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Mr. MURPHY. Without objection, so ordered.
Is there any particular problem with the company submitting?

Mr. Rodwin. If Mr. Smith understands precisely which numbers Mr. Railsback is now asking

Mr. RAILSBACK. I think he probably does, but let me do it anyway. . And I will try to phrase it.

I think what we would be interested in seeing is based on your most recent reporting period if you could give us the increase—and I take it it is an increase-in sales for that ending period, compared to 1 year earlier. That would be the total sales of Talwin nationally.

Then, I would like to compare that with the sales of Talwin in the Chicago area, contrasted to the previous year. In other words, what I am wondering—and that is that question.

And what I think you are telling us

Mr. Smith. May I rephrase that? You are talking about the most recent sales period. We measure against 1977 historical sales.

Mr. RAILSBACK. I think that would be the most relevant period for us. Mr. Smith. I can give you an indication how it went, even right now, without making reference to actual dollars; all right?

Mr. RAILSBACK. Yes. Mr. SMITH. In 1978, third quarter sales for the central region, for which I have six sales divisions, the oral 50 milligram tablet, the one in question, we had an increase over quota, 123.3 percent attainment.

Mr. RAILSBACK. Now, does that include the Chicago area?
Mr. Smith. Yes, it does. That is inclusive

.. Mr. RAILSBACK. That is revealing because despite the substantial dropoff in Chicago, Talwin sales have really been escalating in every one of your other areas.

Mr. Smith. Take a look at Talwin, 50 milligram, in the Chicago area. We had an attainment of-quota of 60.5 percent.

Mr. RAILSBACK. I am not talking now about quota. I don't care about your company quotas. I am really interested in sales.

Mr. SMITH. But do understand that a quota is based on historical sales; all right! So, it is related.

Mr. RAILSBACK. Just so we are crystal clear, I am not asking for your quotas, but your actual sales in the most recent period available compared to the preceding year's sales.

What I would surmise, from what you have just said, is that despite the fact there is a tremendous decrease in sales of Talwin in the Chicago area, there has been a tremendous increase; is that correct?

Mr. SMITH. Which would be predictable; yes, sir. I hope so.

Mr. RAILSBACK. Why would it be predictable if there is a tremendous dropoff here? Predictable--you would have an overall increase?

Mr. SMITH. First of all, I would have to go back to my original statement. There is quite a change in the flow of our business from year to year. You can't

go back and measure—I can't go back to the Zahn account and say he did half a million dollars in 1977, therefore he is going to do another half a million dollars with us. It is predictable he will do that, but he could do $1 million with us.

Mr. RAILSBACK. I really don't understand that. I don't understand what you are saying. We are giving you not just 1 month of volatile information; we are taking the whole year into consideration.

Let's say that you had a certain amount of sales in 1977, and then the year 1978 comes. You have a tremendous decrease in one of your principal sales areas, the Chicago area had an 11-percent increase in the area. But despite the fact you testified that you have had a big decrease in Chicago, for some reason you have a tremendous overall increase.

It means you must be selling much more. That is all I am trying to find out.

Are you selling much more in other areas?

Mr. SMITH. I think I can answer that. I think your original question was what has schedule IV done to our sales? And, predictably, what it will do in the future of our sales is difficult to understand.

Does that answer your question ?

Mr. RAILSBACK. Have your sales gone up in all of your other reporting areas?

Mr. SMITH. Right. That is what I am saying. Nationally our attainment of 131 percent of quota would indicate that our sales have gone up considerably.

Mr. RAILSBACK. They have gone up dramatically everywhere else, but in one of your principal areas, where they have gone down?

Mr. SMITH. Right.
Mr. RAILSBACK. That is what I am trying to get at.

Mr. RODWIN. If I may, Mr. Nellis requested these figures, and they were provided to the committee. It is in the schedule we furnished to you, showing precisely these figures. They didn't include the third quarter, and we would be happy to furnish those.

Mr. RAILSBACK. That would help.

Mr. SMITH. I think an interesting point to be made, and it was interesting to me, is that we are talking about the effect of schedule II on 50 milligram. But I could also say that the compound, the injectible, and total Talwin sales have been affected with a schedule II.

