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Got Hormones - The Controversial Milk Drug that Refuses to Die
Article by Jeffrey M. Smith,
Author of - Seeds of Deception

Institute for Responsible Technology    Spilling the Beans, Dec. 1, 2004

(Note: The following information is carried in this website as a public
service.)

"Effective December 1, 2004, as a current customer, you will have access to
an increased supply of POSILAC."1 This news from Monsanto to its customers
was disappointing for those around the world who understood its
consequences. Back in January, the company announced that they would reduce
their supply of the drug by 50%, after FDA inspectors discovered
unacceptable levels of contamination. Many people hoped that Posilac would
quietly disappear altogether. "If Monsanto gives this stuff up, it would be
a godsend to both cows and people,"2 said Rick North who heads up the
campaign by Oregon Physicians for Social Responsibility to fight the drug.
But on October 8, 2004, Monsanto announced it would be increasing its
supply back up to "at least 70%."

Posilac is a genetically engineered drug that increases milk production in
cows by 10-15%. It is also known as recombinant bovine growth hormone,
rbGH, Bovine Somatotropin, BST, and "Crack for Cows." Its controversial
history has left fifteen years of frustrated whistleblowers strewn in its
wake.

Early casualties were scientists at the Food and Drug Administration (FDA)
during the drug's evaluation. Chemist Joseph Settepani, in charge of
quality control for the approval process of veterinary drugs at the Center
for Veterinary Medicine (CVM), testified at a public hearing about threats
to human safety. Soon after, he was reprimanded, threatened, stripped of
responsibilities, and relocated a trailer at an experimental farm. In later
testimony before a congressional subcommittee, Settepani said, "Dissent
[atCVM] is not tolerated if it could seriously threaten industry profits."3

Division director Alexander Apostolou wrote in an affidavit, "Sound
scientific procedures for evaluating human food safety of veterinary drugs
have been disregarded. I have faced continuous pressure from my CVM
superiors to reach scientific conclusions favorable to the drug industry. .
. . In my time at CVM I have witnessed drug manufacturer sponsors
improperly influence the agency's scientific analysis, decision-making, and
fundamental mission."4 Apostolou was forced out after he began to express
his concerns.

FDA Veterinarian Richard Burroughs said that agency officials "suppressed
and manipulated data to cover up their own ignorance and incompetence."5 He
also described how industry researchers would often drop sick cows from
studies, to make the drug appear safer. Burroughs had ordered more tests
than the industry wanted and was told by superiors he was slowing down the
approval. He was fired and his tests cancelled.

The remaining whistle-blowers in the FDA had to write an anonymous letter
to Congress, complaining of fraud and conflict of interest in the agency.
They described one FDA scientist who arbitrarily increased the allowable
levels of antibiotics in milk 100-fold. This was necessary before approving
rbGH. Since the drug increases the chance of udder infections, farmers
inject cows with more antibiotics. This leads to a higher risk of
antibiotic resistant diseases in cows and humans. According to the letter,
Margaret Miller authorized the increased levels. She had formerly conducted
research on rbGH while with Monsanto and then moved into the FDA department
that evaluated her own research.

Dr. Samuel Epstein, Professor at the University Of Illinois School Of
Public Health, cited numerous potential or theoretical health dangers from
rbGH, including "hormonal and allergic effects . . . premature growth and
breast stimulation in infants," and possibly cancer in adults.6 Epstein
also received an anonymous box of stolen files from the FDA. Documents
revealed that in order to show that rbGH injections did not interfere with
fertility, industry researchers allegedly added cows to the study that were
pregnant prior to injection. Also, blood hormone levels skyrocketed by as
much as a thousand-fold after injections.7

Monsanto tried to silence Epstein. Their public relations firm created a
group called the Dairy Coalition, which included university researchers
whose work was funded by Monsanto, and selected "third party" experts and
organizations. Representatives of the Dairy Coalition pressured editors of
the USA Today, Boston Globe, New York Times and others, to limit coverage
of Epstein.

