving circular advertising from you concerning ---- ----
solution, and I am writing to suggest that until these products
have been approved by the Council on Pharmacy and Chemistry of
the American Medical Association, you are wasting your postage
on the practice. Aside from the fact that these products do not
appeal to me personally, I feel that I am not in a position to
judge the value of such products and I depend entirely on the large
clinical opportunities of the Council on Pharmacy and Chemistry of
the American Medical Association in addition to their laboratory
facilities, in such matters as these. I may, therefore, with all
due respect, suggest that ... it will pay you to eliminate my name
from your mailing list.
The members of the Council on Pharmacy and Chemistry are working week
in and week out without remuneration. Few appreciate how much these
scientific men are doing for rational therapeutics; fewer still realize
how much has been accomplished through their efforts, or how much more
could be accomplished if every physician who at least believes in the
work of the Council would give it his full support.--(_Editorial from
The Journal A. M. A., Nov. 6, 1920._)
DELAYS IN PASSING ON PRODUCTS
Report of the Council on Pharmacy and Chemistry
The Council has adopted the following report and authorized its
publication.
W. A. Puckner, Secretary.
The Council frequently receives inquiries--some of them accompanied by
expressions of impatience--concerning articles, reports on which appear
to be delayed. It therefore seems advisable to make a statement of some
of the factors which enter into this problem.
The Council fully realizes the importance of giving prompt information
to the profession with regard to proprietary medicines under
consideration. It therefore acts as soon as sufficient information
is available to justify a definite judgment, and publishes its
conclusions as soon as possible. When adequate information is available
at the outset, there is no delay in the publication of the Council’s
conclusions.
Unfortunately, but very naturally, there are many cases in which the
information available at the time the product is submitted is not
sufficient to justify the Council in coming to definite conclusions for
or against the preparation. In some cases the manufacturer possesses
the required information, but to obtain it from him takes time; in
other cases the manufacturer does not possess the information--perhaps
he did not realize the inadequacy of his evidence until the subject was
brought to his attention by the Council.
Such cases might be dealt with in either one of two ways: The Council
might at once reject the article because the claims for it are not
supported by adequate evidence; or, the Council might suspend judgment
and give the manufacturer an opportunity to supply the information.
The first method--immediate rejection--would obviously be felt by
manufacturers as a hardship. To afford the fullest possible opportunity
for the presentation of the case, the Council follows the second
method; that is, it suspends judgment and withholds publication of
a report until reasonable time has been afforded for furnishing the
required information, provided the manufacturer or agent appears to
be making honest and diligent efforts to supply it. The collection
and compilation of such information is sometimes a lengthy process,
especially when the products are of foreign manufacture.
Although it would be easier for the Council to render an immediate
decision than to assist manufacturers to supply the data necessary for
the formation of an authoritative judgment, the Council cannot yield to
importunities for hasty action. It must rely on the medical profession
to bear in mind that the character of a product under consideration
by the Council has not yet been determined. The Council holds that,
during this stage, a product is suitable, at most, for experimental
use.--(_From Reports of Council on Pharmacy and Chemistry, 1915,
p. 119._)
COOPERATION OF THE PHARMACEUTICAL HOUSES
Report of the Council on Pharmacy and Chemistry
In reply to the suggestion made last year by President Bevan that there
should be closer cooperation between the large pharmaceutical houses
and the Council on Pharmacy and Chemistry, the Council submitted to the
Board of Trustees of the American Medical Association the statement
which appears below:
“COOPERATION OF THE PHARMACEUTICAL HOUSES: At the opening meeting
of the House of Delegates last year, President Arthur Dean Bevan
suggested the desirability of greater cooperation between the large
pharmaceutical houses and the Council on Pharmacy and Chemistry. The
need of such cooperation has been recognized by the Council from the
first. In no one direction has the Council made greater effort than
in its endeavor to secure the fullest cooperation of the various
pharmaceutical houses. The difficulty has been, and always must
be, the fundamental antagonism between objectives that are largely
commercial on the one hand and purely scientific on the other.
Nevertheless, the Council has always believed--and has acted on the
belief--that there is a possible middle ground wherein the interests
of therapeutics would not be injured but would go hand in hand with a
commercial development based on enlightened self-interest.
“The profits to be made by a pharmaceutical house from the sale of a
staple drug--a pharmacopeial, National Formulary, or nonproprietary
preparation--which enters into free competition with other drugs
of the same kind, are moderate; the profits to be made from the
sale of a proprietary medicine on which the manufacturer holds a
monopoly are usually large--sometimes enormous. There are, broadly,
two kinds of proprietary preparations advertised to physicians:
One represents laborious research ending in the production of
a new medicinal chemical; this product can be patented and the
manufacturer can obtain a seventeen-year monopoly on its manufacture
and sale. The other represents no research but comprises simple
mixtures--frequently of the “shotgun” variety--of well known
pharmaceuticals, or biologic products sold under trade names. As
these do not represent anything new or original the manufacturer is
unable to obtain a patent, but by means of the trade name he can and
does obtain a perpetual monopoly. This, from a business standpoint,
is more valuable than the limited monopoly granted by a patent. It is
not surprising that proprietary remedies of the latter type flourish
so long as physicians unthinkingly accept and prescribe them solely
on the manufacturer’s valuation.
