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#621 - Milk Controversy Spills Into Canada, 21-Oct-1998

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 consumption."[2]

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from an unpublished Monsanto study of rats fed rBGH in high doses for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 doses."[2,pg.883]

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
response."[5,pg.29]

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 www.nfu.ca/nfu/Gapsreport.html.

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" REPORT BY
RBST INTERNAL REVIEW TEAM, HEALTH PROTECTION BRANCH, 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:
www.nfu.ca/gapsreport.html. [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 Nutrilac.

[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;