Product Design
Tobacco Working Group Meeting - N.I.H., Bethesda, October 17, 1973
Abstract
Summarizes a Tobacco Working Group meeting. Reports the current status of skin painting experiments, discusses smoking and health issues and methods for developing a less hazardous cigarette.
Fields
- Author
- Osdene, Thomas Stefan, Ph.D. (Director of Science and Technology, Philip Morris [1986])Ph.D. in Organic Chemistry. Ten years of research when he started with PM in 1965. Worked in Chemical Research Division of PM 1965-66; Chemical and Biological Research Division 1966-69; Director of Research 1969-1984, also assumed independent position as Director of Research and Extramural Studies during these years; became Director of Science and Technology in 1984, reporting directly to Philip Morris USA Executive VP Mark Serrano. Involved with Center for Indoor Air Research (CIAR) 1988. Attended PM's Operation Downunder Conference in June, 1987. Retired 1993.
- Recipient
- Wakeham, Helmut R. R., Ph.D. (PM R&D VP)Vice President and Director of Research & Development, Philip Morris
- Resnik, Frank Edward (Vice Pres., then Pres. and Chairman of Bd, Philip Morris)TI Executive Committee. Prot駩 of Clifford Goldsmith. Vice President Philip Morris, Inc. from 1979 to 1984. President in 1984 and served on the Board of Directors from 1985 to 1989.
- Carpenter, Robert D., M.D. (PM R&D Biological Inhalation Research)Defense
- Hypothesis
- Health effectsDesign changes which have measurably altered health effects of cigarette smoke, both for smokers and nonsmokers.
- Mainstream constituent yieldsModification of selected mainstream smoke constituents in response to health concerns.
- Measuring overall toxicityDevelopment of scientifically valid protocols and methods for testing the health and toxicity effects of changes in product design.
- Smoke constituent testingDevelopment of methods for measurement of gas and particulate yields in mainstream and sidestream smoke.
- Toxicity and consumer intakeDevelopment of scientifically valid procedures for measuring biological activity and neurological effects of nicotine and smoke constituents.
- Use of additivesModification of tobacco products through use of additives and measuring effects on dependence, behavior, and toxicity.
- Use of filters, paper, and ventilationModification of tobacco products through use of filters, paper, and ventilation, and measuring effects on dependence, behavior, and toxicity.
- Keyword
- Animal testing
- Carcinogenic (Cancer-causing)
- Cardiovascular system (Heart)
- Delivery modification
- Inhalation (Smoke inhalation)
- Lower respiratory tract (Lungs, bronchial tubes)
- Mutagenic
- Safer cigarette
- Smoking and Health Controversy
- Total particulate matter (TPM or Tar)
- Smoke Constituent
- Nicotine
- Nitric oxides
- Nitrosamines (N-nitrosamines)
- Total particulate matter
- Design Component
- Bright tobacco (Flue-cured tobacco)
- Burley tobacco
- Filter ventilation (Filter vents, air vents)
- Schweitzer burley stem sheet (SBS)PM
- Air dilution
- Named Organization
- *American Health Foundation (Use American Health Foundation (IFCP)) (Health Research)1993 American Health Foundation - Directed by the late Dr. Ernst Wynder. Took funds from PM and Kraft for research relating to dietary and lifestyle causes of lung cancer.
- American Machine & Foundry Co. (AMF (Founded in 1900. Made automated machines for the industry)
- Enviro Control
- Heart and Lung Institute
- National Cancer Institute NCIDivision of Cancer Prevention and Control, National Cancer Institute located in Rockville, MD
- National Institutes of Health
- *Oakridge National Laboratories (use Oak Ridge National Laboratories)
- Philip Morris Companies Inc. (Parent company of Philip Morris USA, Kraft, Miller)America's seventh-largest industrial enterprise in 1993, owns Kraft, Miller Brewing, General Foods, and more.
- Schweitzer Company (Invented reconstituted leaf (RL) process)
- Tobacco Working Group TWG (Federally funded project to create a safer cigarette)A federally supported project launched by the National Cancer Institute, with the purpose of developing a less hazardous cigarette.
- United Press International
- United States Department of Agriculture (Agency responsible for tobacco price support program)
- Subject
- additives
- Blends (Design)
- Cancer (Health Effects)
- Cardiovascular Effects (Health Effects)
- Filters (Design)
- Respiratory Effects (Health Effects)
- Smoke Constituents
- Smoke Deposition (Measures)
- Smoke Nicotine (Measures)
- Tar (Measures)
- Test/Animal Subject (Testing)
- Test/Skin Painting (Testing)
- Test/Smoke Constituents (Testing)
- Test/Toxicity (Testing)
- Ventilation (Design)
- Brand
- L&M
Document Images
PHILIP MORRIS
u.s.A.
