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Date: Sat, 12 Dec 1998 16:37:22 +0100
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From: Richard Wolfson <rwolfson@concentric.net>
Subject: GENews
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Thanks to Bradford Duplisea <brad@pei.sympatico.ca>
at Sierra Club of/du Canada for posting the following article.
It is a few weeks old, but excellent
*****************************************
Safety's tarnished stamp of approval The agency that guards the health of
the nation is in disarray. Can it be trusted? Nightmares of 'the next
thalidomide'
Wednesday, November 18, 1998
ANNE McILROY Parliamentary Bureau, Globe and Mail, Canada
Ottawa -- Pierre Blais thought it was his duty.
As a scientist employed by the federal health protection branch, Mr. Blais
wanted to ban a popular breast implant because he had evidence that its
foam coating could make women sick.
His superiors disagreed. They tried to bully him into backing off and when
that failed, they fired him. Mr. Blais challenged his dismissal and won,
but he decided to leave anyway.
It was eight years ago, but time has not eased the anger or fear in his
voice as he compares his former workplace to East Germany under the
Communists, a secretive place where those who speak out are intimidated and
big business really calls the shots.
"I left for fear I would be the person who would have been forced to
approve the next thalidomide," he said in a recent interview. "Imagine the
nightmare."
He left in 1990. The following year, the manufacturer took the product off
the market. It was the notorious Meme breast implant.
Today, Mr. Blais is still in Ottawa, working as a consultant and watching
with keen interest as his old workplace is put under the microscope.
Clearly something has gone terribly awry in the complex on the Ottawa River
that houses the health protection branch. Its 1,360 scientists and support
staff are the biomedical guardians of the nation. Their job is to protect
Canadians from bad drugs, contaminated food, tainted blood and unsafe baby
cribs and other consumer products.
Now the question is, can they still do it?
In recent weeks, six of the branch's scientists have complained that their
superiors tried to force them to approve the genetically engineered bovine
growth hormone despite their concerns that it isn't safe. Already in use in
the United States, the hormone increases milk production in cows, but
critics fear that such milk may not be safe for children to drink. The
scientists' testimony before a Senate committee was like a scene from the
conspiratorial television show The X-Files.
Margaret Haydon, her voice quavering, told how her files had been broken
into and how she was taken off the case after she recommended that the drug
not be approved.
She said Monsanto, its manufacturer, had offered Health Department
officials research money they interpreted as a bribe, an allegation the
company denies.
The senators were stunned by the accusations, but Mr. Blais wasn't surprised.
"It isn't an isolated incident, but this is part of a pattern," he said in
an interview in his Ottawa home. "But over the years they have only gotten
more sophisticated at concealing what is going on."
The RCMP believe that the truth is out there, and it has launched three
investigations involving Health Canada.
They are looking into the tainted-blood tragedy of the 1980s, when
thousands of Canadians were infected with the AIDS virus and hepatitis C
while the health protection branch was responsible for regulating the blood
system.
The police are also investigating the destruction of key documents by
Health Canada officials. A damning report from the federal Information
Commissioner found that officials destroyed what might have been crucial
evidence because of pressure from the Red Cross, which feared victims would
be able to use the documents in lawsuits.
The third investigation is an attempt to determine whether Health Canada
officials approved the Meme breast implant despite knowing that it wasn't
safe.
The Public Service Staff Relations Board is hearing a grievance from the
six scientists over bovine growth hormone. Their complaint seems to mirror
earlier accusations levelled against the department and the day-to-day
concerns of other scientists who work there.
They say pharmaceutical manufacturers have far too much influence in the
drug approval process and scientists often feel that their careers are
threatened if they stand in the way of a drug they don't believe is safe.
"The department is saying all over the place that the client -- and this is
in writing -- the client is now the industry and we have to serve the
client. Although we have to ensure that safety is there, our situation has
changed," researcher Shiv Chopra told the Senate committee.
Michelle Brill-Edwards, a medical doctor who quit the branch in 1996, said
the culture of the department is such that scientists who raise questions
about new drugs are deemed to be troublemakers, while those who quietly
approve them are promoted. She left, charging that the branch was putting
the interests of the pharmaceutical companies ahead of public safety, and
went public with her accusations.
Mr. Blais said he was frequently called in for questioning by his superiors
in a manner that made him feel like a criminal for wanting to protect
public safety. Although reluctant to give specifics because of the RCMP
investigation, he said he also was pressured by industry.
"On one occasion they called and said, 'Don't you know we are millionaires?
Why are you making life so difficult for us?' " Mr. Blais said.
The scientists also say cuts to the branch's budget have denied them the
tools they need to challenge manufacturers if a product seems unsafe.
