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thought to be due to a rapid redistribution of the drug from the brain and other tissue.
Data on the reported use of ketamine in primates (NADA 45–290) showed the drug's effects to be somewhat erratic as the dosages for restraint vary from species to species.
A recent letter in The Veterinary Record (July 22, 1978), a journal of the British Veterinary Association, states in reference to alternatives to Sernylan which are commercially viable, the “Ketamine hydrochloride is considerably more expensive and is relatively short-acting. In our experience it is a good drug for a small group of animals but does not lend itself readily to sedation of large groups.”
In a recent phone call (September 15, 1978) with Dr. Bush of the Washington National Zoo he stated that for small primates he preferred to use ketamine but for the larger ones where immobilization is accomplished by utilizing a dart gun, he preferred to use Sernylan because less volume of drug is required. Dr. Bush's comments are based on personal preference but do not speak to expense or duration of effect.
Thus the selection of ketamine or phencyclidine is primarily a matter of personal choice and experience.
The decision of the current sponsors to discontinue marketing in no way reflects on the safety or efficacy and in turn the medical usefulness of the product. It would be scientifically untenable to move the product to Schedule I and essentially deny the marketing by another company that has the security to handle Schedule II drugs.
LESTER M. CRAWFORD, D.V.M.
AMERICAN VETERINARY MEDICAL ASSOCIATION,
Washington, D.C., September 6, 1978. Mr. ANSIS HELMANIS, Office of Legislative Services, Food and Drug Administration, Rockville, Md.
DEAR MR. HELMANIS : This will confirm our recent telephone discussion regard. ing the use of phencyclidine in veterinary medical practice. The American Veterinary Medical Association's Council on Biologic and Therapeutic Agents has recently reviewed this matter and recommends that phencyclidine be continued in Schedule II.
Our review disclosed that phencyclidine is considered to be a particularly effective drug for immobilizing and restraining subhuman primates, particularly in exhibit situations such as zoological parks. While alternative drugs are available for short periods of calming and restraining, none have the ability to modify behavior for periods longer than about three hours. Phencyclidine is used for restraint of subhuman primates in situations where handlers and other personnel could be injured if less effective drugs were used.
Since we understand that phencyclidine, in its veterinary pharmaceutical form, is not being abused and is unattractive for abuse, and is effective for clinical use in subhuman primates, we recommend that it be continued in Schedule II. Sincerely,
W. M. DECKER, D.V.M., Washington Representative.
AMERICAN PHARMACEUTICAL ASSOCIATION,
Washington, D.C., August 4, 1978. Hon. LESTER L. WOLFF, Chairman, Select Committee on Narcotics Abuse and Control, U.S. House of Representatives, Washington, D.C.
DEAR CONGRESSMAN WOLFF: This statement is submitted in reference to S. 2778 and H.R. 11727, a bill relating to increased penalties in connection with phencyclidine and to provide for piperidine reporting. We respectfully request that this letter setting forth our comments be entered into the official record of the hearings being conducted by your Select Committee.
This statement is submitted on behalf of the American Pharmaceutical Association (APHA) which is the National Professional Society of Pharmacists
in the United States. Our membership consists of individual pharmacists practicing their profession as practitioners in community and institutional pharmacies as well as pharmaceutical manufacting, pharmaceutical research, pharmaceutical education, as well as pharmacy students.
APhA has had a long and consistent record of support for both educational and legislative efforts to discourage and control drug abuse. As such, we support the increased penalties proposed in the subject bill relative to the unauthorized manufacture or distribution of phencyclidine (PCP). Phencyclidine has no recognized legitimate use in therapy. On the other hand, it has significant serious abuse potential and efforts to control the article appear to be clearly appropriate in our opinion.
The bill, however, also proposes to establish a new subchapter in the U.S. Code entitled "Subchapter III.-Piperidine Reporting". Our comments in this statement will focus on this latter provision in the bill.
In itself, we are aware of no properties associated with piperidine which would make it attractive to drug abusers. On the contrary, its taste, odor, and related physical properties would make it repulsive to most persons. We are assuming therefore that the intent of this section of the bill is solely to serve as a mechanism to clamp down on the availability of phencyclidine by applying severe controls over one of the compounds (piperidine) used as a precursor in the chemical synthesis of phencyclidine.
Although piperidine is a very logical and convenient starting material in synthesizing phencyclidine, the synthesis requires a fair degree of chemical knowledge and technique as well as chemical equipment and uncommon other precursor chemicals to provide the phenylcyclohexyl portion of the phencyclidine molecule. Given a situation where an unscrupulous person has such knowledge, ability, equipment, and other needed chemicals, then in such situations, piperidine itself could be equally and readily synthesized from various other starting materials. In short, this piperidine reporting provision represents a rather ineffective hurdle to place in the path of persons seeking to make phencyclidine via clandestine synthetic manufacture.
