Monsanto Concealed Potential rBGH Hazards from Public

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. ---October 22, 1998--- .
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In late 1993, the U.S. Food and Drug Administration (FDA) gave
permission for Monsanto corporation to market rBGH, a
genetically-engineered hormone that is injected into dairy cows
to make them produce more milk.[1] In 1990, FDA had declared
rBGH (recombinant bovine growth hormone), "safe for human

Now the scientific validity of FDA's 1993 safety decision is
being challenged by Canadian government scientists. Consumer's
Union (publisher of CONSUMER REPORTS magazine) and other U.S.
consumer groups have called for a Congressional investigation
into FDA's 1993 decision to approve rBGH.[3]

Today tens of thousands of U.S. dairy cows are injected with rBGH
each week, and virtually the entire U.S. citizenry is exposed to
milk from rBGH-treated cows through milk, cream, cheese, yogurt,
frozen yogurt, buttermilk, cream cheese, ice cream, iced milk,
and baked goods. No other country besides the U.S. has approved
rBGH for use within its borders, though Monsanto has sought
approval in Australia, New Zealand, the European Union and Canada.

In 1990, in SCIENCE magazine, FDA published a justification for
its conclusion that milk from rBGH-treated cows was "safe for
human consumption."[2] Such a public justification of a pending
FDA decision is highly unusual, perhaps indicating the
politically charged nature of FDA's decision to allow Monsanto to
treat many of the nation's milk cows with a
genetically-engineered hormone.

FDA's 1990 SCIENCE article offered seven tables of data to
support its conclusion that rBGH is safe. The first two tables
of data were taken from an unpublished Monsanto study of rats fed
rBGH in high doses for 90 days.[4] In SCIENCE, FDA said the
90-day rat feeding study showed that rBGH "is not orally active
in rats"[2,pg.875] and concluded that, "No oral activity was
found when rBGH was administered to rats at exaggerated

However, a recently-released Canadian government report indicates
that the findings of Monsanto's 90-day rat feeding study were
misreported by FDA in SCIENCE in 1990.[5] The Canadian report
says that 20% to 30% of the rats fed rBGH in high doses developed
primary antibody responses to rBGH, indicating that rBGH was
absorbed into their blood. An antibody response is evidence that
the immune system has detected, and responded to, a substance
entering the body. Furthermore, cysts reportedly developed on the
thyroids of the male rats and some increased infiltration of the
prostate gland occurred. Despite these results, FDA reported in
SCIENCE that there were "no... clinical findings" in the Monsanto
rat study.[2,pg.878] The Canadian government report concludes
flatly that "the 3-month rat study did show a physiological

One FDA official told the Associated Press this month that FDA
never examined the raw data from Monsanto's rat feeding study but
based its 1993 safety conclusion only on a summary of the study
provided by Monsanto. John Scheid, of FDA's Center for
Veterinary Medicine, told AP reporter Frederick Bever, "We do not
have the data from that study."[6] Scheid said FDA had relied on
a summary of the study provided by Monsanto. For the past two
days, FDA officials have refused to return phone calls from REHW
seeking comment. Drawing conclusions from a summary of a
scientific study would be equivalent to describing the contents
of a book by reading an author's summary of the book, instead of
reading the book itself.

Furthermore, relying on a summary of a study, rather than on
detailed data from the study, would violate FDA's published
procedures. In its 1990 SCIENCE article, FDA said that "the FDA
requires the pharmaceutical companies to submit all studies they
conducted on their products" and said, "The companies also submit
the raw data from all safety studies that will form the basis of
the approval of the product;...."[2,pg.876] Furthermore, FDA
explained that, "If the initial toxicity study demonstrates that
the protein [such as rBGH] is indeed orally active, additional
testing may be required."[2,pg.876] Thus if FDA had known in 1990
that Monsanto's rat feeding study had indicated that rBGH was
orally active in rats, additional testing could have been
required before a decision was made to approve or disapprove the
genetically-engineered drug.

