Is Monsanto's GM cattle drug dead? (2/6/2004)

This relates to Monsanto's genetically engineered cattle drug rBGH (Bovine Growth Hormone) also known as BST (bovine somatotropin) and under its commercial name Posilac. 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.lobbywatch.org/profile1.asp?PrId=68&page=J

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.


"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."


"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 intro

Go to a Print friendly Page

Email this Article to a Friend

Back to the Archive