INTER-OFFICE CORRESPONDENCE
RICHMOND, M'I R61N I A
Dr. H. Wakeham Date: October 22, 1973
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\ Tobacco Working A ~ Gro,Meeting - N.I.H., Bethesda, October 17, 1973.
-
At your request, I attended the Tobacco Working Group
meeting. A copy of the participants and of the agenda is
attached.
Dr. Gio B. Gori opened the workshop and gave a general
summary of the skin painting program. He stated that the second
series will be completed shortly, but the data as yet is raw
and therefore he will not circulate it at this time. He did
plan to summarize the status at the present time. He brought
up the point of the third series and wished to discuss possible
candidate types (unfortunately no definitive statement resulted
from this in_.further discussion). He stated that new bioassay
systems such as the pelet implantation technique were being
developed and also said that the main effort in the future would
involve inhalation as well as the identification characteristics
of smoke as presented to animals. Apparently, Oak Ridge has
succeeded in depositing large quantities of smoke in lungs.
Within several months, a definitive schedule for small rodent
inhalation will be presented by ORNL. Today's agenda, however,
was concerned with definition of new types for skin painting.
In summary, the high and low nicotine inhalation is being
carried out in Orange, N. J. by some of Auerbach's associates;
chemistry of smoke is being undertaken by Guerin, at Oak Ridge
National Laboratory, and by Hoffmann, at the American Health
Foundation, which is also undertaking epidemiology including
the identification of high risk individuals.
Gori has been using a separate informal group of consultants
from the Hea"rt and Lung Institute and stated that studies in
cardiovascular field were being considered; one wbculd involve
bronchitis (which is reversible), and two, emphysema (irreversible).
This was undertaken to define a less hazardous cigarette and,
therefore, one would have to explore methods to determine end
point. Gori's consultant felt that for bronchitis, man is the N
ideal test subject and early detection of bronchitis could be 0
used to evaluate the less hazardous cigarette. Schneiderman
~
requested that this would be discussed in detail. The problem,
as always, was how do you obtain dosimetry in humans. Experi-
mentally, Gori suggested that they may try to transpose bronchitis ~
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Dr. H. Wakeham
Page 2
October 22, 1973
to: beagles. It is planned, in the next experiment, to study
chronic inhalation in beagles to determine the sequence of
disease states and to see whether there are any predictive
end points of chronic disease capable of being determined.
This could be obtained by using a low tar control and spiking
with a single component. For cardiovascular effect, he
stated that smoking has a more acute effect on the organism
which has already been affected by disease. As a consequence,
screening for a less hazardous cigarette will probably entail
using atherosclerotic animals such as baboons and minipigs.
There is no evidence for any method of early identification
of disease. The plan is to first make atherosclerotic animals;
secondly, to make these animals smoke; and thirdly, test these
animals with spiked smoke. Among other tests, one for blood
clotting would be run. There were no funds for pharmacology
at this time and Gori would like to study nicotinomimatic drugs
when funds are available. Any additional funds are planned to
be used in cardiovascular assays.
The current status of the Tobacco Working Group program
is that the paper on the first painting experiment is now being
written by Gori and staff and will be presented to the Tobacco
Working Group in the spring. Schneiderman was somewhat concerned
that criticism about the whole Tobacco Working Group plan has
not surfaced and wanted a more formal plan from the Tobacco
Working Group for public consumption. (It should be noted that
the man from UPI was present during this part of the discussion.)
Schneiderman further asked where is the program going? What
are the priorities? Should one do biochemistry, etc.? Bock
stated that there should be a review and that this should be
constructive rather than just critical. Kensler asked what
resources were available and which things would be most worth-
while to! do.
This terminated Gori's first part of the presentation and
was followed by Hayward, of Enviro Control Inc., summing up the
first painting experiment. It should be noted that Enviro Control,
Inc. is at present a logistics contractor who may eventually become
a prime contractor.
At this stage the meeting was closed to the public and
the tentative agenda presented by Hayward was followed. However,
it would seem that most of the subjects on this agenda were jy
disposed of without any real details being given.
N
Gori inquired what are the implications of skin painting 1V
tests? Can we identify precursors of undesirable smoke components? ~
What would be the practical method for the removal or reduction 4;b
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Dr. H. Wakeham
Page 3
October 22, 1973
of these components? Secondly, can we improve combustion of
cigarettes by air dilution, additives, process modification,
etc.? Thirdly, can we have selective removal by means of
filtration? Fourthly, the use of artificial smoking materials
and could these be used as experimental tools? Gori at this
stage summarized the results of Experiment One with particular
emphasis to the reconstituted sheet samples and asked both Selke,
of Schweitzer, and Halter, of AMF, to give some details. A
rather unsatisfactory discussion developed which went on for a
long time but gave no definitive statements. It would appear,
however, that certain repeats of the base samples should be
undertaken. These are samples #16 and #20. PSWOT data for
all of these samples were put on the board. Selke was asked
about the process and seemed not to have too many of the answers.
