to explain my attitudes and convictions concerning some of its provisions.

First of all, I believe in our free enterprise system which offers adequate rewards for productivity and inventiveness and for unusual risks. However, I also believe that all industry has certain social responsibilities in addition to providing profits to investors, and that when unusual profits are achieved in a manner that is not in the public welfare, that remedial legislation is called for. I agree with the chairman that the drug industry is in a somewhat unique position and that its social responsibility is greater than that of many, if not most, others. However, I am also of the opinion that the great majority of our leading manufacturers, particularly those who have been in what used to be known as the ethical drug industry for many years, have recognized and tried to discharge their responsibility in the general interest to varying degrees. They have strived to maintain high standards in the products they manufacture and tried to produce better ones and improve their old ones. They have, in general, been honest in promoting their products and have tried promptly to verify and to keep physicians informed about difficulties encountered with their products. They have sought advice from the best available sources and usually have acted on such advice.

Unfortunately, there have been some who have not always been responsive to justifiable criticism. They have often been selective in the choice of data and advice which they accept and transmit or act on, and often bypass or ignore those who might given them honest, reliable, and unbiased opinions that might be unfavorable to them. When they have persisted in ignoring such opinions, they have at times put those advisers in the awkward position of having to go out of their way to point out these errors, sometimes at great sacrifice to their own greater and more fundamental interests which they feel might be more productive. More unfortunately, in recent years, as the opportunity for profits has increased and the competition has intensified, even some of the older and respected members of the industry have relaxed some of their standards.

Regardless of who the culprits are, all of them protest that the objectionable practices have been forced upon them by the actions of their competitors. That being the case, those who are genuinely concerned should certainly be pleased to have these practices scrutinized and should welcome any restrictions which would tend to correct them. On the other hand, those who are responsible merely deserve to have the remedies forced on them.

It is to be expected that some of the restrictions will not be very palatable, but since the members of the industry were unwilling or unable to hold their own members within the bounds which they know to be proper, some outside influence was inevitable. In this sense, I presume that the bill under consideration may be considered as punitive to the industry as a whole. Although I am not qualified to comment on the economic effects of some of the restrictive aspects of this bill, I would like to express the hope that its provisions will not serve to discourage the continued and vigorous pursuit of the search for new and better therapeutic agents and for means of improving and using more effectively those already available.

I also am of the opinion that we in the United States have the best trained and the best informed physicians in the world and that they have the best opportunity to keep informed. However, medical practice even here still leaves much to be desired because physicians are only too well aware of the ever-accelerating rate of increase in the body of knowledge and, hence, also our growing individual deficiency in keeping up with developments that might be useful in the care of our patients. Honest physicians are no longer satisfied that they know or can be expected to know everything; that they can embrace all of the technical, scientific, and medical advances and apply them properly and effectively.

Because this country can afford the best that is available and because physicians are aware of and are dissatisfied with their own limitations, there is an ever-increasing tendency of physicians to specialize so that they can be in a position to encompass and offer the best type of service within a limited area and with the highest degree of competence. Also, this feeling of inadequacy in the individual physicians and their desire to offer to their patients all the advantages of the great and growing body of new knowledge and experience is responsible for the gathering of practicing physicians into groups which share their specialized knowledge, skills, and experience for the benefit of all their patients.

(At this point, Senator Kefauver left the hearing room.)

Dr. FINLAND. With respect to the use and evaluation of drugs, the practicing physicians must, as in other areas, rely on those with more experience and those who have special knowledge, training and experience and who have the facilities and opportunities to make the necessary observations and comparisons that are required to make a reliable judgment. If he is honest, the individual physician will admit that he can only gather impressions concerning the effect of the remedy he uses in an individual patient, but he cannot even in that case determine the likelihood that the response was a matter of chance or was due to any of the different methods of treatment that he employed, nor can he say what might have been the result were some other drug used. Only when adequate numbers of properly studied cases are gathered and the responses analyzed and compared with similar data from other well documented experiences can one gain some approximation of the true effectiveness of any remedy. Obviously, the greater the number of observations and the more intelligently the data are gathered, the more reliable will be the evalua

tion.

