- Recombinant bovine growth hormone (rbGH) is in the toilet
(Scheissen sie in der Toilette).
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- Imagine that you run Monsanto. OK...I'll wait while you
put on your horns, cloven hooves, and red cape.
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- Ready?
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- So...your genetically engineered bovine growth hormone
manufacturing facility has been kicked in the gut by the Food and Drug
Administration because it has produced batch after batch of product with
impurities, including contaminated anerobic microorganisms.
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- FDA has submitted a list of requirements for you to perform
in order to clean up your act. How have you responded to America's senior-most
regulatory drug agency?
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- With all due respect, right?
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- Nah. Why would a criminal do the right thing?
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- Monsanto decided to respond to a long list of FDA's demands
regarding unsafe conditions at their Austrian factory with doubletalk written
in German, not English.
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- How did FDA react?
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- On March 29th, Gloria Dunnavan, FDA's Director of the
Office of Surveillance and Compliance, wrote to the CEO of Sandoz (Monsanto's
rbGH supplier):
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- "We wish to point out that it is not the responsibility
of the Food and Drug Administration or the Center for Veterinary Medicine
to translate documents."
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- Pissed off? You bet. Dunnavan's reaction:
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- "We reviewed your responses...we found that the
responses still lacked sufficient detail, explanation, documentation or
substantive corrective action plans..."
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- FDA's final threat:
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- "Failure to promptly correct these violations may
result in regulatory action being initiated by the Food and Drug Administration
without further notice. These actions include, but are not limited to,
seizure, injunction, and/or civil penalties. Further, if corrections are
not made, we will recommend that your firm's products be placed on import
alert and be denied entry into the United States."
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- Read FDA's entire warning letter to Monsanto:
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- <http://www.fda.gov/foi/warning_letters/g4633d.htm
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- FDA's letter was written on March 29, 2004, and posted
to their website 30 days later on April 28, 2004.
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- Monsanto's response to FDA's letter (written by Brian
Lowry, V.P.):
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- "This letter was issued as part of the normal procedures
followed by FDA..."
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- Sounds pretty abnormal to me. In his press release, Mr.
Lowry writes:
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- "If you have nay (SIC) questions (he must have meant
to write "any" instead of "nay")--
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- A classic Freudian slip.
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- As a matter of fact, I did have a "nay" (negative)
question, and since he was kind enough to post his phone number (314-694-2872),
I called him at 3 PM on Friday (5/7/04) afternoon. Here was my question.
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- "Since dairy farmers are now producing less milk,
they are netting their highest prices in history, over $20 per hundred
pounds. Compare that to just $9 per hundred pounds six months ago. They've
woken up to the fact that 15% more milk means 50% lower net. They've correctly
reasoned that your Posilac is bad for business. What do you say to that?"
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- I spoke to Lowry one week after he wrote the press release,
and his response surprised even me.
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- "I am no longer working in Monsanto's dairy division,
so I really cannot comment on the economic impact of Posilac." __________________________________________________________
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- Dear Monsanto,
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- This is all my doing. I take full credit for initiating
the investigation that will have destroyed your bovine growth hormone business.
I have cost you hundreds of millions of dollars. What do I suggest you
do? Stick it in your ear.
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- I wish only that Dave Rietz could have lived to see this
bit of justice played out.
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- Respectfully, Robert Cohen http://www.notmilk.com 201-967-7001
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