September 14, 1998
BGH Background
What is Bovine Growth Hormone ?
Bovine Growth Hormone (BGH), also known as recombinant Bovine Somatotrophin
(rBST), is the controversial genetically engineered hormone that is
injected into dairy cows to increase milk production. The hormone, made by
the genetic engineering and pesticide giant Monsanto, is approved for use
in the United States, but not yet in Canada or any countries of the
European Union. The genetically engineered hormone is marketed in the
United States by Monsanto under the brand-name Posilac.
History of Monsanto and BGH
Monsanto has been the manufacturer of a number of toxic chemicals that have
ultimately been banned. Every country in the world is now contaminated with
hormone-disrupting, cancer-causing PCBs (polychlorinated biphenyls), thanks
to Monsanto's refusal to be guided by early scientific evidence indicating
harm to human health.
The United States Food and Drug Administration (FDA) approved BGH for use
in dairy cows in 1993. The approval process was riddled with conflicts of
interest, however, as some former Monsanto employees who went to work for
the FDA, oversaw the approval process and then went back to work for
Monsanto.
Although Monsanto states that BGH is one of the most thoroughly examined
drugs in US history, BGH was never tested in the long-term for (chronic)
human health effects. It is a generally accepted principle in science that
two years of testing is the minimal time for long-term health studies. BGH
was tested for only 90 days on 30 rats. This short-term rat study was
submitted to the FDA but was never published. The FDA has refused to allow
anyone outside the administration to review the raw data from this study,
saying that this would "irreparably harm" Monsanto.[1] Monsanto has
continued to refuse to allow open scientific peer review of the 90 day
study. This linchpin study of cancer and BGH has never been subjected to
scrutiny by the scientific community.
Three British researchers - Erik Millhouse of Sussex University, Ian White
of the London School of Hygiene, and Eric Brunner of University College
London - were provided with raw data on BGH by Monsanto. The three say
thatthey were blocked by Monsanto for nearly three years from publishing a
review of this data. Millhouse, Brunner and White believe that, had their
findings been published earlier, they might have influenced the US Food and
Drug Administration not to approve the genetically engineered hormone.
Shortly after the approval of BGH, eleven different consumer surveys were
carried out in the United States. Consumers stated overwhelmingly that they
did not want milk that contains genetically engineered hormones, and that
they wanted their milk labeled to allow them to make an informed choice in
their grocery store.[2]
In response to consumer concerns, the FDA and Monsanto have spoken with a
single voice: the FDA has warned grocery stores not to label milk as ìBGH
freeî[3] and in February, 1994, Monsanto sued two small milk processors
that labeled milk as free of the genetically engineered hormone.[4] The FDA
official who was responsible for the agency's labeling policy, Michael R.
Taylor, was a former partner of King & Spaulding, the Washington, D.C. law
firm that has brought the lawsuits on behalf of Monsanto.
Monsanto fears that informed consumers might choose not to buy milk
produced by BGH-treated cows. An internal company memo dated Sept. 21,
1993, equates a government labeling requirement with a government "ban" on
its product.[5]
Human Health Concerns: What is Insulin-like Growth Factor - 1 (IGF-1) ?
When a cow is injected with BGH, its milk production is stimulated, but not
directly. The presence of BGH in the cow's blood stimulates production of
another hormone, Insulin-Like Growth Factor - 1, or IGF-1. It is IGF-1 that
stimulates milk production. IGF-1 is a naturally occurring hormone-protein
in both cows and humans.
Some scientists maintain that the use of BGH increases the levels of IGF-1
in cow's milk. IGF-1 is not destroyed by milk pasteurization. Because IGF-1
is active in humans, causing cells to divide, any increased levels of IGF-1
in milk raises the question: will this result in cell division leading to
the growth of cancerous tumors?
Monsanto's position that IGF-1 levels are not elevated contradicts the
companyís own studies. In a published letter, the British researcher T. B.
Mepham reminded Monsanto that in its 1993 application to the British
government for permission to sell BGH, Monsanto itself reported that "the
IGF-1 level went up substantially [about five times as much]."[7] The FDA
acknowledges that IGF-1 is elevated in milk from BGH-treated cows.[8] Other
proponents of BGH acknowledge that it at least doubles the amount of IGF-1
hormone in the milk.[9] The earliest report in this literature found that
IGF-1 was elevated in the milk of BGH-treated cows by a factor of 3.6.[10]
More recent studies have demonstrated that IGF-1, in the presence of the
milk protein, casein, largely survives digestion in the stomach and passes
into the intestine for absorption into the bloodstream.[11] In January,
1998, a Harvard study of 15,000 white men that was published in SCIENCE
magazine reported that those with elevated, but still normal, levels of
IGF-1 in their blood are 4 times as likely as average men to get prostate
cancer.[12] Furthermore, ìthere are highly suggestive if not persuasive
lines of evidence showing that consumption of this milk increases risks of
breast and colon cancer,î says Dr. Samuel Epstein, a scientist from the
University of Illinois.