Hormones in Your Milk:

Several claims made by FDA scientists in defense of rbGH have not held up
under scrutiny. For example, they said that bovine growth hormone does not
increase substantially in milk from treated cows. The study they cited,
however, shows a 26% increase in the hormone. Furthermore, researchers
injected cows with only a 10.6 mg daily dose of rbGH compared to the normal
500 mg bi-weekly dose used by farmers. In fact, they didn't even use
Monsanto's rbGH, but rather another version that was never approved. They
then pasteurized the milk 120 times longer than normal in an apparent
attempt to show that the hormone was destroyed during the process. They
only destroyed 19% of the hormone.8 They then spiked the milk with powdered
hormone-146 times the naturally occurring levels-heated that 120 times
longer than normal, and were then able to destroy 90% of the hormone. FDA
scientists reported that 90% of the hormone was destroyed during
pasteurization.9

The hormone most critics are concerned about, however, is insulin-like
growth factor 1 (IGF-1). Natural milk contains IGF-1. Milk drinkers
increase their levels of IGF-1.10 Studies suggest that pre-menopausal women
below 50 year old with high levels of IGF-1 are seven times more likely to
develop breast cancer.11 Men are four times more likely to develop prostate
cancer.12 IGF-1 is also implicated in lung and colon cancer. Milk from cows
treated with rbGH has significantly higher levels of IGF-1.13 (No
comprehensive study has evaluated a direct link between rbGH and human
cancer.)

This potential link between rbGH and cancer was one of the many
controversial topics to be covered in a four-part investigative news series
at a Tampa-based Fox TV station. But four days before the series was to
air, Fox received a threatening letter from Monsanto's attorney. They
pulled the show. The station manager reviewed it, approved the content, and
scheduled it for the following week. A second letter arrived from
Monsanto's attorney, this time threatening "dire consequences for Fox
News."14 The show was postponed indefinitely. Jane Akre and Steve Wilson,
the award winning investigative reporters who had created the report for
Fox, say that they were offered hush money to leave the station and never
speak about the story again. They declined. So Fox's corporate attorney led
them in a series of rewrites, attempting to soften the language and
apparently appease Monsanto. Six months and 83 rewrites later, the
reporters were ultimately fired for refusing to write in the script that
the milk from treated cows was the same as normal milk. The reporters
argued that that Monsanto's own research showed a difference, such as the
increased IGF-1 levels, and even the FDA scientists had acknowledged this.

The reporters sued. Akre was awarded $425,000 by a jury that agreed that
Fox "acted intentionally and deliberately to falsify or distort the
plaintiffs' news reporting on BGH,"15 and that Akre's threat to blow the
whistle was the reason she was fired. But an appeals court overturned the
verdict on the grounds that the whistle-blower's statute only protects
people who threaten to report a violation of a law, rule, or regulation.
Distorting TV news, evidently, is not technically illegal. Akre and Wilson
now have to pay a combined $196,500 to cover some of Fox's legal costs.
This is on top of the $200,000 - $300,000 they already spent on their case.

Attacks on rbGH whistleblowers are not limited to the US. In 1998, six
Canadian government scientists testified before the Senate that they were
being pressured by superiors to approve rbGH, even though they believed it
was unsafe for the public. Their detailed critique of the FDA's evaluation
of the drug showed how the US approval process was flawed and superficial.
They also testified that documents were stolen from a locked file cabinet
in a government office, and that Monsanto offered them a bribe of $1-2
million to approve the drug without further tests. (A Monsanto
representative went on national Canadian television claiming that the
scientists had obviously misunderstood an offer for research money.) The
Canadian scientists later described how their superiors retaliated against
them for testifying. They were passed over for promotions, given impossible
tasks or no assignments at all, one was suspended without pay. Three of the
whistleblowers, who also spoke out on such controversial topics as mad cow
disease, were ultimately fired on July 14, 2004.

Most industrialized nations have banned rbGH. Within the US, many school
systems have also banned it and several dairies refuse to use it. Oakhurst
Dairy of Portland, Maine, for example, requires its suppliers to sign a
notarized affidavit every six months. The Oakhurst label stated, "Our
Farmers' Pledge: No Artificial Growth Hormones." But on July 3, 2003,
Monsanto sued the dairy over their labels. Oakhurst eventually settled with
Monsanto, agreeing to include a sentence on their cartons saying that
according to the FDA no significant difference has been shown between milk
derived from rbGH-treated and non-rbGH-treated cows. The statement is not
true. FDA scientists had acknowledged the increase of IGF-1 in milk from
treated cows. Nonetheless, the misleading sentence had been written years
earlier by the FDA's deputy commissioner of policy, Michael Taylor. Prior
to becoming an FDA official, Taylor was Monsanto's outside attorney. He
later worked at the USDA on biotech issues, and later became vice president
of Monsanto.


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© Copyright 2004 by Jeffrey M. Smith. Permission is granted to reproduce
this in whole or in part.