That mechanism, in fact, was precisely the one most favored at the meeting of 26 September, with PMA, APhA, and Dr. Hussey and myself present. I think this would be a reasonable mechanism and one not burdensome to the physician. I would suggest however, that the wording beside the two boxes be "substitution of equivalent drug product permitted" and "substitution prohibited," respectively.

Interestingly, the copy of the resolution attached to Mr. Stetler's letter bears the heading "Resolution of the Drug Research Board with Regard to Drug Product Antisubstitution Laws." How anybody can now say that the DRB "took no position with regard to State antisubstitution laws" is really beyond understanding.

The PMA Newsletter of December 2, 1974, reported Mr. Stetler's letter of protest which said the statement was "ambiguous" and clearly handed the APhA "an important new weapon in its nationwide campaign to generate State legislation transferring drug product selection authority from the physician to the pharmacist." Thus, the DRB found itself cast in the role of arbiter between claims of the PMA versus those of the APhA.

Mr. GORDON. The PMA itself was originally looking for the weapon, and it got sore because the APhA managed to get it, instead. Dr. PITTMAN. That is my understanding.

In view of the confusion and activity I have just described Mr. Trexler sent a memorandum to the members of the DRB-dated December 20, 1974; attached-in which he (a) again noted that the ALS had approved the resolution on November 19, and (b) stated that "it-the resolution-may be the subject of an NAS press release in the near future." This was Mr. Trexler's second memorandum to the members of the DRB on the resolution, so there really should be no complaint about their not having been notified. I presume they also received the minutes of the meeting itself.

Shortly before that, Mr. Trexler had telephoned me and requested that I prepare a brief resume of the reasoning which had let to our adopting of the resolution and the history of the development of that position. I did this and sent it to him in a memorandum dated December 4, 1974, with the subject given as "Subject: Suggested narrative to accompany distribution of DRB resolution on drug antisubstitution." In other words, I was perfectly aware that this material might be used as the basis for some sort of background statement, contrary to the statement made in an editorial in the April 28, 1975, issue of the JAMA.

On January 21, 1975, the press release was made public [attached]. Objections immediately began to appear, coming chiefly from the industry, I believe. Complaints included the following: One was that the DRB had not been warned that a press release would be made. As I have just pointed out, that is incorrect. Another was that the printing layout of the release implied that the DRB had endorsed the specific wording of the background statement as well as endorsing the resolution itself, and that complaint is correct. In addition, statements in the introduction such as "the DRB pointed out" and the "DRB said in a background statement accompanying its resolution" implied that thte background statement had been reviewed by the DRB. Another complaint was that the layout, with the nam

ing of the entire DRB membership at the end of the press release, implied that all 18 members had been present October 25 and had voted in favor of the resolution [except Dr. Crout]. Of course, this was not correct, since Drs. Calabresi, Drill, Hodges, and Papper were absent from that meeting. The greatest objection, however, was that the title of the press release was misleading in suggesting that the DRB had intended the resolution to be concerned with State. antisubstitution legislation. In this those who complain are pletely incorrect. The whole history of the development of the resolution from its very inception in the suggestion by the PMA that DRB help in retaining these laws, as well as the first paragraph of the resolution itself which states that the goal of statutes and regulations concerning drug product selection *** et cetera, show very clearly that the title, Drug Board Urgs Changes in Drug Substitution Laws, is absolutely correct. While it was inaccurate to imply that the DRB endorsed the background statement and that all members were present, I think the press release fairly represents the position of the DRB at the October 25 meeting.

Mr. GORDON. Did anyone document any errors or inaccuracies in the background statement except the statement about 18 members being present instead of 14?

Dr. PITTMAN. I don't think so.

Mr. GORDON. Thank you.

Dr. PITTMAN. The press release is in the back, under item 8.

Shortly after the press release on January 21, there were requests from the PMA for a special meeting to reconsider the whole matter. The DRB Chairman, Dr. Frederick Shideman of the University of Minnesota Medical School's Department of Pharmacology, told the DRB members via memorandum that if any new data or substantive evidence was brought forward, the matter would be considered at the regular spring meeting, but that otherwise the matter was closed. Requests were received, I understand, from the AMA administration to send representatives to the March 14, 1975, meeting, in addition to their regular AMA liaison representative; but the requests were declined. Nevertheless, Dr. Richard Palmer, chairman of the AMA board of trustees, and Dr. Jerry Annis, a member of that board, came to the meeting and, after some discussion with Dr. Shideman, were permitted to attend. The resolution was specifically not on the agenda. However, Dr. Kenneth Kohlstaedt requested that it be discussed, and it was discussed at some length during the day.

