-
- 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.
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-
- ***** 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.
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- I have a copy of the Federal Register. It says here advertising
this meeting:
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- "FDA is not aware of information that will distinguish
genetically engineered food as a class from other foods."
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- [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.
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- 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.
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- 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?
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- 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.
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- 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.
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- 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%.
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- I called FDA and spoke with Dick Teske. I said, "46%?
You said there were no biological effects!"
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- He said, "That's not statistically significant."
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- I said, "Well, let me see the raw data."
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- He said, "It's a trade secret."
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- 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!"
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- I met with FDA on April 21, 1995, and found out that
this was actually a 180-day study.
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- In Canada, they had this study. I have a letter here
[ROBERT COHEN REACHES INTO HIS BRIEFCASE], an internal memorandum:
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- "This is to advise you that the copies of reports,
letters, etc. for drug submissions have been stolen from my files."
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- This was stolen from a scientist's file in Canada. They
stole the second half of the "90-Day Study."
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- 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:
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- "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."
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- They (FDA) developed a zero day withdrawal - they determined
it was safe to drink.
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- 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
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- [AT THIS POINT, THE MODERATOR INTERRUPTS MR. COHEN AND
TELLS HIM TO WRAP IT UP AND TO ADDRESS LABELING]
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- 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.
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- 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.
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- 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)
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- ***** End testimony 11-30-99*****
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