Mrs. COLLINS. But you do withhold funding if you see an assistant or provider and abuses coming in?

Mr. MILLER. Yes, we do. There are statutory limitations. We can only withhold funding during 120 days.

We also refer to R. & E., but we don't let that delay our action.
Mrs. COLLINS Thank you.

Mr. MURPHY. Mr. Miller, looking at this graph and the close correlation between the use of Talwin and and T's and Blue's, its ups and its downs, do you compare this with any other State agencies who engage in similar work such as yours?

Mr. MILLER. This information was furnished to the Dangerous Drugs Commission. But I don't know of other State agencies that buy drugs in the volume we do. I'm not sure who else would have this kind of data.

Mr. MURPHY. It would be interesting if you would contact agencies such as yours from States that border Illinois and see if there is some correlation between the use of Talwin and doctors moving interstatewise, back and forth, and maybe even people, the names of patients that may be operating in Gary, Ind., one part of the month and Chicago the next part, Wisconsin the next week or month, and as well as the sellers that sell interstate.

Mr. MILLER. I would be happy to do that. I have quarterly meetings with my counterparts in this region. And this is the type of thing we bring to each other's attention, although we missed the last quarter, and we haven't discussed this.

Mr. MURPHY. I think that would be something to put on your agenda. And if you do find any correlation between it, this committee would be happy to receive that information.

Mr. MILLER. I would be happy to report to you one way or the other. Mr. NELLIS. Mr. Chairman, may this chart be entered in evidence? Mr. MURPHY. Without objection, so ordered.

[The chart follows:]

:

han 78

·Apr. 78,

-July 76 #

July 7

Jume 77

- May 77
-Apr

77

Mar.77

Feb. 77

Item # 00241921 – Pontazocine

Item

77

-Sept.

77

-Aug.77

·Feb. 18

-Jan 78

-Dec. 77

-Now 77

50005029 - Tripelennamme (PBZ)-Number of Prescriptions Paid

(Talwin)-Number of prescriptions Paid

Mr. RAILSBACK. I just have a couple more questions. Mr. Miller. As I understand it, there are restrictions placed on a medical practitioner prescribing certain controlled substances. For one thing, I think that a practitioner must-and if I am wrong, please let me know-conduct a physical examination. I also thought he had to obtain a medical history from the patient.

I am just wondering if our medicaid or our public aid doctors are actually fulfilling their professional responsibility.

Mr. MILLER. Yes, there is. Again, we do onsite audits of the physicians whose records appear strange. In other words, because they always bill for the same drug or same set of conditions or because they prescribe the same drugs.

We will do an onsite review. And if it appears to be a medical question, we will have a peer review.

In some cases, if it appears to be something more blatant, like the relationship between a prescribing practitioner and pharmacy, in this case, we can take action without a peer review.

But we do conduct oversight and selection, both based on the nature of the practice and profiling and randomly, practitioners to be conducted and have onsite reviews conducted of their records and practices..

Mr. RAILSBACK. It really sounds like some of these things were like a factory and turnstile where they were able to prescribe drugs for many people in a very limited period of time.

Thank you.

[Mr. Miller's prepared statement appears on p. 487.]

Mr. MURPHY. Any other questions from the panel?

[No response.]

Mr. MURPHY. We appreciate you coming today, Mr. Miller.
Mr. Buckley, do you have anything to say?

Mr. BUCKLEY. No, sir.

Mr. MURPHY. Or add to the testimony today?

Mr. BUCKLEY. No, sir.

Mr. MURPHY. We would appreciate your cooperation in presenting the committee with the requested information.

The committee stands in recess until 1 o'clock.

[Whereupon, at 11:55 a.m., the hearing was recessed, to reconvene at 1 p.m. the same day.]

AFTERNOON SESSION

Mr. MURPHY. The Select Committee on Narcotics Abuse and Control will come to order.

The witnesses this afternoon will give testimony on the role of private enterprise in regard to this Talwin problem.

Our first witnesses are Robert W. Speir, M.D., Sterling/Winthrop Laboratories; Dan B. Leach, product director, and George Doherty, assistant legal counsel, CIBA-Geigy Corp.; and Melvin Zahn, president, Zahn Wholesalers.

Will the gentlemen please come to the table?

Dr. SPEIR. Mr. Murphy, if I may, I would like to introduce my colleagues, Mr. Roger Rodwin of Sterling/Winthrop and Mr. Hal Smith, who is the regional manager in this area.

Mr. MURPHY. Are they going to testify today?

Dr. SPEIR. I would like to have them with me, sir.

Mr. MURPHY. Will all the witnesses raise your right hand?
[The witnesses were duly sworn by Mr. Murphy.]

Mr. MURPHY. Gentlemen, make yourselves comfortable.
Gentlemen, do you all have prepared statements?

Dr. SPEIR. I do.

Mr. MURPHY. Could you summarize them? Are they lengthy statements?

Dr. SPEIR. No. I will try and give a summary of my statement, Mr. Murphy.

Mr. MURPHY. All right, Mr. Speir, we will hear from you first. Will you identify yourself for the record, and the company you represent?

