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Date: Sat Dec 27, 2003 2:35 pm
Subject: History of Monsanto Subversion of FDA regulatory process

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http://www.netlink.de/gen/Zeitung/1999/991206a.htm

GM fraud and corruption in US - testimony at FDA
hearing


Robert Cohen appeared on an FDA panel in Washington on
Tuesday, November
30, 1999. Some of you may have seen his speech on
C-Span.
Mr. Cohen spoke last, and each of the other panel
members read prepared
statements. Members of the panel also included Mildred
Cody, who
represented the American Dietetic Association; Mario
Teisl, a professor
of economics at the University of Maine; John Gray,
president of the
International Food Service Distributors Association;
Kendal Keith,
president of the National Grain & Feed Association;
and Richard Caplan,
an environmental advocate with the US Public Interest
Research Group.]
-------------------------------------------------------------------------
Testimony 11-30-99

Hi everybody, I've got to apologize first - I don't
have a prepared
statement like the other panel members. All I'm going
to give here is
some facts.

I have a copy of the Federal Register. It says here
advertising this
meeting:

"FDA is not aware of information that will distinguish
genetically
engineered food as a class from other foods."

[ROBERT COHEN TURNS AND ADDRESSES FDA PANEL MEMBERS.]
I'm going to give you some information today, guys.

The greatest controversy in FDA history was the
approval process for
Monsanto's genetically engineered bovine growth
hormone. We shouldn't
be here today! We should not be in this room and I
shouldn't be here
because, in 1994, Congress HAD A BILL that was going
to require
mandatory labeling of all foods that were influenced
by genetic
engineering. I got my Congresswoman to co-sponsor that
bill - 181
congresspeople co-sponsored that bill, and you know
what? I learned how
Congress works that year because in 6 months they
stalled the bill - 12
members of the Dairy Livestock & Poultry Committee -
they stalled the
bill until the 1994 session of Congress expired and
the bill died.

I was so upset, I investigated these 12 men and found
that collectively
they took $711,000 in PAC money from companies with
dairy interests, and
four of the members of the committee took money
directly from Monsanto.

Now we've got a lot of political intrigue and some
real science here.
We've got science fiction, we've got a combination of
John Grisham and
we've got a combination of Stephen King.

Nikita Khrushchev said that what the scientists have
in their briefcase
is terrifying - [ROBERT COHEN THEN OPENED HIS
BRIEFCASE AND PULLED OUT
A STACK OF PAPERS] and I've got some interesting
things in my briefcase
to share with you today.

When Monsanto made their genetically engineered bovine
growth hormone,
they noticed a couple of problems right towards the
end - right before
approval. They noticed that laboratory animals were
getting cancer, and
they noticed that cows were getting mastitis, ulcers
in their udders.
They were putting more pus and bacteria into the milk.
So Monsanto
arranged

We've heard from Dr. Maryanski this morning, and Dr.
Maryanski talked
about the Pure Food, Drug, and Cosmetic Act but what
he didn't tell you
was that in 1958, Robert Delaney, a congressman from
New York, added the
Delaney Amendment which was named after him. The
Delaney Amendment
stated that if a food additive caused cancer, it was
not to be approved
- a pretty good law - right?

Monsanto got their attorney, Michael Taylor from the
firm of King &
Spalding By the way, when they started in 1979, they
groomed their
attorney who is now in the Supreme Court, Clarence
Thomas, from the same
law firm.

Anyway, Monsanto's attorney, Michael Taylor, wrote and
minimized the
Delaney Amendment- he wrote a scientific paper that
was published in the
"Journal of Toxicology". Lawyers -they write in law
review journals,
but this lawyer wrote in the "Journal of Toxicology":
"a De-Minumus
interpretation of the Delaney Amendment" became the
new protocol, the
new standard operating procedure at FDA. They
minimized cancer.

Michael Taylor was hired by the Food & Drug
Administration, and became
the second most powerful man there, Monsanto's
attorney - he wrote the
standard operating procedure. In other words, if you
see cancer, ignore
it. Margaret Miller and Suzanne Sechen, Monsanto's
scientists, were
hired by the FDA to review Monsanto's own research.

Margaret Miller knew cows were getting mastitis. The
first week at the
FDA, December 3, 1989, she was given broad power, and
here's an affect
of genetic engineering nobody has considered. She knew
cows were
getting sick from the genetically engineered hormone.
She changed the
amount of antibiotics that farmers could have in their
milk. She
changed it from 1 part per 100 million to 1 part per
million - this is a
fact! She increased it by 100 times.

There is a hero of mine in the audience, Michael
Hansen from Consumer's
Union - Consumer's Union tested milk in the New York
metropolitan area
and
found the presence of 52 different antibiotics in milk
samples.

FDA published on August 24, 1990, the first time ever
in a peer-reviewed
journal, in "Science". "Science" was started by Thomas
Edison in the
1880's. They published a review of bovine somatotropin
-bGH -the
genetically engineered cow hormone. And in that
review, there were
seven
tables of data. Five of those tables came from one
study authored by
Richard, Odaglia and Deslex. This is the famous
"90-Day Study." Guess
what? This was actually a study lasting for 180 days
and when I first
heard about this in 1994, I filed a Freedom of
Information Act Request
for that study - because I saw from the data that the
average spleen of a
lab animal increased 46%.

