BABYPRODUCTSCOMPANY
STRICTLY CONFIDENTIAL

March 3, 1975

SUBJECT

:

Management

Authorization

Additional Talc Safet

for
Studies

Dr. D.R. Petterson
This memo is to request authorization from the Management
Board of $90,000 to cover additional recommended safety
studies for talc. This is money not present in the
c u r r e n t R&D budget.

'

Our

c u r r e n t posture with respect to sponsorship of t a l c
s a fe t y studies has been to i n i t i a t e studies only as
dictated by confrontation. This philosophy, so f a r,
has allowed us to n e u t r a l i z e or hold in check data
already generated by investigators who question the
s a f e t y of t a l c .
The principal advantage for this
operating philosophy l i e s in the fact t h a t we minimize
the risk of possible self-generation of s c i e n t i f i c data
which may be p o l i t i c a l l y or s c i e n t i f i c a l l y embarrassing.
I t has been reasoned t h a t we should wait u n t i l an issue
is raised before we move towards conducting temporizing
studies of our own. The studies proposed under existing
philosophy correspond to a budgetary amount of $60,000
(A and C in appendix).

t h i s approach leaves the t a l c franchise and the
image open to repeated erosion by p r i o r p u bl i c
disclosure of suspected hazards and adversary p o l i t i ck i n g .
Also, there exists a danger that the latent period for
generating J&J data might be too great for the data to be
I t has come to our attention t h a t Drs. Fine
e f fe c t i v e .
Peters of the Harvard School of Public Health w i l l
be presenting to the meeting of the American Occupational
Medical Association in April, 1975 a paper e n t i t l e d
H o w e v e r,

"company

"Respiratory Morbidity in Talc Workers". This study w i l l
show an increase in respiratory morbidity amongst rubber
t i r e workers exposed to t a l c dust in the f a c t o r y.
NIOSH
is also committed to do both an epidemiology and pulmonary
function study of miners in the talc mines of Vermont.
Plaintiff's
Exhibit
2514
Protected Document--Subject to

Protective Order

'

JNJNL61_0OQ016437

 -2-

.

Initial

pulmonary
two months.

data w i l l

be obtained within the next

An alternative philosophy has been presented in recent
discussions at the Talc Advisory Group which would favor
We would c a r r y
us assuming a more anticipative approach.
to continue our
out other reasonable
contradiction of generated negative data and to anticipate
questions on s a fe t y which w i l l probably be raised. This
philosophy offers maximal leverage for defending the
product and is consistent with the policy practised with
regards to clearance of a new product. H o w e v e r, i t faces
the risk of revealing marginal data which may.be d i f f i c u l t
I n spite
to deal with p o l i t i c a l l y and/or s c i e n t i f i c a l l y.
we
far
potential
benefits
t
h
a
t
the
this
risk,
believe
of
outweigh the risks, and provide for a more solid scientific
base fo r baby powder. Following this alternative posture
will necessitate an additional expenditure of $30,000
for a Neutron Activation Study in Hamsters (B in appendix)

thus totaling $90,000.

Details

of the

three

n

studies are described in attachment A.

Study A is a prospective study on Italian Talc Millers
proposed by Professor Rubino and directed towards
demonstrating that pulmonary function is not impaired by

exposure to cosmetic grade t a l c .

B is a Neutron Activation Study in Hamsters to be
performed by Battelle which would render quantitative
lung clearance and deposition data in relationship to_
baby exposure.

Study

covers funds to allow Johnson & Johnsods monitoring
of the NIOSH Harvard Study of Ve r m o n t Talc Workers and
would be d i r e c t e d toward analytical and s t a t i s t i c a l
v e r i f i c a t i o n of the data to be gathered by the Harvard
investigators.
Study

C

-

paj

cc:' Dr. B. Semple

Protected Document--Subject to .Protective Order

JNJN _s1_oooo1s433