Mr. GORDON. Dr. Kohlstaedt is vice president or was vice president of the Lilly Co., is that correct?

Dr. PITTMAN. I think so, yes. He is now professor of medicine at the Indiana University.

Drs. Palmer and Annis spoke against the repeal of the antisubstitution laws-which is not exactly what had been advocated by the DRB that is, not abolition, and against legislation such as that of Florida, which Dr. Annis, who practices in Florida, stated he had handled by simply stamping ahead of time on all prescriptions a statement precluding any substitution.

After the reading by Dr. Kohlstaedt of a statement by Dr. Hugh Hussey, who could not attend the meeting for reasons of health, and

after some rather heated discussion, the DRB again voted on the original resolution passed October 25. The vote was 13 to 1 in favor of the resolution. In other words, the DRB again endorsed, for the second time, the resolution in precisely the wording used before. There was discussion of the material which had been on the agenda that day [the DRB resolution had not been on the agenda], but again there was crowded into the discussion an attempt to clarify the meaning and intent of the resolution. As observed wryly by Dr. Daniel Azarnoff at that time, when someone in Washington clarifies something he said previously, this means: "I take it all back." At any rate, two clarifying statements were offered. The first was offered by Dr. Paul Calabresi of Brown University:

In clarification of the resolution, attention should be drawn to the second "Whereas", which unequivocally states that:

"The physician must have the ultimate responsibility and authority in drug product selection, since he has the fullest knowledge of the patient's needs and responses with attendant obligation to be held accountable for his selection of particular drug products, . . ."

In this context, the intent of the resolution by the Drug Research Board was that the physician, having selected the chemical entity to be used for therapy, should make a choice, each time a drug is prescribed, either to delegate to the pharmacist, or explicitly to retain to himself, selection of the particular drug product to be dispensed and received by the patient.

Dr. Victor Drill, of the Searle Pharmaceutical Co., proposed the following addition to the clarifying statement proposed by Dr. Calabresi :

In retaining to the physician the responsibility for drug selection, the Drug Research Board adopted no position with respect to changes in, or repeal of, drug antisubstitution laws.

These clarifying statements were then typed, argued over, and unanimously approved by the DRB, then retyped. In my estimation, the DRB acted in this instance under pressure from its industryrelated members, particularly Dr. Drill, whom we all respect as a distinguished pharmacologist and scholar.

Mr. GORDON. As I understand it, the members of the DRB who represent industry are Dr. Drill, G. D. Searle; Dr. Robert Hodges of Parke-Davis; Dr. Kenneth Kohlstaedt, who was or is vice president of Lilly; James Price, vice president of Abbott; and Dr. Papper on the board of the Abbott Co.

Now, don't you think that since this matter has an effect on the sales and profit of the industry, in fact the very companies with which these individuals are connected, that they would have excluded themselves from the deliberations on this subject? Isn't there a conflict of interest there?

Dr. PITTMAN. If you want a yes or no, it is always difficult. I suppose you could say there is a co.flict of interest. In my experience with NIH study sections, when an individual's specific university comes up, or lab, he absents himself from the room. But I think the fundamental problem is how one gets experts in a field who are not biased by any relations to anybody in the field. And I think that is a very difficult problem. So I would try to answer that by balancing the committee rather than by saying that people don't have biases. Mr. GORDON. As I understand it, if somebody in Government has a

direct interest, a financial interest, in a particular subject, he excludes himself from participating in any debate-as in Congress or any decision which concerns it.

Dr. PITTMAN. Where are you going to draw the line? I don't believe any particular drug product was discussed at these meetings, so that you wouldn't say that it was this man's company.

Mr. GORDON. I know, but these are drugs.

Dr. PITTMAN. These are generalities, though. I think that is a difficult item. If you try to set up a committee of people who have nothing to do with the industry, then probably everybody on this committee would be excluded, because all of us, including me, have received grants and things from

Mr. GORDON. That is another story. But here we have five members who are directly connected with the industry. They represent the industry, and to them the profits and sales of the industry are important. Their own companies' products are involved. How can they be objective?

