34th Annual Scientific Meeting of the Committee on Problems of Drug Dependence. National Research Council, National Academy of Sciences. May, 1972.

60. Wellisch, David K., Gay, George R., Wesson, Donald R., and Smith, David E. The Psychotic Heroin Addict. Proceedings of the 34th Annual Scientific Meeting of the Committee on Problems of Drug Dependence. National Research Council, National Academy of Sciences. May, 1972.

61. Gay, George R., and Vega, Jonna: The Role of the Ex-Addict in Drug Abuse Intervention. Drug Forum 2(2) 99-102, 1973.

62. Gay, George R., and Sheppard, Charles W.: "Sex-Crazed Dope Fiends"! -Myth or Reality? Drugs in Youth. pp. 149-163 Pergamon Press, 1972.

63. Gay, George R.: Doctor, There's an Unconscious Junkie in your Waiting Room. Contemporary Drug Problems 1(4), 735-746, 1972.

64. Gay, George R.: Emergency Treatment and Detoxification. Proceedings of the 18th Annual AMA Conference of State Mental Health Representatives. Scottsdale, Arizona, April 14, 1972.

65. Gay, George R.: The Haight-Ashbury Free Medical Clinic Drug Detoxification, Rehabilitation, and Aftercare Project. Journal of Psychedelic Drugs. 5(1), 1972.

66. Smith, David E., and Gay, George R.: A Free Clinic Approach to Drug Abuse. Presented at the Pan American Medical Association, 1972.

67. Wesson, Donald R., Gay, George R., and Smith, David E.: Sociological and Political Issues of Barbiturate and Amphetamine Abuse. Journal of Psychedelic Drugs. 5(1), 1972.

68. Gay, George R., Inaba, Darryl S.. Newmeyer, John A., and Sheppard, Charles W.: A New Romance For an Old Old "Girl"; Cocaine in Pharmacological and Sociological Perspective. Journal of Psychedelic Drugs. 5(1), 1972. 69. Gay, George R.: Evolution of Drug Abuse Patterns in The Nixon Era. Presentation at Centennial Celebration, University of Missouri Medical School, 1972.

70. Gay, George R.: "The Battered Flower Child". Inside the Emergency Department. Proceedings, 3rd Annual American College of Emergency Physicians. 9-15, October, 1971.

71. Gay, George R.: "Marijuana and Sex". Human Sexuality 6(9), 1972.

72. Gay, George R.: Immediate Care in the Drug Scene. Hugh E. Stephenson, ed. pub. 1972.

73. Gay, George R., Sheppard, Charles W.: A Gift From the Gods for Relief of Man's Suffering, or "Public Enemy No. 1" A Study of Heroin. National Clearinghouse of Drug Abuse Information. Washington, D. C., 1972.

74. Gay, George R., Sheppard, Charles W., Inaba, Darryl S., and Newmeyer, John A.: Gift from Sun God to Rich Man's Drug: Cocaine in Perspective. Drug Forum, 1972. In press.

75. Gay, George R.: Methadone: Snake Oil for the 70's. Consultants' Editorial. Hospital Physician. 21 February 1973.

76. Gay, George R.: Heroin 'Epidemic' Abating, Expert Says. American Medical News 15(50) 8, 1972.

77. Gay, George R.: Treatment of Overdose: Medical Complications of Drug Abuse. A.M.A. Conference. Washington, D.C. December 7, 1972. (Reproduced, Audio Digest Casettes, A.M.A.)

78. Smith, David E.. Gay, George R., Matzger, Alan D., and McEntee, Roseann: Pioneering Free Clinic Confronts 'New Wave' of Heroin Epidemic. American Medical News. 13: 10-11, December 21, 1970. (Reprinted in Byrd, Oliver E., and Byrd. Thomas R.: Medical Readings on Heroin. Boyd and Fraser Pub., San Francisco, 1972.)

Medical illustrations for:

1. Thompson. Ian M.: Incontinence Following Prostatectomy. Journal Urology 86: 130-133, 1961.

2. Thompson, Ian M.: Management of Exostrophy of the Urinary Bladder by Primary Closure. Southern Medical Journal. 54: 1069-1073, 1961.

3. Thompson. Ian M.: Ureteral Reimplantation: A Variation of Two Surgical Themes. Journal Urology. 86: 232-234, 1961.

4. Engley, Frank B., Jr.: Guide to Medical Microbiology. Little, Brown and Company, Boston, 1963.

Films:

1. Management of the Psychedelic Emergency: Network for Continuing Medical Education, June, 1970.

2. Consultant for Darkness, Darkness. January, 1971.

3. Documentary on Heroin Abuse. National Institute of Mental Health, March, 1971.

4. Treatment of Acute Heroin Toxicity. The Network for Continuing Medical Education, May, 1971.

5. The New Heroin Scene: A Perspective for Physicians. The Network for Continuing Medical Education. June, 1971.

6. "O.D.". Pfizer Pharmaceuticals, March, 1972.