On the other hand, if this measure were to become law, it would work a significant hardship as well as be extremely disruptive to many present-day practices. Specifically, piperidine is a fundamental starting material for the manufacture/synthesis of many other drugs and organic chemical products used in the pharmaceutical industry as well as various other industries including dyes, plastics, cosmetics, foods, etc. Moreover, it is a commonplace chemical not only in chemical research laboratories, but is a common starting material used in laboratory experiments conducted in typical organic chemistry courses of instruction.
We would see relatively little impact of Subchapter III of this bill with respect to the pharmacist engaged in dispensing practice. On the other hand, it would pose a considerable burden at the very least on industrial pharmacists as well as pharmacy educators, pharmacy researchers, and pharmacy students. In evaluating the justification of imposing such a burden, we feel that it is important to keep in mind the likelihood of achieving the intended objective-namely, terminating the source of illicit phencyclidine. For the reasons discussed above, we are of the opinion that it is extremely questionable whether such an objective would be achieved via the mechanism of the proposal for requiring piperidine reporting.
Thank you for the opportunity to submit our views in connection with this pro posed legislation. Sincerely,
WILLIAM S. APPLE.
THE WHITE HOUSE,
Washington, D.C., October 17, 1978. Hon. LESTER L. WOLFF, Chairman, Select Committee on Narcotics Abuse and Control, U.S. House of Representatives, Washington, D.C.
DEAR CHAIRMAN WOLFF: As I mentioned to you last Friday, I am forwarding the Department of Justice's response to several specific questions which the Committee raised after the August hearings on PCP. These comments, together with those from HEW, which I left with you, will be incorporated into the "Federal Response to the PCP Problem."
Again, I plan to give the Committee a status report and evaluation of this effort in early November. I found our discussion on Friday useful and have already taken steps to resolve some of the issues which you raised. I appreciate the time you took from your extremely hectic schedule in the final hours before adjournment of the very productive 95th Congress. Sincerely yours,
LEE I. DOGOLOFF,
Domestic Policy Staff. Enclosure.
OFFICE OF THE ATTORNEY GENERAL,
Washington, D.C., October 2, 1978. Memorandum to: Lee I. Dogoloff, Associate Director, Domestic Policy Staff. From: J. Phillip Jordan, Special Assistant to the Attorney General.
Attached are the DEA-prepared responses to your questions of August 30, 1978. I have discussed these with Dan Meltzer at HEW and we are in substantial agreement.
The only caveat I would lodge concerns DEA's response to Question No. 2. DEA's answer repeats its desire for increased penalties for PCP-related activities. As you know, DEA's push for increased penalties has not been endorsed by the Department of Justice. The Department continues to prefer to consider the penalty structure in the context of the revised criminal code, rather than breaking out certain activities for special treatment at this time. If you have any questions on this score, you should contact Ron Gainer of the Office for Improvements in the Administration of Justice at 739 4601.
1. THE ADVISABILITY OF CONTROLLING ALL PRECURSORS TO PCP AND ITS ANALOGS
The scheduling of drugs by class is not a new idea. It was considered in the scheduling of amphetamines and has been applied to a limited degree in the scheduling of barbituric acid derivatives. In the case of the barbituric acid derivatives the number of drugs controlled is limited by the requirement that the drug produce control nervous system (cns) depressant effects. In most cases this poses a problem for industry because most of these derivatives are not intended for human or animal use and determination of CNS activity has not been made.
There is a large problem with classification of PCP and its analogs. Preliminary work on PCP analogs under one of the DEA contracts suggest that some analogs may be inactive. Another major problem with controlling analogs and precursors is in defining the limits of the drugs to be controlled. DEA had published in the August 1977 issue of Microgram a request for information on analogs of PCP. In that publication, 33 analogs were specifically listed and the possibilities for modification of the molecule with the resulting increase in analogs are limitless. In addition, each analog would have at least one and probably several immediate precursors.
Since PCP and its analogs produce a variety of pharmacological actions and because many of these actions vary with the dosage taken, a limiting factor such as is used with the barbituric acid derivatives (i.e. cns effect) would be difficult to apply.
In addition, hundreds of chemicals used in legitimate industrial processes would be affected if all the precursors of PCP and its analogs were placed under blanket control. The economic impact on industry would have to be closely studied beforo such action is taken.
In light of the foregoing it does not appear to be feasible to control analogs and precursors of PCP except on an individual chemical basis.
2. THE ADVISABILITY OF INCREASED PENALTIES FOR ALL DRUGS IN SCHEDULES I AND II
OF THE CONTROLLED SUBSTANCES ACT
At the present time and without detailed examination of the consequences, DEA considers it inadvisable to propose increased penalties for all drugs in Schedule I and II of the CSA. The necessary studies and research to support such increases are not available or currently planned. At this point in time, and because of the high level of PCP abuse, DEA prefers to restrict its emphasis on increased penalties to PCP and related compounds only.
