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Senator BAYH. They recommended that methaqualone be put on schedule II. HEW and BNDD, those who have been charged with the overall national responsibility, think it ought to be on schedule II. In view of that kind of expertise, it seems to me, takes a lot stronger case than two or three straws that can be presented by individuals who might differ.

We are not going to change each other's minds.

Mr. ECKMAN. We are not going to resolve the scientific question here this morning.

Senator BAYH. No. HEW has already resolved that question and it remains only for the Attorney General to make the final determination, and I hope he will. The only suggestion I might make is that you get a hold of William Haywood, who I understand is your chief security officer, and find out what happened in January, so that it won't happen again.

Thank you, gentlemen. I appreciate the inconvenience to which you put yourself to be with us.

[Mr. Eckman's prepared statement and letter submitted for the record was marked "Exhibit No. 17" and is as follows:]

PREPARED STATEMENT OF JOHN W. ECKMAN, PRESIDENT WILLIAM H. RORER, INC., ACCOMPANIED BY NELSON H. REAVEY-CANTWELL, M.D., M.Sc., PH. D., DIRECTOR OF RESEARCH AND THOMAS E. QUAY, ESQ., GENERAL COUNSEL

Mr. Chairman, I am John W. Eckman, president and chief executive officer of William H. Rorer, Inc. of Fort Washington, Pennsylvania. With me are Dr. Nelson H. Reavey-Cantwell, associate professor of medicine at Jefferson Medical College and director of research of our company and Thomas E. Quay, our general counsel. I am here today in response to this Committee's subpoena of March 27, 1973 to testify on the nature and extent of methaqualone abuse and diversion in the United States. William H. Rorer, Inc. manufacturers and distributes methaqualone under the brand name Quaalude®.

I would like at the outset to clear up any misunderstanding that may have been created by my letter of March 23 declining to accept this Committee's March 12 invitation to testify on March 29. Accompanying my letter was the detailed information responding to the eight questions specifically raised in your letter.

As my March 23 letter to you indicated, the Bureau of Narcotics and Dangerous Drugs on March 15 released its control recommendations to the Department of Health, Education and Welfare for methaqualone. There appeared to be differences between the BNDD recommendations and Rorer's view which, under the controlling statute, would be resolved in a public administrative hearing. Accordingly, I was advised by counsel respectfully to decline to testify because my appearance before this Committee could prejudice the Company by setting out our position in advance of such a hearing. Certainly, there was no intent or desire to withhold pertinent information from this Committee; this we had hoped was made clear by our written response to the specific questions.

Rorer is certainly aware of and concerned about methaqualone abuse in the United States today. We first became aware of methaqualone abuse in this country in early 1972 and we immiediately took steps to define the problem and to determine what we could do to fulfill our corporate responsibilities as a methaqualone manufacturer.

We voluntarily eliminated the mailing of unsolicited samples of Quaalude® to physicians and we have halted all distribution of samples through our representatives who call on physicians. We have always limited the sale of any Rorer product, including Quaalude®, to customers who have furnished us with their BNDD registration number as evidence of their right to handle narcotic and prescription drugs. However, after receiving reports of diversion and abuse, we intituted screening of all Quaalude® orders and we refuse to ship

amounts that are inconsistent with past requirements. We retained the former Commissioner of the Bureau of Narcotics as a consultant and adopted his recommendations for stringent in-plant security measures.

Finally, when it became obvious that abuse was continuing, we wrote to the Director of BNDD expressing our concern and asking that methaqualone be promptly classified as a controlled substance as are many other non-barbiturate drugs in this category.

We think that it is important to view the problem of methaqualone abuse within the context of its medical indications and usage in countries throughout the world for more than 15 years.

A recognized market research service reported that about five million physicians' prescriptions for methaqualone were filled last year in the United States. Additional market research data establish that these prescriptions were written mostly for patients over the age of 40 and for use with patients suffering from such conditions as mental disorders, circulatory disorders, symptoms of senility and in medical and surgical aftercare. The Deputy Regional Chief of Mental Health Services of the Los Angeles County Department of Health Services has written:

"I have had or now have in excess of 500 patients on Quaalude. This experience dates from early 1968 through the present time. A large percentage of the patients who have received the drug, or who are now receiving it are in wellstaffed licensed (State of California) Board and Care Homes and Nursing facilities. We have no patients who are either psychologically dependent or physically addicted to the drug. Therefore to place this drug in Schedule II would be a serious handicap to our prescribing physicians. Due to our tremendous case load and perpetual shortage on psychiatrists, we are unable to see patients as often as we would like to for medication. Thus the need for such a drug as Quaalude is imperative. (Emphasis added) It is safe, clincially effective with little or no side-effects and very dependable. To replace this product in our armamentarium would be a gigantic task within itself."