TESTIMONY OF ROBERT W. SPEIR, M.D., STERLING/WINTHROP LABORATORIES; ACCOMPANIED BY ROGER M. RODWIN, ASSISTANT GENERAL COUNSEL; AND HAROLD E. SMITH, DISTRICT MANAGER, STERLING/WINTHROP LABORATORIES

Dr. SPEIR. My name is Robert Speir, and I am the medical director of the Winthrop Laboratories in New York.

I would like to say at the outset, Mr. Chairman and members of the committee, that we share your concern with this problem. We would like to tell you what we have done in the past to try and prevent such problems from arising and to offer our help in finding a solution to prevent such problems in the future.

Mr. MURPHY. Dr. Speír, would you pull that microphone a little closer to you?

Dr. SPEIR. In response to the request of the committee, we have prepared figures on the production of Talwin and sales in both the Chicago area and nationwide for the past several years and have submitted these to your staff.

In response to the other requests in your letter of September 18, 1978, we would like to outline briefly the development and use of Talwin, or Pentazocine, to use its generic name; then give an account of the internal controls that we initiated starting in 1969 to monitor reports of dependency and monitor the distribution and sales of Pentazocine, and finally to mention our experience with recent reports of the mixed abuse of Pentazocine with Pyribenzamine, or Tripelennamine, to use its generic name.

The origin of Pentazocine goes back to the early 1950's when it was reported that Nalorphine, a drug used as an antidote to morphine and other narcotics, appeared to be an effective analgesic in man. This was the first suggestion that it might be possible to dissassociate analgesia from undesirable effects of narcotics such as dependency.

I won't go into this in any more detail, but there were studies done before this drug was released into the market in the early 1960's at the addiction center in Lexington, Ky., which indicated Talwin did not substitute for morphine or other narcotics.

After the drug was put on the market and the first isolated reports of dependency began to appear, these studies were redone back in the late 1960s at Lexington, and again there seemed to be no ability of Pentazocine to substitute for morphine or other narcotics. And it was very difficult, though possible when you tried very hard, to induce physical dependency.

Mr. MURPHY. Doctor, before you go any further, in talking about the origin of Talwin or Pentazocine, its generic term, you speak of Henry Beecher and Louis Lasagna of the Harvard Medical School. And they reported that the drug probably could be used as an antidote to morphine and other narcotics; it appeared to be an effective analgesic in man. At least the suggestion was there.

Dr. SPEIR. That is right, sir. That is how this all came about, that a morphine antidote seemed to be an effective analgesic. We now know Nalorphine, which at that time was thought to be a strict antagonist of morphine, is a mixed antagonist of the same general group as Pentazocine.

Mr. NELLIS. Mr. Chairman, can I ask one question in that regard? Thank you.

Doctor, I am a little concerned about the starting point. Are you saying that your clinical trials developed information that would show that this particular substance had a minimal potential for dependence? Dr. SPEIR. Yes, sir; that is why it was originally put on the market with the approval of the Government with no Federal controls.

Mr. NELLIS. In 1969 when I was counsel to the Pepper committee, we found Talwin dependence in California. And I contacted Winthrop Laboratories at that time, and I told them that I had been to a hospital in Sacramento where the doctor told me that one of his patients had become dependent, addicted, to Talwin.

That matter was pooh-poohed. It was set aside. No one paid any attention to it. It is in our record of the Pepper hearings.

Dr. SPEIR. It was in the late 1960's that the first reports of dependency did begin to come in.

Mr. NELLIS. What I am trying to find out is why that wasn't found out at the initial trials.

Dr. SPEIR. Because the clinical trials involved, my understanding, about 12,000 patients. After it was released onto the market, there were not thousands or tens of thousands but hundreds of thousands of patients who were given this drug. So the very small potential it had for abuse began to become apparent. There are people who abuse Pentazocine.

Mr. NELLIS. You are saying there wasn't a large enough quantity of people during the clinical trials to show the dependence?

Dr. SPEIR. I think that is one element. The other element, I am sure, Mr. Nellis, is that clinical trials are very carefully supervised by the investigators.

Mr. NELLIS. Are these investigators paid by the company that is seeking the information from the clinical trials?

Dr. SPEIR. Some of them. The drug is certainly supplied to them. They are not paid in the sense, I believe, that you are asking the question.

Mr. MURPHY. Doctor, you say that you tested this clinically before you released the drug on the market?

Dr. SPEIR. This is required by the FDA.

Mr. MURPHY. I understand that. But is there any continuity to that testing, as you say this was about in 1966, the early 1960's?

Dr. SPEIR. Yes, sir.

Mr. MURPHY. Ánd then it go to be a problem in the middle 1970's? Dr. SPEIR. It was apparent by the late 1960's and early 1970's that there was an abuse potential.

Mr. MURPHY. What does your company do? Does it keep testing, monitoring the drug?

Dr. SPEIR. I am going to address myself to that.

Mr. MURPHY. I didn't mean to interrupt you. Go ahead. Continue with your statement.

Dr. SPEIR. A third pertinent study that I would like to point out to you was done here in Chicago in the early 1970's. The question came up, maybe it is not a problem in the laboratory or these very closely supervised hospital situations, but what happens if you have narcotics addicts who are given access to Pentazocine?