~~~~~~~~~~~~

Posts to another listserve circa 2000, on the Olivieri case:

"Dr. Nancy Olivieri was one of the first whistle blowers [as noted
below] relating to industry funded research in Canada.

"Olivieri was exceptional in blowing the whistle on her own drug and
on the drug company that was funding her deferiprone research...
(a television news program} states that Dr. Olivieri
claims to have proven that the thalassemia drug [deferiprone, L1] is
harmful.

Those who read Dr. Olivieri's publications will know that
this is a serious misrepresentation of her view...

Those familiar with the scientific background of the battle between
Olivieri and Apotex will know that it raises profound questions of
physician ethics and research integrity. .......

When Olivieri's colleagues across Canada observe what has happened to
her and to her supporters at Sick Kids Hospital - repeated legal
threats from Apotex, attempted dismissals from the Hospital, demotions,
harassment, and gag orders from senior hospital officials, aggravated
by a steady stream of hate mail - not many will be encouraged to
express legitimate doubts about the safety of new drugs, in a country
where deregulation permits their incautious licensing."

Science Wars: Olivieri under media fire
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
by Professor Schafer, Director of the Centre for Professional and
Applied
Ethics at the University of Manitoba. scha...@cc.umanitoba.ca

Dr. Nancy Olivieri was recently featured in a documentary, produced by
CBC-TV's Undercurrents, apparently intended to undermine the public
perception of her as an heroic underdog. The major theme of this
programme
was that Dr. Olivieri is a media-savvy "Goliath", well able to look
after
herself in the fierce battle with the combined forces of a powerful
drug
company Apotex and the top administration of The Hospital for Sick
Children.

One week later, the CBC followed this effort with a full-edition
documentary on the National News Magazine, artfully edited by Hana
Gartner
and colleagues to imply that Olivieri is not only an incompetent
scientist
but carries responsibility for the suffering and death of thousands of
patients worldwide. That's a pretty impressive charge sheet, one that
appears to be metastasizing faster than a cancer cell.

A serious issue of medical ethics is now glossed with an issue of
journalistic ethics. I'll leave to others the task of figuring out the
CBC's motives for joining forces with Apotex in their campaign to
discredit Olivieri's scientific integrity. Those familiar with the
scientific background of the battle between Olivieri and Apotex will
know
that it raises profound questions of physician ethics and research
integrity.  The danger now is that the grave factual errors and
innuendo
of the CBC's documentary will obscure, for millions of viewers, the
important underlying moral issues. The CBC's well-earned reputation for
high journalistic standards enhances the danger.

Throughout the documentary, Ms. Gartner states that Dr. Olivieri claims
to
have proven that the thalassemia drug [deferiprone, L1] is harmful.
Those
who read Dr. Olivieri's publications will know that this is a serious
misrepresentation of her view. What she has stated, repeatedly, is that
her preliminary data point in the direction of serious harm arising
from
use of the drug and that, therefore, patients have a right to be
informed
of this risk. Because Apotex cancelled the crucial experiment, it is
now
impossible to say conclusively that deferiprone will cause liver and
heart
damage to patients who use it.

Although Ms. Gartner interviewed the world's most distinguished
thalassemia researcher, Sir David Weatherall of Oxford, who supports
both
Olivieri's science and her ethics, the clip used from his interview was
so
brief that, if you sneezed you would have missed it. By contrast,
Gartner
lavishes air-time on another physician, Dr. Beatrice Wonke, who claims
that because of Olivieri''s campaign against deferiprone, thousands of
patients worldwide are suffering and dying. Those children would be
saved
from pain and death, it was implied, if only nasty Olivieri had stifled
her doubtful scientific opinions and Apotex were permitted to sell its
pills to patients all over the world.

The CBC documentary relies heavily on the opinions of Wonke who,
Gartner
assures Canadians, is an "independent" researcher: "We went to see Dr.
Wonke because she answers to no pharmaceutical company. Her research is
independently funded." Independent? Wonke? The New England Journal of
Medicine requires that scientists declare their conflicts-of-interest,
so
that readers are assisted in recognizing possible bias induced by
divided
loyalties. In their issue of December 3, 1998 Wonke acknowledged
financial
support of her research from Apotex, which funds a member of her
research
staff.

Later in the programme the CBC quotes another doctor critical of
Olivieri's science, Geoffrey Dougherty and, again, fails to inform
viewers
of his financial ties to Apotex.

