U.S. reaffirms safety of Monsanto milk drug
By Robert Steyer,The Post-Dispatch
Copyright 1998 St. Louis Post-Dispatch
January 23, 1999
Reaffirming that a Monsanto Co. drug is safe, the nation's
top health officer
has rejected appeals from crtitics to pull the genetically
engineered product
from the market.
Donna E. Shalala, secretary of health and human services,
said the critics of
BST - the drug that increases cows' milk production - have raised
"no new scientific concerns" about the drug's safety.
That means the Food and Drug Administration, which reports
to her,
"does not intend to remove the product from the market,"
Shalala said in a letter sent Thursday to Vermont Sens. Patrick J.
Leahy and
James M. Jeffords.
They had asked her to re-examine the FDA's review of BST
based on complains
from two
Vermont groups that oppose the drug. In addition,
anti-biotechnology and
consumer groups petitioned the FDA in mid-December to remove BST
from the
market, alleging that the original testing was flawed.
The FDA approved the drug in 1993, saying that BST was safe
for humans who
drink milk from
BST-treated cows and for animals. Monsanto began selling BST in the
United
States in February 1994.
After a slow start, the drug, sold under the brand name
Posilac, has recorded
higher sales each year. Last year, it produced an
estimated $ 200 million in revenue.
The FDA's approval was made
"following extensive review of the data to support the safety
and effectiveness
(of BST)," Shalala said
The FDA has since completed a
"page-by-page audit" of tests, again concluding that the
drug is safe, Shalala said. Critics
"did not
review relevant data correctly," she added.
The FDA's original ruling has been endorsed by many
organizations, such as the
American Medical Association and American
Cancer Society. It also has been supported by government agencies
such as the
National Institutes of Health and a committee that represents the
World Health
Organization and Food and Agricultural Organization.
Government support is not unanimous. Canada's top health
agency, HealthCanada,
rejected BST last week, saying that the
risk of certain animal diseases, such as udder infections, was too
great. But it
said milk from BST-treated cows is safe for humans.
Monsanto disputed HealthCanada's analysis of
BST's impact on animals, and is appealing the ruling.
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