We think that there is substantial evidence that hundreds of thousands of sick people benefit from the physician-directed use of methaqualone. We feel that the needs of these sick people must be considered in any effort to control the diversion of methaqualone.

We recognize that at these hearings questions have been rasied as to why the distribution of methaqualone is growing, whether the legitimate medical use of methaqualone is increasing and, as a corollary, whether other similar drugs would not be suitable alternatives. For some years, the medical use of barbiturate drugs has been declining as non-barbiturates as a group have increased. With specific reference to Quaalude®, physicians have told us that they are impressed with the lack of cardiovascular and respiratory depression accompanying overdosage of methaqualone as contrasted, for example, with overdosage of barbiturates. Many patients are alive today who attempted suicide with methaqualone and would surely have died had they taken the same number of barbiturate tablets.

On this same subject, we would like to point out that our literature on methaqualone has always outlined very clearly and extensively the dangers of over-dosage and since 1968 has warned against use by persons who cannot be relied upon to handle therapeutic doses, are addiction-prone, or might use it with alcohol or other CNS drug. The Overdosage Section of our package insert starts out with the statement:

"Acute overdosage may result in delirium and coma with restlessness and hypertonia, progressing to convulsions."

In light of these and other warnings about the hazards of overdosage and misuse, we are surprised to have been accused in the press of creating a false image of unlimited safety.

The very symptoms of delirium and convulsions, mentioned above as expected reactions to acute overdose, are often misinterpreted as being withdrawal symptoms associated with addiction.

It is easy to see how overdosage and withdrawal symptoms become confused. Typically, a young abuser exhibiting delirium or convulsions is brought into a drug crisis center or hospital emergency room. Usually it is impossible to determine how many different drugs have been taken or in what quantity or over what period. The physician on duty institutes emergency measures and notes on the chart that the patient is apparently a methaqualone addict suffering

from withdrawal symptoms. In fact, we have investigated each of these situations that have been brought to our attention and in each case determined that the symptoms were those of overdose and not of withdrawal.

In a definitive publication of the World Health Organization in 1970, two of the world's leading authorities on drug dependence review the dependence liability of all then-available non-narcotic psychoactive drugs. They described psychic dependence to methaqualone as "probable" and physicial dependence as "not established". These conclusions were reached after a thorough study of the world literature, including the experience abroad in Japan and elsewhere when widespread abuse of methaqualone occurred, usually in countries where the drug was freely available without prescription.

We have followed carefully the popular press and lay-oriented reports of methaqualone abuse in the United States. We do not believe that any of the reports, including those most recently described to this Committee, differ qualitatively or quantitatively from the literature of abuse in other countries available to Doctors Isbell and Crusciel when they reached their conclusion for WHO. Framed in terms of the criteria in the Controlled Substances Act, we do not believe there exists substantial evidence that abuse of methaqualone produces severe psychological or physical dependence.

In summary, after evaluating the legitimate medical use of methaqualone, its reported street abuse, and the available scientific information on dependence liability, Rorer supports controls for methaqualone akin to those for other controlled, nonbarbiturate sedative-hypnotics. However, Rorer opposes controls that would place methaqualone on a par with morphine and other hard narcotis in Schedule II and make it difficult, if not impossible for the drug to fill legitimate medical needs.

We oppose S. 1252 not only because we believe that Schedule II is scientifically and medically unwarranted, but also because we believe the criteria and procedures of the Controlled Substances Act are fully adequate to resolve the proper scheduling of methaqualone.

We have taken our own steps to protect against illegal diversion of Quaalude, and would cooperate with the prompt adoption of scientifically supportable controls for methaqualone under the Controlled Substances Act.

