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EXHIBIT 26

(From New England Journal of Medicine, July 7, 1960

SPECIAL ARTICLE

DRUG TERMINOLOGY AND THE URGENT NEED FOR REFORM⭑

THE nomenclature of drugs has long created con

fusion in medicine, in addition to which some of the least glamorous events in medical history are associated with efforts to obtain excessive prices from the use of misleading or special terms for medicinal products. The futile efforts of Dr. William G. Morton to confuse his colleagues and the public regarding the true nature of his sleep-producing agent when he selected the term "letheon" for ether is a historic example of the use of a special terminology to protect the interests of the individual.'

Although nearly all scientifically trained persons are more or less motivated by the ideal of contributing to the welfare of mankind and many have worked for the betterment of the human race without thought of financial reward, others have been impressed by the profits that may be drawn from industry. Furthermore, the protection afforded by patent and copyright laws has encouraged enterprising individuals and companies to develop new drugs for financial reward. The profits of industry not only have represented personal economic gain to the producer but also have made available additional means for improving scientific effort, unquestionably a trend that has led to the more rapid development of new medicinal agents Accompanying the trend is an increasing pressure to protect, extend and encourage its development, which has unfortunately led at times to situations where the practices developed have been of questionable merit for those using the products of the industry. An un

•Prepared by the Journal's Committee on Advertising

fortunate part of the picture is the deliberate confusion engendered by the current system of naming pharmaceutical products.

At present every drug has at least three names. and certain ones have as many as a dozen. Thus, every chemical compound is assigned a chemical-scientific name at the time of its creation. If the product is medicinally useful and is put on the market, the manufacturing firm patents the drug for its own protection and assigns a trade name, which is copyrighted, thus affording further protection. Finally. the producer, in collaboration with the Federal Food and Drug Administration and the Council on Drugs of the American Medical Association, assigns a generic name, which may be used by any interested party.

The chemical name specifically identifies the compound and is useful to a few technically trained persons. These names are, for the most part, straightforward and make scientific sense. There is, however, need for still better standardization. The great and growing interest in new chemical compounds has exposed a much wider audience to the vagaries of chemical terminology, and many persons not intiinately working in the field find surprising, and at times erratic, developments in the naming of products, which can be most confusing. The efforts of certain nonchemical, scientific journals to educate much wider audiences in chemical terminology should be encouraged. for they give pharmacologists and physicians a chance to obtain a far better understanding of what the chemists are doing and why the drugs they are working with have certain designations."

Trade names are copyrighted terms selected by manufacturers to designate their particular products and serve as important symbols in establishing the drug in the minds of the physician and the public. Since copyright laws prohibit anyone else from employing the term and since other laws prevent pharmacists or any other persons from substituting other, although perhaps chemically identical, drugs for the trade-named article, the manufacturer enjoys a high degree of protection.

The drug manufacturer claims certain advantages for the use of trade names in addition to their protection of his interest in a drug. They ensure that the physician and ultimately his patient will get the drug so designated by the manufacturer. Since the trade-name drug is an index of his reliability, the reputable manufacturer does his best to ensure that his product is the best he can make it. His standards, indeed, may be even higher than those established by semiofficial bodies such as the United States Pharmacopoeia.

Much effort is put into making most trade-named products pharmaceutically fine and esthetically elegant, factors that are often overlooked by those opposed to the trade-name practice. These factors, however, can be important and at times may contribute very materially to the value of the drug. As an illustration of this point one need go no farther than the widely used acetylsalicylic acid, more commonly known as aspirin. Here is a highly useful drug that has been recently under considerable controversy in both scientific and trade journals. Some authors claim that acetylsalicylic acid is irritating to the stomach and produces mild to severe gastritis with slight to rather severe gastric hemorrhage unless taken with buffering materials, and others deny such an action. Since both groups are composed of capable investigators a perplexing situation existed until a careful study showed why both parties were correct in their findings. They found that the results of investigators were predicated on the kind of tablet selected for the study. If the drug prepared by certain manufacturers happened to be selected it caused gastric irritation and hemorrhage, but if the tablet used was prepared by other manufacturers there was little or no irritation or hemorrhage. It was found that if the tablet quickly disintegrated in the stomach and released very fine, rapidly dispersed particles, thus avoiding clumps of the chemical, no irritation resulted and no buffering was needed. If, on the other hand, tablets were made by poor procedures, with large particles and poor disintegration so that clumps formed, irritation almost invariably resulted.'