Is Animal Health Being Compromised ?
There is extensive evidence of animal health problems resulting from the
use of BGH. Though Monsanto denies the connection as anything but a
management problem, the product label itself lists more than 20 serious
side-effects associated with its use. The most serious side-effect is an
increased risk of mastitis; a painful udder infection. Monsantoís own data
shows a startling 79% increase in mastitis. Farmerís resort to intensive
antibiotic treatments to control these infections. Scientists have raised
concerns regarding the probable development of human antibiotic resistance
resulting from increased exposure to antibiotics in our food.
Other serious side-effects stated on the BGH label include increased
somatic cell counts; increases in cystic ovaries and disorders of the
uterus; decreases in gestational length and birth weight of calves;
increased digestive disorders such as indigestion, bloat and diarrhea;
increased numbers of enlarged hocks, lesions and foot disorders; increased
periods of ëoff-feedí; injection site reactions and other heath problems.
Furthermore, milk from BGH-treated cows is very likely to feature: more pus
>from infected cows' udders; an "off " taste and shortened shelf life,
because of the pus; higher fat content and lower protein content; and
presence of more antibiotics. Some farmers have observed that the use of
BGH shortened the life of their cows by an average of two years.
Is Health Canada Working for Canadians or Multinational Corporations ?
Examination of the review process for the safety of BGH reveals the
powerful influence of multinational corporations over government
departments, particularly Health Canada. In November 1994 the CBC-TV
program "The 5th Estate" reported that Monsanto Canada Inc., at a meeting
with representatives from Health Canada, offered a bribe of one or two
million dollars for the speedy approval of BGH without any further testing.
In May 1997, The Globe and Mail reported that Health Canada was a
department riddled with managers easily influenced by powerful
pharmaceutical corporations.
In 1994 BGH was examined by the Standing Committee on Agriculture and
Agri-Food in hearings that concluded with recommendations to place a
one-year moratorium on the approval of BGH to allow for further study. The
Committee agreed that there were too many unknowns to approve the use of
BGH in Canada at that time.
In June 1995 Monsanto threatened to pull some of their investments from
Canada if the moratorium on BGH was extended. Member of Parliament, Wayne
Easter, was quoted in The Globe and Mail as stating, "What they're saying
is blackmail and nothing less."
Conflict of interest questions have also been raised in Canada surrounding
government employees and Monsanto. The Globe and Mail reported that Dr.
Leonard Ritter, while on unpaid leave from the Bureau of Veterinary Drugs,
appeared before the Standing Committee on Agriculture and Agri-Food as a
representative of the Canadian Animal Health Institute, an industry lobby
group of manufacturers and distributors of veterinary medicines. Dr. Ritter
stated that he was responsible for the program in which Health Canada had
previously reviewed BGH. Ritter was accused in the House of Commons of
acting as a lobbyist for BGH manufacturers.
Health Canada Scientists Allege Harassment to Approve Drugs
On September 15-16, 1998, in the CD Howe Building (240 Sparks Street, 7th
Floor) at 9:30 am, the Public Service Staff Relations Board will be hearing
three grievances filed by six Health Canada scientists. The grievances were
filed through their union, the Professional Institute of the Public Service
of Canada (PIPSC).
The scientists, all employees of the Bureau of Veterinary Drugs at the
Health Protection Branch, state that upper-level management of Health
Canada is pressuring them to approve drugs despite unresolved safety
questions. The scientists allege persistent harassment by management,
including coercion, conspiracy, threats, intimidation and defamation. In
1994, the CBC-TV program "The 5th Estate" reported in an expose on BGH,
that the files of one of the scientists had been stolen.
Dr. Michelle Brill-Edwards resigned from Health Canada in 1996 because of
her fears that public safety was being subordinated to industry demands. In
a recent interview on CTV's Canada AM, Dr. Shiv Chopra, one of the grieving
scientists, was asked why he thought that he was under pressure from Health
Canada to approve products so quickly; Dr. Chopra replied, "Well, what do
you think? Money. For multinational companies that produce those things."
The scientists approached PIPSC after having received no satisfactory
response from Health Canada to their complaints. Health Canada downplayed
the scientists' concerns, referring to them as matters merely of employee
relations. The scientists disagree with this conclusion. They view the
issues as critical to their ability to protect public health and safety,
and to work free from employer interference. The scientists have requested
the Prime Minister call a judicial review of Health Canada.
The public insists that access to information from Health Canada scientists
is essential to food safety and to public trust in Health Canada. The
public demands that these greater issues be addressed, including public
access to information on the safety of products, and the protection of
pubic servants through "whistle-blowing" legislation.
The scientists have been ordered by Health Canada not to voice their
concerns in public. Several scientists have received severe reprimands by
the department for speaking to the public and to the media. The public is
being denied access to the scientists who review drugs for safety.
