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REGULATION OF TOBACCO PRODUCTS (Part 2) Y 4. EN 2/3; 103-153 Regulation of Tobacco Productsi (Pa... HEARINGS BEFORE THE SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OP REPRESENTATIVES ONE HUNDRED THIRD CONGRESS SECOND SESSION APRIL 28, MAY 17 AND 26, 1994 Serial No. 103-153 Printed for the use of the Committee on Energy and Commerce REGUUTION OF TOBACCO PRODUCTS (Part 2) HEARINGS BEFORE THE SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED THIRD CONGRESS SECOND SESSION APRIL 28, MAY 17 AND 26, 1994 Serial No. 103-153 Printed for the use of the Committee on Energy and Commerce U.S. GOVERNMENT PRINTING OFFICE 84-528CC WASHINGTON : 1995 ForsalebytheU.S.GovernmentPrintingOffice SuperintendentofDocuments.CongressionalSalesOffice,Washington,DC 20402 ISBN 0-16-046535-4 COMMITTEE ON ENERGY AND COMMERCE JOHN D. DINGELL, Michigan, Chairman HENRYA. WAXMAN, California CARLOS J. MOORHEAD, California EPHDIWLAIPRDR.J.SHMAARRPK,EYIn,diMaansasachusetts JTAHCOKMAFSIELJ.DSB,LITLeExYa,sJr., Virginia AL SWIFT, Washington MICHAEL G. OXLEY, Ohio CARDISS COLLINS, IlUnois MICHAEL BILIRAKIS, Florida MIKE SYNAR, Oklahoma DAN SCHAEFER, Colorado W.J. "BILLY" TAUZIN, Louisiana JOE BARTON, Texas RON WYDEN, Oregon ALEX MCMILLAN, North CaroUna RALPH M. HALL, Texas J. DENNIS HASTERT, Illinois BILL RICHARDSON, New Mexico FRED UPTON, Michigan JIM SLATTERY, Kansas CLIFF STEARNS, Florida JOHN BRYANT, Texas BILL PAXON, New York RICK BOUCHER, Virginia PAUL E. GILLMOR, Ohio JIM COOPER, Tennessee SCOTT KLUG, Wisconsin J. ROY ROWLAND, Georgia GARY A. FRANKS, Connecticut THOMAS J. MANTON, New York JAMES C. GREENWOOD, Pennsylvania EDOLPHUS TOWNS, New York MICHAEL D. CRAPO, Idaho GERRY E. STUDDS, Massachusetts RICHARD H. LEHMAN, Cahfomia FRANK PALLONE, Jr., New Jersey CRAIG A. WASHINGTON, Texas LYNN SCHENK, California SHERROD BROWN, Ohio MIKE KREIDLER, Washington MARJORIE MARGOLIES-MEZVINSKY. Pennsylvania BLANCHE M. LAMBERT, Arkansas Alan J. Roth, StaffDirector and ChiefCounsel Dennis B. Fitzgibbons, Deputy StaffDirector Margaret A. Durbin, Minority ChiefCounsel and StaffDirector Subcommittee on Health and the Environment HENRY A. WAXMAN, California, Chairman MIKE SYNAR, Oklahoma THOMAS J. BLILEY, Jr., Virginia RON WYDEN, Oregon MICHAEL BILIRAKIS, Florida RALPH M. HALL, Texas ALEX MCMILLAN, North Carohna BILL RICHARDSON, New Mexico J. DENNIS HASTERT, UUnois JOHN BRYANT, Texas FRED UPTON, Michigan J. ROY ROWLAND, Georgia BILL PAXON, New York EDOLPHUS TOWNS, New York SCOTT KLUG, Wisconsin GERRY E. STUDDS, Massachusetts GARY A. FRANKS, Connecticut JIM SLATTERY, Kansas JAMES C. GREENWOOD, Pennsylvania JIM COOPER, Tennessee CARLOS J. MOORHEAD, California FRANK PALLONE, Jr., New Jersey (Ex Officio) CRAIG A. WASHINGTON, Texas SHERROD BROWN, Ohio MIKE KREIDLER, Washington JOHN D. DINGELL, Michigan (Ex Officio) Karen Nelson, StaffDirector WiLLL\M SCHULTZ, Counsel Phillip Barnett, Counsel Mary M. McGrane, Minority Counsel 01) CONTENTS Page Hearings held on: April 28, 1994 1 May 17, 1994 157 May26, 1994 331 Testimonyof: Califano, Joseph A., Jr., president. Center on Addiction and Substance Abuse at Columbia University 162 DeNoble, Victor John, senior behavior analyst, Delaware Community Mental Retardation Program 4 Glenn, James F., chairman, president, and CEO, Council for Tobacco Research, USA 340 Mele, Paul C, Armed Forces Radiobiology Research Institute 16 Material submitted for the recordby: Coalitionon Smoking OR Health: News release and statement 395 Council for Tobacco Research, USA: Letter dated September 27, 1994, additional clarification ofquestions asked Mr. Glenn at May 26, 1994 hearing 403 Health and the Environment Subcommittee, majority staff report: Hill and Knowlton Documents: How the Tobacco Industry Launched Its Disinformation Campaign 418 Health andthe Environment Subcommittee: Additional questions for Dr. DeNoble