Monsanto's application to market rBGH in Canada has reportedly
created political pressures on government scientists there to
sidestep normal safety protocols.

** Canadian government scientists say that the Canadian government
has failed to require follow-up studies that seem to be called
for by the findings of the Monsanto rat-feeding study. In their
report released earlier this month, they say, "The usually
required long-term toxicology studies to ascertain human safety
were not conducted. Hence, such possibilities and potential as
sterility, infertility, birth defects, cancer, and immunological
derangements were not addressed."[6]

** The scientists who wrote the report testified before an inquiry
board earlier this month that they have been pressured by
higher-ups to alter the content of their report, which has now
been published on the internet at

The purpose of the Canadian report was to identify data gaps, and
procedural gaps, in the handling of Monsanto's application to
market rBGH in Canada.

** Two of the report's authors, and four other Canadian government
scientists, testified that they have been threatened with
transfers to other jobs where "they would never be heard of
again" if they did not speed up approval of Monsanto's rBGH
product in Canada, despite the absence of long-term data showing
the product is safe for humans. Monsanto's application to market
rBGH in Canada has been pending since 1990. According to the
TORONTO STAR, "The scientists contend managers in Health Canada
[the Canadian equivalent of FDA] are more concerned about
pleasing the companies that submit the drug applications and are
paying for their approval than they are about protecting
health."[7] The Canadian scientists have been forbidden to speak
to the press about their concerns, but they testified last month
before a government board of inquiry.

** The same rat-feeding study that has raised such controversy in
the U.S. has also proven controversial in Canada. A Canadian
legislator, Mira Spivak, whose committee is investigating the
approval process for rBGH in Canada, says Canadian health
officials provided her staff with a copy of the Monsanto study in
which the information about the potentially troubling effects of
rBGH on rats was "blocked out."[8]

** The Canadian government report, which is critical of the rBGH
review process in both Canada and the U.S., will be sent on to a
panel of experts (six members from the Royal College of
Physicians and Surgeons and six from the Canadian Veterinary
Medical Association) for a "completely objective and arm's length
review." However, the TORONTO STAR has reported that one of the
physicians reviewing the report, Rejeanne Gougeon, served as a
consultant to Monsanto from 1993 until May, 1998. In 1994
Gougeon published a paper recommending that the Canadian
government approve rBGH. The paper was supported with a grant
from a lobbying group that Monsanto helps finance, the STAR said.
Gougeon told the STAR that she had never promoted rBGH, but that
in the past Monsanto had paid her to give talks to consumers
about genetic engineering "in a friendly context."[9]

** The Canadian government report (pg. 26) says that levels of
IGF-I (insulin-like growth factor-1) are elevated in the milk
produced by rBGH-treated cows. IGF-I is identical in cows and in
humans and, as the name implies, it promotes growth. The
Canadian report notes that U.S. FDA acknowledges that IGF-I is
increased in milk from rBGH-treated cows. The Canadian report
concludes, "There is insufficient information [about IGF-I] to
provide a quantitative risk assessment; therefore, many potential
health concerns remain unresolved."

** The Canadian government report offered additional data which,
if corroborated, could have prevented U.S. FDA from approving
rBGH for injection into cows. FDA says that, before a drug can
be approved for use in animals, "the company must show that the
drug is effective and safe for the animal."[2,pg.875] The
Canadian government report (pg. 29) says, "Evidence from the
animal safety reviews were [sic] not taken into consideration.
These studies indicated numerous adverse effects in cows,
including birth defects, reproductive disorders, higher incidence
of mastitis [infection leading to inflammation of the udder],
which may have had an impact on human health." Furthermore, the
Canadian government report says (pg. 14), "There are reports on
file that Monsanto pursued aggressive marketing tactics,
compensated farmers whose veterinary bills escalated due to
increased side effects associated with the use of rBST [rBGH],
and covered up negative trial results. All the four U.S.
manufacturers [Monsanto, Eli Lilly, Cyanamid and Elanco, with
only Monsanto actually marketing a product] refused to disclose
the lists of their research grants to U.S. universities."
Without such lists, one could not inquire what effects (if any)
had been revealed by animal experiments.