Early in the course of the present series of hearings, Dr. Hugh H. Hussey, Jr., professor of medicine and dean of the school of medicine at Georgetown University, appeared before this committee in his capacity of chairman of the board of trustees of the American Medical Association. At that time, he outlined the history of the AMA's part in promoting legislation designed to improve the manufacture and distribution of pure foods, drugs, and cosmetics. He enumerated some of the long list of legislative measures which the AMA, through its council on pharmacy and chemistry, the forerunner of the present council on drugs, either was instrumental in initiating, or urged upon

1 At the time I prepared this statement, Dr. Hussey's was the only statement by any witness of your current hearings which was available to me.

the Congress, or strongly supported. Dr. Hussey expressed the justifiable pride which the AMA takes in its long history of support and sponsorship of legislation directly concerned with the public health and well-being. He also indicated the many ways in which the council on drugs has cooperated and worked in close relationship with the FDA for the same useful purposes.

As a physician engaged in the practice of medicine, I am also a member in good standing of the AMA. Although as an individual, I have not been in sympathy with its position relating to certain legislative matters, I certainly agree that its stand and actions in the past on matters relating to the maintenance of high standards in the manufacture, distribution and use of drugs has been very laudable and in line with what is to be expected from the major scientific and professional organization of practicing physicians in the world. Unfortunately, as I intimated during my previous appearance here, I have been disturbed by the apparent relaxation in both attitude and performance in the matter of acceptance and promotion of new drugs during the past few years-almost, it seems, in proportion to the vigor with which the more aggressive and less scrupulous among the manufacturers were relaxing their standards in the types of new products they offered and particularly in the methods of promoting their products.

Dr. Hussey further outlined the steps that the AMA has taken and plans to take with respect to improving its educational program in order to reach and inform practicing physicians more effectively concerning new drugs. I think it is fair to point out, however, that this plan as presented, and the methods that have recently been used, could, in my opinion, turn out to be merely an efficient method of offering to the medical profession the information and views which the manufacturer wishes to transmit. There are no adequate provisions in these proposals, as I read them, to make sure that the manufacturer has obtained the data and observations from reliable sources. Unless I am mistaken, the AMA under the present or contemplated plan expects the manufacturer to present his data to the council on drugs at the same time that the new drug application is filed with the FDA so that publication of the council's evaluation can be made to synchronize with the approval of the application by the FDA. To be sure, this is highly desirable and should satisfy the manufacturer's objections to the long delay before the practicing physicians and the public are made aware of the new product and, thus, permit more expeditious exploitation of the new product. The manufacturer, in turn, could then be expected to acquiesce more readily to the demand that his promotion of the drug be delayed until the profession is properly and authoritatively informed.

I would like to mention features in these proposals which give me reason for concern.

1. Since this is a voluntary program, there can be no guarantee of full cooperation by the manufacturers particularly by those who are least likely to comply adequately.

2. There is no control over the quality of the observations to be presented for evaluation or over the competence of the observers whose reports are to be evaluated. It is possible for the manufacturer to gather large numbers of reports from what has been called by one of your witnesses a stable of testimonial givers who, for some con

sideration, or merely because they don't know any better, or because they believe all that they are told, are willing to attest to it, even in publications. Unless the drug has been tested by experienced investigators who can make and interpret the pertinent observations and are properly equipped to do so, the AMA can do nothing but accept the data on its face value. The same, of course, is now true of the position of the FDA.

3. There is no way to prevent the manufacturer from being selective and from withholding from the council information which he may feel or know is not to his advantage. He may then benefit from the early favorable report and exploit it for a long time before any adverse reports can become available, much to his profit but to the detriment of many patients.

