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in the literature. The company's clinical trials are done with the drug used properly, not with simulated abuse.
The other sources of information, the medical community and the medical literature are likely to report past events; that is, abuse which has already occurred.
Finally, you have asked about what initiatives a manufacturer can take to insure the safe use of its products. Once a drug has been manufactured and packaged, the manufacturer has the responsibility of employing all reasonable control systems to insure that this product is eventually dispensed to the ultimate legitimate consumer.
Such a system is employed for distributing CIBA products to only licensed wholesale, retail, and hospital outlets. Each of these must verify to CIBA that they have met all necessary State and Federal requirements for dispensing or distributing drug products.
Beyond this, the manufacturer has the responsibility to cooperate fully with any law enforcement or regulatory agency in monitoring the safe use of drug products. We recognize this responsibility and have historically cooperated with these agencies.
Now, the remainder of the statement has to do with the sales figures, national sales figures, as well as figures related specifically to the Chicago area. If there are any questions about these, I will be happy to respond to these questions.
Mr. MURPHY. Well, Mr. Leach, the same questions we asked Sterling Drug Co., I suppose could be asked of your company with regard to your antihistamine.
Were you inquisitive at all about the use of your drug in the last few years here in the Chicago area, the increased use shown by the graphs of the Illinois Public Aid Society, Public Aid Department?
Mr. LEACH. Mr. Chairman, today is the first time we have seen these graphs. One of the reasons we have not been particularly concerned about any potential problem with Pyribenzamine is the fact that its sales have shown a steady decline, and I think that this is shown from the sales figures that we have presented.
That decline has been, for the most part, a nationwide decline.
True, there are peaks and valleys in this, but this is a seasonal product. It is an antihistamine.
This past year we had quite a high pollen count throughout the country.
Mr. NELLIS. One question, Mr. Leach. When did you first become aware that your product was being used in combination with another product to produce substitute euphoria ?
Mr. LEACH. We became aware of the incident related to the Mohawk Clinic, and Curtis Pharmacy in particular, when this became public knowledge.
As a matter of fact, this was brought to our attention by our Chicago sales office. Subsequent to this knowledge, a representative of our home office came to Chicago and met with company managers, sales managers, as well as sales representatives, and informed them of the problem, as well as the implications of this problem.
Mr. NELLIS. And when did you say that was- -a few months ago?
Mr. LEACH. Yes, sir.
Mr. NELLIS. I wonder, Mr. Leach, did it occur to you-and, if not, there must be a reason-did it not make sense for you to get in touch with the manufacturers of Talwin and try to work out something between you with respect to this problem of abuse of the two substances together?
Mr. LEACH. Sir, all of the information that we had seemed to indicate that no one really knew anything about Pyribenzamine was the drug, the antihistamine that was selected or why even an antihistamine was chosen to be the drug.
Mr. NELLIS. You could have gone to the DEA or to the Illinois Dangerous Drug Commission, Mr. Kirkpatrick, or contacted any one of a dozen Federal, State agencies and found out what the problem was.
What I am getting at is why is it that drug manufacturers, pharmaceutical houses, are so reluctant to get involved in the public problem when it surfaces to the point where it is in the newspapers every day or on television every other day?
I don't understand it.
Mr. LEACH. I think in this case that the main reason that we were not getting involved with this situation is because we had no evidence that indicated that Pyribenzamine was the problem. And as I have already indicated, the sales of Pyribenzamine have shown a steady decline since 1952.
I think that, however, historically, CIBA-Geigy has been directly involved and has cooperated fully with DEA. And I will mention a drug that one of my colleagues has already mentioned, and that is the drug Ritalin, which is a CIBA product. And I think that the record will show that when this became a problem, then we agreed for a schedule II for this product.
Mr. NELLIS. When Ritalin became an abuse problem, the company agreed to a schedule II for the drug, is that right? Mr. LEACH. That is correct.
Mr. NELLIS. I only want to ask this last question because it occurs to me that it might be useful for the manufacturers to consider. You have a Pharmaceutical Manufacturers' Association. I take it you both belong to it!
Mr. LEACH. Yes, sir.
Mr. NELLIS. Would it make sense, as part of your regular meetings, to discuss drugs of abuse, particularly now that we are having such an enormous problem in the United States with manufactured drugs, so as to be prepared to meet some of these emergencies when they arise?
Mr. LEACH. I think that certainly does make sense.
Mr. NELLIS. I hope you will take that into account, because the committee would like to see that done.
Mr. LEACH. We will.
Mr. MURPHY. Mr. Leach, you indicated in your testimony that the PBZ sales in the Chicago area did not alert your company to any irregularities in the movement of PBZ. And to support this, you indicate that the total national sales for the quarter in May 1978 decreased by a percent over a similar quarter in 1977.
However, the materials submitted to the committee by CIBA, indicate that the Chicago area sales of the 50-milligram PBZ tablet, the
form reportedly abused, did not decrease in that order, but increased.
Furthermore, when compared to cities randomly chosen by CIBA for comparative purposes, Chicago area sales are the only ones which increased during that quarter. How do you explain that?
Mr. NELLIS. Mr. Leach, the real point of the chairman's inquiry is this: There seems to be a parallel in the Chicago area on sales of Talwin and sales of Pyribenzamine. They move on parallel tracks. And when one goes down, the other goes down; one goes up, the other goes up.
All we are saying, then, is that for some reason the addicts have selected your product as a companion product to Talwin with which to effectuate this euphoria. That's all we are saying.
Mr. LEACH. OK.
Mr. LEACH. Sure. Sure. However, I would point out that the figures that you are showing there are figures from medicaid. Is that not correct?
