The Illinois Department of Public Aid has noted excessive prescriptions for Talwin. The Illinois Department of Registration and Education has increased the number of actions taken against pharmacies and police reports of street sales have multiplied.

In May 1978, the regional summary for Chicago showed Talwin ranked fifth in drugs of abuse. And its increase has been detected in the south and west side of Chicago as well as in the suburbs and other urban areas of the State.

Since August of 1977, the central intake unit for Chicago drug abuse program treatment programs have processed more than 900 clients seeking treatment for Talwin. This represents 25 to 30 percent of all of the new clients screened during this period.

From April 1977, to April of this year, there were 384 emergency room visits reported in the Chicago metropolitan area.

Nationally, as reported at crisis centers, the major source of Talwin is reported as legal prescriptions from doctors. Street buys make up only one-fifth of the source, but in Chicago, they make up three-fourths of the actual drug source which lends credence to the trend that abuse of Talwin is no longer confined to health service personnel and patients receiving legal prescriptions, but has become a commercial business criminal venture.

In other words, it isn't the doctor prescribing directly to the patient; it is a third party. Now, another party has gotten into this chain and is purchasing and receiving dosage units in the thousands. And in fact, one individual who we have record of, purchased $133,000 worth of Talwin at 6 cents a tablet that could have retailed for $4 million probably wholesale for between $1 and $2 million.

So you see the profit margin is in the millions for an investment of $133,000. So we have got a serious criminal activity ongoing in Chicago where people are not just getting an extra tablet or two of Talwin; they are being sold on the street.

Mr. MURPHY. Peter, may I ask you, is this starting to spread? I know this is a problem in Chicago. Do we find it in our surrounding States now?

Mr. BENSINGER. Yes, we do, Mr. Chairman. And that is one of the reasons why I am convinced we need to have Talwin scheduled. And that process is going on. And we need it reviewed because schedule IV may not be sufficient.

There have been problems identified in Detroit, Buffalo and Syracuse and St. Louis and in New Orleans. And there are other major metropolitan areas.

And Larry Snyder can talk about the Chicago regional area, but it is no longer just a single city problem. And I am concerned about it because it is clearly an abuse, a drug abuse situation, arising out of a lack of a serious penalty, a lack of proper requirements for inventory, for quotas for auditing, for investigative purposes, and relates to the risk and priorities in terms of the addict population with respect to heroin.

In 1975, DEA agents were joined by members of the department of law enforcement for the State and the department of registration and education and established what we call a DIU unit.

The agents at this DIU, the State agents and our Federal agents, realized that several noncontrolled pharmaceutical drugs, including

Talwin and Pyribenzamine were very popular in inner cities and sections with high heroin abuse. Street dealers offered to sell these drugs to undercover agents, but since this wasn't a controlled substance, we in the Federal level would not have had a prosecutable violation. As such, the undercover agents didn't make purchases.

Mr. MURPHY. So it is your opinion, then, Mr. Director, that Talwin should be a scheduled drug and schedule II?

Mr. BENSINGER. It is certainly my opinion that it should be a scheduled drug. We have received authority from HEW, Assistant Secretary Julius Richmond, for a schedule IV. However, I have requested a compliance recommendation to make national survey to develop additional data. And if that data merits it, to report back to HEW its findings on a national abuse situation.

We put a notification in the Federal Register some 3 weeks ago allowing for comments to be made up to a 30-day period. And I wouldn't want to prejudge that until we had that period run according to the law. Then, if there is any objection to having it scheduled in schedule IV, a hearing officer and our administrative law judge will take note of whatever comments are received, evaluate that and make a recommendation to me to change the scheduling in any way, shape or

form.

But I think, Mr. Chairman, scheduling is essential because it will give authorization then for the Federal Government to require inventories. It will require ordering records. It will establish a method by which firm data can be developed. It will not, however, as a schedule II provide for quotas. And it will not have the same penalties. It will have a 3-year criminal sanction and a fine will not be a significant penalty as a schedule II.

Mr. MURPHY. The gentlelady has a question. Mrs. Collins.

Mrs. COLLINS. Mr. Bensinger, what is the difference between a scheduling in regard to the number of refills and the dosages?

Mr. BENSINGER. That is an important characteristic. With a schedule II drug, there are no refills allowed. There is a triplicate order form required. And if it is a nonnarcotic, the penalty is 5 years. And if it is a narcotic, it is 15 years. With a schedule IV, there can be refills limited to five within a 6-month period. There is no quota, and the penalty is 3 years.

