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The Names of Radicals Individuals who complain that nonproprietary names are too long, especially if they are unfamiliar with chemistry, often quote examples such as demethylchlortetracycline hydrochloride, which, undeniably, is 13 syllables long. What this view neglects is that the last four of those syllables are accounted for by a part of the name that conveys indispensable information on the general nature of the drug and scarcely can be abbreviated. To drop them from the name cited would indicate the base form of the antibiotic, which has significantly different properties. Thus, in fairness to those who strug. gle with the difficulties of keeping names short, it must be said that the very nature of the articles being named often creates a 3- or 4-syllable handcap at the outset.

The problems posed by the names of the radicals commonly used in drugs have assumed proportions that can no longer be ignored. Quite commendably, our organic chemists are ranging farther and farther in successful efforts to overcome disadvantages in valuable drugs, such as insolubility in water, by such means as attaching a large, watersoluble radical to the parent molecule. Thus, hydrocortisone sodium succinate is a water-soluble form of the insoluble hydrocortisone, and its water solubility facilitates the preparation of sterile solutions for intravenous injections, an obvious advantage. Other derivatives of hydrocortisone include the simple acetate; tertiary butyl acetate; trimethyl acetate; dimethylamino acetate; and cyclopentylpropionate. But it will be observed that the last-named radical adds eight syllables to an already fairly long name. Prednisolone, the closely related steroid, is available in almost as large an array of derivatives.

The general problem of nomenclature involved here will be met only by setting up abbreviations for the chemical names of the radicals in common lise. Probing steps in this direction have been taken. Years ago the word “musonate” (still 3 syllables!) was coined for methanesulfonate, but it never caught on, possibly because there was no comparable abbreviation for the more commonly used ethanesulfonate. Recently, the British-Approved Name, erythromycin estolate, was coined by the British Pharmacopoeia Commission for the form of the antibiotic distributed first in the United States under the nonproprietary name propionyl erythromycin ester lauryl sulfate. The latter name will be replaced here by the shorter name erythromycin estolate as soon as present stocks of labels are used

an international effort is illustrated by the discrepancy that exists between the United States and Great Britain in the abbreviations chosen in naming the anthelmintic known here as pyrvinium pamoate and in Great Britain as pyrvinium embonate. Inasmuch as it is a salt formed from 2,2-dihydroxy-1,1'dinaphthylmethane-3,3'dicarboxylic acid, which is known also as embonic acid, the weight of evidence favors the British Approved Name. Yet to change now from “pamoate” to “embonate” here is bound to be confusing.

Physicians today need not be greatly concerned over the intimate chemical nature of every compound they use; and whether it is a hydrochloride, methylsulfate, or cyclopentylpropionate matters little just so they know what to expect of it and how to use it most effectively. This suggests that purely functional terms might distinguish the different forms of drugs. Thus, those forms of hydrocortisone intended for oral administration might be designated simply as hydrocortisone tablets or capsules or oral suspension, according to the physical form of the preparation and regardless of the exact chemical nature of the active ingredient.

Actually, a precedent for this approach exists in the case of erythromycin. The U.S.P. definition of Erythromycin Tablets reads, “Erythromycin Tablets contain ... the labeled amount of erythromycin or erythromycin stearate, or other suitable salt or ester of erythromycin recognized in this Pharmacopeia.” Similar definitions are given for both the injectable and oral liquid forms. What is needed to make this kind of definition complete is some sort of generic designation (using the adjective in its true sense) to permit distinction, where such exists, of forms of the drug which act more promptly or more slowly than others. This is exemplified in naming the two modified forms of crystalline zinc insulin suspension, which are distributed under the trademarks "Semi-lente” and “Ultra-lente" insulin. The respective nonproprietary names recently adopted by the AMA Council on Drugs are "insulin zinc suspension prompt” and “insulin zinc suspension de. layed.” Unfortunately, these differ from the corresponding British Approved Names (which are used in the British Pharmacopoeia), “insulin zinc suspension (amorphous)" and "insulin zinc suspension (crystalline),” respectively. The Council's selection of names having functional significance in terms of their duration of action reflected the view that the British names really mean so little that the risk of serious confusion is great even to diabetics, who, as a group, are sufficiently well-disciplined to be permitted to buy insulin without prescriptions.

The Core of the Problem One who has contributed constructively to the voluminous literature on drug nomenclature is Charles O. Wilson, Dean of the School of Pharmacy, Oregon State College, and co-author of the

up.

