Regards,
Larry Holden, Monsanto Ag, St. Louis, MO
e-mail: lrhold@ccmail.monsanto.com or lrhold@igc.apc.org
phone: (314) 537-6885
===============
October 28, 1994
John Maddox, Editor
Nature
1234 National Press Building
Washington, DC 20045
Dear Mr. Maddox:
We write to correct inaccuracies presented in the commentary by
Millstone, Brunner and White, Nature Vol. 371:647-648, "Plagiarism or
Protecting Public Health". The main thesis of the commentary by
Millstone et al. was that Monsanto has suppressed information on
the real change in somatic cell content (SCC) of milk from bovine
somatotropin (bST)-supplemented cows and that this has public health
implications. Therefore, they contend they were justified in trying to
publish Monsanto data without permission of the scientists who
gathered the data. Science is a self-correcting institution striving
to find truth based on published data. The truth in this case is that
the impact of bST on SCC of cow's milk has been widely published
(1,2,3,4,5,6,7) in journal articles and book chapters from prestigious
publications in this field by university, government and corporate
scientists. Moore and Hutchinson (3) reviewed 20 published studies
and indicated that 18 reported a slight decrease or no change in SCC
of milk from bST-supplemented cattle and two showed a slight increase.
White et al., (7) summarized 15 Monsanto sponsored studies (including
the eight studies mentioned by Millstone et al.) demonstrating a
slight increase in SCC of milk. Thomas et al., (6) summarized data
from 15 U.S. commercial herds demonstrating no effect of bST on SCC of
milk. Monsallier (2) reported SCC of milk was not affected from 19
French commercial herds using Monsanto's bST formulation and three
French research trials using Eli Lilly's bST formulation. McClary et
al., (1) published data on six research studies using Eli Lilly's bST
formulation and reported a slight increase in SCC of milk from
bST-supplemented cows. The papers cited represent over 5000 dairy
cows from 77 individual studies in peer reviewed articles. This
hardly represents suppression of the facts. This literature was never
mentioned in the Millstone et al., commentary.
The SCC data from Monsanto studies has been peer reviewed through
several venues. First, all information was submitted to the Committee
for Veterinary Medicinal Products (CVMP) of the EEC as well as the
Center for Veterinary Medicine (CVM) of the Food and Drug
Administration (FDA) in the United States. The CVM also conducted a
public hearing on mastitis incidence in bST-supplemented cows (March
31, 1993) where the Monsanto data were again reviewed by experts from
the Food Advisory and Veterinary Medicine Advisory Committees of the
FDA. The FDA and the CVMP are the appropriate regulatory authorities
for evaluation of human and animal safety. They are charged with,
among other things, evaluating the impact of bST on public health.
These organizations, using experts in the field of mastitis also
carried out their own analysis and review of the data. Both of these
organizations have concluded that bST is safe for use in lactating
dairy cows to increase milk production (CVMP, January 3, 1993; FDA,
November 5, 1993). The conclusions of these reviews are also a matter
of public record. Second, the entire data set from all Monsanto
studies is published in the JDS article. Third, all of the individual
studies were published separately or in the case of the clinical
trials as a group in several journals and these are referenced in the
JDS paper.
We welcome open discussion of original data and support the peer
review process. As presented above, data on SCC of milk from
bST-supplemented cows is available from a number of sources. These
data and the published conclusions of the appropriate regulatory
bodies do not support a public health risk from milk derived from
bST-supplemented cows.
Sincerely yours,
Robert J. Collier, Ph.D. Douglas L. Hard, Ph.D.
Senior Fellow and Technical Services Director
Dairy Research Director
REFERENCES
1. McClary, D. G., Green, H. B., Basson, R. P. and Nickerson, S. C.
1994. The effects of a sustained-release recombinant bovine
somatotropin (Somidobove) on udder health for a full lactation.
J. Dairy Sci. 77:2261-2271.
2. Monsallier, G. 1991. Somatotropine bovine: Impact sur la sant
des mamelles. In: J. Espinasse (Editor), Mammites des Vaches
Laitires. Socit Franaise de Buiatrie. 18-19 Dec., Paris,
pp. 60-67.
3. Moore, D. A. and Hutchinson, L. J. 1992. BST and animal health.
In: M. C. Hallberg (Editor), Bovine Somatotropin and Emerging
Issues: An Assessment. Westview Press, Boulder, pp. 99-141.
4. Phipps, R. H. 1989. A review of the influence of somatotropin
on health, reproduction, and welfare in lactating dairy cows.
In: K. Sejrsen, M. Vestergaard & A. Neimann-Sorensen (Editors),
Use of Somatotropin in Livestock Production. Elsevier Applied
Science, New York, NY, pp. 88-119.
5. Schmitz, F., Everett, R. W. and Galton, D. M. 1993. Milk and
somatic cell count response to sometribove (recombinant methionyl
bovine somatotropin) in five New York field trial herds. J.
Dairy Sci. 76 (Suppl. 1):164 (Abstract)
6. Thomas, J. W., Erdman, R. A. Galton, D. M., Lamb, R. C., Armbel,
M. J., Olson, J. D., Madsen, K. S., Samuels, W. A., Peel, C. J.
and Green, G. A. 1991. Responses by lactating cows in
commercial dairy herds to recombinant bovine somatotropin. J.
Dairy Sci. 74:945-964.
7. White, T. C., Madsen, K. S., Hintz, R. L., Sorbet, R. H.,
Collier, R. J., Hard, D. L., Hartnell, G. F., Samuels, W. A., de
Kerchove, G., Adriaens, F., Craven, N., Bauman, D. E., Bertrand,
G., Bruneau, Ph., Gravert, G. O., Head, H. H., Huber, J. T.,
Lamb, R. C., Palmer, C., Pell, A. N., Phipps, R., Weller, R.,
Piva, G., Rijpkema, Y., Skarda, J., Vedeau, F. and Wollny, C.
1994. Clinical mastitis in cows treated with sometribove
(recombinant bovine somatotropin) and its relationship to milk
yield. J. Dairy Sci. 77:2249-2260.