In 1993-94, the budget was $237-million; in 1999-2000, it will be
$118-million. Laboratories have been closed or scaled back and staff
reassigned.
"I am miserable," one researcher said, speaking on condition she not be
identified, "because I am responsible for deciding if a product is safe and
I can't do my own research, or even access the research of others, to find
out. It is a terrible feeling, knowing you are responsible but that you
can't do your job."
The scientists also complain that managers without scientific experience
regularly overrule their decisions. The result has been strained and at
times poisonous employee-management relations.
"The frustrations in the workplace that detract from job satisfaction
generally involve the lack of support, inaccessibility, lack of technical
knowledge and the inability to admit mistakes," a 1994 report on morale
reads. "The decision-making process was thought to be untimely,
inconsistent, unfair and, at times, politically based."
A culture of intense secrecy makes it difficult for scientists to do their
jobs and for Canadians to know whether they can have faith in the system,
the six scientists say.
They were ordered not to speak out publicly. They testified before the
Senate committee only after receiving written assurances from Health
Minister Allan Rock that they would not be punished.
Mr. Blais said the problems began in the mid-1980s, when the Progressive
Conservatives took office in Ottawa. In an effort to cut the backlog of
drugs seeking approval, the government contracted out safety reviews to
private consultants, some of whom also work for drug manufacturers.
The Liberals took power in 1993 determined to cut the deficit, which
exacerbated the problems.
More of the costs have been transferred to the pharmaceutical industry,
which now pays for about 70 per cent of its product reviews. Critics say
that gives it far too much control over how the department works, an
allegation that Health Canada says is unfounded.
Mr. Rock became Health Minister last summer, eager to avoid controversy
over a branch that posed problems for his predecessor. He froze the budget
cutting, set up an advisory board of independent scientists to help him
make decisions and launched a three-year "transition process" to consult
Canadians on the future of the branch.
But the furor over bovine growth hormone -- including accusations that
managers shredded key documents -- blew up just as the first stage of
public consultations were ending.
Obviously frustrated, Mr. Rock has insisted repeatedly that the hormone
will not be approved until it is proved to be safe, and his deputy
minister, David Dodge, has attempted to reassure the public.
"The job of the department, and we must be extraordinarily clear about it,
is to protect the health and safety of Canadians . . .," he told the Senate
committee.
Mr. Dodge, a former deputy finance minister, told the committee that the
branch suffers the pressures of competing interests.
On one hand, when new drugs -- for example ones used to fight AIDS -- are
available elsewhere but not in Canada, the public clamours to speed up
their approval. On the other hand, approving unsafe drugs can be deadly.
Mr. Dodge added that the secrecy is necessary because drug companies invest
millions in research and do not want it to fall into a competitor's hands.
If that were to happen, they will simply ignore the relatively small
Canadian market.
However, there has to be a way to "shine light" on branch activities
without giving away secrets, Mr. Dodge said. The options would include
using the Internet or allowing consumer representation in the approval
process.
As for social and moral questions such as those raised by bovine-growth
hormone, he said the answer may be to give Parliament a greater role in the
decision making.
One major obstacle to the "transition" process for the branch is the low
morale among the staff and the deep suspicion some researchers have of
their managers and political masters. There is a fear that the proposed
reform is actually the final step in the deregulation of health protection
begun by the Conservatives.
For example, the government has been accused by the Canadian Health
Coalition (made up trade unions and other groups with an interest in the
branch) of wanting to rewrite the Food and Drug Act to remove the
government's criminal liability should something go wrong. It's an
allegation that Ian Shugart, who is in charge of revamping the branch, has
denied many times.
And what does Pierre Blais make of it all?
He remains convinced that any change will be cosmetic. "The biggest danger
of the process is that it will lull the general public into believing they
are protected."
RISKY BUSINESS
A sampling of health protection branch controversies:
Bovine growth hormone
The big current item, this drug has been under review for more than eight
years. The Health Minister says it won't be approved until he is satisfied
it is safe. Documents show that senior branch officials have already told
the manufacturer that it poses no threat.
Vinyl toys
This week, the Health Department issued a warning about toxin dangers in
soft plastic toys that youngsters might put in their mouths.
Environmentalists want the warning also applied to plastic raincoats,
backpacks and dozens of other toys. An earlier study found no risk
associated with any such products.
The Meme breast implant
Allowed on the Canadian market without a safety review, it prompted branch
scientist Pierre Blais to seek a ban in 1990 after finding that it was
covered with a foam used in carpets and upholstery. A year later, the
manufacturer withdrew the product after the U.S. government determined that
the cover leaked a potential carcinogen.
