The Pharmaceutical Industry and the Doctor
N Engl J Med 1961; 264:75-79January 12, 1961DOI: 10.1056/NEJM196101122640205
IN a movie filmed during World War II, the family of the patient after several telephone calls located a doctor who appeared to be in his late seventies. Laboriously, he climbed the stairs to the patient's room, greeted the patient, set his bag on the bedside table and fished from it a bottle from which he poured a couple of tablets into his hand. Then he swallowed the tablets! The laughter of the audience was a recognition that this was so unusual as to be ridiculous. For the doctor is not usually the recipient of drugs; he is the middleman. Not a middleman in the economic sense of participating in the profits but in the sense of a traffic policeman. Except for drugs of minor importance, drugs can get to the patient only by the order of the doctor. And, just as the traffic policeman must be aware that a factory two blocks away will erupt a thousand employees at 4 o'clock, so the doctor wants to know about the source of drugs that may be channeled to his patients. But here the analogy ends, because the doctor is interested in much more than the source, volume and route of the drugs. He must know their content, their effects upon patients and their potential toxicity. Furthermore, knowing his patients intimately as he does, he must also be concerned with costs.
Small wonder then that doctors have followed with interest the hearing on the manufacture and marketing of drugs before the Senate Subcommittee on Antitrust and Monopoly (the Kefauver Committee). Although some of the statements before the Committee and in the press have been strongly partisan, it is my belief that doctors must maintain a balanced point of view. The controversy is complicated because it affects matters as far apart as the American system of free enterprise and the plight of the desperately sick father of a large family who is unable to buy a drug he needs, and because the attitudes engendered range all the way from a cost accountant's estimate of the profits to be made on a new drug or of the behavior of a company's stock on the stock exchange, from an erudite study of the reactions of physicians to advertisements of drugs, or of the fall in mortality since the introduction of the antibiotics—all the way from these to a violent emotional defense of the drug industry's methods, or to an equally emotional plea for the plight of the aged patient who cannot afford to have the doctor's prescription filled. A complex problem is seldom solved by a single measure. For this reason, I should like to outline a series of steps that I believe, taken together, will help to resolve the difficulties that have arisen among patients, doctors and pharmaceutical manufacturers. The ideas expressed formed the substance of my testimony before the Kefauver Committee.
In general the criticisms directed toward the pharmaceutical manufacturers have fallen into two categories: prices of drugs are considered to be too high; and the high-pressure promotion of drugs is thought to be not only unnecessary and expensive but also actually harmful, in that it may induce the doctor to prescribe the wrong drug.
New drugs are a product of research, which is usually done in a university, in a research institute or in the laboratories of a pharmaceutical company. Continued research requires capital, and it must be recognized that there is a kernel of substance in the drug industry's claim that such capital can only come from profits. The drug industry has made and is making important contributions to research on drugs. If profits sufficient to continue or preferably to increase the present amount of industry's research were not forthcoming from the sale of drugs, the alternative would be for the federal Government to finance the research abandoned by the pharmaceutical industry. I am sure that all will agree that this would not be in the best interests of the country because research projects should not be initiated from a single source. Nor should I wish to see all the capital for research come from industry. The springs from which research arises must be jealously guarded so that all kinds of ideas are represented. It is too easy for the stream of research to dry up if its tributaries are limited.
How can one make sure that a proper share of profits will go into research and not into wasteful competition or into excessive dividends? Americans are interested in preserving the wholesome principle of competition that is inherent in their system, and at the same time they want to be certain that the companies will compete with the kinds of drugs and with methods that are beneficial to the public. At the present time, competition between pharmaceutical companies is wasteful because it is mostly in the wrong area. Competition today usually involves minor modifications, which are devised, produced and marketed at a frenetic pace. Examples abound: the various sulfonamide analogues; the antihistamines; the barbiturates; the various corticosteroids; and, more recently, the tranquilizers. In the field of the antibiotics, this kind of competition has produced the "battle of the blood levels" among the penicillin salts, among the tetracyclines and in the erythromycin-carbomycin-oleandomycin group.
Now, producing and marketing these modifications is not reprehensible or morally wrong. But the promotion of so many drugs that are essentially the same (and each drug may be marketed under several different trade names) is confusing to the physician, and the money spent on discovering, developing and promoting these drugs is largely wasted. This money could be better spent in a search for truly new drugs.
