of every sales dollar is expended for promotion, or roughly four times the amount spent on research. That promotional expenditures have reached such proportions in this industry is particularly surprising in view of the fact that the most expensive media normally used for advertising-television, newspapers, and magazines are not employed in the regular course of prescription-drug advertising. In this industry there is a separation of the buyer from the orderer. The former, namely the patient, pays the bill but the latter, the physician, places the order. And it is therefore to the physician that this vast expenditure of advertising resources is directed. Three principal media are used: visits by salesmen, known in this industry as detail men; advertisements in medical journals; and direct-mail advertisements sent to the physician's office.

So important is the first of these media that from 1 out of 5 to 1 out of 8 of all employees of major drug companies is a detail man. So much money is spent in sending advertising literature to the physician's office that he is literally inundated. According to the testimony of Dr. James E. Bower before our subcommittee:

It would take 2 railroad mail cars, 110 large mailtrucks, and 800 postmen to deliver the daily load of drug circulars and samples to doctors if mailed to one single city. Then after being delivered, it would take over 25 trash trucks to haul it away, to be burned on a dump pile whose blaze would be seen for 50 miles around.

All told nearly 60 pharmaceutical houses were represented in the grand total of circulars and samples that began to pile up in my office in both the 1957 and 1959 survey. In a single day these varied from 1 to 28 pieces with a daily average of 10.5. (The average in 1957 was 9.1 pieces as shown in table 1.) This means that the estimated 150,000 doctors all over the country were receiving daily over 1.5 million pieces of mail.

What purpose does it accomplish for the drug manufacturer or for the doctor? Does a doctor, who has a professional education, require so much repetition to get across to him the idea of a new drug, or push an old one? And do the drug firms have the right to take up so much of a doctor's time or his tax money and that of other taxpayers-by burdening the post office to deliver circulars at a reduced rate? (Hearings, pt. 18, p. 10453, 10454.)

But above and beyond the quantity of this advertising and promotional material, there is the further and more serious question of its quality. It is indeed a serious question because if the physician is misled, the public health is endangered. It was therefore most dismaying to learn from medical authorities that this advertising is often misleading and sometimes downright false. For 3 years one medical college has included in its course work for second-year medical students an evaluation of drug advertising. According to Dr. Solomon Garb, who conducted the course:

In all 3 years it was found that the majority of the mailed ads were unreliable, to the extent that a physician trusting them could be seriously misled.

Part IV of the report contains excerpts of testimony from eminent medical authorities criticizing the quality of drug company advertising and giving specific examples of misleading claims.

Concerning their new arthritic drug, Merck informed physicians in an advertisement that "no worrisome side effects attributable to [it] have occurred as yet." During the hearings I asked the company's medical director, "Is that statement true?" He replied, "As of today I would say it is not true" (hearings, pt. 14, p. 8185).

Pfizer, in introducing its new antidiabetic drug, withheld from the medical profession a report addressed to the president by its own medical officer who was in charge of clinical testing of the product. His summary report showed that of a total of nearly 2,000 clinical cases tabulated, no fewer than 27 percent reported one or more side effects. These side effects included not only minor irritations_but adverse effects upon the central nervous system, serious skin disorders, and jaundice. Although this information was in the possession of the company, the original package insert first sent out in 1958 began with the statement:

Side effects are generally of a transient and nonserious character (hearings pt. 20, pp. 11296, 11344, 11370).

The subcommittee has received hundreds of letters from physicians from all parts of the country denouncing the flood of advertising with which they are inundated. Many report that they destroy the directmail advertising immediately upon arrival, denouncing these advertising claims as extreme and unsupported. The testimony of Dr. Harry F. Dowling, head of the Department of Medicine, College of Medicine, University of Illinois, aptly summarizes the lines of thought expressed in these communications:

One especial source of confusion for the practicing physician is printed advertising that comes to him by direct mail or in medical journals. In this 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 doctors to make mistakes in using their drugs; it also affects other pharmaceutical companies adversely (1) because it destroys the confidence of the physician in the industry as a whole, and (2) 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 (hearings, pt. 24, p. 14172).