Mr. RAILSBACK. Could I just ask one question?

Mr. MURPHY. Mr. Railsback.

Mr. RAILSBACK. Isn't there also a difference in whether they are able to order by phone a schedule II drug? My understanding is they have to have a written prescription unless it is an emergency. And even then, there has to be a followup.

Mr. BENSINGER. Yes, and there is also a much greater limitation on the inventory and pharmaceutical practices with respect to the order forms.

Mr. RAILSBACK. It is a separate recordkeeping.

Mr. BENSINGER. For a schedule II drug. The recordkeeping for schedule II is much more detailed. And the audit trail is much clearer for the investigating agency.

I would make one comment with respect to the type of problems that have surfaced here. In one specific physician's clinic, the usual

prescription was Talwin/Pyribenzamine, Tedral and Valium. The doctor was arrested by the Illinois Department of Law Enforcement, not the Federal Government, and approximately 3,000 presigned Illinois Department of Public Aid prescriptions for Talwin and a few other substances were seized.

These prescriptions lacked only the patient's name and address. In other words, there are 3,000 prescription forms, the department of public aid forms, already signed. And it is obvious that agents could have purchased unlimited quantities of Talwin.

Pharmacists as well as doctors are involved in traffic, I am sad to report.

Mr. NELLIS. Mr. Chairman, excuse me.

Mr. Bensinger, right on that point, the chairman mentioned in his opening statement a problem that is a very serious one that the committee has given great thought to. I'm sure vou have as well.

We have focused on Talwin because Talwin has become such a major problem here in Chicago, but there are a number of other analgesics for which approval has been obtained or is being obtained that have been the same agonistic and antagonistic characteristics as Talwin. What are we going to do about all these new drugs coming on the market? They have got to be scheduled. They have got to be looked at so they don't become a street problem.

Mr. BENSINGER. I think that is correct. I think, chief counsel, you are absolutely right. And our feeling is that new drugs having the same qualities as others on the controlled substance list such as Talwin should be scheduled.

I could call on our technical experts to give you more detailed reasons, but there is a list of them. There is currently a situation where there are three similar drugs. Nalbuthon is one of them. It is kind of an antagonist. You get into some technical terms. And it does have characteristics that our people in compliance and regulatory affairs feel are similar and in abuse potential worrisome to the extent that that prescription drug should also be controlled.

And I think, chief counsel, my answer would be to your question affirmative.

Mr. NELLIS. Mr. Bensinger, I want to follow that up just briefly. DEA is more or less in a position of being a protagonist, an advocate, before FDA. When you propose a schedule, you have to go before FDA in effect and show that the criteria are met. That puts you in the position of being an advocate for a particular scheduling.

What kind of reception do you get from the FDA when you do this? I know you failed in Talwin in 1974, not for trying, but you failed. What is the reason that DEA would fail with an administrative agency that you are equal to ?

Mr. BENSINGER. Well, I am not in a position to speak with personal knowledge about what happened in 1974 because I was not present. Mr. NELLIS. But you are aware of the history.

Mr. BENSINGER. I am aware of the history. And there is now a check and balance between FDA, HEW, and DEA. And we cannot schedule a drug without FDA and HEW's concurrence. We cannot schedule a drug higher than they allow us to put it on the schedule.

We have had situations where there was a hearing relating to PCP which you and members of this committee very dramatically

participated in. And there was quite a discussion about it, what level that drug should be scheduled.

In 1974, we submitted information suggesting and recommending and requesting authority to schedule Talwin. Two years later, FDA and HEW advised us that we didn't have sufficient evidence to justify scheduling.

Mr. NELLIS. Does that mean people have to die or wind up in emergency clinics before you can get a dangerous drug scheduled?

Mr. BENSINGER. I hope not, Mr. Chairman, but the track record on this particular substance is not good in that regard. It has taken from 1974 to September 1978, to get a publication in the Federal Register. That is too long. Too many deaths, too many injuries.

I think the process by which a law enforcement agency by and of itself can't schedule a drug because it is something the medical community needs to evaluate, I accept. But I think the timeliness of exchange of information needs to be improved upon between the different bodies involved. And there are three of them.

I for one want to direct our efforts more in the area of identifying drugs earlier on than what has been the case traditionally.