4. There is no guarantee that the evaluation by the AMA will always remain in the hands of the same very high quality of individuals who now constitute its council on drugs. Nor is there any guarantee that the administrative officers of the AMA will, under all circumstances, permit adverse reports of the council to be published or that they would not put pressure on the council to take into account considerations other than those having scientific or medical merit in their judgments on drugs. There is, at present, even the possibility that some administrative officers of the association with personal convictions based on considerations other than those of scientific merit may take it upon themselves to make representation to the Secretary of HEW or to the FDA concerning drugs without the expressed approval of the members of the council or even contrary to the known convictions and judgments of the majority of its members. In other words, there is no guarantee that the officials who control the publications and policies of the AMA will publish unfavorable reports of the council based on objective review and scientific merit if those judgments appear objectionable to those officials. I would like it understood that I am not making assertions that these situations exist or have existed, but I would feel happier if there were safeguards against their arising. The very fact that the association has so recently been moved to a concerted effort to introduce new plans for vigorously pursuing its educational program with regard to drugs is, in a way, an admission that this aspect of its program which it had so admirably developed and pursued in the past had not been adequately sustained and that the situation had been allowed to deteriorate.

The same may also be said about the policies of the AMA with respect to advertising in its journals and the implementation of those policies. The advertising committee of the AMA now has and always has had every opportunity to demand to get, for the journals it publishes and for many others, only advertising copy that is accurate, informative, and dignified-without flares and fluorishes, exaggerations, distortions, or misleading quotations or assertions. In other words, it is in a position to accept only the kind of advertising that befits the dignity and intelligence of the profession it serves. It needs only the courage of its conviction and the willingness to resist all pressures to relax its ideals in order to accomplish this and to set the proper standard and example for all reputable publications intended for physicians. Here also there are signs of recent intensification of

activity in this direction, but there should be some assurances that these efforts will be effectively, vigorously, and continuously pursued. With these reservations in mind, it is my present opinion that, if the selection of the members of the council on drugs continues to be such as to insure high degrees of competence, interest, sense of responsibility, and freedom from organizational pressures, other than those based on purely scientific and medical considerations, this body could very well serve as the best source of advisers to the FDA in evaluating the acceptability of new drug applications. The council, so constituted, would then also be expected to seek advice from other unbiased and distinterested experts and urge or require further evaluation by competent individuals and under acceptable conditions before passing on their advice and judgment to the FDA. If this were the case, the FDA could call upon the council and rely upon it to help in making the determinations of efficacy and safety. However, the FDA must, of course, have the authority to insist that all the data be made available for such evaluations and that the data presented are such as to permit proper evaluation. The qualifications and experience of the clinical investigators should come under scrutiny just as are the qualifications of the individuals responsible for producing and maintaining the quality of the drugs that are offered.

After this rather lengthy introduction, I would like to offer my opinions and comments on some of the general and specific provisions of S. 1552.

First, with regard to the Sherman Act amendment, I cannot claim competence to comment on the proposed addition of section 7.

In the portion dealing with patents for drugs, there is offered an amendment consisting of several parts which are detailed in four paragraphs beginning on page 3, line 8, and ending on page 5, line 12. I suppose that you would like me to comment particularly on paragraphs (1) and (2). I would like to address myself first to part (B) of paragraph (1) which, as I interpret it, provides that no patent may be granted for any molecular modification or other modification of any patented or unpatented drug or for a combination of two or more drugs unless the Secretary of Health, Education, and Welfare has determined that the therapeutic efficacy of such modification is significantly greater (the italic is mine) than that of the drug so modified, or that the therapeutic effect of such drugs when taken in combination is significantly greater than the therapeutic effect of those drugs when taken separately. Paragraph (2), which follows, calls upon the Commissioner (I presume that means the Commissioner of Patents) to transmit to the Secretary of Health, Education, and Welfare a request to determine that the modified drug or the drug in combination is really significantly more efficacious than the drug before it was modified or combined.

I presume that the purpose of this provision of the bill is to reduce or hold down the number of minor modifications of drugs and the flood of combinations that are of little or no therapeutic value or which add little or nothing of value to the practicing physician in his difficult task of choosing effective drugs for his patient. Its purpose, in other words, is to reduce the possibilities of producing an artificial demand for drugs by modifying or combining known agents and promoting them unjustifiably as new therapeutic advances. I