7. The Emergency Treatment of Drug Overdose. Eli Lilly, Inc., 1972.

8. Television Special: "Tell It Like It Is" (With Aaron Stern, Norman Doorenbos, and Thomas Ungerleider). (Nominated for "EMMY" Award in Public Service).

9. Television Documentary: "The G.I. Junkie".

10. "Junkies Are People". Haight-Ashbury Films, Inc., June, 1972. In addition, appearances in over 70 drug abuse prevention films.

Senator BAYH. Our next witness this afternoon is Dr. Leslie M. Lueck, vice president of quality control and government regulations, Parke, Davis & Co., Detroit, Mich.

Mr. Lueck, I appreciate your being with us here this afternoon, and hope that the earlier statement that I made relative to who was subpenaed and who was not will relieve whatever grief may be caused by the earlier misinterpretation.

[Discussion off the record.]

Senator BAYH. Again, my appreciation for your being here, and your company's willingness to let us have your thoughts on this subject. Please proceed.

STATEMENT OF LESLIE M. LUECK, PH. D., VICE PRESIDENT, QUALITY CONTROL AND GOVERNMENT REGULATIONS, PARKE, DAVIS & CO., ACCOMPANIED BY MR. CHARLES LENTS, DIRECTOR OF REGULATORY AFFAIRS, PARKE, DAVIS & CO., AND MR. GERALD E. GILBERT, HOGAN, AND HARTSON

Mr. LUECK. Thank you, Mr. Chairman.

My name is Leslie M. Lueck. I have been employed by Parke, Davis & Co. for almost 20 years and I am presently vice president of quality control and Government regulations. As requested by the subcommittee chairman, a biographical sketch is included with this

statement.

Senator BAYH. We will put your statement in the record at the conclusion of your remarks.

Mr. LUECK. I would like to thank you for the opportunity to be here with you today. I have with me in the hearing room Mr. Charles Lents, the gentleman with the gray suit, who is our director of regulatory affairs for Parke, Davis & Co., and Mr. Gerald E. Gilbert of the law firm of Hogan and Hartson, our Washington counsel, and Jerry is in the blue.

Senator BAYI. I think he is the one that expressed, shall I say moderate concern.

Mr. LUECK. Going on with my prepared statement, I wish to express, on behalf of Parke, Davis & Co., the grave concern that we have over the national problem of drug abuse, demonstrated by this

subcommittee, and to state most emphatically that the concern is shared by Parke, Davis & Co.

cipally as a prescription house engaged in the manufacture and disAs you know, Mr. Chairman, Parke, Davis & Co. is known printribution of drugs for over 100 years. We are particularly concerned with the abuse of methaqualone since Parke, Davis & Co. manufactures and distributes this drug for legitimate medical uses on prescription by a licensed physician. For this reason, we welcome the opportunity extended by the chairman to express our views on the issues of methaqualone diversion and abuse.

We wish to state at the outset that Parke Davis recognizes the serious abuse problems with methaqualone which is currently subject to only prescription restrictions. Because of its misuse we wish also to state that the company is of the strong opinion that this drug must be controlled under the Controlled Substances Act of 1970. Parke, Davis will not oppose any scheduling determined to be necessary to control the illegitimate use of this drug.

Before addressing ourselves to the abuse and control issues, we believe it would be helpful to the subcommittee to relate the company's history of manufacturing and distributing this drug, and the reasons why we believe it should remain available through legitimate channels, even though controlled.

Parke, Davis & Co. initiated sales of a 200-milligram methaqualone capsule in the first quarter of 1970 and added a 400-milligram methaqualone capsule in the last quarter of 1970. These new products were in response to a recognized medical need for a nonbarbiturate sedative-hypnotic agent for a significant patient population. Additionally, it was well recognized that the barbiturates were becoming more and more susceptible to drug abuse. This latter fact was dramatically brought home to the public and the professions in this subcommittee's hearings on S. 3538 and S. 3539 just last year.

As one would expect, there has in recent years been a shifting of the prescribing and drug specification of sedative-hypnotic agents by physicians to the nonbarbiturates. Parke, Davis' sales of methaqualone have increased in its short marketing history in conjunction with this compounded relationship, that is to say normally expected increases in years following new product introductions and the declining sales position of the barbiturates for the safety and abuse reasons mentioned previously.

Current market trends indicate that the total barbiturate sales in recent years are down; total nonbarbiturate sedative-hypnotic sales are fairly constant with population size. Independent market sources show that Parke, Davis' methaqualone sales are closely accounted for by physicians' prescriptions and hospital usage. I want to hasten to add, however, that these sources are not sufficiently precise to determine the degree of abuse resulting from diversion of products that are distributed through legitimate channels.

We believe the value of methaqualone as a legitimate drug should be brought into perspective. A single capsule of methaqualone is a very safe and useful medication when prescribed by a physician for the purpose for which it is intended, mainly to help a person suffering from the distressing effects of insomnia to get a good night's

sleep. It is a dangerous medication when it is used in excess doses in order deliberately to induce a state of inebriation. An analogy might be made to a sharp knife. It is excellent for its purpose and dangerous when misused.