Consumers are only being allowed information from official Health Canada
spokespeople.
A complete report from Health Canada on the safety of BGH is being withheld
>from the Senate and from the public. This report, referred to as the "Gaps
Analysis" report, is reported to summarize the gaps in Health Canadaís
evaluation of the safety of BGH.
The Standing Senate Committee on Agriculture and Forestry has begun to look
at BGH and this fall will hold further hearings. The National Farmers Union
is asking the public to write to Senators and request that the scientists
appear as witnesses and that the "Gaps Analysis" report be subject to
rigorous evaluation and public scrutiny.
Who Wants a Ban on BGH ?
Numerous farm, environmental and health organizations are opposed to the
use of BGH in Canada. They include the National Farmers Union, the Sierra
Club of Canada, the Council of Canadians, and public health boards, school
boards, and consumer groups across the country.
REFERENCES
[1] In his book MILK, THE DEADLY POISON [ISBN 0-9659196-0-9] (Englewood
Cliffs, NJ: Argus Press [Tel. (201) 871-5871], 1997), pgs. 67-96, Robert
Cohen describes his extensive efforts to obtain a copy of this unpublished
study from FDA. Cohen filed a Freedom of Information Act request for the
study and was refused; he appealed within FDA and lost. He then filed a
lawsuit in federal court and, again, lost. FDA and the courts agree that
the public should never learn what happened to those rats fed BGH because
it would "irreparably harm" Monsanto. Based on the scant information that
has been published about the weight gains of the rats during the 90-day
study, Cohen believes that many or perhaps all of the rats got cancer.
Weight-gain in the rats is described cryptically in Tables 1 and 2 in
Judith C. Juskevich and C. Greg Guyer, "Bovine Growth Hormone: Human Food
Safety Evaluation," SCIENCE Vol. 249 (1990), pg. 875-884.
[2] Michael Hansen, "Testimony Before the Joint Meeting of the Food
Advisory Committee & the Veterinary Medicine Advisory Committee on Whether
to Label Milk From BGH-Treated Cows by Michael K. Hansen, Ph.D.," May 6,
1993. Available from: Consumer Policy Institute, Consumers Union, 101
Truman Ave., Yonkers, NY 10703-1057. Telephone (914) 378-2000.
[3] Keith Schneider, "F.D.A. Warns the Dairy Industry Not to Label Milk
Hormone-Free," NEW YORK TIMES February 8, 1994, pg. A1.
[4] Schneider, note 1 above. In an interview with RHWN March 15, Matt
Bennett of King & Spaulding refused to discuss these lawsuits, referring us
to Tom McDermott at Monsanto in St. Louis, whom we could not reach before
our press deadline.
[5] Virginia V. Weldon, "Coehlo Talking Points for Espy Dinner," a memo on
Monsanto company letterhead dated Sept. 21, 1993.
[6] Council on Scientific Affairs, American Medical Association.
"Biotechnology and the American Agricultural Industry." JAMA [JOURNAL OF
THE AMERICAN MEDICAL ASSOCIATION] Vol. 265, No. 11 (March 20, 1991), pg.
1433.
[7] Robert J. Collier and others, "[Untitled Letter to the Editor]," LANCET
Vol. 344 (September 17, 1994), pg. 816. Monsanto Senior Vice President
Virginia V. Weldon, MD, says, "...the FDA has concluded from detailed
studies that IGF-1 is not increased." See Virginia V. Weldon, "Re 'A
Needless New Risk of Breast Cancer, Commentary, March 20'," LOS ANGELES
TIMES April 4, 1994, pg. 6.
[8] William H. Daughaday and David M. Barbano, "Bovine somatotropin
supplementation of dairy cows: is the milk safe?" JOURNAL OF THE AMERICAN
MEDICAL ASSOCIATION Vol. 264, No. 8 (August 22, 1990), pgs. 1003-1005.
[9] C. G. Prosser and others, "Increased secretion of insulin-like growth
factor-1 into milk of cows treated with recombinantly derived bovine growth
hormone," JOURNAL OF DAIRY SCIENCE Vol. 56 (1989), pgs. 17-26.
[10] C. G. Prosser and others, "Increased secretion of insulin-like growth
factor-1 into milk of cows treated with recombinantly derived bovine growth
hormone," JOURNAL OF DAIRY SCIENCE Vol. 56 (1989), pgs. 17-26.
[11] Xian et al, 1995; Kimura et al, 1997
[12] June M. Chan and others, ìPlasma Insulin-Like Growth Factor-1 [IGF-1]
and Prostate Cancer Risk: A Prospective Study,î SCIENCE Vol. 279 (January
23, 1998)
For more information please contact:
Bradford Duplisea, Sierra Club of/du Canada (613) 241-4611
For more information on BGH and the FOX lawsuit, you can refer to website:
www.foxBGHsuit.com
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