The added protection afforded by the trade name encourages manufacturers to develop new drugs and thus may be a boon not only to the pharmaceutical industry but to the public as well. Unquestionably, however, trade-name protection is for the most part

a device to protect the interests of a manufacturer. and it presumably increases the cost of drugs to the

consumer.

Most trade names are carefully selected to avoid confusion in terminology, being at the same time acceptable to the eye and ear. Furthermore, many are designed to have a mnemonic connotation or to appear to represent scientific terminology, with the hope that they will be easy to remember and simple to write.

There are, however, distinct disadvantages to the physician, pharmacist and others engaged in the use of drugs in the employment of trade names. The trade name is not official and is often belittling to the intelligence of anyone with scientific training, as well as being frequently a plain nuisance, leading to multiple names for one chemical entity. Thus, there are a dozen trade names for reserpine, six for isoniazid and so on through a long list of agents, a practice that is confusing and has no merit other than to increase the profits of the manufacturer, who often has made no scientific effort and taken no risk in the development of the product.

As an answer to these well founded criticisms, many persons believe that a really effective system of generic terminology might be at least a partial solution. Generic names can be anyone's property and, if properly developed and utilized, could clear up much confusion. As they are handled at present, however, they often leave much to be desired. Although some terms are excellent others are too complex and confusing; they have been developed after the trade name is firmly established and at times border on the ridiculous as far as auditory, visual and mnemonic considerations are concerned.

The well selected generic name, if put to wide use by the profession, would end much of the confusion and duplication and the need for learning several trade names for the same item. (At present each producer would prefer that his name only be learned.)

A present disadvantage in the use of generic names is that many of the more recent ones have been cumbersome, confusing and so difficult to remember as to make them almost useless. This can be corrected. Another is that their use gives to the pharmacist the decision regarding the brand that will be given to the patient. For most products this is usually satisfactory, but there are exceptions, such as the case of acetylsalicylic acid, mentioned above.

Unscrupulous manufacturers would benefit from the widespread use of generic terminology as established at present, and the Food and Drug Administration with its limited facilities might find it impossible to check all drugs put on the market by such manufacturers. Nevertheless, if generic terminology is made sensible and uniform it is by all odds the terminology of choice. The following suggestions are therefore proposed:

The generic term must be selected and made available for every new drug before it is put on the market. This should be a requirement of the Food and Drug Administration. Generic names should be selected by a National Advisory Committee appointed by the Food and Drug Administration. This committee should consist of experts in medicine, pharmacy, psychology and marketing. The terms must be brief and designed with regard for their dignity, visual and oral reception and mnemonic connotations. Certainly, such an expert committee could design much better generic terminology than is at present available.

Once the generic term is selected and adopted it must represent the highest standards available for that product. These standards must encompass the best technical, chemical and pharmaceutical procedures in manufacturing as well as the highest content of active drug and lowest content of impurities possible. In other words the standards established for generic-named products must be every bit as high as that of the highest-type ethical manufacturer with the best technical facilities. Once this is done the physician can be certain of the drug his patient will receive.

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The medical profession should engage in a campaign to urge physicians to give generic names prominence in all medical writing, advertising and usage. Medical-journal editors should join in this campaign and see to it that generic terminology is the terminology of choice in advertising.

A monthly glossary of generic names and the standards that they represent should be published in leading medical journals and perhaps sent to physicians by the Food and Drug Administration.

Finally, many medical authorities agree that inclusion of the manufacturer's name after the generic name would in the end give him equal protection and even more favorable recognition than the present undesirable trade-name practice. For the belief is growing that a manufacturer's reputation and good will are associated rather with his company name than with fanciful copyrighted and generally inane neologisms.

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3. Levy, G., and Hayes, B. A. Physicochemical basis of buffered acetylsalicylic acid controversy. New Eng. J. Med. 262: 1053-1058,

1960.

EXHIBIT 27

(From J.A.M.A., February 12, 1955)

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During these days of proposed revision, increasing enforcements by administrative bodies and other restrictions which seem to be a sign of the times, it is refreshing to observe how a body with no legal power can create changes with far reaching effects. In the past thirty-nine years there has been no single body which has created as much change in the practice of therapeutics as has the Council on Pharmacy and Chemistry. The Council was organized in 1905 to serve the medical profession and the public by providing accurate information on the status of agents used in the treatment of disease. Since that time its activities have grown, and as it enters its fortieth year in 1944 the members can look back with satisfaction on the service that has been provided. Even though the Council is an integral part of the American medical profession, many members profess confusion regarding Council makeup and activities. It is to dispel some of this confusion that this paper is offered.