BIOGRAPHY, JOHN WHILEY ECKMAN

Residence: 511 Hillbrook Road, Bryn Mawr, Pa. 19010.
Born July 20, 1919, Forest Hills, New York.

Education: Yale University, 1937-1938. University of Pennsylvania (Wharton School), B.S. in Economics-1943.

Military U.S. Navy, 1943-1946.

Service: Submarine Officer.

Employment: Smith Kline & French Laboratories, Phila., Pa. 1947-1952, Marketing. Thos. Leeming & Co., Inc., New York. N.Y. 1952–1962, Vice President. William H. Rorer, Inc., Fort Washington, Pa. 1962-1966, Executive Vice President. 1966-present. President, 1971-present, Chief Executive Officer. RorerAmchem, Inc.. Fort Washington, Pa.. 1968-1970, Executive Vice President. 1970-present, President, 1971-present, Chief Executive Officer.

Board Memberships: Member, Board of Directors, First Pennsylvania Corporation.. Phila.. Pa. Trustee and Member of Executive Board, University of Pennsylvania. Vice President, Board of Managers and Executive Committee, The Wistar Institute of Anatomy and Biology, Phila., Pa. Director, Greater Philadelphia Chamber of Commerce. Director, The Haverford School, Haverford. Pa. Director (Past President). Wharton School Alumni Society. Director, Fidelity Mutual Income Investors. Inc.

Other Memberships: American Association for the Advancement of Science. New York Academy of Sciences. Greater Philadelphia Committee for the Medical-Pharmaceutical Sciences. Crime Commission of Philadelphia. Division Chairman, United Fund Torch Drive. Member (Past President), Pharmaceutical Advertising Club. Historical Society of Pennsylvania. German Society of Pennsylvania. The Pennsylvania Society. Society of Sons of the Revolution. Sigma Chi. Beta Gamma Sigma. St. Andrew's Society. Elder, Bryn Mawr Presbyterian Church, Bryn Mawr, Pa.

Married: Barbara Harding.

Children: Alison E.. born September 23, 1953; Student, Connecticut College. Stephen K.. born October 8, 1959; Student, The Haverford School.

EXHIBIT NO. 17

WILLIAM H. RORER, INC., Fort Washington, Pa., April 16, 1973.

SENATE SUBCOMMITTEE TO INVESTIGATE JUVENILE DELINQUENCY,

Senate Annex, Washington, D.C. (Attention: Mary Jolly).

DEAR MISS JOLLY: In response to Miss Falco's April 9, 1973 letter to Mr. John W. Eckman, I am returning, with our corrections, the transcript she forwarded along with insertions for p. 237 (Giordano Report on Maryland) and p. 267 (package insert).

Additional information follows:

(a) Re: p. 230, lines 14-15; page 47 (attached) of WHO article indicating that Dr. Isbell's article did address the abuse dosages and was not merely "talking about the results when therapeutic dosages were used." (Senator Bayh, page 229, lines 22–23.)

(b) Re: p. 241, lines 4-7: Lea Associates, Inc., Ambler, Pa., reported 15 deaths from aspirin and only 4 from methaqualone alone in Sept. through Dec., 1972 as part of its study for the Bureau of Narcotics and Dangerous Drugs. Also the HEW's National Clearinghouse for Poison Control Centers, Sept.-Oct. 72 Bulletin, Table I-C-1971 reports more fatalities for aspirin than for the combined category "non-barbiturate sedatives," of which methaqualone is one.

(c) Re: p. 244: Rorer's Security Officer, Mr. William Haywood, on Jan. 24, 1973, received a telephone call from a local detective who said he's heared a "report" of a theft from Rorer's plant of 24,000 Quaalude® tablets. Mr. Haywood knew nothing of the theft, but invited the detective in to investigate. The results showed a discrepancy of ten cases between book and physical inventory, part or all of which could have been shipped out to legitimate channels. The theft "report" was, therefore, not substantiated by the investigation. Very truly yours,

THOMAS E. QUAY, Assistant Secretary and Counsel.

Senator BAYH. Our next witness this morning is Mr. Glendon E. French, Jr., executive vice president and chief administrative office, with Arnar-Stone Laboratories, Inc.

[Additional information supplied for the record was marked "Exhibit Nos. 18, 19, and 20" and are as follows:]

95-295 - 73 - 20

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