It is time for an effort, preferably at the international level, not only to select abbreviations for radicals already in use, but also to set up patterns for those that may be encountered in the future with reasonable frequency. The need to make this

vey needed information to the very person who requires it most, i.e., the physician who is to prescribe the drug. It is not unfair to say that few physicians are sufficiently conversant with organic chemistry to be able to recognize a compound by its chemical name. Indeed, this may be said also of most pharmacists and pharmacologists who deal with today's drugs. Therefore, it would appear that the terms of the Federal Food, Drug, and Cosmetic Act are less specific and direct in this connection than might be desired, but this deficiency can be overcome by promulgation of regulations without amending the law.

A Proposal for Improvement Two procedural changes would go far toward answering the complaints that are voiced against the prevailing system. The first of these would call Some Prefixos Used with Laboratory Code Numbers for

Experimental Compounds

annual American Drug Index.“ In an article that appeared in 1959' and in testimony before the Senate Subcommittee on Antitrust and Monopoly in 1960, he examined the basis for complaints against present pharmaceutical nomenclature practices. The basic difficulty, he noted, is inconsistency, which is attributable to poor choices of names, seemingly less by accident than by design, and to a lack of authority (1) to require the selection and use of a nonproprietary name for every drug entity and (2) to prohibit the selection and use of more than one name for any single compound. He noted that long chemical names, which were next to meaningless to physicians, were used on labels for long periods after a drug's introduction on the market. Among the examples he cited was methylbromtropinmandelate being used for U.S.P. Homa. tropine Methylbromide. He deplored the lack of authority on the part of any agency, including the American Medical Association, the U.S. Pharmacopeia, and the Food and Drug Administration, to exercise much influence on the selection of suitable names or on the use of such names once they are available. He reported that nothing prevents the selection of more than one nonproprietary name for a given compound, and he listed a great many examples of multiple naming taken from labeling and from the literature. Dean Wilson's proposal for corrective action was to grant the Food and Drug Administration the needed authority to deal effectively with the problem. The view that this is unnecessary is discussed in the following section.

One of the most serious obstacles to an orderly process of selecting nonproprietary names is the lack of uniformity in the manner in which individual pharmaceutical firms go about naming their products, especially in respect to timing. Some firms make a practice of selecting both the trademark and nonproprietary names prior to marketing the drug so that both names will appear in all medical articles and announcements on it. Most firms fol. lowing this policy have cooperated closely with the AMA Council on Drugs to the end that the Coun. cil's views on nomenclature are reflected in the names chosen. Other firms, seemingly exhausted by the effort of creating and developing the drug, including the search for a "catchy“ trademark, put off choosing a nonproprietary name.

The Federal statute permits the use of chemical names for drugs where no other name may be regarded as “common or usual." In this respect, it seems that the law fails to take account of two important facts. First, the rules of chemical nomenclature are such that most complex drugs of today can be correctly represented by several chemical names, some of which may very well obscure the true nature of the compound. For example, ethyl alcohol may properly be called ethanol, hydroxyethane, methylcarbinol, or hydroxymethylmethane. Second, the use of the chemical name fails to con

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Bristol Labe • The autbor le tndebted to Mr. Donald Gholaton, editor of United Drugs and a inember or the Ubrary star of the sun institute for Netieel Hesea reh, for instalace in Bating sone *? difereat code Drefa that have come to Dla attention to meet nedteal pubiestici

for reaching an agreement within the pharmaceutical industry to use a system of code prefixes in identifying compounds during the period of laboratory and clinical trial. The second change would call for similar industry agreement to select nonproprietary names, in cooperation with the Council on Drugs, for all new drugs before their introduc tion on the market, preferably at the time that New Drug Applications are filed with the Food and Drug Administration.

There is nothing really new in either of these 2 proposals except the idea of achieving adoption on a nation-wide (and perhaps international) scale. Code prefixes are already used by a considerable number of companies. Indeed, it appears that exactly 57 varieties of them now appear in the American literature. The table lists some selected code prefixes, from which it will be evident that, for the most part, they are readily identified with the laboratory that uses them.

It will be noted that already one conflict has

appeared in that the same prefix has been used by two different laboratories. There is obviously a need for central registration and publication of a list of the prefixes in use from time to time. Some arbitration may possibly be needed to settle disputes over claims to a given prefix during the period of scrambling for especially desirable combinations of letters.

The obvious advantages of using code numbers with identifying prefixes are that the practice (1) meets the tests of convenience and specificity; (2) sets apart the drugs still under trial; (3) identifies experimental drugs with those responsible for them; (4) attributes credit to the firm or institution behind the drug in an unobjectionable manner; and (5) reserves nonproprietary names to drugs that actually come on the market.