MEMBERSHIP

The Council consists of seventeen outstanding scientists, each associated with some recognized medical center, and a Secretary who is a full time employee of the American Medical Association with an office in Chicago. The members are David P. Barr, professor of medicine, Cornell University Medical College; J. Howard Brown, associate professor of bacteriology, Johns Hopkins University School of Medicine; S. W. Clausen, professor of pediatrics, University of Rochester School of Medicine and Dentistry; Harold N. Cole, clinical professor of dermatology and syphilology, Western Reserve University School of Medicine; Morris Fishbein, Editor of THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION; E. M. K. Geiling. professor of pharmacology, University of Chicago School of Medicine; Robert P. Herwick, chief, Drug Division, U. S. Food and Drug Administration; Chester S. Keefer, Wade professor of medicine, Boston University School of Medicine; Eugene M. Landis, professor of physiology, Harvard Medical School; James P. Leake, medical director, Epidemiological Section, National Institute of Health; George W. McCoy, professor of preventive medicine and public health, Louisiana State University School of Medicine; Perrin H. Long, professor of preventive medicine, Johns Hopkins University School of Medicine; Stuart Mudd, professor of bacteriology, University of Pennsylvania School of Medicine; E. M. Nelson, chief, Vitamin Division, U. S. Food and Drug Administration: W. W. Palmer, Bard professor of medicine, Columbia University College of Physicians and Surgeons; Elmer L. Sevringhaus, professor of medicine, University of Wis

consin Medical School, and Torald Sollmann, professor of pharmacology and dean, Western Reserve University School of Medicine. Many others will be remembered for their long association with Council activities and scientific contributions. Since the Council's organization on Feb. 11, 1905 there have been appointed sixty members. The average tenure of membership has been eleven years.

The members of the Council serve without remuneration but freely give a large amount of their time and effort to the Council's work. This work cannot be estimated purely in terms of hours per week, as every afternoon or evening sacrificed by a Council member for consideration of some Council problem means the loss of that time for some other urgent problem which may relate to his family or the institution with which he is connected,

The Council on Pharmacy and Chemistry has served as a model for the Council on Physical Therapy and the Council on Foods and Nutrition of the American Medical Association and for the Council on Dental Therapeutics of the American Dental Association. There is at the moment no successful counterpart outside the United States, although representatives from several countries recently have visited the Council office to learn the details of Council functioning so that similar bodies can be established in these other countries when the time seems propitious.

ACTIVITIES

In addition to considering proprietary drugs the Council reviews the status of other agents which the medical profession, and even the public, may be urged to use, publishes reports on claimed advances in the use of medicinal preparations, with the Chemical Laboratory elaborates standards on drugs introduced into materia medica, provides information for physicians, members of the armed forces and others, sponsors the publication of several books and numerous research projects, and maintains a cooperative relationship with many governmental and nonofficial organizations. Its information and advice are frequently sought; it is often invited to participate in cooperative projects with other agencies. It does not hesitate to initiate an investigation when a grievous error occurs in the manufacturing and dispensing of drugs; a few such instances are well known to all. The Council also maintains cooperative relationships with many countries other than the United States, and much correspondence is exchanged on problems of

mutual interest.

The publications sponsored by the Council include New and Nonofficial Remedies, Useful Drugs, Epitome of the U. S. Pharmacopeia and National Formulary, Annual Reprint of the Reports of the Council, and Glandular Physiology and Therapy. It also supervises the preparation of the Intern's Manual. By the end of 1943 well over 400,000 copies of Council publications had been distributed over the last twenty year period. Of this number New and Nonofficial Remedies comprised about 260,000 copies.

The Council has assumed ever increasing importance in the field of medicine until now it is truly considered one of the leading authorities on rational therapeutics. There are few who are not familiar with the Council's seal, and yet there are many who have only the vaguest conception of how this seal is issued.

PROCEDURE FOR ACCEPTANCE

The use of the seal is restricted to those products which have been found acceptable for inclusion in New and Nonofficial Remedies, a yearly publication of the Council. The Council considers articles for listing in this book according to a set of rules which permit consistent and fair application for all firms and their products. The rules essentially provide that an accurate statement of composition must be provided; suitable tests must be available for identification; the article cannot be advertised either directly or indirectly to the public unless it is one of those agents information on which the Council feels may be made available to the public (for example, first aid measures, laxatives, vitamins); statements regarding origin and source of raw material must not be misleading; therapeutic claims shall not be exaggerated or misleading; the label must list the active substances; the name under which

the product is sold shall not be misleading or suggestive of diseases or therapeutic indications; patent numbers and trademarks, if any, must be furnished, and the preparation must not be unscientific.