“The Council has practically the undivided support of
manufacturers of medicinal chemicals; that is, of proprietaries
of the first mentioned type. But pharmaceutical firms which
have found it profitable to promote proprietaries of the second
type--“specialties,” unscientific or ordinary mixtures of
pharmaceuticals or biologic products sold under trade names--have not
supported the Council.
“When the Council was organized, it was hoped and believed that all
the large pharmaceutical houses would find it possible and desirable,
if not actually more profitable, to shape their business methods so
as to make their proprietary and other articles conform to those
conservative standards on which the Council bases its rules, and thus
render such articles acceptable for New and Nonofficial Remedies.
It soon developed, however, that the methods of the pseudochemical
companies, whose sales propaganda in the interest of unscientific
nostrums with its attending damage to scientific medicine had led to
the establishment of the Council, had found their lodgment in most
of the pharmaceutical houses. It was a genuine disappointment to the
Council to find that some of the large and old-established firms
were not only unwilling to cooperate with the Council, but in many
instances exhibited a definite antagonism to the Council’s work.
“The object--and duty--of the officers of pharmaceutical houses is
primarily to pay dividends to their stockholders. Through skilful
advertising or the persuasiveness of “detail men,” they are able
to induce physicians to prescribe their controlled products, on
which there are large profits, even though such products have not
only not been accepted by the Council, but in many instances, have
been disapproved. Is it any wonder that concerns which put out such
products are indifferent or openly antagonistic to the work of the
Council? The matter is largely one of business policy. When the
medical profession as a unit will support the Council in its work,
then such firms will find it good business policy to accede to Dr.
Bevan’s suggestion--but not before.”
Evidently the problem resolves itself into this: The Council,
constituted of scientific men, working without remuneration in
the interest of scientific medicine and the medical profession,
expects--and rightfully--the cooperation and support of the members of
that profession. What is needed, therefore, is the active, sympathetic
cooperation of physicians; the cooperation of pharmaceutical houses
will follow as a matter of course. (_J. A. M. A._ =74=:1235 [May 1]
1920.)
The following is the recommendation of the Reference Committee to
which the Report of the Board of Trustees was referred: “A perusal
of the Trustees’ Report, ‘Cooperation of the Pharmaceutical Houses’,
is well worth the time of every member of the profession, and your
committee would emphasize the statement of the Trustees: ‘The
Council, constituted of scientific men, working without remuneration
in the interest of scientific medicine and the medical profession
expects--and rightfully--the cooperation and support of the members of
that profession. What is needed, therefore, is the active sympathetic
cooperation of physicians; the cooperation of pharmaceutical houses
will follow as a matter of course.’
“Your committee would go still further and move that a vote of thanks
of the House be extended to those scientific men who have devoted so
much valuable time to the welfare of the Association.”
(_J. A. M. A._, =74=:1322 [May 8] 1920; _from Reports of Council on
Pharmacy and Chemistry_, 1920, p. 56).
W. A. Puckner, Secretary.
BUDWELL’S EMULSION OF COD-LIVER OIL, NOS. 1 AND 2
Report of the Council on Pharmacy and Chemistry
The Budwell Pharmacal Company, Lynchburg, Virginia, which markets these
preparations, claims that “No. 1” contains cod liver oil, “Iodide of
Arsenic,” “Iodide of Calcium,” and “Iodide of Manganese.” “No. 2” is
said to contain in addition to the ingredients of No. 1, creosote
carbonate and guaiacol.
It is known that arsenous iodid is decomposed by contact with water. It
is recognized that creosote carbonate is unstable and prone to liberate
creosote. Iodide of manganese not being official, the supply on the
market is not controlled in any way: Tests of purity are not prescribed
by the Pharmacopeia, the National Formulary, New and Nonofficial
Remedies or other books of standards. Therefore doubt must be expressed
as to the accuracy of the formulas as given. The Council cannot accept
such statements of composition without further evidence.
“No. 1” is commended for use in
“Chronic Rheumatism, Glandular Swellings, later forms of Syphilis,
convalescence from Scarlet Fever, La Grippe and Malaria, Chronic
Malarial Infection, Marasmus, Joint or other suppuration of
standing, diseases of skin, chorea, anaemia, neurasthenia,
obstinate neuralgia, scrofulous affections in general, and diarrhea
or dysentery (subacute or chronic) in childhood.”
“No. 2” is said to be
“Prepared especially for the treatment of Chronic Throat, Nasal,
Bronchial and Pulmonary Diseases.”
In the advertising circular statements regarding the various
ingredients of Budwell’s Emulsion are quoted from obsolete text
books. These statements, for the most part, do not represent modern
opinions on the subject. For instance, the circular praises the action
of guaiacol as eliminated directly by the lungs, thus exerting a
beneficial local effect and causing bacilli to diminish in numbers or
to disappear. All of this is directly contradicted in authoritative
modern publications on pharmacology, which hold that the excretion of
guaiacol by the lungs is infinitesimal and its action on bacilli is
nil. The Council held the preparations in conflict with its rules as
follows:
1. Many of the therapeutic claims are exaggerations.
2. The method of exploitation amounts to an indirect invitation to the
public to use these preparations as “consumption cures.”
