Powerful FDA testimony re: labelling GE foods

Toby Hemenway hemenway at jeffnet.org
Thu Jan 6 14:34:30 EST 2000



I wanted to share this excellent inditement of GMOs with you, sent to me by
the editor-in-chief at Chelsea Green Publishing
http://www.chelseagreen.com. A couple of months ago, someone on this
listserv was asking about the FDA's revolving door with inductry. Here it
is.

>Thursday, December 2 - Day 26
>The FDA Testimony
>
>[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
>(gap in testimony)
>
>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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