I called FDA and spoke with Dick Teske. I said, "46%?
You said there
were no biological effects!"
He said, "That's not statistically significant."
I said, "Well, let me see the raw data."
He said, "It's a trade secret."
I called Monsanto, they laughed at me. They said,
"It's a trade secret
and you will never see it."

I'm smart, I filed a Freedom of Information Act
Request, but I didn't
realize you can't find out the study. I went to
Federal Court, I said,
"Your honor - spleen increase of 46%, that's leukemia
in 90 days!"

I met with FDA on April 21, 1995, and found out that
this was actually a
180-day study.

In Canada, they had this study. I have a letter here
[ROBERT COHEN
REACHES INTO HIS BRIEFCASE], an internal memorandum:

"This is to advise you that the copies of reports,
letters, etc. for
drug submissions have been stolen from my files."

This was stolen from a scientist's file in Canada.
They stole the second
half of the "90-Day Study."

We've got real science here. I'm going to talk briefly
about the real
science because when Monsanto made this hormone, they
had to tell the
FDA - they had to draw a chart of every amino acid -
the 191 amino acids.
And when FDA wrote their paper in "Science" magazine
they wrote that one
amino acid changed - it was a different hormone than
the naturally occurring
one.

At the same time, somebody hired C. Everett Koop to
come and say that
genetically engineered milk and the good old wholesome
milk is
indistinguishable. Well, it wasn't. Something happened
to the hormone
that Monsanto made. The FDA said that there was one
change in the
endamino acid. It became epsilon-N-acetyllysine. FDA
had written if there was a
change in the middle of the protein, there could be
disastrous results.
They cited Jerome Moore. I got Jerome Moore's paper.
It said if there
is a protein change in the middle, there could be
Alzheimer's or sickle
cell anemia or diabetes.

Four months after the hormone was approved, one of
Monsanto's
scientists, Bernard Violand, published in the July 3,
1994 issue of the journal
"Protein Science" evidence that Monsanto made a
mistake.

Oops! Monsanto created a freak amino acid. Did you
ever see that movie
"The Fly" with Jeff Goldblum when the fly comes in and
he becomes
half-human and half-fly? Monsanto created a freak
amino acid. Monsanto
admitted it but didn't tell the FDA. [ROBERT COHEN
TURNS AND POINTS TO
THE FDA PANEL MEMBERS].

Gentlemen, the hormone that's on the market today is
different than the
one you tested for seven years. Monsanto spent 500
million dollars,
submitted 55,000 pages of information to you, learned
late in the
process that they created a freak amino acid - that's
what was tested on
laboratory animals and it didn't matter because FDA
said to Monsanto,
you know something? It's safe because when you
pasteurize milk, you destroy
the hormone.

They performed this research up in Guelph, Ontario by
Paul Groenewegan,
and I've got his study. [ROBERT COHEN AGAIN ADDRESSES
FDA PANEL MEMBERS]
To this day, FDA thinks -it's on your web page - that
90% of the bovine
growth hormone is destroyed by pasteurization. But
what Paul
Groenewegan did working with Ted Elasser and Brian
McBride, two Monsanto scientists,
was he pasteurized milk for 30 minutes at 162ºF, and
when I read that -
I
said, wait a second, milk is pasteurized for 15
seconds at that
temperature - not 30 minutes. They intentionally tried
to destroy the
hormone, they only destroyed 19% of it - somebody
lied. And at that
moment, FDA said to Monsanto:

"Because you destroy it by pasteurization, you don't
have to do further
toxicology studies. You don't have to develop a test
for this hormone
in milk. It's now safe to drink."

They (FDA) developed a zero day withdrawal - they
determined it was safe
to drink.

We have a lot of political intrigue here. We have an
interesting
situation where people have said that a revolving door
policy exists at
FDA. I mean, where is the ex-FDA commissioner, guess
who he is working
for? He is working for Monsanto. Bob Dole ran for
President, his Chief
of Staff was Donald Rumsfeld (ex-president of Searle,
owned by Monsanto).
I have one last comment

[AT THIS POINT, THE MODERATOR INTERRUPTS MR. COHEN AND
TELLS HIM TO WRAP
IT UP AND TO ADDRESS LABELING]

I know, but we have a labeling issue here - we have a
right to know - I
have listened to comments about "multi-faceted
educational effort that
we need" - that's called brainwashing! I don't want a
"multi-faceted
educational effort" - I want a double helical
structure (AUDIENCE
APPLAUDS) on a piece of food that I'm going to buy in
the supermarket
because I have a right to know.

Because the bottom line is - mistakes were made and
when I hear from the
American Dietetic Association, [ROBERT COHEN ADDRESSES
A MEMBER OF THE
AMERICAN DIETETIC ASSOCIATION WHO PREVIOUSLY SPOKE
AGAINST LABELING], I
want to remind you that Monsanto gave you $100,000 to
set up a toll-free
hotline about the bovine growth hormone.

Mistakes were made! We've got political intrigue here
and the bottom
line is we have a right to know what we are eating.
Thank you. (APPLAUSE)

End testimony 11-30-99

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