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1-Hormones: Serious concerns about Health Canada's safety review of rBST



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TITLE:  Serious concerns about Health Canada's safety review of
        rBST
SOURCE: Globe & Mail, Canada, by Anne McIlroy
DATE:   May 12, 1999

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Ottawa - The Prime Minister's Office stepped in with serious
concerns about Health Canada's safety review of a hormone that
boosts milk production in cows, according to a departmental memo
obtained under the federal access-to-information legislation. The
memo, written in February, 1998, by Health Canada senior official
Joel Weiner, informs fellow bureaucrats that officials in Prime
Minister Jean Chretien's office were not sure if Health Canada
had asked the right questions about the safety of the
controversial hormone known as recombinant bovine somatotropin,
or rBST. "Has Health Canada conducted tests to assess the impact
of rBST on infants, pregnant women and young children who consume
milk in large quantities?" Mr. Weiner said the PMO wanted to
know. "If the answer is no, the consensus view holds that the
supplementary question is: Why not-what has Health Canada
actually been doing over the past nine years?" And the answer to
the question was no, according to the Senate committee that
investigated the controversy around bovine growth hormone.

But Lynn LeSage, a Health Canada spokeswoman, said yesterday that
an outside expert advisory panel that was set up within months of
the memo's being written looked at scientific literature from
other countries about the impact the hormone might have on
pregnant women and children. When Health Canada decided not to
approve the drug in January, it was on the advice of a second
expert panel, made up of veterinarians. That panel looked into
the impact the drug would have on cows. The human-health panel
concluded that milk produced by cows injected with the drug would
not cause problems for people who drink it. Monsanto Canada Inc.,
the company that makes the drug, is still pushing for its
approval.

The memo, obtained for The Globe and Mail by Ottawa researcher
Ken Rubin, is a sign of a political judgment within the
government that important research on the hormone was lacking. It
also indicates a lack of confidence within the Prime Minister's
Office in a beleaguered branch of government that was at the
heart of more than one controversy, including the tainted-blood
tragedy of the 1980s. Monsanto argues that it has done all the
research necessary to prove milk made with the help of rBST is
safe. But the Senate agriculture committee disagreed. In a report
released in March, the committee echoed the concerns raised in
the departmental memo. The report quotes the testimony of Health
Canada scientists who said the manufacturer had not been asked to
provide long-term toxicology studies to determine human safety
"or investigate the potential that the drug might cause
sterility, infertility, birth defects, cancer and immunological
derangements." It urges Health Canada not to reverse its decision
on the hormone until the long-term health studies are carried
out. The hormone was approved in 1993 in the United States, where
on average it increases milk production by about 15 per cent. It
has been criticized by public-interest groups and some scientists
who warn that it could result in more udder infections in cows
and so lead to the increased use of antibiotics that could end up
in milk.

Mr. Weiner was travelling yesterday and was not available to
comment, a Health Canada spokesperson said. In its report, the
Senate committee said the federal government should review Health
Canada's drug-approval process to ensure that it fully safeguards
human and animal health. "The committee heard testimony about
management problems in the department and suggestions of
pressure, coercion, document theft and gag orders. Feeling the
best decisions are made in an atmosphere of trust, the committee
recommends Health Canada officials appear before the committee to
provide information about steps they have taken to resolve the
problems." Senior officials from the department, including deputy
minister David Dodge, are to appear before the committee
tomorrow.



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