The attempt in this bill to prevent physicians from being misled about the therapeutic properties and dangerous consequences of drugs surely cannot be interpreted as an attack upon adverstising in general. In their appearance before the subcommittee, physicians repeatedly emphasized that today the busy doctor has little time in which to make his own evaluation of a new drug, based upon his own analysis of the scientific literature. They stated that it is utterly impossible for the practicing physician to keep up with the medical literature on the flood of new drugs, particularly those outside his specialty. Under these circumstances it is inevitable that the massive amounts of advertising and promotional activity to which the physician is subjected have a very definite effect, and this, in fact, is demonstrated in the evidence developed in our hearings. In the words of Mr. William Bean of the School of Medicine, Iowa State University:

Advertising by mail must be effective, or it would not be so prevalent. The sample for the physician's personal use or for some handy patient works on the principle that a pill in the hand will be put into somebody's mouth. As a method of practice, it appeals to the lazy or hurried and harried physician. But it is the practice of expediency, not of mature thought. One never knows when the mail will bring a pillow and a pill for peace of mind. Samples may provide an alarming toy for children playing at doctor or for those who are still curious. The drug sample is a poor substitute for thought in the practice of medicine (hearings, pt. 18, p. 10336).

Against the background of this rather serious problem, the provisions of the bill are relatively mild in character. It would require the Food and Drug Administration to determine whether or not a new drug is "efficacious." Today the FDA is limited to a determination of safety. In other words, a drug which has no therapeutic effect but which is not harmful can be marketed; under the bill it could be marketed only if, in addition to being safe, it can be shown to be efficacious. In addition, the bill would require all advertisements and other printed material issued by the manufacturer to include

a warning approved by the Secretary of Health, Education, and Welfare as to any dangerous or harmful effects, and a full and correct statement of the drug's efficacy.

The bill would also require manufacturers to send to all physicians a copy of what is referred to as the "package insert." This is the brochure containing information on dosage, usefulness, side effects, and so forth, which must be approved by the Food and Drug Administration for all new drugs. It is the one document in which the information contained about the drug has been approved by the FDA. The reason for a requirement in the bill that these package inserts be sent to physicians arises from the curious fact that this is not now being done. In order to send out their vast quantities of advertising, the drug companies use mailing lists of physicians, broken down in detail by specialty, by geographic area, and so forth. For some unknown reason they have not seen fit to use these same mailing lists to regularly send to physicians copies of the one Governmentapproved document which sets forth the bad as well as the good points about a new drug. In the past the FDA has never required them to do so. In the absence of such a requirement, the package inserts for the most part go to the pharmacist, to whom they may be of some interest and who may on occasion pass along some of the information to a physician. But since the pharmacist, of course, cannot alter the prescription, the package inserts tend to end up in the watepaper basket. In any event, it is obvious that the recipient of the Government-approved information should be the man who writes the prescription. In addition to requiring the manufacturers to send the brochures to physicians, the bill directs the Secretary of Health, Education, and Welfare to publish their contents in convenient and readable form and distribute them to doctors, hospitals, and others concerned with the handling and utilization of drugs.

Finally, to help physicians identify those drugs for which they should be particularly on guard, the bill requires the Secretary of Health, Education, and Welfare to publish and distribute to physicians annually, and at such other times as he deems desirable, a list of drugs which have the potentiality of particularly serious, dangerous, or harmful effects as he may consider in the interest of public health. The advertising profession is noted for its extreme sensitivity to criticism on proposed restraints of any kind. Although what we are dealing with here is indeed a serious problem, there is in these bills nothing in the way of censorship or Government control of advertising content. There are merely requirements that a drug to be sold must be efficacious as well as safe; that advertising and promotional material contain information about a drug's efficacy and safety; that the package inserts, which have long been regularly

prepared for approval by the Food and Drug Administration, be regularly sent to those for whom they would have primary value; namely, the physicians; and that drugs with particularly dangerous side effects be "flagged" to permit quick and ready identification. If the drug companies and the drug advertising agencies permit themselves to be outraged by these very modest proposals, I submit that they have lost all touch with reality.

PATENT MONOPOLIES

The most controversial part of S. 1552 will certainly consist of the provisions dealing with patents. Obviously, no legislator wishes to jeopardize other parts of a bill by including therein a highly controversial provision unless he feels that he absolutely must do so. Such is the position in which I find myself.

