Bill Liebhardt
Univ Calif SAREP
wcliebhardt@ucdavis.edu
------------------------- Forwarded Message Follows -------------------------
Date: Fri, 11 Nov 94 11:53:06 EST
>From: David Kronfeld <KRONFELD@VTVM1.CC.VT.EDU>
Subject: Re: sanet
To: wcliebhardt@UCDAVIS.EDU
In-Reply-To: Your message of Thu, 10 Nov 1994 17:09:34 -0800
Content-Type: text
Content-Length: 5199
Bill, Thank you for forwarding to me the comments in SANET about the
Millstone article on BST induced increases in milk SCC (Nature Oct 20). I'm
surprized at the hard feelings towards Monsanto scientists, whose duty is to
serve the best interests of their company, compared to the lack of
attention to
academic consultant-contractees who have reported the partial truth about the
adverse health effects of BST in the interests of the sponsoring company
rather than the whole truth in the interests of the public.
My count of the side effects listed by the POSILAC package insert is 21. Only
4 of these have been previously reported in the dozens of papers by
Monsanto's academic beneficiaries. Another 4 have been reported by professors
supported by other companies. All 21 side effects are 'repeatable' and all
but a couple, which are rare (such as twinning), are statistically
significant,
according to the FDA. All those papers in the Journal of Dairy Science that
reported good health in cows given BST, thereby confirming Bauman's
homeorhetic
theory, simply refrained from telling the whole truth.
In the beginning, adverse health responses in the first 3 Monsanto and first
4 Cyanamid trials were reported more or less informally (for details see my
review in Large Anim Vet 42.8, 14, 1987 and letter to Feedstuffs 59.28, 8
1987)
These were the basis for my statement: "Unfavorable results have been delayed,
subdued and obscured" (J Am Vet Med Ass 192, 1693, 1988). High milk SCC in BST
groups were reported verbally with data on a slide, but were not mentioned in
the written abstract (Hutchison et al J Dairy Sci 69 suppl 1, 152, 1986) in
one of the first 3 Monsanto trials. All told,
adverse health effects were reported for 7 of the first 9 long-term
trials of BST, but those who did not hear the talks would never know, unless
they read my review (LAV 1987). Then came a well controlled silence about
adverse health effects until 1991, when well-spun results started to come
out (see my review, JAVMA 204, 116-130, Jan 1, 1994).
Two exceptions were the active misreportings from Vermont and Cornell that are
detailed in my papers in the proceedings of the Forum of the Am College of Vet
Internal Medicine (12, 678-684, 1994). Vermont reported good health and low
SCC in 1988 (Pell et al JDS 71 suppl 1, 206, 1988) but following pressure
from
the State legislative committees on agriculture eventually admitted a massive
outbreak of clinical mastitis, 10% affected cows in control group compared to
40% in POSILAC group, 4 new cases compared to 29, and 1.5 days antibiotic
treatment per case compared to 8.9 days (JDS 75, 3461, 1992). This case
received much public attention in Vermont, in contrast to the Cornell case
that has virtually escaped notice.
Bauman, Hard and others reported the first long term POSILAC trial (JDS
72, 642, 1989): "no adverse health results were observed...[a]nimals were
in good health throughout the study." At the FDA's mastitis meeting (3/31/93),
Dr RJ Condon's slide 5 listed mastitis incidence data with Cornell coded
as NY: 4 of 42 control cows were affected with clinical mastitis, compared
to 14 of 42 POSILAC cows, a 3.5-fold increase, a massive outbreak of
mastitis deliberately and actively misreported in 1989. These data, 10% versus
35%, have been confirmed as an open triangle in Figure 1 of the 15-herd
review of mastitis by White et al (JDS 77, 2249, 1994). Thus the gross
misreporting by Bauman, Hard and others in 1989 is likely to escape general
attention.
The White paper is the formal presentation of a story told previously by
Bob Collier at the FDA mastitis meeting (3/31/93), where it was rejected
at least 3 times by the FDA's spokeman, statistician Bob Condon. Also, it
was presented in the Mastitis section of the Technical Manual for POSILAC,
released by Monsanto, Nov 1993. On June 13, 1994, a letter from Doug Hard
covered a revised Mastitis section "at the direction of the U.S. Food and Drug
Administration." It's clear that the FDA is not satisfied with the substance
of White's paper and Monsanto's claim that the increase in mastitis is
account-
ed for by the increase in milk production. On my count, 14 of the 27 authors
work in publically funded universities or research institutes.
The White paper is faulty in many ways in regard to preventive medicine and
epidemiology, too many to be detailed here. The shuffling of data from a 42%
increase in mastitis incidence on a herd basis to a 13% increase in terms of
production groups could be verified only with access to individual cow data.
So only the FDA could verify this mathematical manipulation of the data,
and the FDA has rejected it repeatedly.
Monsanto's claim that mastitis incidence does not increase significantly when
expressed per unit of milk has served to conceal the previous inadequate and
misleading reporting of mastitis results. Ironically, the claim has no use
in preventive medicine, because we are not going to try to reduce BST-mastitis
by reducing milk production (see Preben Willeburg, J Am Vet Med Ass 205, 538,
1994).
I'm not familiar with SANET, so leave any forwarding of this commentary
to your good judgement.
David Kronfeld