Tuesday, April 29, 2008

GM fraud and corruption in US - testimony at FDA hearing

Robert Cohen appeared on an FDA panel in Washington on Tuesday, November30, 1999. Some of you may have seen his speech on C-Span.Mr. Cohen spoke last, and each of the other panel members read preparedstatements. Members of the panel also included Mildred Cody, whorepresented the American Dietetic Association; Mario Teisl, a professorof economics at the University of Maine; John Gray, president of theInternational 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 11-30-99Hi everybody, I've got to apologize first - I don't have a preparedstatement like the other panel members. All I'm going to give here issome facts.I have a copy of the Federal Register. It says here advertising thismeeting:"FDA is not aware of information that will distinguish geneticallyengineered 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 forMonsanto's genetically engineered bovine growth hormone. We shouldn'tbe here today! We should not be in this room and I shouldn't be herebecause, in 1994, Congress HAD A BILL that was going to requiremandatory labeling of all foods that were influenced by geneticengineering. I got my Congresswoman to co-sponsor that bill - 181congresspeople co-sponsored that bill, and you know what? I learned howCongress works that year because in 6 months they stalled the bill - 12members of the Dairy Livestock & Poultry Committee - they stalled thebill until the 1994 session of Congress expired and the bill died.I was so upset, I investigated these 12 men and found that collectivelythey took $711,000 in PAC money from companies with dairy interests, andfour 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 andwe've got a combination of Stephen King.Nikita Khrushchev said that what the scientists have in their briefcaseis terrifying - [ROBERT COHEN THEN OPENED HIS BRIEFCASE AND PULLED OUTA STACK OF PAPERS] and I've got some interesting things in my briefcaseto share with you today.When Monsanto made their genetically engineered bovine growth hormone,they noticed a couple of problems right towards the end - right beforeapproval. They noticed that laboratory animals were getting cancer, andthey noticed that cows were getting mastitis, ulcers in their udders.They were putting more pus and bacteria into the milk. So MonsantoarrangedWe've heard from Dr. Maryanski this morning, and Dr. Maryanski talkedabout the Pure Food, Drug, and Cosmetic Act but what he didn't tell youwas that in 1958, Robert Delaney, a congressman from New York, added theDelaney Amendment which was named after him. The Delaney Amendmentstated 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 theirattorney who is now in the Supreme Court, Clarence Thomas, from the samelaw firm.Anyway, Monsanto's attorney, Michael Taylor, wrote and minimized theDelaney 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-Minumusinterpretation of the Delaney Amendment" became the new protocol, thenew standard operating procedure at FDA. They minimized cancer.Michael Taylor was hired by the Food & Drug Administration, and becamethe second most powerful man there, Monsanto's attorney - he wrote thestandard operating procedure. In other words, if you see cancer, ignoreit. Margaret Miller and Suzanne Sechen, Monsanto's scientists, werehired by the FDA to review Monsanto's own research.Margaret Miller knew cows were getting mastitis. The first week at theFDA, December 3, 1989, she was given broad power, and here's an affectof genetic engineering nobody has considered. She knew cows weregetting sick from the genetically engineered hormone. She changed theamount of antibiotics that farmers could have in their milk. Shechanged it from 1 part per 100 million to 1 part per million - this is afact! She increased it by 100 times.There is a hero of mine in the audience, Michael Hansen from Consumer'sUnion - Consumer's Union tested milk in the New York metropolitan areaandfound the presence of 52 different antibiotics in milk samples.FDA published on August 24, 1990, the first time ever in a peer-reviewedjournal, in "Science". "Science" was started by Thomas Edison in the1880's. They published a review of bovine somatotropin -bGH -thegenetically engineered cow hormone. And in that review, there wereseventables of data. Five of those tables came from one study authored byRichard, Odaglia and Deslex. This is the famous "90-Day Study." Guesswhat? This was actually a study lasting for 180 days and when I firstheard about this in 1994, I filed a Freedom of Information Act Requestfor that study - because I saw from the data that the average spleen of alab animal increased 46%.I called FDA and spoke with Dick Teske. I said, "46%? You said therewere 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 secretand you will never see it."I'm smart, I filed a Freedom of Information Act Request, but I didn'trealize 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 a180-day study.In Canada, they had this study. I have a letter here [ROBERT COHENREACHES INTO HIS BRIEFCASE], an internal memorandum:"This is to advise you that the copies of reports, letters, etc. fordrug submissions have been stolen from my files."This was stolen from a scientist's file in Canada. They stole the secondhalf of the "90-Day Study."We've got real science here. I'm going to talk briefly about the realscience because when Monsanto made this hormone, they had to tell theFDA - 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 oneamino acid changed - it was a different hormone than the naturally occurringone.At the same time, somebody hired C. Everett Koop to come and say thatgenetically engineered milk and the good old wholesome milk isindistinguishable. Well, it wasn't. Something happened to the hormonethat Monsanto made. The FDA said that there was one change in theendamino acid. It became epsilon-N-acetyllysine. FDA had written if there was achange in the middle of the protein, there could be disastrous results.They cited Jerome Moore. I got Jerome Moore's paper. It said if thereis a protein change in the middle, there could be Alzheimer's or sicklecell anemia or diabetes.Four months after the hormone was approved, one of Monsanto'sscientists, 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 becomeshalf-human and half-fly? Monsanto created a freak amino acid. Monsantoadmitted it but didn't tell the FDA. [ROBERT COHEN TURNS AND POINTS TOTHE FDA PANEL MEMBERS].Gentlemen, the hormone that's on the market today is different than theone you tested for seven years. Monsanto spent 500 million dollars,submitted 55,000 pages of information to you, learned late in theprocess that they created a freak amino acid - that's what was tested onlaboratory animals and it didn't matter because FDA said to Monsanto,you know something? It's safe because when you pasteurize milk, you destroythe 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 bovinegrowth hormone is destroyed by pasteurization. But what PaulGroenewegan 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 -Isaid, wait a second, milk is pasteurized for 15 seconds at thattemperature - not 30 minutes. They intentionally tried to destroy thehormone, they only destroyed 19% of it - somebody lied. And at thatmoment, FDA said to Monsanto:"Because you destroy it by pasteurization, you don't have to do furthertoxicology studies. You don't have to develop a test for this hormonein milk. It's now safe to drink."They (FDA) developed a zero day withdrawal - they determined it was safeto drink.We have a lot of political intrigue here. We have an interestingsituation where people have said that a revolving door policy exists atFDA. I mean, where is the ex-FDA commissioner, guess who he is workingfor? He is working for Monsanto. Bob Dole ran for President, his Chiefof 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 WRAPIT UP AND TO ADDRESS LABELING]I know, but we have a labeling issue here - we have a right to know - Ihave listened to comments about "multi-faceted educational effort thatwe need" - that's called brainwashing! I don't want a "multi-facetededucational effort" - I want a double helical structure (AUDIENCEAPPLAUDS) on a piece of food that I'm going to buy in the supermarketbecause I have a right to know.Because the bottom line is - mistakes were made and when I hear from theAmerican Dietetic Association, [ROBERT COHEN ADDRESSES A MEMBER OF THEAMERICAN DIETETIC ASSOCIATION WHO PREVIOUSLY SPOKE AGAINST LABELING], Iwant to remind you that Monsanto gave you $100,000 to set up a toll-freehotline about the bovine growth hormone.Mistakes were made! We've got political intrigue here and the bottomline is we have a right to know what we are eating. Thank you. (APPLAUSE)End testimony 11-30-99

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