New Brunswick, N.J.

October 18, 1973
Subjec.t:

.Ep.ide.miological Study of
Workers in Italian Talc Mines

Dr. D. R. Petterson

On Monday, October 15, 1973, a meeting was held with
Professor Giovanni Rubino, who is Director of the
Institute of Industrial Medicine at the University of Turin
in Italy.
In view of the increasing interest on the part of the F. D. A.
in the effect of talc on health, the owners of the Italian talc
mines became interested in the pos sibility of evaluating the
health of talc wor~ers as a means of demonstrating the lack
of health hazard of talc and had asked Professor Rubino to
consider possible epidemiologic:"l studies. Professor Rubino
has conducted epidemiological studies on the health of industrial workers and has published on the relationship of pulmonary
changes to exposure to talc.
.

Professor Rubino expressed an interest in helping conduct
appropriate epiden~iological studies in the miners in the
Italian talc mines and submitted the attached suggested
program for epidemiological research.
It was ascertained that Professor Rubino has in his department
several physicians training to be epidemiologists as well as
nurses and that these personnel could be utilized in the study.
Professor Rubino is in a position to obtain all the records of
the mining companies on workers who have worked in the mines
since 1945 and with these records he will be able to determine
who are currently working in the mines, who have left the mines
and are working elsewhere, and who have died. The studies
that he could conduct would relate to:

1.

The Dead
In this study, the death certificates of those who have died
will be located as the population in question is stable and
all death certificates return to the community in which the
subject was born.

RECEIV~D

,OCT 21.1973
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~Q':H~SON & JOHNSON
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Dr. D. R. Petterson
October 18, 1973
Professor Rubino believes that he can obtain the cooperation
of local community officials and obtain copies of all death
certificates as well as interview local physicians and families
to obtain precise information on the cause of death where the
data may be questionable.
All these data will be put in a computer for analysis in order
to assess whether the cause of death of the miners was
different from that of the national population of Italy and a
control group obtained in a neighboring area where there are
no talc miners. The data froln the control lnatched group will
also be placed on the computer. for comparative analysis.
Professor Rubino believes that analysis of the cause of death
of mine workers and a control group in the Italian national
statistics could be completed with the aid of six associates
by July 1, 1974. Each assistant would be paid $400 per month
and Professor Rubino believes that $25, 000 would be required
to obtain the data by July l, 1974.
2.

Living Workers
In order to assess the heal.th of current workers in the mines
it would be necessary to complete a detailed case history
report on each subject, conduct chest x- rays, respiratory
function tests and possibly biochemical tests, and compare
them with similar data on workers in other industries on
which Professor Rubino has a significant alnount of data.
The data obtained on the workers would be cOlnputerized
and compared with available data already in a data bank.
The procurement of information on current miner s would be
time-consuming and 'Wuld take a year to accumulate and
evaluate. It would cost about $25 per subject to obtain appropriate clinical data. The cost of personal needs and statistical
analysis has not been determined.
As in other mining operations the dust conditions in the Italian
mines were improved in 1960 when wet mining conditions were
established. As such, miners exposed prior to 1960 worked
under considerably different dust conditions from those working

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Dr. D. R. Petterson
October 18, 1973
only since 1960. It was 'suggested that miners working only
since 1960 should be studied initially and the data obtained
should be compared with Professor Rubino's data as well as
the data obtained on the Vermont miners.
Professor Rubino seemed interested and anxious to conduct
epidemiological studies on the miners .and would be prepared to
initiate studies as soon as Johnson & Johnson defined the nature
of the study needed and was prepared to cover the cost.
COMMENTARY

1.

The Italian mine\mrkers represent a comparatively large
stable group of miners from whom definitive epidemiological
data can be obtained as to the influence of talc on the cause of
death and the effect of working in a 11 clean" talc mine on health
where modern mining methods are utilized (i. e., since 1960).
Before embarking on any studies we must determine whether
further epidemiological data should be gathered in a world
showing increasing interest on the effect of the environment on
health.

2.

It is known that the M. R. C. group in Cardiff is most anxious

to do a critical epidemiological study on these Italian miners.
If they can find a way to reach the group, they' will certainly
have such a study conducted.
3.

Before any study is commenced with the Italian miners a
critical protocol should be drawn up with the help of leading
epidemiologists in this country who could act as consultants.
The concept of consultants designing the protocols was quite
acceptable to Professor Rubino.

4.

Professor Rubino has a written agreement with the owners
of the Italian mines that any data generated will remain confidential, and Professor Rubino was in agreement that any
data generated on behalf of Johnson & Johnson would be retained
as confidential unless Johnson & Johnson was interested in
publishing it.

5.

It is recommended that in view of the wide use of Italian talc,
it would be wise to determine whether Italian talc mine workers

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Dr. D. R. Petterson
October 18, 1973
die from causes that would be considered significant in
relation to a control population or the Italian national
population. It would also be of value to determine the
health of talc workers in the mines since 1960 and correlate
that with the dust exposure' and the nature of the material
to which they were exposed.
6.

The risk/benefit ratio of conducting an epidemiological
study in these mines must be considered. In order to
minimize the risks someone should visit the mines,
ascertain the conditions in them and interview the owners
in relation to the health status of the miners.

Gavin Hildick-Smith
GHS:jd
cc: Dr. R. A. Fuller / '
Dr. W. Nashed -:/'
Dr. T. H. Shelley

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