from Hon. Thomas Bliley, Jr., and responses 151 Listofdocuments which havebeen retained incommittee files 155 (III) REGULATION OF TOBACCO PRODUCTS THURSDAY, APRIL 28, 1994 House of Representatives, Committee on Energy and Commerce, Subcommittee on Health and the Environment, Washington DC. The subcommittee met, pursuant to notice, at 10 a.m., room 2123 Raybum House Office Building, Hon. Henry A. Waxman (chairman) presiding. Mr. Waxman. The meeting of the subcommittee will come to order. This hearing is a continuation of the subcommittee's oversight hearings on tobacco products. The witnesses this morning are Dr. Victor DeNoble and Dr. Paul Mele. Dr. DeNoble worked in Philip Morris's behavioral pharmacology laboratory from 1980 to 1984. During most ofthat time, he directed animal research on nicotine and substances that might be sub- stituted for nicotine. Dr. Mele worked with Dr. DeNoble in his laboratory. On March 31, I released a study that Dr. DeNoble had coau- thored with Dr. Mele and that demonstrated that nicotine has rein- forcing properties, which the National Institute of Drug Abuse has stated is a hallmark for addiction. The study was accepted for pub- lication in 1983, and again in 1986, but each time, Philip Morris directed Dr. DeNoble to withdraw it. As a consequence, it was never published. Today, Dr. DeNoble and Dr. Mele are here to testify about these incidents and others during their employment at Philip Morris. To my knowledge, they are the first scientists to be released from their confidentiality agreements by a tobacco company. On behalf of the subcommittee, I want to welcome Dr. DeNoble and Dr. Mele, and to say that we are pleased that they are willing to testify in the subcommittee's oversight hearings on tobacco products. But before calling on the two ofyou, I want to recognize members for any opening statements they wish to make, and to recognize Mr. Bliley first. Mr. Bliley. Thank you, Mr. Chairman. Today we will hear in greater detail about an issue that was raised at the subcommittee's last two tobacco hearings, research on nicotine undertaken by former Philip Morris research scientists in the early 1980's. And, as with the other tobacco-related issues that this subcommittee has recently considered, this issue already has been aired in the press. It is therefore critically important that, once again, our deliberations attempt to separate fact from fiction, and that we opt for good policy rather than good headlines. I hope that (1) we approach the proceedings today from the benefit of a wisdom that can only be achieved through experience. In this case, the experience is very recent because we have been down this road before. Just a month ago, allegations were flying in the media about nicotine spiking. In response, top executives from the major tobacco companies came before us voluntarily and under oath to put these unfounded claims to rest and to set the record straight. Hopefully, the process will allow for a similar fair hearing for all concerned regarding this issue. In conclusion, I am here to listen. But because we have the benefit ofhearing only one side ofthe issue here today, additionsd questions surely will arise. Therefore, this hearing should be viewed as but part of a larger process that allows both sides of the issue to be properly aired. Mr. Waxman. Thank you, Mr. Bliley. I agree with your comments that this is one part of a series that will be available for us to get the information to the subcommittee. Mr. Synar? Mr. Synar. Thank you, Mr. Chairman. As early as 40 years ago, researchers informed Americans of the harmful effects of smoking. The industry continues to deny the deadliness ofsmoking. On April 14th ofthis year, the CEO's ofthe seven major U.S. tobacco companies flatly denied, while under oath, that nicotine is addictive and that smoking causes cancer. Today, Dr. Victor DeNoble, the former associate