Many people suffer from serious insomnia caused by a variety of medical conditions. Making effective medications unavailable to them will not only increase their distress, but also can aggravate their underlying illnesses. Methaqualone has important clinical advantages in the treatment of insomnia in that when taken in normal doses it does not produce the depression of heart function, blood pressure, and respiration that some of the other drugs do. In addition, it does not cause the abnormal druglike sleep that drinking too much alcohol or taking barbiturates do. There is little or no depression of what scientists call REM sleep, which is the few hours of most restful sleep which one would experience in the course of 8 hours sleep.

There is seldom a hangover effect so often experienced with barbiturates and with alcohol. In elderly people, and in people suffering anxiety from heart attacks and debilitating diseases, methaqualone sometimes satisfactorily helps insomnia when other agents fail. However, any good medicine when taken in excessive doses may be dangerous. We feel that methaqualone is a good medication when used properly.

One of the leading and most up-to-date textbooks in pharmacology states, "Almost 100 reports from 15 countries have appeared. attesting to the satisfactory sedation and hypnosis produced by methaqualone, and in most instances that were cited, the patient preferred it to a barbiturate." The same textbook goes on to state that "a decade of clinical use of methaqualone has revealed a lower incidence of adverse reactions from that drug than from the barbiteratures." This is from Krantz and Carr's Pharmacologic Principle of Medical Practice, 8th Edition, 1972.

In spite of the important contribution of methaqualone to the ability of the medical profession to successfully treat and help patients in need of a sedative-hypnotic agent, we again state that we recognize the fact that methaqualone is being abused. This is uncontroverted from the testimony presented to this subcommittee, the evidence documented by the regulatory agencies, and the articles researched by a concerned press. Parke, Davis shares this concern and feels a high degree of social responsibility because we are one of the five distributors of methaqualone. We find no hesitancy in supporting either legislation or regulations which would place methaqualone under the control of the "Controlled Substances Act of 1970." We have publicly and officially stated this position to the regulatory agencies and other responsible individuals.

S. 1252, the Methaqualone Control Act of 1972, introduced by the chairman of this subcommittee on March 15, 1973, would place methaqualone on schedule II. The Bureau of Narcotics and Dangerous Drugs also has proposed that methaqualone be placed on schedule II. This would impose the same type of restrictions on methaqualone as those applicable to the hard-core drugs, including raw opium, codeine, morphine and other opiates. We submit that from an objective, scientific point of view, methaqualone does not have the same char

acteristics as such compounds. The drugs now on schedule II are potentially dangerous and addictive at their normal recommended dosage levels. Such is not the case with methaqualone at recommended dosage levels.

Parke, Davis agrees with the sincere intent behind S. 1252. Something is needed to protect the public from abuse of methaqualone and the abuse of similar drugs in the future. It is difficult and frustrating to see delays in arriving at an effective enforcement posture. The difficulty in arriving at this effective enforcement posture appears to relate in large part to the statutory requirements of the above act in scheduling a product of this kind. The Bureau of Narcotics and Dangerous Drugs must make a detailed and documented history of misuse of the product and justify the need for its control. Additionally, there must be a scientific and medical determination. as to the proper controlled drug schedule the product should be placed in upon scheduling. This latter determination requires referral to the Department of Health, Education and Welfare on the medical considerations of the product.

Apparently the greatest hindrance in quickly scheduling methaqualone by regulatory agencies relates to a lack of scientific data upon which to determine the physical and psychological dependence characteristics required by schedule II. Indeed, this point is brought out in the recent Bureau of Narcotics and Dangerous Drugs', "Control Recommendations for Methaqualone."

Parke, Davis feels that from a purely technical point of view, one must strain the medical-scientific facts to justify a schedule II classification for a drug such as nethaqualone, and that there will undoubtedly be similar situations involving other drugs in the future. History has shown that drug abusers have moved from one drug to another depending upon their needs, availability, etc. Just as in the current case, there will be drugs that do not fall clearly within the hard core drugs category of schedule II but which are the subject. of serious abuse. Just as in the case of methaqualone, such circumstances will entail procedure delays because of the difficulty in ascertaining the scientific evidence necessary for placing the drug on schedule II. There is always the alternative of placing such drugs in a lesser schedule in a prompt manner and in conformity with existing statutory and regulatory authority.

Senator BAYI. Excuse me just a moment. Off the record. [Discussion off the record.]

Senator BAYI. Mr. Rector will preside in my absence. I have a few questions I hope you will not mind responding to; but there is one that I notice is not on the list that we prepared. I would like to have your thoughts now or submitted later, regarding the type of scientific evidence necessary to support the schedule II classification. I think that we need to recognize that some distinctions may exist between methaqualone and barbiturates, but we must also look at the experience we have had in dealing with amphetamines, Ritalin® and Preludin.R

It is foolish if when we focus on the abuser's first drug of choice, which we know is a problem we do not recognize that there are other similar drugs that we had better try to deal with too. You might address yourself to that at a convenient time.