Mr. NELLIS. The graphs, yes. That shows sales by medicaid. But it is pretty typical of the community.
Mr. LEACH. OK. I would simply point out one other thing. And that is that CIBA is not the only manufacturer and distributor of the product tripelennamine. It is no longer a patented product. And there are now some 25 additional either manufacturers or distributors. I simply mention that.
Mr. MURPHY. We appreciate your testimony, Mr. Leach. [Mr. Leach's prepared statement appears on p. 490.] Mr. MURPHY. Mr. Zahn.
TESTIMONY OF MELVYN ZAHN, PRESIDENT, LOUIS ZAHN DRUG
CO., ACCOMPANIED BY MARVIN KAMENSKY Mr. ZAHN. Well, due to the shortness of time, Mr. Chairman, I would just like to ask that my written testimony be made a part of the record. If you have any questions, I would be more than happy to answer them.
Mr. NELLIS. Yes; I would like to ask Mr. Zahn a couple of questions.
Mr. Zahn, your company apparently furnished a large percentage of the 3 million Talwin tablets that we talked about earlier. You were here. And I am wondering, didn't there come a time when you were alerted that there was an inordinate amount of movement of that product through your wholesale distributorship?
Mr. ZAHN. Was there a time?
Mr. NELLIS. Did there come a time when you were alerted to an inordinate amount of movement of this product?
Mr. Zahn. When certain agents from the State of Illinois came to us, we checked it and found that to be true.
Mr. NELLIB. But until you were alerted by agents of the State, you said
Mr. Zahn. Right.
Mr. NELLIS [continuing). You had no knowledge you were ordering a much larger quantity than the year before!
Mr. ZAHN. No. Mainly, that is because we order 99 percent of our products by computer.
Mr. NELLIB. The computer doesn't tell you when a dangerous drug is being ordered in heavy quantities?
Mr. Zahn. Nobody told us it was a dangerous drug. Mr. NELLIS. You didn't know that Talwin was a dangerous drug? Mr. Zahn. Are you asking me personally? Mr. Nellis. Yes; personally. Mr. ZAHN. No. Mr. NELLIS. You know it now, though? Mr. ZAHN. I sure do. Mr. NELLIS. Let me ask you this: When you were alerted by the State agents about the inordinate distribution of this product, what did you do, if anything!
Mr. Zahn. We programed our computer to try and work with the law enforcement agencies to come up with more specific information for them so they could carry on their investigative work.
Mr. NELLIS. What kind of information, Mr. Zahn?
Mr. Zahn. Right. It is a breakdown that we now give to the enforcement agency of Illinois when they come in and ask us. We can show them by month exactly who ordered Talwin, what days they ordered it, and how much they ordered.
Mr. NELLIS. Do you know the gentleman sitting on your right?
Mr. Zahn. He is the regional manager of our area. He is not the salesman.
Mr. NELLIS. Who is it that calls on you!
Mr. NELLIS. Where does Talwin fit in that category? Which buyer would you select ?
Mr. Zahn. Pharmaceuticals. We have one buyer that buys all our pharmaceuticals.
Mr. NELLIS. What is his name?
Mr. NELLIS. He is the gentleman that makes the purchases from Mr. Smith's salesman ?
Mr. Zahn. He is the one that signs the purchase order; right.
Mr. NELLIS. When he signs them, is that the end of it? You don't have to review what he orders ?
Mr. ZAHN. No.
Mr. NELLIS. Well, my last question, Mr. Zahn, is this: Does your computer ever kick out information concerning inordinate requests to buy a particular drug?
Mr. ZAHN. No.
Mr. NELLIS. For instance, suppose your Demerol sales were to treble in a month. Would you know about it?
Mr. Zahn. I am sorry, what about the Demerol?
Mr. NELLIS. If your sales of Demerol were to treble in one month, or percodan or tolpane or quaalude. Let's take quaalude.
Mr. Zahn. No; it would not kick out. However, we do send the monthly reports to the government listing every purchase or every sale that we make
class II item. Actually, we do it two ways. We send the customer a listing every month. And a copy of that goes to the law
enforcement agencies. Mr. MURPHY. How do you do that, Mr. Zahn?
Mr. Zahn. Through our computer. We also send the record to the Government in Washington on a report called RCOS, which is a report that lists every class II and some class III drugs, showing who they were shipped to, what quantities they were shipped, and the date they were shipped.
Mr. MURPHY. Mr. Zahn, the committee requested certain data from you regarding your sales of Talwin in the Chicago area. Since you have this sophisticated machinery, the committee wonders why you have not been able to provide the committee with that request of the sales.
Mr. Zahn. I have it with me.
Mr. Zahn. I have the sales of Talwin. You asked for the Chicago area. We don't break our sales down that way.
Mr. MURPHY. How do you break them down?
Mr. Zahn. Actually, we just break our sales down by customer. We don't even break it down by product.
Mr. MURPHY. You tell me you send a schedule II.
Mr. Zahn. Now, we do. First of all, I am talking about Talwin. So, therefore, it is not a class drug.
Mr. MURPHY. But your computer would be able to do it, would it not? Obviously, Talwin is in the computer by either a signal name or its generic name or its commercial name.
Mr. Zahn. Now, I can do it.
Mr. Zahn. Back last fall, we reprogramed our computer. We can do it now, but it can't go back.
Mr. MURPHY. You cannot supply this committee with your sales of Talwin for the last 2 years, gross sales?
Mr. Zahn. I can. I brought them with me. I just failed to put them in the testimony.
Mr. NELLIS. Do you have them with you?