3. The preparations are unscientific, they constitute a reprehensible
invitation to uncritical prescribing and their use is inimical to the
best interests of the profession and the public. It is difficult to
imagine in what conditions such a combination would be indicated. These
preparations are a remnant of the days of polypharmacy. Their use is
not in keeping with present medical thought and practice.--(_From The
Journal A. M. A., Feb. 20, 1915._)
RHEUMALGINE
Report of the Council on Pharmacy and Chemistry
Rheumalgine (Eli Lilly & Co., Indianapolis) is put up both in tablet
form and as a liquid. Each tablet, or teaspoonful of the liquid, is
said to contain:
“Strontium salicylate from Natural Oil 5 gr.
Hexamethylenamin 2 gr.
Colchicine 1/200 gr.”
The advertising matter contains several statements regarding the
individual ingredients to which objection must be made.
It is claimed (quoting from Hare) that strontium salicylate
“... is not so disagreeable to the taste as the corresponding
sodium salts, and more important still, it is far less apt to
disorder the stomach.”
“Taste” is a difficult subject to dispute; but in the experience of the
referee, patients object more to the strontium than to the sodium salt.
No evidence is submitted to prove that the strontium salt is less apt
to disorder the stomach. In observations made under the direction of
the referee, the nauseant and emetic doses are about the same as, or
even less than, those of sodium salicylate.
Under hexamethylenamin, the recommendations are not confined to
its recognized use as a urinary antiseptic; it is also said to be
“unexcelled” as a “germicide,” and to prevent the formation of urate
and phosphate deposits. These statements are contrary to facts.
“Rheumalgine ... may be used in all cases where the salicylates
are indicated. It is superior to preparations containing sodium
salicylate, in that it does not cause nausea or disturb the
digestion.”
Both the preceding statements are misleading. The necessity of giving
1/200 grain of colchicin for each 5 grains of salicylate would
certainly interfere with the use of adequate doses of the latter. The
colchicin would produce digestive disturbance quite apart from the
salicylate.
The mixture is described as:
“... ANTIRHEUMATIC, ANTIPYRETIC, URINARY ANTISEPTIC, AND URIC
ACID ELIMINANT. Useful in Acute Articular and Chronic Rheumatism,
Muscular Pains, Lumbago, Sciatica, Migraine of the Rheumatic, Gout,
and in Nervous Irritability of the Gouty or Lithemic.”
The facts are: Salicylates are useful in some of these conditions,
colchicin occasionally in a few, hexamethylenamin in none.
The combination is conducive to uncritical prescribing. For
instance, salicylates are effective in acute articular rheumatism;
hexamethylenamin and colchicin are useless; salicylates are of very
little use in chronic rheumatism, sciatica and nervous irritability,
while hexamethylenamin and colchicin are useless in these conditions;
colchicin is sometimes effective in gout, salicylates perhaps also;
hexamethylenamin is not.
Attention should also be called to the high dosage of colchicin,
namely, 1/100 to 1/50 of a grain of the alkaloid, every three or
four hours, the dose then to be “slightly reduced,” but continued
for several days; or in chronic cases, 1/100 to 1/30 grain per day,
continued indefinitely. This dosage appears high, if a really active
preparation is used.
Finally, the name “Rheumalgine” encourages thoughtless and unscientific
prescribing. If a mixture is used at all, the prescriber should be
constantly reminded of its composition.
It is therefore recommended that Rheumalgine be held in conflict with
Rules 6 (unwarranted therapeutic claims), 8 (nondescriptive name) and
10 (unscientific composition).--(_From The Journal A. M. A., June 26,
1915._)
GRAY’S GLYCERINE TONIC
Report of the Council on Pharmacy and Chemistry
The Council adopted the following report and authorized its publication.
W. A. Puckner, Secretary.
Gray’s Glycerine Tonic Comp. (Purdue Frederick Company, New York) is
a mixture said to be made according to a prescription of the late Dr.
John P. Gray, superintendent of the state hospital, Utica, New York. As
to the composition, the following statement is furnished by the company:
“This preparation is a combination of Glycerine, Sherry Wine,
Gentian, Taraxacum and Phosphoric Acid with carminatives.”
The label declares the presence of 11 per cent. alcohol, and the dose
is given at from two teaspoonfuls to a tablespoonful. A study of
the ingredients will show that, aside from the alcohol, the mixture
contains but one really active drug, gentian. Essentially, then,
“Gray’s Glycerine Tonic” is a mixture which, in addition to the
narcotic effect of the alcohol, depends on a bitter, gentian, for
whatever therapeutic action it may possess.
The bitters, of which gentian is a type, were once credited with
many therapeutic virtues which time has shown they do not possess.
Pharmacologic research has demonstrated that their utility consists in
stimulating the appetite through their action on the taste buds. On
this account they were believed also to increase the secretion of the
gastric juice by a psychic impression. More recently, however, even
this has been questioned--by Carlson, for instance.
These facts are fully understood, presumably, by all physicians. Yet,
according to the advertising circular, this “tonic,” which, for all
practical purposes, is merely a simple bitter, is good for thirty-two
diseases ranging from amenorrhea to whooping cough!
The conditions in which Gray’s Glycerine Tonic is asserted to be
especially efficient are described on the label of the bottle and the
outside wrapper, in popular terms, more or less typical of “patent
medicine” exploitation, such as “catarrhal conditions,” and “stomach
derangements.” Similar statements are contained in the leaflet
accompanying the trade package. For instance:
“It is, therefore, an effective, reliable tonic in nervous
exhaustion, general debility, impoverished conditions of the blood
and nervous system, Bright’s disease, diseases of the liver,
disorders of the urinary organs, etc.”