The original breakthroughs — the first sulfonamide, the first tranquilizer, the first barbiturate, penicillin G, chlortetracycline and erythromycin — were important and original contributions to science and to human welfare. The company making the original discovery was entitled to profits from that discovery, some of which it would be expected to plow back into research, which would, in turn, lead to more discoveries. But, as things are, to obtain enough profits to provide capital to go on with its work, a successful pharmaceutical company apparently has to divert its research facilities to make minor modifications in the original product to compete with other companies that had promptly started making minor modifications of the first company's discovery. Furthermore, each company has to step up its advertising campaign to compete with the others.
The company that makes an original breakthrough is entitled to have, and the public would be benefited if it did have, more protection by law against competition than is given under the present laws; a company that subsequently introduces the same drug or a minor modification of a drug should have less protection. I believe that the following series of proposals will bring this about. First of all, legislation should be enacted allowing only a single trademark (the so-called trade name) to be granted for a particular drug. This could be used by the discoverer and its licensees. Used in advertising, this trade name should enable them to garner the good will, and profits, that are the due reward of the original discoverer. If another company preferred not to purchase the right to use the trade name and devised an independent method of manufacturing the drug, it could market the drug under the nonproprietary name (the so-called generic name). This procedure would have the important advantage that the physician need remember only one trade name in connection with an official name, instead of several as is usually the case today. Furthermore, it would make the retail pharmacist's task easier and would reduce his overhead, because he would not have to stock so many brands of each drug. The reduction in overhead could be passed on to the consumer in the form of lower prices.
Two objections might be made to this: brands of the same drug made by different companies might differ in quality; and the physician could not specify a drug made by a particular company. Regarding the first of these, if drugs are not up to standard, they should not be on the market at all. The prevention of the use of substandard drugs should not have to depend upon the vigor of the advertising campaigns of the companies whose drugs are up to standard. But, more importantly, most practicing physicians are not in a position to judge for themselves the quality of the drugs prescribed. Clinical tests of new drugs are usually valid only when they are done in medical centers where large numbers of patients can be tested with a particular drug and laboratory facilities are available for careful studies. Therefore, the practicing physician is unable to associate a particular brand name with good or poor quality on the basis of his own experience.
The standards are stated definitely in the United States Pharmacopoeia and the National Formulary, which are the work of impartial organizations composed of members of the medical and pharmaceutical professions. The Federal Pure Food and Drug Acts recognize these standards, and the Food and Drug Administration is the agency designated to enforce them. But this agency struggles to attract personnel in the face of a low budget. Furthermore, demands upon it are increasing as the drug industry grows and as the number of new drugs increases. The status and salaries of the professional employees in the Food and Drug Administration should be raised to provide sufficient incentive for competent persons to enter and remain in this important branch of Government service, and more personnel should be provided for.
Some critics will say that there is already too much Government regulation. But all the facts show that the pharmaceutical industry is continuing to grow year by year, and the facilities for regulation must grow with the industry. An eight-year-old boy can umpire a baseball game among six-year-old boys, but it is best to have a grown man umpire a game among professionals. At the same time, one need not go too far: it should not be necessary to have twelve umpires for any baseball game.
Regarding the second objection, that a single trade name for each drug would not allow the physician to prescribe a particular company's product, the physician could still do this by prescribing the name of the drug followed by the name of the company, as erythromycin — Lilly, or erythromycin — Abbott; tetracycline — Lederle; tetracycline — Bristol, or tetracycline — Pfizer. If he believed that one company generally made superior products, he could prescribe its products consistently, and he could do this more easily than in the present system under which he has to remember the trade name of each drug to prescribe a particular company's products.
The objection may also be raised by persons critical of industry that the limiting of trade names would give one company greater monopoly than any company now has. How can one be sure, these critics would say, that the profits will be plowed back into research and not converted into excessive dividends? In the first place, I should expect that, under the legislation I am proposing, the competition for the discovery of genuinely new drugs would be as intense as it is now for the discovery of modifications of drugs. Secondly, I believe that the profits made under the protection afforded by the proposed legislation should be used for the purpose of discovering new drugs and not for marketing the drug. To this end I propose that the discoverer be required to license the drug to other companies. As stated before, these companies would not have to purchase the right to use the trade-marked name, nor could they be granted another trade name for the same drug; they would be free to market the drug under the nonproprietary name.
The use of a single trade name for each drug will not ease the incentive for minor modifications of drugs. To make such modifications less profitable, the patent laws should be made more strict so that the developer of the analogue would not receive a patent until he had proved that the new drug served an important purpose not served by the previous one, or was clearly less toxic than its predecessor.
Furthermore, more information regarding the individual merits and demerits of the originally introduced drug and its analogues should be brought to the physician so that he could properly judge whether to change to the new one or continue to prescribe the old. Since this involves the transmission of information about new drugs to the practicing physician, I should like to turn now to that subject.