Mr. RAILSBACK. Let me just ask you one other question. I think you have testified accurately and truthfully about the effect. You have given us your facts on the effect of schedule II designation. There has been a tremendous drop. Now, to what do you attribute that drop caused by schedule II ?

Mr. SMITH. I would primarily say—and perhaps the doctor could answer this also, but there is concern on the part of the physician. There is confusion on his part. There is question as to what he needs to do. There is concern on the part of the patient because you have to admit that there has been a great deal of publicity and exposure on the television. And to some patients the name Talwin has become a household name, something to identify with; where, heretofore, they didn't know the product, they didn't identify with it.

Mr. RAILSBACK. I understand. I think, again, you are answering truthfully. But what the requirements are of schedule II, as I understand it—are separate recordkeeping, more accurate records, prescription in writing.

What I don't understand is where you have something where there is evidence that it is being seriously misused, aside from your tremendous dropoff in sales, which I can understand from an economic standpoint. But if you are also concerned about the public and the problem, I would think that just the fact that you have to keep better records, I would think you would want to be very cooperative.

Dr. SPEIR. We do want to be cooperative, Mr. Railsback. Insofar as the drop represents a decrease in misuse, we are all for it.

Mr. RAILSBACK. Do you think it does, in the Chicago area? Do you think that represents a decrease in misuse in the Chicago area?

Dr. SPEIR. I think that part of it undoubtedly does.

Mr. RAILSBACK. Or don't you? Based on everything we have heard, even from you, I would think without a doubt it represents a substantial decrease in misuse.

Dr. SPEIR. That part of it we are in complete agreement with. What I would be concerned about is to what extent it represents a lack of use of this drug for its general medical indications. There is a fair amount of evidence to suggest that putting anything on schedule II tends to decrease its use, its proper use by physicians or patients in pain.

Mr. RAILSBACK Even more important, maybe, is misuse, if it has been misused.

Dr. SPEIR. There are these tradeoffs when you have controls. To what extent can you get one without the other.

Mr. NELLIs. One last question. Mr. Smith, I think I have heard you use the word "quotas.” I am curious to know does the company place sales quotas on detailmen and on your men with respect to the sales of Talwin?

Mr. SMITH. With respect to our entire line; yes, sir. Mr. NELLIs. But on Talwin, specifically, they tell you, “This is your quota for the year out of this division."

Mr. SMITH. We do it on a smaller scale than that. We do it on a quarterly basis. We set target projections. Sure; they are salesmen, and they are expected to sell.

Mr. ÑELLIS. To sell up to that target projection?
Mr. SMITH. Hopefully to meet their projection.
Mr. NELLIS. Which is a quota?
Mr. SMITH. Yes, sir.

Mr. NELLIS. If they don't meet that quota, there are adverse circumstances, are there not?

Mr. SMITH. No, sir.

Mr. NoLLIS. Well, the guy on the bottom of the totem pole isn't going to win the trip to the Hawaiian Islands.

Mr. Smith. That is right. He wouldn't be the one to get the glory.

Mr. NELLIS. What I need to know then, Mr. Smith—and, Dr. Speir, perhaps you can answer this question—when an ethical drug company places sales of dangerous drugs, aren't you adopting a promotional technique that is probably more apparent in the soap business than the ethical drug business?

Why would anyone want to promote a dangerous drug beyond its legitimate medical need? Why would you want to tell doctors who don't want to prescribe Talwin that they ought to prescribe Talwin?

Dr. SPEIR. I don't think we put it in that way, Mr. Nellis.
Mr. NELLIS. How do you put it?

Dr. SPEIR. I would put it we want to offer them the information about its appropriate use. It is up to them to decide.

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Mr. NELLIS. You must agree, being a doctor yourself, that detailmen who advertise, and advertising in JAMA results in some response from the medical profession?

Dr. SPEIR. Yes; it does. And all I can tell you is there is a continuing dialog and sometimes a rather tense dialog between those who wish to push the marketing and those who feel there are constraints to be put



Mr. Nollis. Doctor, I am sure you, as a doctor, would respond favorably to my suggestion that this committee has seen so many of the instances of the promotion of dangerous soap, or frosted flakes, it becomes very, very difficult to distinguish between what an ethical company should be doing and what it is doing.