In 1974, we were concerned about Talwin. We were concerned again about it in 1976 and 1977. And in the meantime, the State of Illinois has acted and scheduled it itself without waiting for the Federal Government to act.

I think they were wise in doing that. I commend them-Tom Kirkpatrick and the Dangerous Drugs Commission, the State Judiciary Committee under the leadership of State Senator Dick Daley and Mayor Bilandic, and the Chicago Police Department for moving.

I think at the Federal level, Talwin will represent one of the major so-called and nonschedule I or II drug problems that our country will have to deal with. And I appreciate the questions. I think they are on point.

Mr. MURPHY. Mrs. Collins?

Mrs. COLLINS. Mr. Bensinger you mentioned about schedule II. You have to have triplicate forms. Does DEA currently receive one of the copies of these forms?

Mr. BENSINGER. For schedule II drugs, yes, it would. And it would become part of the ARCOS recordkeeping system. So we were able in 1976, for example, in San Francisco where we saw tremendous quantities of schedule I and II drugs, schedule II drugs specifically; not schedule I-being ordered and shipped to manufacturers, to a large number of pharmacies in the San Francisco area. For that reason, we directed a major investigation involving literally 26 different pharmacies, dozens of doctors, millions of dosage units, and we were able to have an impact.

A number of doctors lost their licenses. A number of pharmacists and doctors went to jail in Federal penitentiaries as a result of that. With schedule II, that order form will enable us to audit inventories and unusual ordering patterns, and it is important.

Mrs. COLLINS. Do you use it all the time in your work?

Mr. BENSINGER. We do use it. It is a very helpful tool from the standpoint of monitoring national distribution. It is also a good tool to highlight investigative areas that look to be out of Washington with what the dosage requirements would be.

When you have 3 million Talwin units diverted in the city of Chicago, that is a pill for every person, almost.

Mrs. COLLINS. Thank you.

Mr. BENSINGER. In terms of the doctors and pharmacists involved, the DIU unit made a series of drug purchases without prescriptions, although it is a prescription drug, from a registered pharmacist and his apprentice. They purchased Valium, Tenuate, Dexedrine, and some noncontrolled substances purported to be Tylenol and codeine. Talwin was available, but not purchased since it was not a controlled drug. These two individuals were arrested and charged. Within a few days of the pharmacy being closed down, another took its place.

In terms of Talwin's relative availability, we feel individuals and organizations will look to trafficking in Talwin because of the lack of a serious penalty. That is, until there is a control placed on the drug and until at the Federal level penitentiary sentences can be imposed on those breaking the law.

Under schedule IV, Talwin will require strict accounting and recordkeeping by manufacturers, drug wholesalers, pharmacists, and other legitimate handlers. Prescription for these drugs would be limited by law to five refills within 6 months, and, as I indicated, up to 3 years in prison and a $10,000 fine would be levied for the first offense and double for subsequent offenses.

We believe the scheduling of Talwin is urgently needed.

And, Mr. Chairman, that will conclude the formal comments. I would be happy to answer questions and to call upon some very knowledgeable technical experts that deal with this problem right here in Chicago and in Washington on a daily basis.

[Mr. Bensinger's prepared statement appears on p. 484.]

Mr. MURPHY. Your full statement will be ordered printed and submitted for the record.

Peter, in summing up, then, do you see the reduction in the amount as well as the purity in the Chicago area relating to the Talwin problem?

Mr. BENSINGER. Clearly, Mr. Chairman. There is a relationship, and I think individuals in the medical community as well as the law enforcement community would be happy to amplify that testimony. Mr. MURPHY. Any other members of the panel?

Mrs. COLLINS. Yes, sir.

Mr. BENSINGER. Mrs. Collins.

Mrs. COLLINS. Mr. Bensinger, I have a couple of questions I would like to ask.

You mention moving Talwin from schedule IV to schedule II. According to this book, under Criminal Penalties for Trafficking, First Offense, there is a more severe penalty for a narcotic than nonnarcotic. When you reschedule Talwin, will you be able to move this drug from a nonnarcotic to narcotic classification?

Mr. BENSINGER. That will depend upon the decision of FDA and HEW. There is in our opinion good arguments that could be made that this is a narcotic substance. But we would not be the final authority on that. The Department of HEW would be.

Mrs. COLLINS. Speaking of HEW, it is my understanding that it wasn't until September of this year that HEW finally agreed to classify Talwin under the schedule IV; is that right?