“It is an unexcelled restorative in that very common class of cases
in which there is no positive organic disease, but the patient
complains that he ‘does not feel well’ or ‘is out of sorts.’”
Here are some of the claims made in other advertising matter:
“All stages of bronchitis ... are rapidly improved by the use
of Gray’s Glycerine Tonic Comp. This remedy has a direct tonic
influence upon the circulation of the respiratory mucous membrane;
it relieves congestion and restores tone to weakened blood vessels.”
“... improves the appetite, gives valuable aid to the digestive and
absorptive processes, and reinforces cellular nutrition in ways
that insure a notable gain in vitality and strength.”
+-----------------------------------------------------------------+
| In Gastro-Intestinal Catarrh |
| |
| --and other afflictions of the stomach and bowels characterized |
| by muscular weakness and glandular insufficiency--there is no |
| remedy more prompt and effective in its action than |
| |
| Gray's Glycerine Tonic Comp. |
| |
| Under its systematic administration the appetite is restored, |
| the alimentary processes greatly improved, the nutrition |
| promoted and every vital function throughout the body given a |
| new and substantial impetus. As the digestive and assimilative |
| functions are restored to their normal efficiency, a notable |
| increase in the restorative and recuperative powers of the body |
| naturally follow. |
| |
| THE PURDUE FREDERICK CO. |
| 135 Christopher Street, New York City |
+-----------------------------------------------------------------+
Mention ILLINOIS MEDICAL JOURNAL when writing to advertisers.
[Illustration: This appeared in a journal owned and controlled by the
second largest state medical association of the country.]
Even granting that gentian may improve the appetite, how absurd it
is to claim that this mixture “relieves congestion,” “restores tone
to weakened blood vessels,” “gives aid to the absorptive processes,”
“reinforces cellular nutrition,” or increases vitality!
Neither the composition of Gray’s Glycerine Tonic nor the clinical
evidence warrants the belief that it has any therapeutic value other
than that due to the psychic effect of the bitter drug gentian.
Physicians who have prescribed it have done so because of the
advertising. This nostrum has been kept so constantly before the eyes
of medical men that they think of Gray’s Glycerine Tonic when they
cannot remember the official drugs that may be indicated in the case.
The moral is that liberal advertising will sell anything.
It is recommended that Gray’s Glycerine Tonic Comp. be declared not
eligible for inclusion in New and Nonofficial Remedies on account of
conflict with Rules 1, 6, 8 and 10.
[Editorial Note.--An old practice in hospitals--happily now practically
obsolete--was to have certain stock mixtures prepared in bulk. Among
these there was usually a so-called tonic mixture, used in a more or
less haphazard manner when nothing in particular seemed indicated. Such
a stock mixture was used in the State Hospital for the Insane at Utica,
N. Y., during the many years that Dr. John P. Gray was superintendent
(from the early fifties to the early eighties), although it is very
doubtful whether he originated the mixture. After the death of Dr.
Gray--so the story runs--one of his sons, with a partner, formed the
firm of Purdue Frederick Company, and began the exploitation of the
elder Dr. Gray’s name, in connection, presumably, with this stock
preparation. As indicated in the Council’s report, Gray’s Glycerine
Tonic Comp.--and what an absurd name!--is simply a mixture of ordinary
drugs, requiring no skill whatever in compounding. If there is a
physician living who cannot write a prescription offhand as good as
this formula, that physician should either go back to a medical school
or change his vocation. There is, and can be, no excuse for prescribing
such a ready-made mixture, for every cross-roads drugstore has the
ingredients and any pharmacist worthy of the name could compound it.
Among the scores of nostrums that disgrace the medical profession
of this country, none is more typical of all that is inimical to
scientific medicine, to the medical profession and above all to the
public--for, after all is said, it is the public that ultimately is
humbugged.]--(_From The Journal A. M. A., July 10, 1915._)
TONGALINE AND PONCA COMPOUND
Report of the Council on Pharmacy and Chemistry
The Council, having considered “Tongaline,” “Tongaline Tablets,”
“Tongaline and Lithia Tablets,” “Tongaline and Quinine Tablets” and
“Ponca Compound Tablets,” found these preparations ineligible for New
and Nonofficial Remedies and authorized publication of the following
report.
W. A. Puckner, Secretary.
TONGALINE
Tongaline (Mellier Drug Co., St. Louis) is a fancy name given to what
is essentially a sodium salicylate mixture. The air of mystery created
by the name permits the manufacturers to make claims for the product
which would be ludicrous if the medical profession was fully conversant
with the very ordinary character of the preparation.
Tongaline receives its name from tonga, an inert, long-discarded
mixture of various barks and herbs said to be gathered and prepared
by Fiji Islanders. Its constituents evidently tend to vary with
the collector. The history of the introduction of this indefinite
combination of simples is thus given in The Journal, May 10, 1913.
“A supply of the crude drug was carried to England by a man who had
lived for a short time in the Fiji Islands and it was placed in the
hands of a retail house in London. This occurred about 1879. In
1880, two English physicians of repute published laudatory articles
on the therapeutic value of tonga in neuralgia and rheumatism. This
created a demand for the drug which extended to the United States.”