senior scientist with Philip Morris, will tell us a different story. His testimony will directly contradict the tobacco executives' statements that nicotine is not addictive, and it will show that the companies have proof of nicotine's addictiveness. Now, why do our executives continue to deny it? Because to do anything else would subject them to expensive and immediate li- ability. This concealment, coupled with the industry's continued direct targeting ofchildren, is criminal. Americans are beginning to demand some answers from tobacco companies, not to bring back the 8 million lives lost, but to prevent the next generation of children from taking up this addiction that will, in all likelihood, result in their deaths. I look forward to this important and revealing accumulation of information today in the continuing battle with the largest prevent- able cause ofdeath in our society. [The opening statement ofMr. S3niar follows:] Statement ofHon. Mike Synar As early as 40 years ago, researchers informed Americans of the harmful effects ofsmoking. In the years since the 1964 Surgeon General's Report on Smoking, the tobacco industry has continuously denied the deadliness ofsmoking. On April 14, 1994, the CEO's of the seven major U.S. tobacco companies flatly denied, while under oath, that nicotine is addictive and that smoking causes cancer. Today, Dr. Victor DeNoble, former Associate Senior Scientist with Philip Morris, will testify concerning an article entitled, "Nicotine as a Positive Reinforcer in Rats: Effects of Infusion Dose and Fixed Ratio Size", which he submitted to Pyschopharmacology on May 16, 1983. His article, never published because he was forced to retract it by Philip Morris, concluded that "all the rats initiated and main- tained nicotine self-administration." This directly contradicts the tobacco executives' statements that nicotine is not addictive. It shows the companies had proofofnico- tine's addictiveness. This concealment, coupled with the industry's direct targeting of children, is criminal. American Tobacco Company, which sold offits tobacco products line this week, saw the writing on the—wall. Americans are beginning to deman—d some answers from tobacco companies not to bring back the 8 million lives lost but to prevent the next generation of children from taking up the addiction that will, in all likelihood, resultin theirdeaths. Mr. Waxman. Thank you very much, Mr. Synar. Mr. Wyden? Mr. Wyden. Thank you very much, Mr. Chairman. I too want to commend you for the painstaking approach you are taking on the health hazards of tobacco. I think of this series of hearings as an effort to get at the core of the onion by peeUng away the deceptive practices we have seen in this industry layer by layer. Today's Hearing is especially important because we have a respected re- searcher, a former tobacco industry scientist who, in effect, is brought in from the cold. Now, this is no spy novel. But the whole environment of the tobacco industry and its relationship to tobacco consumers very often does read like a cloak-and-dagger thriller. This industry works with secret lists, confidential technologies, and veiled advertising mes- sages. And, in effect, through these practices, can orchestrate a world-class confidence game. Individuals like Dr. DeNoble who get in their way because ofem- barrassing information they might have to offer are, in effect, pushed to the sidelines. And it seems to me the losers are consumers who each day by the tens of thousands decide to take up this deadly habit. Now, the corporate leaders who run this industry have told the subcommittee, in sworn testimony, that they have no proof that their products are addictive. Recently they came before us and said that they are making a safe product that millions of Americans enjoy. In effect, their message was that the United States Congress was the bad guy for trying