Obviously it is the right and duty of the physician to know the essential composition of the drugs he prescribes. He also wishes to know if the mixtures are unnecessarily complex, being mindful of the fallacy of prescribing unnecessary potent agents and prescribing routinely several drugs of different actions in fixed proportions in one preparation. The physician also is justified in demanding that the claims offered on behalf of a product which he is urged to use should be in line with demonstrable facts. The value of such rules is self evident. When the Council insists that manufacturers keep their advertising material within the limits prescribed by Council rules, it serves to protect the public and the physician.

Some manufacturers more interested in self gain than in the welfare of the public or the physician formerly used the doctor as a means of promoting their medicine to the public. The technic was simple: Promoters were convinced that the easiest way to establish a demand for their goods on the part of the public was to make available a catchy name, especially if it was suggestive of a disease or treatment, and advertising material which could be read by the curious patient and

his friends and relatives. The late Dr. Simmons referred

on more than one occasion to an article on proprietary medicines which was published in an advertising journal; this read in part "But the patent medicine of the future is the one that will be advertised only to doctors. Some of the most profitable remedies of the present time are of this class. They are called proprietary medicines. The general public never hears of them through the daily press, for their publicity is secured through the medical press by means of the manufacturer's literature." This statement appeared in print almost forty years ago, and yet it is still admirably descriptive of some present day promotional practices.

PROPRIETARY NAMES

The profits to be made by a pharmaceutical house (from the sale of a drug which is offered under an official name usually is quite moderate. The profits to be made from the sale of the same drug sold under a proprietary name is frequently enormous. For example, a survey in the September 1941 issue of a popular price list of drugs revealed that the total cost of an ounce of each of nineteen substances under a protective name was $48.67, whereas the total cost of an ounce of each

of these substances under a nonprotected name was $15.67; thus, the cost of a proprietary name to the consumer would be $33. This represents retail price, the material being reduced to terms of ounces for convenience. Included in these nineteen agents were sedatives, vasoconstrictors, local anesthetics, anti-infective agents and analgesics. Some years ago a large hospital in an eastern city adopted a set of specific regulations which, in effect, did away with the expense of prescribing proprietary agents when official counterparts were available, and unnecessarily complex mixtures and the absurd practice of prescribing names instead of therapeutically active agents. This pharmacy within one year effected a saving of $50,000. Thus the manufacturer frequently considers it of prime importance that his product be endowed with his own protective

name.

With the desire of encouraging the introduction of drugs that are an advance over those previously known, the Council does not offer objection to the application of a proprietary, exclusive name, provided the drug to which it is applied really presents something new. Thus the Council recognizes such names for products not previously known, for substances previously known but not used in medicine, for unique and worth while variations for making this drug available, and when a known substance is found to have new value, even if that substance was used in the practice of therapeutics at an earlier date. Obviously the new value has to be worth while. If a manufacturer will read the Council rules, he will know if his new product merits recognition under a proprietary name and if the chosen name is acceptable. However, he frequently spends several years promoting the agent without regard for the rules and then feels offended if the Council will not accept the agent under the proprietary name. How simple it would be if the manufacturer would place the name before the Council when the product is ready for the market (and even before it is ready for the market) and ask the Council to consider its acceptability in the event the product is submitted to the Council for inclusion in N. N. R. If any changes are necessary they can be made easily at the time of this preliminary consideration with no inconvenience or expense for the manufacturer. The present trend is to do this.

One of the greatest evils of the use of protected names lies in the confusion they create. The old story of methenamine being prescribed in one prescription under six different names is a standing joke in materia medica classes, and yet other examples just as questionable are evident in everyday practice. In the United States the practice among the better pharmaceutical drug manufacturers seems to be decreasing, partly because these organizations are acquiring critical medical and other technical personnel and partly because experience shows a certain amount of resentment on the part of the medical profession; there is a greater tendency to reserve proprietary and protected names for specialties of the house rather than for official agents. However, there is still room for much improvement.

It is interesting to observe the nomenclature situation in an allied country, England. There, sulfanilamide is offered under fifty odd names, including Antistrept, Astreptine, Bacterimide, Bactericide, Cepticide, Erysipitan, F1162, PABS, Septinal, Strepamide, Streptamide, Streptosal and Therapol. Can any one hope to memorize fifty such names, none of them chemically descriptive, for one agent? Sulfapytidine is sold or prescribed under nine different names, sulfathiazole

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