For each new drug, there are three tasks: to obtain all the facts that one can; to clear the channels of false and misleading information; and to widen the channels for transmitting the proper information.
After a drug is discovered and tested in animals the present laws require that it be tried in human beings before it can be sold. Clinical testing must be done by physicians who have had special experience in the testing of drugs and in the kinds of illnesses for which the particular drug is supposed to be effective. Unfortunately, there are not enough trained physicians available to do this, and those who are competent are attracted instead into more basic research because of its greater prestige and because adequate funds are available for such research. Drug manufacturers contribute funds toward clinical testing, but many people believe that they do not pay their full share of the costs. Greater contributions from industry, placed on a more solid basis so that they could be counted on over a period of years, would do much to raise the prestige of testing drugs and to encourage competent physicians to participate in this important job. Many hospitals, for instance, have large numbers of patients and inadequate staffs to care for them. Funds made available by pharmaceutical firms to such hospitals to set up laboratories and wards for the testing of drugs would increase facilities for drug testing and, at the same time, improve the care of their patients.
Furthermore, as an aid to the clinical testing of drugs, the Food and Drug Administration should have funds at its disposal to finance the testing of a drug by an independent agency (which would usually be a medical school or hospital) in cases in which the Administration was not satisfied with the evidence submitted by the manufacturer of the drug. Furthermore, it should have a council of leading scientists, who would advise it regarding over-all policies, and panels of experts in various areas, who could be called upon to render an opinion regarding a certain drug or class of drugs. These councils and panels not only would give expert advice but also would present an unbiased point of view to the personnel of the Food and Drug Administration, who often hear the point of view of industry alone.
If facilities and funds were made available, from industry and from the Government, for more adequate testing of drugs, physicians would be attracted into the area, and young men would be trained in the concepts and methods of drug testing. They need not fear that this will be a blind alley. When investigators are alert and interested and the spirit of inquiry prevails, practical studies of this kind can lead into fundamental research just as easily as fundamental research can lead to practical results.
Dissemination of Results
After getting more and better information about new drugs, how can one clear false and misleading information from the channels of dissemination to physicians? It has been said that a majority of practicing physicians obtain their first information about a new drug from a detail man. This is neither necessary nor desirable. Speed is not an important object in most cases, since most drugs that are newly marketed do not really represent something new. When a drug is really new, information about it spreads with rapidity in medical meetings, through articles in medical journals and by word of mouth among physicians. Furthermore, the principles upon which the use of a truly new drug is based and the methods of using it are both likely to be so different from those relating to previously used drugs that the practicing physician should get a thorough knowledge of the drug from a competent authority when he first hears about it. Detail men are valuable for the purpose of getting information to physicians and pharmacists regarding the availability, packaging and prices of products distributed by their companies. Being salesmen, they cannot be expected to give unprejudiced advice. Not being physicians, they cannot instruct physicians regarding the principles upon which the use of a new drug is based.
One especial source of confusion for the practicing physician is the printed advertising as it comes to him by direct mail or in medical journals. In the present era, when truly new drugs are appearing with rapidity and causing revolutionary changes in the practice of medicine, the physician needs facts most of all. Because misinformation and mistakes about drugs can affect health and life, advertising of drugs cannot be allowed to fall to the level of other advertising. Advertising of drugs should be informative. Above all, it should not be misleading. Misleading advertising by one company not only causes the doctors to make mistakes; it also affects other pharmaceutical companies adversely because it destroys the confidence of the physician in the industry as a whole and because competitive advertisements may tempt another company to make its own advertising a little more blatant, a little more suggestive than it would otherwise be, thus making this competing company's advertising misleading also.
I should like to make certain positive suggestions for clearing the channels of misinformation and getting worth-while information to the doctor. First of all, the Food and Drug Administration should be empowered to examine the efficacy as well as the toxic effects of all new drugs. It should be obvious to everyone that insufficient knowledge on the part of doctors regarding the efficacy of a drug can harm the patient just as much as a toxic action of the drug. With the exception of insulin and some antibiotics that are certified, the Food and Drug Administration does not at present have the power to pass upon the efficacy of a new drug, whereas it is instructed by law to pass upon the toxicity of all new drugs. Secondly, nonproprietary names should be emphasized more than they are at present. The nonproprietary name is usually a shortened version of the chemical name and, therefore, has an intrinsic meaning that the proprietary name usually does not have. Furthermore, the nonproprietary names of analogues are usually similar, thus helping the physician to classify the drug in its proper group. The use of the nonproprietary name is educational as well as regulatory in its function. The physician would thus be put on the alert to determine whether a new modification of an existing drug were superior to, the same as, or even inferior to the drug already on the market. He would be less likely to switch to the newest drug in his prescribing, unless the newest drug represented a real advance.