Time showed that tonga was inert therapeutically, and authorities
on pharmacology now no longer notice it. As the Council previously
reported,[12] the indefinite character of the mixture should, alone,
be sufficient to exclude it from practical therapeutics. During the
temporary popularity of tonga, the proprietary mixture Tongaline was
put on the market for physicians’ use by the Mellier Drug Company,
St. Louis. In this, tonga was named as the active ingredient. The
commercial interests thus involved have faithfully nourished and kept
alive the “tonga” myth.
[12] Reports of the Council on Pharm. and Chem., 1912, p. 40.
In a recent advertising booklet, “The Therapeutic Properties of
the Ingredients of Tongaline,” the virtues of tonga, blue cohosh,
colchicum, jaborandi and salicylic acid are discussed. The label of a
recently purchased bottle reads:
“Tongaline contains Tonga, Cimicifuga Racemosa, Salicylate of
Sodium (the salicylic acid being made from pure natural oil)
Colchicum and Pilocarpin.”
It will be noticed that Tongaline is “made from the pure, natural oil.”
In fact, the statement is repeated in red ink, in large letters running
across the face of the label, thus emphasizing the alleged importance
of this assertion. In this connection it is only necessary to recall
that it has been proved clinically, chemically and physiologically that
there is absolutely no difference between the salicylic acid made from
the natural oil and the synthetic.
The formula was thus commented on in the article previously quoted from
The Journal:
“Tongaline ... is essentially a preparation of sodium salicylate,...
The Mellier Drug Company realized the impossibility of creating
any marked demand for a nostrum unless it had some real drugs
in it--hence the presence of the salicylates. What the actual
composition of Tongaline is, no one but the manufacturers know. At
one time the following was given as the formula:
Fluid Tonga 30 grains
Extract of Cimicifuga Racemosa 20 grains
Sodium Salicylate 10 grains
Pilocarpin Salicylate 1/100 grain
Colchin Salicylate 1/500 grain
“These amounts refer to the quantity of drugs in each fluidram of the
preparation. Whether the nostrum still has this composition we do
not know, but assuming that it has, it is quite evident that sodium
salicylate is the essential and active ingredient.”
The therapeutic indications given on the label of the bottle are:
“Rheumatism, Neuralgia, Grippe, Gout, Nervous Headache, Sciatica,
Lumbago, Malaria, Tonsillitis, Heavy Colds, Excess of Uric Acid,
and wherever the use of the Salicylates is indicated.”
In a recent booklet this semisecret salicylate mixture is recommended,
not only in conditions in which salicylates are indicated, but also
combined with aconite for rheumatic fever, with benzoate of soda in
the treatment of “grippe,” with potassium bromid in nervous headaches,
with gelsemium, glycerin and whisky for “heavy colds,” with ammonium
chlorid, stramonium and cimicifuga in “rheumatic dysmenorrhea,” and
even with mercury biniodid as a treatment of syphilitic eruptions!
“When administered with good judgment, Tongaline exerts a
stimulating effect upon every organ of elimination; cleansing
the complex sewerage system and putting it into working order.
When this is done, the sluggish blood current begins to flow more
freely; the lymphatic and glandular systems to give up and carry
off the toxic products, so long retained ...”
TONGALINE TABLETS
Then because of a “desire to put Tongaline in a more compact and
convenient form,” the same concern puts on the market Tongaline
Tablets. Whether Tongaline Tablets are of the same composition, the
doctor who prescribes them is not advised. In this form we have
Tongaline and Lithia Tablets, and Tongaline and Quinin Tablets.
Presumably those who are attracted by the word “lithia” are
sufficiently uncritical to be content with the statement that:
“The addition of Lithia to Tongaline presents a most useful
combination which does not rely upon its action on the kidneys
alone as is the case with Lithia salts or Lithia waters as
administered ...”
And the foregoing quotation, be it remembered, is for the information
of the medical profession! Tongaline and Lithia Tablets, we are
informed, are:
“... particularly indicated for certain diseases which are caused
by deposits of urates in the joints and kidneys, and can be used
with much benefit for many people who indulge in generous or
intemperate habits of living.”
Tongaline and Quinine Tablets are also exploited without statement
of composition. The promoters are probably justified in feeling that
physicians who prescribe quinin in combination with “Tongaline” care
little about the dosage.
It is unnecessary to discuss the silly claims made for Tongaline and
its combinations, although it is worth while to point out that the
prescribing of such nostrums by physicians is an imposition, if not a
fraud, on the public.
PONCA COMPOUND
Ponca Compound, also made by the Mellier Drug Company, St. Louis, is a
“female weakness remedy” in tablet form. The name suggests that “ponca”
is a medicinal substance, and, in fact, at one time, “Ext. Ponca” was
named as an ingredient. The nature of “Ext. Ponca” was apparently never
explained. It is now replaced in the “formula” by “senecin,” and the
only information concerning the composition at present given is:
“Ponca Compound Tablets Contain Extract of Mitchella Repens,
Senecin, Helonin, Caulophyllin and Viburnin.”
This “formula” is practically meaningless, not only because the
amount of each ingredient is not stated, but also because “senecin,”
“helonin,” “caulophyllin” and “viburnin” are in themselves variable
mixtures of unknown composition.[13]
[13] See Report of the Council on Pharmacy and Chemistry on “Resinoids
and Concentrations,” J. A. M. A., Nov. 13, 1909, p. 1655.