Research conflicts of interest are a huge ethical issue for modern
medical
science. Evidence is accumulating that industry-sponsored research is
far
more likely to report favourably on new drugs than industry-independent
research. The dangers for patients arising from corporate-induced bias
cannot be overstated. Olivieri was exceptional in blowing the whistle
on
her own drug and on the drug company that was funding her deferiprone
research. By falsely denying (in the case of Wonke) or misleadingly
concealing (in the case of Dougherty) their financial ties to Apotex,
the
CBC does a profound disservice to its viewers.

The CBC documentary also failed to inform its viewers that every
published
study using the direct measurements of investigation (liver biopsies to
measure iron concentration) has confirmed Olivieri's concerns. Even Dr.
Wonke has admitted in print (though not in the broadcast interview)
that
her data are consistent with Olivieri's fear that deferiprone may cause
liver iron build-up to dangerous levels. The key scientific point here
is
that no study other than Olivieri's has examined serial liver biopsies
over a sufficient duration to assure patients of the absence of liver
damage. The research that could have settled this crucially important
question was terminated by Apotex before it could provide a conclusive
answer.

Is this "don't look, don't find" approach good enough when human lives
are
at stake?  These are important scientific issues, but the worst sin
committed by the CBC's documentary is that it obfuscates the
fundamental
moral issues.  It is of transcendent importance that doctors, to whom
very
sick patients entrust their lives, should live by the basic rule of
physician ethics: first, do no harm. Related to this principle is
another,
the precautionary principle, which states that where doubt exists, and
where human lives and health may be at stake, those in authority ought
not
to proceed without a reasonable assurance that it is safe to do so.

Alas, in the current climate of government deregulation, the rules
governing drug safety have changed. It is no longer necessary in Canada
or
in the European Community to demonstrate that a drug is effective in
order
to get it to market. Recent policy changes allow drug companies to sell
first and do research later.

Gartner's documentary sneers at Olivieri's efforts to block licensing
of
deferiprone in Europe, and portrays her as pursuing an irrational
obsession. But, given the fact that Olivieri's preliminary data point
to
the drug being dangerously ineffective in 50% of patients, does she
have
any moral choice but to oppose licensing of this drug until research is
done which proves it safe and effective? Keep in mind that the standard
therapy for thalassemia works well for the vast majority of patients,
albeit at the cost of regular painful needle injections and hours
attached
to an over-night portable pump.

If media journalists had some historical memory, then patients and the
public could be reminded of some important hard-learned lessons. A
controversy similar to that surrounding deferiprone emerged in the
early
1990s, with the famous CAST trials. These involved several
widely-marketed
drugs intended to stop fatal heart rhythm disturbances.. The fact that
these drugs indeed increased the rate of death four-fold was not
detected
in short-term trials, or in everyday use by doctors: the deaths that
resulted were wrongly assumed to occur from heart disease alone. It was
only a long-term study that eventually proved these particular drugs to
be toxic.

Olivieri and her many supportive colleagues have merely been asking
that a
similar large trial - to replace the ones stopped prematurely by Apotex
-
be conducted before the drug is sold for profit. Apotex wants it sold
now.
It shouldn't be this difficult to protect patients.

When Olivieri's colleagues across Canada observe what has happened to
her
and to her supporters at Sick Kids Hospital - repeated legal threats
from
Apotex, attempted dismissals from the Hospital, demotions, harassment,
and
gag orders from senior hospital officials, aggravated by a steady
stream
of hate mail - not many will be encouraged to express legitimate doubts
about the safety of new drugs, in a country where deregulation permits
their incautious licensing. Shouldn't this concern all Canadians?

It should! The precautionary principle exists to protect all of us.
Where
there is doubt and uncertainty, ethics dictates that we err on the side
of
caution.
=========================================================================We sent the following letter, with copy to U of T administration ... to

Dr. Nancy Olivieri, Department of
Medicine, University of Toronto

Dear Dr. Olivieri:
We of Science for Peace are jolted out of our too-long silence by
Arthur
Shafer's article copied below) in the Toronto Star of April 10th. It
seemed for a time that the stream of misrepresentation had been
stemmed,
and reparations were under way.  Why the CBC - or some improperly
supervised subcluster thereof - has renewed the smear attack on you,
one
cannot know.  But the CBC's "reputation for high journalistic
standards"
has been dealt a severe blow by its own folly.

Science for Peace has the ethical practice of science at its core, and
we have watched you with admiration as your saga unfolded.  We wish you
enduring strength in upholding the standards that must continue to
guide
us all."

       Sincerely,

       Phyllis Creighton and Eric Fawcett
       Co-Chairs, Science and Ethics Working Group

       and Prof Terrell Gardner, Board Member

-------------------------------------------------------