A question of the mechanical elimination of waxy
materials was discussed briefly as was the nicotine content.
A question by Spears was what happens to the aqueous extract of
the Schweitzer process when we concentrate it? Gori wondered
whether we enhanced losses, whether this would make a better
sheet, or whether it might be vice versa. Gori also commented
that there was apparently a trend that in tobaccos containing high
nicotine there was a high tumor production (since nicotine goes
along with TPM this is not a surprising conclusion).
Schneiderman commented on some of the chemical correlation
work and pointed out that there were reductions in the lipid
residues from 60 to 30 in sample #16--Schweitzer sheet. Bock
suggested that in sample #16 this might first be extracted with
hexane, then processed by the Schweitzer method, discard the
aqueous fraction, and restore the hexane solubles. Senkus
inquired whether the Schweitzer reconstitution process was the
same in all countries; however, Selke did not answer this.
Keith suggested extraction of SEB with hexane and comparing it
with paper-made Schweitzer RTS.
Gori mentioned that he has received all of Dontenwill's
cigarettes and iss measuring the isoprene content. He also
mentioned that the expanded tobaccos were all slightly better
than the standard blend. Eventually, it was decided to request
Selke to come up with a proposal for a new sheet. This should
not contain any additives. Selke said he would try to do this
within two weeks.
Gori gave a brief summary of the preliminary results
on the second skin painting experiment and pointed out that
once again there was no dose response and all the data were
based on the lower dose (25 mg) group.only.
Dr. H. Wakeham
Page 4
October 22, 1973
The following figures refer only to uncorrected tumor
bearing animals:
Low Nicotine Materials
High Nicotine Burley
Flue Cured
20
or
40
Expanded 30s
(freeze dried, no data
available yet due to 8
months delay in start of
experiment)
Synthetics 5-6
Synthetic Mixtures with SEB
5~0/50 35
Fatty Alcohol(Normal level) 27
Fatty Alcohol SEB(spiked
100-fold) 30
Hand Suckered Materials 32
SEB-2 50
A brief discussion on synthetic materials arose and
Doyne indicated that 20% of NSM would be acceptable to consumers
in the United Kingdom. Gori felt that they should get an outside
contractor to evaluate cigarette "acceptability". The trend here
was toward the preparation of "'a best cigarette" and I felt the
"'best" concept was slowly emerging. Gori asked who should
recommend "a less hazardous cigarette", Gori or the industry?
There was no reply from any industry representatives.
Next, filters were discussed. The only suggestion for a ~
filter entrant in the next series was the F5 filter from L&M,
N
which is apparently specific for NO removal. They will also test N
an air dilution filter.(?). ~
Gori mentioned the subject of confidential disclosures to ;h
him and felt it should be left to the discretion of NCI to test
one or two proprietary materials if they deemed it worthwhile. ~
06
T. C. Tso, USDA, requested that two or three spots be left
open for him in the third skin painting round and this was agreed
upon; one sample would be a tobacco grown without any pesticides
what so ever.which would be possible in Prince Edward Island, Canada.
Dr. H. Wakeham
Page 5
October 22, 1973
This would be tested against a sample exposedd to a"'cocktail" of
pesticides. Apparently the thrust here is purely political.
The question of nitrosamine derived from nicotine was
brought up and I questioned how this would occur. It was stated
that nicotine is demethylated to nornicotine which in turn is
nitrosated (chemically this is most improbable). Nevertheless,
Hoffmann, at the American Health Foundation, has apparently done
this and is planning to do additional experiments to test the
hypothesis. This is in line with the high nicotine tobacco
giving high tumor yields.
Some discussion on experimental dosages occurred. Bock
suggested that the high dose was too high in Experiment Two.
He suggested that one stay at the 25 and 50 mg dosages but only
use the 50 mg dose when the level of nicotine in the 50 mg,dose
does not exceed that of SEB-1 at the 25 mg dose. It was suggested
that only 100 animals be used in the group of negative controls.
Gori stated that he hoped to be ready to start the third
round of skin painting by February 15. (If any specific suggestions
for the new round of'skin painting exist they should be
transmitted to him within two week4. This, of course, is quite
unrealistic and as per your instructions I stated that Philip Morris
would not undertake to make these samples since we were already
making the 2Rl group.
The meeting closed at 4:45.
TS0/mro
cc: Mr. F. E. Resnik
Mr. R. D. Carpenter
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