I understand you indicated in your submission to the Illinois Dangerous Drug Commission that you engaged in a promotion in Talwin in 1977; is that true?

Dr. SPETR. There are advertising plans; yes. The marketing people made decision as to which areas of our market they wish to

Mr. NELLIS. Was there an Illinois or specific Chicago-area promotion of this drug?

Dr. SPEIR. Not to my knowledge, I believe these are all done on a national basis, but I cannot give you expert opinion.

Mr. SMITH. In answer to that, Mr. Nellis, we offer to major key accounts for example, the wholesaler like Mr. Zahn-an opportunity to buy our product.

And we perhaps might give dating—we might give an off invoiceand all of these are inducements to

Mr. NELLIS. You do more than that. You give free goods, don't you? Mr. SMITH. No; we don't. It has not been our policy; no. Mr. NELLIS. Do you offer cooperative institutional advertising? Mr. SMITH. Not with ethical prescription pharmaceuticals. Mr. Nellis. What inducements might you give ? Mr. SMITH. A dating of 60 days, extra dating, 55 percent off invoice; whatever it is, it is a decision in headquarters. There are several reasons for this. It is cash flow reason, and they are able to move product.

Mr. NELLIS. Mr. Chairman, I could go on for a couple of hours, but I am sure you don't want me to.

Mr. Chairman, the material we have from the company, as Mr. Rodwin has suggested, may be confidential. You are talking about the schedule ?

Mr. RODWIN. Yes, Mr. Nellis, I represented that it was.

Mr. NELLIS. Under those circumstances, I recommend it be kept in the files rather than put on the record. Is that agreeable, Mr. Chairman?

Chairman MURPHY. Yes; that is agreeable.
Mr. Zahn, do you wish to say anything?
Mr. NELLIS. We have to get Mr. Leach's testimony first.
Chairman MURPHY. Oh, Mr. Leach.



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Mr. LEACH. Mr. Chairman, and members of the Select Committee, in view of the fleeting time and, I am sure, your interest to maintain a schedule, and, finally, in view of the fact you have our prepared statement, I would simply offer to give you a very brief outline of the statement and then be willing to answer any questions.

Is that agreeable?

Chairman MURPHY. Your statement will be made part of the record, without objection; and you may say what you want.

Mr. LEACH. Then, let me tell you, I am director of product management for CIBA Pharmaceutical Co., a division of CIBA-Geigy Corp.

The product that is being discussed from the CIBA standpoint today is Pyribenzamine, or PBZ; and this is CIBA's trademark for tripelennamine.

Tripelennamine is an antihistamine which has been on the market as a prescription drug since 1946. Pyribenzamine is recommended for the control of signs and symptoms associated with various allergic conditions.

In the 32 years Pyribenzamine has been on the market it has had an excellent record of safety when prescribed in accordance with information contained in the approved package insert or labeling. Likewise, over this one-third century the effectiveness of this product has been repeatedly demonstrated.

A careful review of the records and data maintained by the company indicates that Pyribenzamine in itself, when taken orally, does not produce tolerance, physical or psychological dependency, and thus lacks abuse liability. It has never been a controlled substance under Federal law or any State law.

Sporadic reports, often confined to geographic areas of the country known to have a drug problem, are occasionally received describing the misuse of this drug in combination with other drugs. Such use is usually associated with hardcore narcotics addicts, a population who will abuse most anything they can get their hands on.

The pharmacological basis for this addict's selection of this particular antihistamine or any other antihistamine is at the present time unclear. We have reviewed the reports regarding the recent illicit use of Talwin and Pyribenzamine in combination and we simply do not know the pharmacological rationale for combining these two drugs.

As Dr. David Fedders has recently stated in the Cincinnati Journal of Medicine, “Pyribenzamine is an antihistamine. Why this particular one is selected for the T and B combination is unclear. It is not known to be addicting

You have inquired how a company can discover abuse of its products. In the case of a product like Pyribenzamine, a product long marketed without any problem, we are no more able than law enforcment agencies to guess whether our drug will be tried by habitual drug users.

The company's experience about a drug comes from clinical trials it conducts, experience reported by physicians, and experience reported

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