Monsanto will appeal Canada's BST rejection
Saturday, January 16, 1999
By [Robert Steyer</a>]
Of The Post-Dispatch
Post-Dispatch Wire Services Provided Some Information For This Story.
* Company claims regulators reviewed tests on other companies' drugs, a
method it says is unreliable.
Monsanto Co. said Friday that it would appeal the Canadian government's
decision to reject the sale of bovine somatotropin, the company's genetically
engineered drug that increases cows' milk production.
Canada's health department, Health Canada, said Thursday that it would ban
BST, sold under the brand name Posilac, because the drug increased the rates
of diseases such as mastitis, an udder infection.
The drug presents a "sufficient and unacceptable threat to the safety of dairy
cows," Health Canada said.
But the health agency added that BST posed no health problems for humans.
Monsanto is "surprised and extremely disappointed" by Health Canada's
decision to reject the drug, said Gary Barton, a company spokesman.
Another Monsanto executive accused Health Canada of reviewing tests on
BST made by other companies. Their drugs have different formulations and
doses, the company said.
"This approach is not an accepted method utilized by regulatory agencies
around the world," Dr. Jerry J. Hjelle, a Monsanto agricultural products vice
president, said Thursday. BST has been available to American farmers since
early 1994.
The U.S. Food and Drug Administration, as well as a host of health
organizations, such as the American Medical Association and the American
Cancer Society, say BST is safe.
Since the drug was approved in the United States, the FDA and Monsanto
have closely monitored the safety and efficacy of Posilac," the agency said in a
statement late Thursday. "The number and nature of [reports of animal health
problems] raise no new animal health concerns."
Comments by the FDA and health-care organizations haven't dissuaded U.S.
biotechnology critics from trying to get the drug banned.
Last month, the Washington, D.C.-based Center for Public Safety, petitioned
the FDA to suspend sales of BST, arguing that the agency hadn't properly
reviewed all scientific data. It argued that the original testing of the drug was
flawed.
Although Monsanto doesn't provide details about BST sales, the Post-Dispatch
has estimated from available data that the BST produced about $160 million in
revenue in 1997 and an estimated $200 million last year.
The company says the drug is profitable, but won't provide details. It expects to
finish building a BST production plant in Augusta, Ga., this year. The drug is
now made in Austria.
Monsanto says that about 30 percent of the 9 million U.S. dairy cows have
been injected with the drug and that 13,000 dairy farmers have purchased
Posilac.
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