Upjohn & Monsanto to merge to deceive and hurt our health..

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Ira M. Fine

iramfine@...

P.S. Happy New Year to all of you.

Subj: DEB HungerStrike UPDATE: There MUST be a law!

Date: 12/26/1999 4:37:07 PM !!!First Boot!!!

From: dorietz@... (DEB News)

Reply-to: dorietz@...

dorietz@... (DEB News list)

********* Please pass to friends and family *********

SUBSTANTIAL DIVERGENCE

On this 50th day of my hunger strike, I have learned a new secret, and I

am very greatly concerned.

While anti-biotech protestors were rioting in the streets of Seattle, a

new episode in the continuing saga of Monsanto's revolving door tactics

quietly developed beyond FDA's " palace " doors.

Somebody may be breaking the law, participating in unethical activity at

the least, insider trading and influence, betrayal of our health

interests, and the time has come for us to ask: " What's up? "

The same grandiloquent question that Bugs Bunny asks Elmer Fudd can

fittingly be asked of our scientists and government regulators: " What's

up, Doc? "

Appropriately, that question should also be directed to the president of

Monsanto, Shapiro. " What's up, Bob? "

Actually, as we get closer to asking this very same question to the

guiltiest of conspirators, we have discovered a source of future ills in

the nick of time. Knowing the proper question to ask might very well

nip the problem deep within the pollen of its genetically engineered

bud.

THE REAL ENEMY

Today, on this first day after Christmas, let us ask together, " What's

up, . " You might be wondering just who this fellow is.

Actually, it's UPJOHN. You might ask, " What's up, ? " Well, I'm

gonna tell you. Activists of the world, unite. We have met the enemy.

(UPJOHN is not where I want you to stick your proverbial placards and

banners of protest. Not yet, anyway.)

When Monsanto first presented their research to the FDA for approval of

the genetically engineered bovine growth hormone (rbGH), there were also

three other pharmaceutical companies with their own different versions

of the genetically modified organism.

Monsanto's protein formula was different than the naturally occurring

bovine growth hormone. Monsanto's hormone was not an exact version of

the natural pituitary extract from a cow. The end amino acid (amino

acids are the building blocks of proteins) was just a little bit

different than what naturally occurs in nature. Actually, it was VERY

different, but Monsanto neglected to reveal all of their secrets until

after their drug received official FDA approval.

THE MAGICIANS PERFORMED THEIR SLEIGHT-OF-HAND TRICK

Monsanto received approval for rbGH on Friday, February 4, 1994. There

must have been quite a celebration in their St. Louis corporate

headquarters on that day. Perhaps the celebration continued through the

weekend. What happened the following Monday provides the " smoking gun "

evidence to Monsanto's crime. On Monday, a group of Monsanto scientists

photocopied, collated and stapled together the most incriminating

scientific document in history and sent it to a peer-review journal for

publication. On Thursday of that week, the journal " PROTEIN SCIENCE "

officially received Monsanto's study.

In that paper, Monsanto admitted that they made significant errors in

their formula. WHAT'S UP, JOHN?

What's up, doc? Monsanto waited until after approval, just in case, to

admit their errors. After approval, Monsanto admitted that the errors

were fixed. However, in making this no-win admission, Monsanto also

revealed that all of the research submitted to FDA from 1985 until 1993

was performed with a different hormone than the one that is currently on

the market.

Funny creatures, these scientists. Most of the authors of the study

worked for Monsanto. Most, but not all.

A few researchers were with other firms. One researcher, located after

three phone calls told me that he worked for Monsanto nearly two years

before the hormone was approved. Then he made a number of career moves,

but still received credit for his work in co-authorship. What does this

prove? Simply, that Monsanto knew the errors were made, but held off

until after approval. By leaving the firm, the co-author placed a time

stamp upon when the " crime " was actually known, and when it was

committed.

Monsanto's genetically engineered bovine growth hormone (trade name =

POSILAC) has never been tested on a laboratory animal. Nor as it been

tested on a cow.

Before approval, the FDA required Monsanto to perform hundreds of

millions of dollars worth of new research. Equivalent in 1989 did not

mean that a perfect match existed. The other three pharmaceutical

companies elected not to continue with their research. Eli Lilly had

created a bovine growth hormone with seven additional amino acids.

American Cyanamid created a version with three new amino acids. Now to

the theme of this column. UPJOHN's version was an exact duplicate of

what naturally occurs in nature. Exact by 1990 standards, that is.

The reason that this holds so much significance is that MONSANTO and

UPJOHN will soon be merging into one very large company. Criminal

co-conspirators will be committing a crime together, and then they'll

change their name and identity. Will you even recognize the crime?

You most certainly will by reading the rest of this column!

UPJOHN's version of the bovine growth hormone was " supposedly " identical

to the hormone naturally manufactured in a cow's brain.

UPJOHN has recently applied to FDA for approval of their hormone, based

upon the theory of " substantial equivalence. " I learned about UPJOHN'S

application early Thursday morning. Their application is so secret that

FDA will not even confirm that it has been made. On that Thursday

before Christmas, I requested the file number from an employee at the

Center for Veterinary Medicine (CVM), FDA's investigative branch. She

put me on hold and spoke to the director, Sundlof. After a

minute, she came back and apologized. " We cannot reveal the file number

until the drug is approved. " I was stunned by their secrecy. By that

time, it will be too late. After that phone conversation, I filed a

Freedom of Information Act request for the case file. Will I be denied?

Time will tell.

UPJOHN'S application and FDA's review is based upon substantial fraud,

not substantial equivalence.

Genetic engineering is not a perfect science. When cow hormones are

combined with E. coli bacteria, one of the resulting amino acids often

becomes a freak. That amino acid, LYSINE, has an acetyl group added to

it. Chemists call this process " acetylization. "

Suffice it to say that this is a big error…one small error for Monsanto

and UPJOHN, one giant OOPS for mankind.

Monsanto created five freak amino acids. UPJOHN most certainly did the

same. In 1990, FDA reviewers did not have the sophisticated tests

necessary to detect such errors. New technology provides those tests

today. Rubber stamping UPJOHN's application because of substantial

equivalence cannot be allowed to occur. There is no substantial

equivalence when mistakes occur. Monsanto should repeat their research.

UPJOHN did not receive approval in 1990, and chose not to invest

hundreds of millions of dollars to gain approval. They should not be

given a free pass today.

We cannot, must not, will not let FDA apply their doctrine of

substantial equivalence to UPJOHN. We have discovered Monsanto's plan,

and are not happy that these two schemers long ago applied to FDA for

approval, while discussing merger talks. Their intent is clear.

Deceive, divide, and conquer.

There has got to be a law!

Cohen