The Canadian government report concludes (pg. 5) that, in Canada,
"Both procedural and data gaps were found which fail to properly
address the human safety requirements of this drug under the Food
and Drugs Act and Regulations." It is evident from the Canadian
report that the U.S. approval process for this drug was equally
flawed. None of the questions raised by the Canadian government
scientists have been addressed by U.S. FDA.
--Peter Montague
(National Writers Union, UAW Local 1981/AFL-CIO)

[1] See REHW #381, #382, #383, #384, #454, #483, #593, #598.

[2] Judith C. Juskevich and C. Greg Guyer, "Bovine growth
Hormone: Human Food Safety Evaluation," SCIENCE Vol. 249 (August
24, 1990), pgs. 875-884.

[3] Consumer Policy Institute, "Statement of Michael Hansen... on
Canadian rBST (rBGH) 'Gaps Analysis' Report and FDA Inaction
October 5, 1998" (Yonkers, N.Y.: Consumer Policy Institute
[phone: (914) 378-2455], October 5, 1998. And see:
Correspondence from Anthony Pollina, Vermont Public Interest
Research Group [phone (802) 223-5221], and Ellen Taggert, Rural
Vermont [phone: (802) 223-7222], to Senator James Jeffords,
Senator Patrick Leahy, and Representative Bernie Sanders, dated
October 1, 1998.

[4] The complete Monsanto rat feeding study has never been
officially released, published, or, so far as we know, subjected
to peer review. FDA has vigorously resisted all efforts by
citizens, under the federal Freedom of Information Act, to obtain
a copy of the complete study including the raw data. For the
story of one citizens's attempts to obtain a copy of the study,
see Robert Cohen, MILK THE DEADLY POISON (Englewood Cliffs, N.J.:
Argus Publishing, 1997), pgs. 77-96. ISBN 0-9659196-0-9. FDA has
successfully argued in federal court that release of the Monsanto
study "would cause substantial competitive and financial harm to
the company." If John Scheid of FDA is right, FDA could not
release the study because, Scheid says, FDA has never
possessed a complete copy of the study.

[5] Shiv Chopra and others, RBST (NUTRILAC) "GAPS ANALYSIS"
HEALTH CANADA (Ottawa: Health Canada, April 21, 1998). Health
Canada is the Canadian equivalent of the U.S. Food and Drug
Administration. This report was recently made available on the
world wide web at: [The Canadian
government report is available from us for $5.00; write to
Rachel's, P.O. Box 5036, Annapolis, MD 21403.] To avoid using the
word "hormone" to describe rBGH, Monsanto renamed the drug
recombinant bovine somatotropin, or rBST. In the U.S., Monsanto
sells rBGH (or rBST) under the trade name Posilac; in Canada,
they are seeking approval to sell it under the trade name

[6] Frederick Bever [Associated Press], "Canadian Agency
Questions Approval of Cow Drug by U.S.," RUTLAND [VERMONT] HERALD
October 6, 1998, pg. unknown.

[7] Laura Eggertson, "Researchers threatened, inquiry told,"
TORONTO STAR September 17, 1998, pg. unknown.

[8] Anne McIlroy, "Health Canada cover-up alleged," [TORONTO]
GLOBE AND MAIL September 17, 1998, pg. A3.

[9] Laura Eggertson, "Expert worked for drug firm," TORONTO STAR
September 21, 1998, pg. A2.

Descriptor terms: milk; food safety; rbgh; rbst; monsanto;
canada; genetic engineering; consumer's union; michael hansen;
cattle; cows; agriculture; dairy farming; fda; whistle blowers;

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