3. INFORMATION ON THE RELATIONSHIP BETWEEN PCP AND CRIME
There are at least three possible types of relationship between PCP users and crime, as well as the relationship that exists between PCP traffickers and crime. The first relationship would try to establish a correlation between PCP use and the committing of "street" crimes like robbery, burglary, etc. The analogy would be with the correlations shown in some studies between heroin addiction and the crime rate. The information is being obtained by the Census Bureau for LEAA. It should be mentioned, however, that PCP is readily available and much cheaper than heroin, thus greatly diminishing the need to rob and steal to support a "habit”.
Studies designed to determine relationships between PCP and crime are being conducted. In February 1978, a survey of inmates of local jails was initiated by the Census Bureau for LEAA. DEA participated in the development of the drug abuse questions in this survey and set aside a special category dealing with PCP. Thus, inmates of local jails will be asked such questions as: had they ever used PCP? what was their frequency of use, their age at first use on a regular, or daily, basis? was PCP used during the month prior to time first admitted to jail? what was their use at time of first offense for which sentenced to serve time (if a previous offense had occurred) ? and was the inmate under the influence of PCP at the time of the offense (for which presently convicted and in jail now) ? Specific tables relating PCP to offenses should become available in early 1979.
Another survey is being planned by LEAA and the Census Bureau of inmates of State Correctional Facilities. This survey should be fielded sometime next year. DEA will play a major role in developing the drug abuse questions included on the survey instrument, ard it is planned to have a separate category for PCP. Together with the findings from the survey of inmates of local jails, the findings from this planned survey should add significantly to the body of knowledge existing about the relationship between PCP and crime.
A second relationship between PCP users and crime involves violent crimes committed by persons under the influence of PCP. While we know of no statistics available on this relationship, the daily news is full of examples of PCP users becoming psychotic or paranoid and committing suicide and violent crimes. The September 1978 issue of Reader's Digest tells of a 26-year old who killed his mother. The June 1978 issue of Human Behavior relates the incident of a man high on PCP who slit the throat of a woman in a parked car. Afterwards, the man did not remember the incident. Such stories are frequent and have been a major source of the extreme concern about the growing use of PCP.
A third possible relationship between PCP users and crime concerns the idea that a lot of young people are being "criminalized” as a result of being arrested for PCP use. A few years ago, there was a lot of concern that young people were getting criminal records because of marihuana possession arrests, and that this criminal record was worse than the potential harm from using marihuana. There is no data available to show whether a lot of young people are getting criminal records for PCP possession. However, even if this were the case PCP has been documented to be so harmful that health hazards outweigh the damage of obtaining a criminal record.
The fourth type of relationship is that which exists between PCP traffickers and crime. Because the profits obtainable are so enormous, both newcomers and established drug dealers are attracted to the manufacture and distribution of PCP. The assets from the illicit market can be invested either in further illegal drug ventures or legitimate business serving to establish the criminal element in society. Many of those arrested for PCP trafficking are repeat offenders and involved in trafficking in other dangerous drugs or narcotics. Ties to organized crime have also been established. Sam Annerino, who ran a lucrative drug business in Chicago, dealing in PCP, cocaine, and amphetamines, was apparently slain by organized crime figures for withholding illegal drug profits. The enormous return on investment for those dealing in PCP, and the potentially light sentences from being convicted of PCP trafficking, have apparently led organized crime into the illegal drug business.
4. BREAKDOWN OF PCP-RELATED DEATHS (OVERDOSE, ACCIDENT, INJURY, ETC.)
DAWN PCP mentions for the period June 1977 through July 1978, show a steady increase in emergency room mentions from 193 in June of 1977 to 388
mentions in July of 1978. Medical examirer mentions of PCP deaths also show an increasing trend. Attached Table 1 shows both medical examiner mentions and emergency room mentions by month. Attached Table 2 breaks down PCP deaths by month and cause of death.
An alarming statistic in the area of PCP deaths is the increase of PCP in drug related homicides. A total of 8 PCP related homicides are reported in May of 1978 and 5 in June of 1978. Only one PCP homicide was reported during the ten month period prior to May of 1978.
Additional insight is provided by the attached NIDA Services Research Report.
TABLE 1.-DRUG ABUSE WARNING NETWORK, CONSISTENTLY REPORTING EMERGENCY ROOMS, AND ALL MEDICAL
TABLE 2.-DRUG ABUSE WARNING NETWORK, MEDICAL EXAMINERS PCP ONLY CAUSE OF DEATH
5. AN UPDATE OF PCP-RELATED ACTIVITIES
(I understand that Bob Angarola has already been in touch with your staff about this.) Precursor Liaison Program
This program has been conducted for several years by DEA and its predecessor agencies. It consists of carefully monitoring of unusual or suspicious orders for precursors and is based on liaison and voluntary cooperation by 'the chemical industry. DEA field coordinators establish contact with the firms and identify to them the chemicals in which DEA is interested. The firm is requested to give added scrutiny to purchases of the identified chemicals and to notify the local DEA office in the event of an unusual order. As a result of a special meeting in September, specific agents in each field office were