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: