without question there is just a tremendously serious problem, forgetting even deaths.

Dr. SPEIR. I agree, sir. However, I do not know what the basis of Dr. Panio's information is. If it is the same kind of data as the data on 39 deaths due to Talwin, it means I would seriously question it.

I would like to point out that last spring, last April, when I first heard of Dr.-I gather it is a doctor-Panio now, was concerned with this, I called him from California, arranged to fly back and meet with him, which I did the next day. At that time, I requested any information he could give me of case reports about these cases and also asked if I might meet some of the addicts and find out more about this problem. I have yet to receive any such case reports, and I really do not know what the basis of these statements is.

I would like to point out also

Mr. MURPHY. Doctor, before you go any further, you are not taking issue with the testimony of the DEA and the Chicago Police Department officials that there are gang wars in this city and other cities for the control of Talwin and its distribution?

Dr. SPEIR. I have no way

of

Mr. MURPHY. And you won't take issue-I don't know if you have seen this graph, but this is the Illinois Public Aid's own graphics of the use of Talwin and Pyribenzamine and how it has declined and how they are used together.

Dr. SPEIR. I have not seen it before, but I would take no issue with that whatsoever. There undoubtedly is a problem.

Mr. MURPHY. And you also have the figures from your own company that produces Talwin about the increase.

When did this drug first come on the scene? What year?

Dr. SPEIR. 1977 is what I put in here.

Mr. MURPHY. You must have seen a tremendous jump in the use of Talwin, in its production.

Did your company have any idea when it first produced this drug what it was to be used for and what the potential of sales would be?

Dr. SPEIR. It was considered to be a moderate to strong analgesic with few, if any, of the side effects of narcotics. And it was felt that the potential was immense.

Mr. MURPHY. When you say immense can you define that in numbers?

Dr. SPEIR. I can't give a figure on that. There was a very real potential. It was a very exciting development in those days.

Mr. MURPHY. It was a $20-million exciting development to your company.

Proceed, then.

Mr. NELLIS. May I just ask if you would direct your answer in this way: Do you deal directly with retailers or only through wholesalers? Dr. SPEIR. We have what we call our direct accounts. And these are largely wholesalers. We will deal on occasion with a particularly large retailer, but there are certain minimal dollar requirements for orders directly.

Mr. NELLIS. And you would then detail men to contact these accounts as other drug compafties do?

Dr. SPEIR. Oh, yes.

Mr. RAILSBACK. There is just one other thing I would like to ask. Doctor, I regard you as an expert, and I respect your experience.

Do you think that it would be a very valuable thing for either the manufacturer or for the Food and Drug Administration to grant a license for a particular substance to be taken as an analgesic, or conduct tests in combination with other substances to see what might have a harmful effect?

Dr. SPEIR. I think it is a good idea in principle. I think, in fact, deciding how far you are going to extend these tests would have the practical problems that were mentioned earlier.

Mr. RAILSBACK. Except where we have experience that we have an analgesic and when it is taken in combination with an antihistamine, it produced some very negative effects and consequences. And, then there may be another analgesic similar to the one that has been used in combination which may become readily available. Wouldn't it be wise to at least test this in combination with other substances? Dr. SPEIR. I would certainly agree it would.

Mr. RAILSBACK. Does the Food and Drug Administration do that now?

Dr. SPEIR. Not to my knowledge.

Mr. RODWIN. Mr. Railsback, I am Roger Rodwin. I am assistant general counsel for the Sterling-Winthrop.

May I suggest to you your question contemplated, I think, the proper use of the drugs when you said in combination to be tested prior to marketing. What we are talking about, if I understand it correctly, is a total misuse of the drugs.

That is to say, rather than being taken orally, these drugs are crushed up, melted in some fashion, filtered, and injected, mainlined, a totally noncontemplated misuse of either drug.

Mr. RAILSBACK. Well, I accept that as very true, except that I think I would not limit it. I think I would not limit the testing to a licit use. I think, where we have had experience with illicit use, it would be very wise for us to even know the results of that.

Mr. RODWIN. I agree with you. I suggest in contemplating some of the studies, we run into some ethical questions as to whether or not we can duplicate those studies with humans. We have done it experimentally with animals.

Mr. MURPHY. Counsel, you say you have a licit drug, it has a proper purpose, but it is being misused.

Wouldn't you think that a company that produces that and sells it to the public, offers it on the public market, has a dual role and responsibility that when it knows that it is being used in combinations for illicit purposes and produces consequences, undesirable and not really intended by the company, that the company would, in conjunction with the Food and Drug Administration, sit down and counsel together and maybe submit the drug through strict controls?

Mr. RODWIN. I thought we were contemplating the question of testing and what would be appropriate.

Mr. MURPHY. No; I am using your statement to this committee that you are producing a licit drug and not intended for illicit means. Mr. RODWIN. That is correct.

Mr. MURPHY. But the fact of the matter is it is being used in combination for illicit means;

All I am saying is I think you have a dual role and responsibility to the public on offering a product like this to the public that you counsel with the Food and Drug Administration.

As your own doctor, Dr. Speir testified, there have been evidences of misuse. And it has come to your attention. You would have some social responsibility to meet with the Food and Drug Administration and maybe submit to voluntary controls.

Mr. RODWIN. I will try to answer that in several steps. First of all, we have counseled with not only the Narcotics Administration, but Food and Drug Administration, on many occasions in connection with abuse and misuse of this and similar drugs.

The most formal counseling, if you will, took place in 1974, at which time a half dozen of the most outstanding, knowledgeable individuals in the field of drug abuse formed a committee, which was a council to the Food and Drug Administration. And the Secretary of Health, Education, and Welfare listened to the presentation of every available witness furnishing information on any misuse or abuse of Talwin.

At that time, six other drugs were being considered for the same purposes. That is, should controls be imposed? And of those six drugs, five were recommended for controls. The sixth was reviewed a year later, but all those present unanimously agreed that the facts did not warrant controls of Talwin at that time.

Now, if you are talking about the recent developments, what Dr. Speir, I think, has been trying to say is that we have tried to learn all the information that we could possibly learn about the situation.

While it has been difficult in coming to us, and still is not complete in our hands, we think there is a problem. We don't know the precise nature or extent of the problem. We don't know if it is truly related to Talwin, and we don't think that controls, particularly in schedule II, will meet the problem.

Mr. RAILSBACK. Would you yield?

Mr. MURPHY. I yield.

Mr. RAILSBACK. I am a little bit familiar with the 1974 findings, and the finding was there was not sufficient danger to the public at that time, not enough evidence of abuse.

Now we have a different circumstance. We have alleged, anyway, if not proven widespread abuse. What we are suggesting to you is not that we want to ban a legitimate analgesic, a licit analgesic that may be a very valuable medicine. But what we are saying is, what the chairman asked, which I think is a very relevant question. When you have evidence of illicit use in combination, wouldn't we all be wise to control it, maybe even control it under schedule II?

What do you do when you control it? You require separate reportkeeping. There are certain stringent requirements that make it a little bit less accessible. But isn't that really the issue? You are worried there aren't going to be as many sales of your drug.

Mr. RODWIN. I understand what you are saying, Mr. Railsback, and let me assure you, on behalf of the company, we are not interested in illicit sales of our drugs.

But, in direct answer to Mr. Murphy's question, and your seconding of the question, in view of what has apparently occurred, regardless of the fact that we don't share all of the views that have been ex

pressed, we have not opposed, and we have accepted the Federal Government's suggestion, that this product be controlled in schedule IV, on a Federal uniform basis.

Mr. NELLIS. In fact, may I not remind you, Mr. Rodwin, am I correct, and I believe I am, in my assessment of the company's position on control, the company has resisted control right along, beginning in 1974 and as recently as here in Illinois.

Mr. RODWIN. In 1974, the first proceeding in the Federal context, recommending control of the drug, we did not agree with the basis upon which the drug was recommended for control. And six experts who were to decide the question agreed with us unanimously. Mr. NELLIS. Who are those experts?

Mr. RODWIN. Members of the Controlled Substances Committee, which was consulted by the Secretary of Health, Education, and Welfare in 1974. I can furnish their names to you.

One of them happened to have been the fellow who directed the Haight-Asbury community, Dr. George Gay.

Mr. NELLIS. Yes; I am aware of that, Mr. Rodwin. Let me point out something to you here, and to Dr. Speir, that I think is extremely important, in view of what both the chairman and Congressman Railsback have mentioned.

You indicated in your testimony that increased orders by Chicago wholesalers didn't alert you to the problem here, because one wholesaler had gone out of business. I am going to read you some statistics of your sales: "As of 1977, Chicago area sales of 50-milligram Talwin tablets”—this is the form that is so badly abused-increased 109 percent over 1976 sales. Fourth quarter 1977, sales increase by 242 percent over 1977 Chicago area sales."

The 1977 Chicago area sales of 50-milligram Talwin tablets increased to 11 percent of your total national sales, wherein 1976 Chicago area sales consisted of only 5 percent. You had, in effect, a doubling of your sales in this area, right along this period 1976 to 1977.

And, yet, if I understand it correctly, you people have in 1974, successfully and not so recently unsuccessfully resisted the scheduling of this drug.

Didn't you file a lawsuit in Illinois to prevent the drug from going on schedule, too?

Mr. RODWIN. We did, sir.

Mr. NELLIS. What was your position with respect to scheduling on the Federal level?

Mr. RODWIN. We have not asserted a position at this time. We intend to assert it prior to October 13. As. Mr. Bensinger said, that is the date upon which we must respond.

Mr. NELLIS. Are you able to give us a preview of your position? Mr. RODWIN. I think we stated to you in our statement, sir-we say we are going to accept the Federal Government's recommendation. Mr. RODWIN. No; I refer you to our statement.

Mr. NELLIS. You are not going with it on schedule II?

Mr. RODWIN. I refer to our statement, Mr. Nellis. In view of the recommendation by the Federal Government for scheduling, in schedule IV, we are not going to oppose; and we will accept that proposed scheduling.

Mr. NELLIS. That schedule, of course, involves the possibility of five refills without reference to a physician after the original prescription; isn't that correct?

Mr. RODWIN. I think it refers to five refills, in accordance with the original prescribing physician's order.

Mr. NELLIS. That is what I said.

Mr. RODWIN. You said "without reference."

Mr. NELLIS. What about schedule II? Would you be willing to accept schedule II?

Mr. RODWIN. No. I think I have said twice now I don't think the company is, and that is why we are in court here in Illinois.

Mr. NELLIS. Dr. Speir, I am not able to understand, and I am sure the chairman shares my view, as well as Mr. Railsback, how you can say over the past several years your system has detected several situations in which inappropriate distribution of the drug may have been taking place, in light of the figures here in Chicago. I just don't understand how you can have a reconciling of the two.

Dr. SPEIR. May I address that?

Mr. NELLIS. Sure.

Dr. SPEIR. And I quite share your concern, upon looking at those figures.

The first thing, these are figures we are looking at retrospectively. These are not figures we have had before us until very recently. Mr. NELLIS. You know your figures every month.

Dr. SPEIR. Not on this basis, Mr. Nellis.

Mr. NELLIS. You mean you can't tell how much of your product you sell in the Chicago area? Doesn't your company have computers that do that?

Dr. SPEIR. Not in that particular way. What we do get are figures for a given office, or a given number of accounts. And there were several things that went into this.

This has been a grave concern to us, I asure you, as we look back and try to figure out what went wrong.

Mr. NELLIS. What went wrong is that your sales doubled and you didn't know about it. You didn't know anything about it, despite your statement in which you say you have taken appropriate steps.

I would like you to show me one letter to your distributors that says something like, "Hey, watch the Talwin. It is being misused on the streets. Make sure you know who you are selling it to."

Dr. SPEIR. The system that we have worked well when it related to accounts that remained constant over a period of time. For example, a large retailer who gets the same kind of orders for the same kind of drugs over a period of time. Then, if there is a sudden increase, it is easily picked up.

I am told what has happened within the last couple of years is a change in the pattern of our doing business-that we handle fewer direct accounts, that these direct accounts tend to buy from wholesalers. So that there has been a movement from what we call "retail accounts" to wholesalers.

Mr. NELLIS. Let me interrupt. Sitting at your left is Mr. Melvyn Zahn, wholesaler, one of your valued customers. His purchases of your