Tainted blood This fall, Health Minister Allan Rock announced the spending
of $125-million over five years to implement the recommendations of the
Krever inquiry, which was highly critical of the branch's handling of the
blood supply in the 1980s, when thousands of Canadians were infected with
hepatitis C and the AIDS virus.
Imitrex
Dr. Michelle Brill-Edwards resigned from the department in part over the
approval of this migraine drug, later found potentially dangerous to people
with heart conditions.
.................
This is from a european newsletter
GenetiX Update
December/ January 1999 Number 11
Newsletter of the Genetic Engineering Network: Information for Action
LEAKED MONSANTO REPORT REVEALS RETAILERS FEAR THEY WILL LOSE ON GM FOODS
There is now no doubt about the tremendous impact that campaigns across the
UK against genetically manipulated foods are having on Monsanto and major
food retailers.
The massive propaganda campaign run by Monsanto over the summer has
completely failed. A report leaked to Greenpeace, written for Monsanto by a
former polling advisor to Clinton, Blair and Nelson Mandela, reveals "an
on-going collapse of public support for biotechnology and GM foods. At each
point in this project, we keep thinking that we have reached the low point
and that public thinking will stabilise, but we apparently have not reached
that point." Retailers interviewed in the report suggest that GM food
could "turn out like irradiation. Which is, you don't do it." Others talk
of a "fifty-fifty" chance of "losing to the pressure groups".
Such comments reflect the amazing amount of work that has gone into the
campaign against GE and provides inspiration for it to continue to grow.
More and more people are opposing the activities of biotech giants like
Monsanto and the complicity of major retailers and food producers. The
public perceived the biotechnology companies as " willing to risk great
human danger in order to make profits." The message for Monsanto is clear:
stop genetic manipulation of food.
What is also depressingly clear from this report is the acceptance by
politicians of the "benefits" of genetic manipulation, "70% of the MPs
(interviewed) reacted positively to GM foods." Just how out of touch are
these people? Even a moratorium " gets little support among the MPs and
civil servants."
For a copy of the Monsanto leak phone 0800 269065 or visit the Greenpeace
website:
<http:/www.greenpeace.org.uk/monsanto>http:/www.greenpeace.org.uk/monsanto
.................
A PUBLIC POLICY PRESS RELEASE:
>From the Organic Farmers Marketing Association
Communication/Telecommunication Committee Co-chairs: Cecilia Bowman,
cvof@iquest.net, Eric Kindberg, erorganic@aol.com
Website: www.iquest.net/ofma/
December 4, 1998
After due consideration the Board of Directors of the Organic Farmers
Marketing Association has determined the following:
The Organic Farmers Marketing Association calls for an complete
prohibition on the use of Genetically Engineered plants, seeds, microbials,
animals and derivatives from GE products in certified organic farm food and
fiber production.
.............
(13 December 1998)
Front Page - UK Independent on Sunday
Revealed: risks of genetic food
By Marie Woolf, Political Correspondent
A KEY government report on the effects of growing genetically modified
crops has been suppressed because of its controversial warning of serious
environmental risks. It says there are serious dangers to Britain's
hedgerows, birds and indigenous plants from growing GM crops on a
commercial scale.
The report, commissioned by ministers to assess the potential effects of
cultivating GM food in Britain, concludes that there are insufficient
safeguards to stop the creation of hybrid multi-resistant plants.
It lists a series of "gaps" in the UK's regulatory framework, leaving
Britain's wildlife at serious risk of damage from genetically modified
plants and other intensive farming methods.
The news comes as the Health and Safety Executive, responsible for
monitoring GM crop trials, has revealed that in the six months between
April and October this year more than one in 10 of the 49 sites inspected
during that period had been breaking the regulations governing trials. This
week it is expected to prosecute Monsanto for such breaches - the first
ever criminal case of its kind.
The study, written by civil servants after widespread consultation with
government advisers, also warns that the commercial growth of GM crops
could lead to more pesticides being sprayed on Britain's fields.
_________________________________________________________
Richard Wolfson, PhD
Consumer Right to Know Campaign,
for Mandatory Labelling and Long-term
Testing of all Genetically Engineered Foods,
500 Wilbrod Street
Ottawa, ON Canada K1N 6N2
tel. 613-565-8517 fax. 613-565-1596
email: rwolfson@concentric.net
Our website, http://www.natural-law.ca/genetic/geindex.html
contains more information on genetic engineering as well as
previous genetic engineering news items
Subscription fee to genetic engineering news is $35 for 12 months
See website for details.
__________________________________________________________
__________________________________________________________
--Dan in Sunny Puerto Rico--
dan.worley@mindless.com