Table Of ContentREGULATION 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 (chair-
man) presiding.
Mr. Waxman. The meeting of the subcommittee will come to
order. This hearing is a continuation of the subcommittee's over-
sight 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 lab-
oratory.
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 prod-
ucts. But before calling on the two ofyou, I want to recognize mem-
bers for any opening statements they wish to make, and to recog-
nize 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 sub-
committee 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 bene-
fit ofhearing only one side ofthe issue here today, additionsd ques-
tions 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 compa-
nies 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 di-
rect 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 an-
swers from tobacco companies not to bring back the 8 million lives lost but to pre-
vent 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 to-
bacco 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 consum-
ers 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 espe-
cially 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 re-
search 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 subcommit-
tee and the extent ofyour rights during your appearance today.
Do you desire to be represented by counsel, or advised by coun-
sel, 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 subcommit-
tee 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 be-
havioral 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;