to dampen enthusiasm for a harmless vice. But the fact ofthe matter is that all Americans ought to be trou- bled by what we are going to learn today, which is that when the tobacco industry does research and the results hurt them, the in- vestigators and their data are buttoned up tight. What we are learning is that tobacco science is politicized science. And it is especially important that we have Dr. DeNoble's message today. Mr. Chairman, I look forward to pursuing this with you. You have taken, in my view, another important step by bringing Dr. DeNoble here, and I look forward to our questions. Mr. Waxman. Thank you very much, Mr. Wyden. Dr. DeNoble and Dr. Mele, we are pleased to welcome you both to our subcommittee hearing today. You were both employed as research scientists by Philip Morris during the early 1980's. I under- stand, Dr. DeNoble, that you are going to make a statement, but that Dr. Mele wishes simply to be available to answer questions. But before we get to your testimony, I want to inform you that the applicable rules of the House and the rules of the committee are in that blue and white pamphlet that is on the table before you. They will inform you of the limits on the power of this subcommittee and the extent ofyour rights during your appearance today. Do you desire to be represented by counsel, or advised by counsel, during your appearances today? Mr. DeNoble. Mr. Chairman, I do have counsel with me, and I would like the opportunity to talk with him, ifnecessary. Mr. Waxman. ok. Dr. Mele? Mr. Mele. Yes. I would likewise. Mr. Waxman. Do you object to appearing before the subcommittee under oath? Mr. DeNoble. No, sir, I do not. Mr. Mele. No. Mr. Waxman. OK. If you have no objections to appearing before us under oath, I'd like to ask you both to rise and raise your right hand. [Witnesses sworn.] Mr. Waxman. Please consider yourself to be under oath. I'd like to ask each ofyou to identify yourselffor the record. Mr. DeNoble. I'm Dr. Victor John DeNoble. Mr. Mele. I am Dr. Paul C. Mele. Mr. Waxman. And would you introduce anyone who is with you today? Could you be sure the mike is turned on? There is a button that pushes forward. Mr. DeNoble. I have with me my wife. Chum DeNoble, and my counsel, Eric Snyder. Mr. Mele. Yes. I have my wife, Joy Mele; my son, Tristan Mele; my counsel, Dave Vladeck. Mr. Waxman. Thank you. Dr. DeNoble, I'd like to recognize you to make your comments. Mr. DeNoble. Thank you. Mr. Waxman. Would you pull the microphone close to you so that we can be sure to get all ofthis on the record? TESTIMONY OF VICTOR JOHN DENOBLE, SENIOR BEHAVIOR ANALYST, DELAWARE COMMUNITY MENTAL RETARDATION PROGRAM, ACCOMPANIED BY PAUL C. MELE, ARMED FORCES RADIOBIOLOGY RESEARCH INSTITUTE Mr. DeNoble. Mr. Chairman and members of the committee, I am Dr. Victor John DeNoble, and this is my colleague and friend. Dr. Paul Mele. We are grateful to have this opportunity to talk to you about our research. Mr. Waxman. Excuse me, Dr. DeNoble. I'm not sure your mike is on. Is your light on? Mr. DeNoble. The light is on, yes, sir. Mr. Waxman. Pull it closer to you then. Mr. DeNoble. My career began in 1976 when I received a Ph.D. in experimental psychology from Adelphi University in New York. After receiving my degree, I began post-doctoral research on the behavioral and the electrophysiological effects of alcohol in non- human primates at Downstate Medical Center, in New York. Following this, I accepted a post-doctoral position sponsored by the National Institute of Drug Abuse at the University of Min- nesota. At Minnesota I studied the self-administration techniques in rodent, non-human primates. I am currently a senior behavioral analyst with the Community Mental Retardation Program for the State ofDelaware. From April of 1980 to April of 1984, I was employed at the Philip Morris Research Center in Richmond, Va., as an associate scientist;