Presumably, “senecin,” “helonin,” “caulophyllin” and “viburnin” are
extractives of some kind prepared, respectively, from senecio aureus
(life root), helonias dioica (false unicorn), calophyllum thalictroides
(blue cohosh) and viburnum prunifolium or opulus (black haw or cramp
bark). These are, one and all, practically inert drugs. There is no
reason to believe that any or all of them can have any beneficial
influence in the many and varied conditions for which Ponca Compound is
advertised.
The following are excerpts from the advertising matter:
“Ponca Compound is a remedy of a very beneficial character for
Functional, Uterine and Ovarian troubles, which will respond to
internal treatment, especially when digital examination or surgical
interference is undesirable.”
“Ponca Compound is also valuable during gestation and after
parturition.”
“Uterine Alterative for Leucorrhoea, Dysmenorrhoea, Amenorrhoea,
Metritis, Endometritis, Menorrhagia, Metrorrhagia, Irregular
Menstruation, Subinvolution, Painful Pregnancy.”
It is recommended that Tongaline and Ponca Compound and all their
preparations be held in conflict with Rule 1, in view of their
semisecret and indefinite composition; with Rule 6, for the grossly
exaggerated therapeutic claims made for them; with Rule 8, because of
their misleading names, and with Rule 10, in view of their unscientific
character as irrational combinations. It is also recommended that this
report be published.--(_From The Journal A. M. A., July 17, 1915._)
ALFATONE
Report of the Council on Pharmacy and Chemistry
The Council has found Alfatone ineligible for New and Nonofficial
Remedies and has authorized publication of the following report.
W. A. Puckner, Secretary.
Alfalfa is good cattle feed but only nostrum exploiters have suggested
its use as a medicine for human beings. While it may seem a waste of
time to discuss the medicinal value of alfalfa its recent exploitation
by the Norwich Pharmacal Company, Norwich, N. Y., as “a reconstructive
tonic and nutrient” in the form of a mixture called “Alfatone,” calls
for comment. According to the label on the preparation:
“Each fluidounce represents:
Alcohol 15 per cent.
Medicago sativa (Alfalfa) 120 grains
Taraxacum 2-1/2 grains
Gentian 1 grain
Berberine Hydrochloride 1/40 grain
Glycerin and Aromatics.”
“Dose.--One to three fluidrams (4 to 12 c.c.) 4 times daily.”
Each maximum dose, therefore, should represent 45 grains of alfalfa, 1
grain of taraxacum (dandelion), 3/8 grain of gentian, 1/100 grain of
berberin hydrochlorid, and 27 minims of alcohol. Since the bitter drugs
are present in such small amounts that the preparation is almost devoid
of bitterness, and as the medicinal value of alfalfa is practically
nil, it is evident that whatever action Alfatone may have is due to the
stimulant effects of the alcohol.
Some of the claims made for Alfatone are:
“A reconstructive nutritive tonic indicated in general debility,
neurasthenia, convalescence, etc.”
“... a Galactagogue of merit as well.”
“... improves the appetite, aids the processes of digestion and
assimilation, facilitates elimination and effects gradual but
decided gains in strength, vitality and weight.”
It is suggested that:
“... in case of idiosyncrasy the addition of Tr. Nux Vomica 5 to 10
minims to the dose, unless contraindicated, will secure excellent
results.”
The Norwich Pharmacal Company naively remarks:
“The dearth of medical literature on Alfalfa has lead us to present
below a few of the findings of the Bureau of Plant Industry of the
Department of Agriculture ... as well as those from several state
experiment stations ...”
Here are the “findings”:
“... Digestible nutrients in 100 pounds of Alfalfa,... Protein,
11.0 pounds; Carbohydrates, 39.6 pounds; Ether Extract, 1.2 pounds.”
“... The high value of Alfalfa is due to the amount of protein that
it contains; to the large percentage of protein that is digestible
and the palatability of Alfalfa.”
“... Table showing pounds of elements removed from the soil by one
ton of crop.
Alfalfa Wheat
Potash 49.79 12.52
Phosphoric Acid 8.27 9.08
Lime 43.51 2.95
Nitrogen 44.01 22.30”
“... The abundance of muscle and bone producing material in Alfalfa
makes this crop especially good.”
Thus estimates of the value of a farm crop and cattle fodder are made
to do service as testimonials to its therapeutic merit for human
beings! Has the “patent medicine” promoter ever dared to insult the
intelligence of his patrons by a cruder absurdity? Yet it is not to the
nontechnical and unscientific public, but to a profession presumably
scientifically trained in pharmacology and therapeutics that this
concern presumes to offer its fodder tincture on the basis of testimony
to the agricultural value of the fodder plant.
Alfatone is a worthless alcoholic cordial. The audacity of the attempt
to promote its sale by a discourse on the merits of a well-known fodder
plant is the sole reason for devoting any attention to it. It is
recommended that Alfatone be held ineligible for New and Nonofficial
Remedies, and that this report be published.
