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* Note from Sheryl *
Reproduced in its entirety with permission of the author Robert Cohen
FDA Testimony 11-30-99
By Robert Cohen notmilkman@notmilk.com
[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.]
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 **** 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 162 F, 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)
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