Dr. PITTMAN. I don't believe anybody is objective except in that they can base their arguments on data. And this is my complaint in the PMA responses, that they are not based

Mr. GORDON. There is no data; PMA didn't submit data, and the AMA didn't submit data.

Dr. PITTMAN. That is what I mean. The only data shown were those which came from the APhA.

The CHAIRMAN. On the very issue we are discussing-antisubstitution laws of course there is a specific, important direct economic interest by any brand name company in seeing that the antisubstitution laws are not repealed, because prescribing drugs by their brand name freezes them in. So there is a very strong economic interest, and no matter what the argument is, you are unlikely to get prominent brand name companies to agree that their products are substitutable. Dr. PITTMAN. I would only point out that at the March 14 meeting, again with all those individuals present, they voted 13 to 1 in favor of the resolution. I think it is a difficult issue which simply has to be resolved by the people running the meeting as to whether this is directly connected enough to require the individual to absent himself from the room.

Mr. GORDON. I refer to Dr. Drill's proposed paragraph in which he states that the physician should retain the responsibility for drug selection and that, "the Drug Research Board adopted no position with respect to the changes in, or repeal of, drug antisubstitution laws."

How do you interpret that to modify, if it does, the resolution that was actually adopted?

Dr. PITTMAN. I think it is incompatible. I think it doesn't make sense. I go on to say here, I was so irritated by that last statement here, the Drill clarifying statement, that I went home that night and wrote a letter back to Dr. Shideman requesting that this last statement be deleted, and that the Drug Research Board be polled by mail. Now, I think cards were sent out. But I don't think any action has been taken on that. However, this clarifying statement was sent the following Monday, March 17, to the Assembly of Life Sciences, and

the Assembly of Life Sciences declined to issue any statement or clarification. And I doubt that my letter had much to do with that, since the Drill clarification is so clearly in conflict with the resolution itself.

But this sequence of events has been followed bu further acrimony. And it has been implied, for example, that my secretary, Mrs. Mary Gilmer, and I couldn't prepare the 6 pages of review and 65 pages of documentation to get them back to Washington in 48 hours, implying some sort of collusion with the NRC staff. But I can only answer that that is exactly how it happened.

The CHAIRMAN. You say you suggested to the Chairman of the Drug Research Board that the membership be polled on this proposed Drill clarification, and that they were polled, but the results aren't in?

Dr. PITTMAN. Well, I think a lot of people didn't want to be polled, didn't think this was a proper procedure. And the matter is going to be taken up again at the end of this month in another meeting.

The CHAIRMAN. So the issue of Dr. Drill's paragraph will be back before the Board again, is that what you are saying?

Dr. PITTMAN. The whole matter will be on the agenda the 29th of this month, I believe.

The CHAIRMAN. I am just puzzled a little bit about this. If, in fact, you are going to allow the pharmacists to make a decision unless the physician specifically reserved to himself the naming of the particular brand, wouldn't it be better to tackle the problem head-on and say that all drugs be prescribed by their official name? We would knock out all kinds of confusion in physicians' minds, patients' minds, and everybody else's minds. If the physician then wishes to retain himself the right to prohibit any substitution, or retain to himself the right to specifically name the drug manufacturer, then he must put the official name of the drug on the prescription and then name the company. Isn't that the simplest way of accomplishing the same end?

Dr. PITTMAN. I personally agree to that, yes.

Mr. GORDON. You say that this is going to be reconsidered at the next meeting? Is it your opinion that any consideration of this matter should be in full public view with public participation?

Dr. PITTMAN. You are asking me to comment on the procedures of the National Academy of Sciences and National Research Council? Mr. GORDON. Do you think that this kind of a matter, which really impinges on the public directly

Dr. PITTMAN. They do have-I would think it might be useful. But it depends on what you are looking for. I think if you are looking for an opinion of a relatively small group of individuals, thenMr. GORDON. I personally would like to be there.

Dr. PITTMAN. I imagine you would be welcome. You would have to write Dr. Shideman and get permission.

The CHAIRMAN. They would be glad to have you.

Dr. PITTMAN. We do have forums which are open to the public. The CHAIRMAN. Go ahead, doctor.

Dr. PITTMAN. I simply have a paragraph here stating that I think the DRB has been attacked as being frivolous and not considering