As for the agency that might serve as a central registry, the American Medical Association should be mentioned first because it is already deeply involved in the problem of choosing nonproprietary names. Certainly the U.S. Patent Office should register the prefixes as a means of assuring their continued availability to the rightful parties. It should suffice simply to make known the lists of prefixes from time to time. Since all specific inquiries on the identity of a given compound should be directed to the firm concerned, the burden of keeping the list up to date should not be great. Actually, it is being done currently by the periodical, Unlisted Drugs.

The early selection of nonproprietary names has been practiced for years by those firms that have cooperated with the Council on Drugs of the American Medical Association. At present, the Council advises on the selection of drug names on a wholly voluntary basis. This was not always the case, for, while the acceptance seal program was in force, the AMA Council (on Pharmacy and Chemistry) had considerable influence over name choices inasmuch us the AMA seal could be withheld at least until the Council's wishes had been seriously considered. Inasmuch as advertising in the AMA periodicals

was restricted to articles having the. AMA seal, this seal was highly coveted and persuasion to the Council's viewpoint was less difficult. With the abandonment of the seal program, the Council was left only with such persuasive power as it could muster.

The degree of cooperation that the Council has obtained from the industry is a tribute to both parties and constitutes the strongest argument that no new federal legislation is needed. There seems to be every justification for looking upon the use of a single nonproprietary name for each active ingredient in the labeling of a drug preparation, including mixtures, as having a material bearing on the safety of the preparation. It follows that there is ample justification for requiring use of the Council-adopted nonproprietary name in every New Drug Application filed with the Food and Drug Administration. By the same token, the labeling and brochures on old drugs should follow the same rule. It should be apparent that surveillance over drug advertising, which is a function of the Federal Trade Commission, should include insistence that the only nonproprietary name to be used in advertising shall be the one that has common acceptance by the medical profession acting through the AMA Council on Drugs.

Finally, medical editors should lend the weight of their influence to the use of accepted nonproprietary names in approving articles for publication.

With full utilization of these measures, the problems of nonproprietary nomenclature for pharmaceutical preparations should reach their irreducible minimum. 46 Park Ave., New York 16.

References 1. Stecher, P. G.: Generic Names of Drugs, I Chem Educ 34:454-456 (Sept.) 1957.

2. Wilson, C. 0. Inconsistency in Pharmaceutical Names, Am J Hosp Pharm 16:433-440 (Sept.) 1959.

3. Wilson, C. O., and Jones, T. E.: American Drug Inder, Philadelphia, J. B. Lippincott Company, Publisher, 1961.

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EXHIBIT 6

REPORT ON A STUDY OF ADVERTISING AND THE AMERICAN

PHYSICIAN

PART I. THE ADVERTISERS' VIEWPOINT

AN OPINION SURVEY MADE FOR THE AMERICAN MEDICAL ASSOCIATION

BY BEN GAFFIN & ASSOCIATES, BOARD OF TRADE BUILDING, CHICAGO 4, ILLINOIS,

MARCH 6, 1953

FOREWORD

This report covers “The Advertisers' Viewpoint", the first part of the Study of Advertising and the American Physician, made by Ben Gaffin and Associates for the American Medical Association. The second part, “The Physicians' Viewpoint”, will be submitted in April, 1953.

In our proposal to Mr. Thomas Gardiner dated September 3, 1952, we defined the objectives of the study : "To uncover fundamental thinking of advertisers and physicians regarding basic advertising problems in general, and the peculiar problems of medical advertising in particular. This information will enable the American Medical Association, through its publication advertising, to better serve its readers and advertisers and by so doing, to increase its advertising revenue".

This first report on "The Advertisers' Viewpoint" is based upon extensive informal personal interviews with 92 executives of 78 representative companies. These companies, all interested in medical advertising, range from ethical drug manufacturers, medical equipment manufacturers, and their advertising agencies, to large consumer product manufacturers with only slight interest in medical fields, and large consumer-account advertising agencies. The firms represented are located in New York and Chicago, and the areas in between. A list of the companies and the individuals interviewed is contained in the appendix. These interviews were conducted between October 20th and December 12th, 1952.

We would like to include in this foreword what is probably an unnecessary word of caution. In reading over this report one will find a number of unflattering comments regarding the AMA, the Councils and the AMA space-selling methods. In context, these critical comments were aimed at AMA policies and practices as interpreted or misinterpreted by the advertisers, and not at any individuals in the AMA administration.