[Editorial Note.--What a comment on American medicine that a concern
can even contemplate the possibility of making a commercial success
of the sale of such a silly nostrum as Alfatone! And yet, when one
remembers that a proprietary in which oats constitutes one ingredient
(“Pas-Avena”) for years has been advertised to physicians and
presumably prescribed by them, it is not altogether inexplicable that
business men should get the impression that the medical profession
is “easy” enough to “fall for” anything in the line of proprietary
mixtures. Perhaps we may look forward to being offered proprietaries
based on other cheap and well-known fodder plants. Tincture of Timothy
Hay, Blue Grass Tonic, Cornhusk Wine! Why not? The enterprising
companies that may put them out can easily publish tables to show
the digestible nutrients in each and indubitable testimony can be
furnished to prove the excellence of any of them as stock feed. If a
pitchforkful of timothy hay makes a good fattening ration for a growing
steer why should not a teaspoonful of tincture of timothy hay make a
“reconstructive tonic and nutrient” dose for a man? If an arm load of
thistles (carduus) makes a luscious food for _equus asinus_ why should
not a pinch of thistle in alcohol and water be a good “tonic”? Great
are the possibilities! They are limited only by the gullibility of the
medical profession and the public. Certain it is that some proprietary
manufacturers are firmly convinced that no combination can be too
preposterous to be worth trying on the medical profession.]--(_From The
Journal A. M. A., Aug. 7, 1915._)
ARTICLES REFUSED RECOGNITION
Report of the Council on Pharmacy and Chemistry
Below appear abstracts of the Council’s actions on articles refused
recognition which were not deemed of sufficient importance to require
lengthy reports.
Uricsol
Uricsol is marketed by the Uricsol Chemical Company, formerly of Los
Angeles, now of Boston. Regarding its composition only vague statements
are made. In an advertising pamphlet it is promised that the formula
will be sent to physicians on request. Such a request from a physician
elicited the following statement:
“URICSOL is a non-irritating, alkaline solution, containing Lithium
Citrate, Acid Citric and Potassium Nitrate, together with a saline
laxative in the form of Glycero Sodium Phosphate, with Vegetable
Tonics added.”
The Association Laboratory has made an examination of Uricsol to
determine its composition and reports as follows:
LABORATORY REPORT
A trade package purchased in March, 1915, from a wholesale drug house
was labeled:
“Uricsol Rheumatic Remedy, Uric Acid Solvent, Kidney and Liver
Stimulant, Manufactured by the Uricsol Chemical Co., Los Angeles,
Cal.”
This package was wrapped in a circular entitled “The Great California
Remedy--Uricsol.” The preparation is a viscid, slightly turbid light
brown liquid, with a faintly aromatic odor and a salty, bitter
taste. The diluted solution is acid in reaction toward litmus and
phenolphthalein and alkaline toward methyl orange.
Qualitative tests showed a presence of phosphate, citrate, nitrate,
sodium, glycerin, and a small amount of lithium in aqueous solution.
Besides these a small amount of some organic, nonalkaloidal substance
was found, which from its bitter taste suggested gentian. From the
qualitative tests it appeared that the phosphate was the predominating
ingredient and accordingly a phosphate determination was made. The
results, calculated to sodium phosphate, U. S. P., indicated the
presence of 64.20 gm. per 100 c.c., held in solution by citric acid and
sodium nitrate.
Uricsol evidently is a solution containing a large amount of sodium
phosphate with small amounts of lithium, nitrate, citric acid and
glycerin, with probably some vegetable extract.
In general Uricsol is similar to the once widely exploited proprietary
“Melachol,” which has been frequently imitated. A preparation
essentially identical is in the United States Pharmacopeia, under the
title “Compound Solution of Sodium Phosphate.”
The Uricsol Company calls its preparation
“... the latest word in the treatment of Rheumatism and that allied
group of ailments which is caused by an excess of Uric Acid.”
Hay fever, bronchial asthma and neuritis are conditions in which it is
recommended. The claim is made that
“Uricsol quickly controls Vasomotor Rhinitis and eliminates such
conditions from the system.” “In fact, it will correct FAULTY
METABOLISM.”
To a few practitioners of an older generation the pharmacologic basis
of a remedy for rheumatism was sufficiently defined by saying that it
increased the solubility of uric acid or affected it in some way. This
theory is obsolete; there is not, and never was, any reliable evidence
on which to base the theory that rheumatism is in any way caused by
uric acid. The exploitation of Uricsol as a “uric acid solvent” is
merely another illustration of the way in which nostrum manufacturers
play on disproved theories. Of course the claim that sodium phosphate
has any particular power to control vasomotor rhinitis, hay fever,
asthma, and to correct faulty metabolism is foolish.
To summarize: Uricsol is a mixture of well-known drugs, marketed with
false claims as to therapeutic action, with misleading and meaningless
statements as to composition and under a name which invites uncritical
prescribing. Uricsol is held ineligible to inclusion in New and
Nonofficial Remedies.
Jubol
The following ridiculous statements are addressed, not to the laity,
but to the medical profession:
DO YOU SUFFER FROM Constipation--Hemorrhoids--Enteritis--Mucous
discharge--Pituita--Acidity of the stomach--Vertigo--Sick
Headache--Disturbed Sleep--Insomnia--Sallow Complexion--Coated
Tongue--Offensive breath--Fatigue and depression--Boils--Pimples?
“ONE of these symptoms alone shows that there is defective or
insufficient function of the intestines, even if the stools are
regular.
“Excrements remain too long in the intestine and set up
fermentation. The harmful poisons and Ptomains which they produce
are re-absorbed by the blood and poison the whole system.
“The Intestines must be cleared and re-educated with JUBOL.
“Jubolise your Intestines.”
