GMW:_is_Monsanto's_GM_cattle_drug_dead?

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GMW:_is_Monsanto's_GM_cattle_drug_dead?

" GM_Watch "

Wed, 2 Jun 2004 11:19:35 +0100

 

GM WATCH daily

http://www.gmwatch.org

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This relates to Monsanto's genetically engineered cattle drug rBGH (Bovine

Growth Hormone) also known as BST (bovine somatotropin) and under its commercial

name Prosilac. It is designed to boost milk production

 

Whether all of the information given below hangs together we wouldn't like to

say but the question US consumers might like to ponder, is why this GE drug,

widely used in the US where Monsanto has taken legal action against companies

advertising their milk as BGH-free, is banned not only throughout the Eutopean

Union but even in Canada - and that's despite immense and dubious regulatory

pressure to have it approved.

 

Even the staunchly pro-GM Prof Jonathan Jones of the John Innes Centre was

driven to write to The Guardian to support an article by George Monbiot

expressing concern over this GM drug. Jones wrote, " he is certainly right to

highlight concern... about milk from cows treated with bovine somatotropin

(BST). It appears suspect both on animal welfare and human health grounds " .

http://www.gmwatch.org/profile1.asp?PrId=68 & page=J

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Douglas Hinds to the SANET list:

 

A post on another list claims that the FDA closed down Monsanto's Bovine Growth

Hormone production facility years after a report sent them by researcher Robert

Cohen blew the whistle on a serious defect present in the finished product.

 

The following url may have more on this: http://www.notmilk.com/

....

The genetically engineered bovine growth hormone is dead. Posilac, aka rbGH,

rbST, cow-fuel, milk-poison, will soon cease to exist.

 

Four months ago (Sunday, December 21, 2003), I filed a Freedom of Information

Act (FOIA) request with the Food and Drug Administration (FDA).

 

One day earlier, I had received a copy of a letter alerting dairy farmers that

Monsanto's genetically engineered bovine growth hormone (rbST) would be in short

supply. Monsanto wrote:

 

" Supplies of Posilac bovine somatotropin (rbST) are temporarily limited while

necessary corrections and improvements in manufacturing are made by Monsanto's

supplier. "

 

I smelled something rotten in Monsanto-land.

 

That next day, I called many people at FDA, attempting to get the facts. Nobody

was talking. In 1999, I had filed a citizen's petition with FDA to take Posilac

off the market. I submitted evidence of how Monsanto defrauded FDA. It took FDA

five years to act. They closed Monsanto's Posilac factory a few months ago.

Monsanto lied to dairy farmers, calling it a " temporary production problem. "

 

Monsanto had created a potential catastrophe for humankind. I give FDA credit

for finally acting.

 

I discovered that Monsanto had made a gene transcription error during the

development of their new genetic technology. Proteins are made up of amino

acids. Each time that Monsanto attempted to re-create their new hormone, one

amino acid, lysine, was incorrectly transcribed as a " freak " amino acid,

epsilon-N-acetyllysine.

 

For nearly five years, FDA ignored my request.

 

Then, things became interesting. Monsanto mailed a letter to Posilac-using dairy

farmers on December 19, 2003. Monsanto shocked farmers by alerting them that

Posilac would be in limited supply until:

 

" Conditions and improvements in manufacturing are made... "

 

Monsanto accepted no new customers, and anticipated their " shortfall " to last

for " several months. "

 

Monsanto attempted to fix the errors. They have not been successful. FDA now

knows of those mistakes because my whistleblowing broke windows.

 

What became the snowflake to make the snowball to begin the avalanche?

 

On Wednesday, February 4, 2004, I received the damning evidence that confirmed

Monsanto's crime against humankind. Thirty hours of non-stop research and

confirmation later supported the magnitude of Monsanto's crime.

 

In a column written before last Christmas, I predicted:

 

" Mark down this date, 12/19/03. This may very well be the defining moment that

ends the use of genetically engineered foods in America's food. "

 

On January 30, 2004, I received a warning that represented a threat to my well

being. I wrote a column the next day, responding to that threat:

 

" I have been threatened, and my enemies can go to hell. They will read this, and

know that there will be many witnesses to any future coincidences. You, my

readers, are an insurance policy that may or may not have matured to its full

term...I will not turn my back on the children. So, I continue my course. Full

speed ahead. "

 

Four days after writing and posting that column, I received an envelope from FDA

confirming my worst fears. My FOIA request. Truth, at last. The entire request

cost me $18.30. This revelation shall cost Monsanto and its stockholders

considerably more.

 

The most damning evidence was found in observation number 1, filed by an FDA

investigator after inspecting Monsanto's rebombinant bovine somatotropin (rbST

or Posilac) production facility at Biochemisetrasse 10, Kundl, Austria.

 

OBSERVATION 1

 

" There is a failure to thoroughly review the failure of a batch or any of its

components to meet any of its specifications whether or not the batch has been

thoroughly distributed. "

 

" Specifically, the corrective actions implemented after the investigation of

nine sterility failures reported since 2001 (3 for 2001, 3 for 2002, and 3 for

2003) for Posilac injection or for the lyophilized active ingredient

(Sometribove zinc) have not been effective in preventing reoccurrence. In five

instances (2 for 2001, 1 for 2002, and 2 for 2003) the organism was identified

as Propionibacterium acnes; Staphylococcus species have been identified in three

instances and in one instance (in 2002) Bacillus pumilus was found.

Propionibacterium was found in environmental samples of the manufacturing areas.

Batches manufactured around the same period of time and under the same

conditions of the affected lots have been released to the market. "

 

OBSERVATION 2

 

" Equipment for adequate control over micro-organisms is not provided when

appropriate for the manufacture, processing, packing or holding of a drug

product. "

 

It has been well reported that a new emerging species of bacteria has developed,

immune to antibiotic treatment. Staphylococcus aureus plagues many American

hospitals in this new outbreak. Could

the etiology of the mother of all deadly staph infections be traced to a new

genetically engineered version of staph, a superbug inadvertently produced by

Monsanto and then introduced into the food supply? In 1989, such staphyloccus

infections were unknown to hospitals. By 2002, nearly two-thirds of all hospital

infections could be attributed to antibiotic-resistant staphlococcus infections.

 

A second bacterium on FDA's (once) secret report reveals that Posilac samples

were found to contain bacillus pumilus. This bacterium degrades cellulose. What

would be the result of genetically engineering something that breaks down the

heartiest of plant cells with a cow hormone?... " God only knows. "

 

A third bacterium found was identified as propionibacterium acnes (P-acnes).

What the heck is P-acnes? An Internet search revealed:

 

" P. acnes is the causative agent of acne vulgaris (pimples)... Other infections

for which P. acnes has been implicated include corneal ulcers, heart valves and

prosthetic devices, and central nervous system shunts. A rare heart disease

known as

Propionibacterium acnes endocarditis has been discovered in a prosthetic valve

infected with P. acnes. The valve was also complicated by multiple mycotic

aneurysms. "

 

The world works in funny ways, but there is always balance Monsanto's hormone

will soon be off the market. FDA will allow Monsanto to withdraw their drug with

corporate dignity. Posilac will soon take its own life and cease to exist.

 

 

 

 

 

 

 

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