It is true that many of the nonproprietary names are long and difficult to pronounce (and thus hard to remember). In this country, at present, these names represent a compromise between the wishes of the manufacturer of the drug and the Council on Drugs of the American Medical Association. They have no official status until they are published in the next edition of the United States Pharmacopoeia or the National Formulary. By that time the name has usually become so well established that it is difficult to change it. But the Council on Drugs and the Committee on Revision of the Pharmacopeia are at present considering ways of co-operating in naming drugs. One of the by-products of such co-operation should be simpler names.
One more point: nonproprietary names are international. The Council on Drugs of the American Medical Association transmits proposed names for new drugs to the World Health Organization and to foreign pharmacopeias. When the final decision on the nonproprietary name is made the name is almost always alike for all countries. On the contrary, trade names for the same drug are usually different in different countries. In these days, when medicine transcends national boundaries and when doctors are increasingly reading journals published abroad and attending international meetings, ready knowledge of the nonproprietary names is an added aid to understanding, and attempts to identify drugs by their various proprietary names result only in confusion.
The present Food and Drug Laws provide that the common or usual name of a drug should be given equal prominence with that of the trade-mark. The Food and Drug Administration has not interpreted this to mean that the nonproprietary name should appear in the same size type as the trade name. I believe that the same size of type should be required for both names in the label and the circular accompanying the package as well as in advertising that is mailed to the physician. This simple measure would help educate the physician in the proper names of the drugs he uses and could pave the way for editors to establish the same requirements in advertisements in medical journals.
The information in the circular that has been passed upon by the Food and Drug Administration should be the basis of all advertisements. In fact, leading companies in the pharmaceutical industry could perform a great public service by utilizing the information they have gathered in the course of their investigations on a drug to develop genuinely factual advertisements. These would be bound to elicit praise from physicians. Furthermore, they would stimulate other companies to abandon the suggestive type of advertising that now prevails.
I believe that everyone involved — the pharmaceutical manufacturing industry, the medical and dental professions, editors of journals, retail druggists and others directly concerned — should get together and agree upon a code of ethics to be used in all advertising. Failing this, I see no alternative to more explicit federal laws governing advertising of drugs to the medical profession and more power to control such advertising in the public interest on the part of the regulatory agencies. This would be difficult and expensive; I hope that it would not be necessary.
These recommendations have been made not with the thought that they are necessarily the best answer to the problem, but with the hope that they will stimulate thoughtful persons in the medical profession, in the pharmaceutical industry and elsewhere to think about the subject and come up with their own suggestions for improvement. I am convinced that when they think seriously about the problem, they will find that no single measure will bring a solution and that an important change would require a series of interlocking modifications until a new equilibrium was reached. It is for this reason that I have made a series of proposals, which are expected to act upon each other.
Two major recommendations are made: the intense competition that prevails in the drug industry should be shifted from the present focus upon slight modifications of existing drugs to the discovery of truly new drugs; and bringing information about new drugs to physicians requires getting more and better information by better clinical testing, clearing the channels of misleading information and widening the channels so as to bring more accurate information to the practicing physician. To accomplish these objectives the following suggestions are offered:
A single trade-mark should be allotted to a drug.
Holders of the patent on a drug should be required to license others to manufacture and distribute it for a reasonable royalty.
The patent laws regarding drugs should be made more stringent, so that the superiority of a new drug over drugs already patented would have to be proved before a new patent was issued.
The Food and Drug Administration should be empowered to determine the efficacy as well as the toxicity of drugs.
A council and panel of experts should be set up to advise the Food and Drug Administration.
Appropriations to the Food and Drug Administration should be increased for the above purposes and also to provide for better control of the standards of quality of drugs and contracts for the independent testing of drugs by outside agencies.
If advertising of drugs is not brought under better control by the pharmaceutical manufacturers in co-operation with the medical and dental professions and pharmacists, legislation should be enacted for stricter federal control of the advertising of drugs.
In addition, I suggest to the pharmaceutical and medical professions that the channels for transmitting information on drugs to practicing physicians be cleared and widened by improving facilities for and the prestige of the clinical testing of drugs, establishing and adhering to a code of ethics on advertising of drugs and educating physicians more thoroughly regarding the nonproprietary names, analogues, uses and toxic effects of drugs.
*From the Department of Medicine, Research and Educational Hospitals, and the University of Illinois College of Medicine.
†Professor of medicine and head, Department of Medicine, University of Illinois College of Medicine; chief of medicine, Research and Educational Hospitals.
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