Jubol tablets are sold in the United States by Geo. J. Wallau, Inc.,
New York, and are said to be prepared by J. L. Chatelain, Paris,
France. The following incomplete and nonquantitative “formula” is
furnished:
“... compounded chiefly [!] of Agar-Agar, Biliary Extracts and pure
Extracts from all the intestinal Glands.”
It is asserted that
“The tablets are coated with a protective covering in order that
they may act on the intestine only.”
The tablets contained in a regular-size trade package, obtained direct
from the agent, readily separated into two halves and disintegrated
within a few minutes when agitated with water. It is thus evident
that, under ordinary conditions, the intestinal ferments in Jubol (if
they are present, as claimed) would be destroyed during their passage
through the stomach. In direct tests, however, practically no tryptic
activity was demonstrated.
The composition of Jubol is not declared; grossly unwarranted and
incorrect claims are made for its therapeutic actions; the name does
not indicate the alleged ingredients and so much of the composition as
is declared indicates an unscientific mixture. The Council decided that
Jubol should be held ineligible for New and Nonofficial Remedies, and
that this report should be published.
Urodonal
Urodonal is said to be “produced in the laboratory of J. L. Chatelain,”
Paris, France. It is marketed in this country by Geo. J. Wallau, Inc.,
New York.
The preparation is claimed to be a chemical compound, and the
advertising matter furnishes a “formula,” which consists of the
formulas of lysidin, sidonal and hexamethylenamin, connected by plus
signs:
{H₂C Az } CO₂H--C--OH AzH Az
{H₂C C--CH₃} + { H₂C CHOH } {H₂C CH₂} {H₂C CH₂ CH₂}
{ AzH } {OHHC CH₂ } {H₂C CH₂} + {Az.CH₂ Az.CH₂ Az}
{ CHO } { AzH } { CH₃ }
That the substance is a chemical compound is highly improbable, and no
evidence has been submitted to substantiate the claim. On the contrary,
in the following statement the phrase “based on” is a virtual admission
that the preparation is merely a mixture:
“Urodonal ... is a granular effervescent preparation based on
methylglyoxalidine [Lysidine], quinate of diethylene-diamine
[Sidonal] and hexamethylene-tetramine [Formin, urotropine].”
Mystery is added by the mention of undefined “special products” in the
following:
“The fact of combining these two salts [lysidin and sidonal] in
Urodonal, in strictly determined proportions and in the presence of
special products, gives this preparation very considerable power in
dissolving uric acid.”
These contradictory statements of composition conflict with Rule 1.
Urodonal is marketed in typical “patent medicine” style: the name
“Urodonal” is blown in the bottle and the label contains a list of
“Indications,” including rheumatism, gout and gravel (Rule 4). That
this form of marketing has introduced it to the public is suggested by
the following in an advertising circular:
“... Urodonal is now popular--even classic--throughout the world,
where thousands of doctors and millions of patients agree in
asserting that ‘Urodonal is to rheumatism what quinine is to
fever.’”
There are also other indications that the mixture is to be exploited to
the laity. For instance, the U. S. distributor sends out a portrait of
Sarah Bernhardt bearing the legend:
“I am positive that URODONAL preserves youth’s freshness with
clearness and strength to brain and heart. I have taken it for two
years with the greatest benefit. Sarah Bernhardt.”
A circular advises this mixture
“For all who suffer from Arthritis, Rheumatism, Arterio-Sclerosis,
Renal and Bilious Lithiasis, Headache, Gout, Gravel, Lumbago,
Sciatic Pains, Neuralgia and all uric acid troubles.”
“In fact, Urodonal is five times more active than piperazine, and
thirty-seven times more active than lithia. We are, therefore,
entitled to say that no other eliminator of uric acid can be
compared with it.”
“Being _37 times more active than lithia_, it clears the heart
valves of any sandy substances which may clog them, and checks the
atheromatous degeneration of the blood vessels.”
These extracts indicate sufficiently the extravagant tone of the
advertising (Rule 6): None of the ingredients are notably active in
dissolving uric acid when administered by mouth. None produce any
marked increase of uric acid elimination. No intelligent physician
would use a uric acid solvent for “bilious lithiasis”; and their
usefulness in the other conditions is open to doubt, to put it mildly.
Although the preparation is a simple mixture, the name does not
indicate the components, but inclines to therapeutic suggestion (Rule
8).
Nothing is to be gained by combining several drugs which are useless,
severally, for the purpose intended, as in the present case (Rule 10).
Urodonal is marketed under inconsistent statements of composition and
with exaggerated therapeutic claims; the name is nondescriptive and
the mixture is unscientific. The Council decided that the preparation
should be declared ineligible for conflict with Rules 1, 4, 6, 8 and 10
and that this report should be published.--(_From The Journal A. M. A.,
Aug. 14, 1915._)
FORMAMINT
Report of the Council on Pharmacy and Chemistry
The following report has been authorized for publication.
W. A. Puckner, Secretary.
Formamint is a proprietary medicine manufactured by the A. Wulfing
Company (New York, London and Berlin), which is affiliated with the
Bauer Chemical Company.
It has been widely advertised in Europe for several years, and is now
on the American market;[14] it is advertised in this country both in
newspapers and medical journals.
[14] The Journal A. M. A., Feb. 24, 1912, p. 572.
Following is a brief review of the more important alleged
investigations that have been reported from time to time in various
European journals.