While some savings would occur and they would be very substantial for nonpatented drugs by the greater use of generic name prescribing, the hard fact remains that the leading products in most of the major categories of ethical drugs-steriod hormones, tranquilizers, sulfa drugs, oral antidiabetics, and broad-spectrum antibiotics are protected by patents. Where the drug is patented and the patent-holder licences none or only a very few other firms, the price tends to be the same whether the prescription is written in terms of its generic name or its trade name. For example, the buyer will pay the same price for Parke, Davis antibiotic regardless of whether the physician writes out the prescription for Chloromycetin, the trade name, or chloramphenicol, the generic name. Therefore, if any real progress is to be made in reducing the exorbitant prices of ethical drugs, there is no way of avoiding the necessity of facing up to this thorny problem of patents.

There is a widely held and quite mistaken view that the present provisions of the patent law, under which exclusive rights are granted for 17 years, are contained in the Constitution itself. Yet, nowhere in the Constitution is the word "patent" used. Article 1, section 8 merely provides:

The Congress shall have power

to promote the progress of science and the useful arts by securing for limited times to authors and inventors the exclusive rights to their respective writings and discoveries.

The "exclusive right" referred to is left to be defined by Congress and is subject to redefinition by Congress. Indeed the most prominent inventors among our Founding Fathers, Benjamin Franklin and Thomas Jefferson, were opposed to patents an attitude shared, though many years ago, by some of the founders of today's giant drug companies.

It is also not generally known that most countries of the world do not grant product patents on drugs. "Process" patents-that is, patents on methods and processes of producing drugs-are granted. But on the product itself, 49 out of 77 countries for which information has been obtained do not award patents in the pharmaceutical field. Of the 17 foreign countries for which usable price information was obtained for the subcommittee by the Department of State, 11 do not grant patents on pharmaceutical products, while only 6 do. Most of these six have either compulsory licensing provisions or price con

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trol on drugs or both. The United States is the only major economic power which grants products patents on drugs without imposing any of these limitations or safeguards to the public welfare.

The practice followed by most other countries of making drugs an exception to their patent laws is based upon the simple moral belief that no one should have the right to withhold from the public products which are vital to the health of mankind. No one, it has been felt, should make a monopoly profit on the sale of such products. Any suggestion of limiting the patent grant on drugs will be immediately denounced on the grounds that it would dry up research and thus prevent the development of new drugs. Yet it is a curious fact that the great fountainhead of drug discovery, Germany, does not now and never has granted product patents on drugs. Other countries which have historically followed the same policy and have been outstanding in the development of drugs include France, Switzerland, and Sweden. In a tabulation of important drug discoveries included in the report, it is revealed that drugs discovered in foreign countries without product patents outnumber those discovered in countries with such protection in the order of 10 to 1.

U.S. discoveries are outstanding in steroid hormones and in antibiotics. But according to the Pharmaceutical Manufacturers Association, prednisone, the most widely used steroid hormone in recent years, was invented by a Mexican firm. While the American companies have made important discoveries in the field of antibiotics, these contributions are all based fundamentally upon the original discovery of penicillin in 1929 by Sir Alexander Fleming and on the investigative work carried on at Oxford University and English hospitals a few years later. Moreover, the work of American companies in this area was greatly aided by substantial grants from the Federal Government during the war and by important scientific discoveries made by the Northern Regional Research Laboratory of the U.S. Department of Agriculture in Peoria, Ill.

As might well be anticipated, prices for individual drug products are higher for countries with than for those without product patents. This was found to be true for each of 12 individual products for which such comparisons could be made. A particularly interesting comparison involves products discovered by foreign firms. Here, the price of the inventing company in its home country is contrasted with the price of the American licensee in the United States. Although the American firm was not the one which made the discovery, its price in the United States ranged from two to eight times the price charged by the inventing company in its own country. I wish to stress again that these observations should not be regarded as an attack upon the patent system as such. But we are confronted with a situation in which prices of this critical industry are extraordinarily high and frequently outrageous, in which there is little possibility of obtaining any widespread reductions in these excessive prices without imposing limitations upon the patent grant, and in which from the evidence of other countries the discovery of new drugs can and does proceed without the benefit of any patent protection whatever. To those who are concerned that a limitation on the patent grant in this industry would spread in other fields, may I state that