A number of the advertisers, as a matter of fact, stated specifically that the present AMA administrative, editorial, and advertising department personnel were the most cooperative and the most efficient that they had ever dealt with at the AMA. Almost universally, too, the fact that they were being invited to express their opinions and make suggestions in the survey was taken by the advertisers as an indication of the progressiveness and desire for improvement of advertiser relations of the current AMA personnel.

This report is divided into three parts: recommendations based on what the advertisers told us, the advertisers' attitudes toward their own problems, and the advertisers' views of how the AMA can sell more space in its publications. RECOMMENDATIONS

CONTENTS
Foreword.
Recommendations.
Findings
Part I. Problems Facing the Medical Manufacturer :

1. Purpose of Advertising.
2. Budgeting.
3. Selection of Advertising Channels.
4. Deciding For or Against Council Acceptance.

5. Selection of Specific Journal Media.
Part II. Advertisers' Views on How the AMA Can Sell More Space.

1. The AMA Should Change Its Attitude Toward Advertisers.
2. The AMA Should Improve the Councils and Sell the Value of the Seals.
3. The AMA Should Sell the Journal as a Medium.
4. The AMA Should Increase the Value of the Journal for Its Readers.

(a) Suggestions for technical or production changes.
(b) Editorial changes.

(c) Changes in advertising policy. Appendix : Companies and Individuals Interviewed.

The AMA has two strong motives for improving its relations with medical advertisers. The AMA is the logical agency to exercise leadership in medical advertising. This leadership will enable the AMA to raise the standards of inedical advertising and to help convert the $130 million now being spent each year on medical advertising from an annoyance to the average physician into a constructive source of useful information on new developments in the fields of drug and other medical products.

The second motive for improving its relations with medical advertisers is the possibility of increasing its advertising revenue by several million dollars per year.

The following recommendations, based on the comments and suggestions of advertisers, constitute a program for the AMA which will help to accomplish these objectives.

These recommendations are offered with the realization that the official nature of JAMA and the overall policies of the AMA involved may militate against their complete adoption as given. 1. Improve AMA-advertiser relations

The advertisers should be made to feel that the AMA personnel believe in the honesty of the advertisers, and that they feel that medical advertising has a worthwhile place in AMA publications.

The advertisers, in general, feel that the AMA, especially through the Councils, distrusts them and views them as potential crooks who would become actively unethical if not constantly watched.

This feeling of the advertisers may or may not have foundation. If it does, then the AMA should review its attitude and attempt to correct it.

In any case, whether true or not, this mutual feeling of distrust must be eliminated as the first step in improving AMA-advertiser relations. The basis for cooperation and for a really successful sales campaign on the part of JAMA must rest on the establishment in the minds of the advertisers of a feeling of mutual respect and a belief in the willingness of the AMA to go half-way in working out mutual understanding between the AMA and the advertisers.

The professional advertisers must be made to feel that their advertising is wanted by the AMA. At present, they have the feeling that the AMA looks on space-selling as a favor to the advertisers, and merely as a source of some additional revenue which it can very well do without. The fact that in 1952 the AMA derived $3,137,000 from advertising, most of it from JAMA, is an indication of the importance of advertising to the AMA.

The manufacturers of drugs and other medical supplies are no longer in the position where they have to bow down to the AMA. They can circumvent direct control of their advertising and products by the AMA by refraining from submitting products to the Councils and by channeling their advertising and promotion efforts through non-AMA journals or through detailing and direct mail. The fact that since 1948 advertising space in Medical Economics and Modern Medicine has increased 40% while AMA space sold has decreased 3% during the same period, is proof that advertisers are tending more toward non-AMA media.

The fact that the AMA gets as much advertising income as it does, the majority of advertisers state, is because of the unique position of JAMA, and in spite of the feeling toward the AMA, and the AMA's relatively ineffective space-selling methods.

The report will show that a number of advertisers question the need for getting Council Acceptance for the ordinary product, and question whether or not JAMA is well-read by physicians. It seems likely that more than a little of this feeling is an attempt to rationalize the advertisers' resentment at AMA aloofness."

The industry expresses a desire for working with the AMA in maintaining high standards in the medical field, rather than in working independently of it. It feels, however, that the AMA should give some concrete evidence of willingness to cooperate on the other side.

Good advertiser relations can be built if the AMA will make a systematic effort, thorugh editorials, through speeches, and through personal contact with manufacturers and their trade associations, to explain its point of view to the industry, and to attempt to understand the industry's problems and point of view.

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