Correspondents Report - Sunday, 19
September , 2004
Reporter: Leigh Sales
HAMISH ROBERTSON: Just how safe are
anti-depressants?
Well, it's a highly controversial
issue, and there's been a good deal of sometimes acrimonious
debate among psychiatrists and other mental health
professionals.
While most medical specialists seem to
agree that anti-depressants, including the widely used
Selective Seretonin Reuptake Inhibitors ? or SSRIs ? can be
highly effective in the treatment of some forms of depression,
recent research has also suggested that their use is not
without risk.
Well, in the United States last week, the
Food and Drug Administration ordered drug companies to label
anti-depressants with a strong warning that they can cause
suicidal tendencies in children and teenagers.
The
FDA's decision is the strongest stand it could take, other
than banning the medication outright for use in children. And
it could influence authorities in Australia to impose greater
safeguards on the prescription of these drugs
here.
Professor David Healy of the University of Wales,
is one of Europe's most renowned experts on depression, and he
was in Washington last week for the FDA's hearings into
anti-depressants.
Our North America Correspondent Leigh
Sales asked him to explain the significance of the
decision.
DAVID HEALY: What it will mean is that over
here in the US, any physician, giving these drugs to children,
will actually have to take the issue about the hazards
actually into account and parents and children will have to be
told about this and they will have to have the opportunity to
talk through the issues and be warned as to what things to
look out for.
And if that happens, then these drugs can
be used much more safely than they have been used
hitherto.
LEIGH SALES: Why has the FDA done a back flip
on this, because previously it disputed that these drugs were
actually dangerous?
DAVID HEALY: It's very hard to know
just why the FDA did a back flip, in that in one sense
actually the data for this group of drugs? the clinical trials
that were done actually for adults years and years ago, gives
you just the same figures that we have for kids now.
So
really the FDA had just as good a signal that there is an
issue here for the last fifteen years as they have
now.
LEIGH SALES: Does that mean that could be opening
itself up to some sort of legal action?
DAVID HEALY:
It's very, very hard to know how these things work. When
people begin to look at the issues more closely, when they
begin to look at the data that has been there for years and
years and years, and when they begin to extrapolate from that
as to how many people may have actually lost their lives who
wouldn't perhaps have done so if the drugs had had the warning
that they could have had years and years ago, I think
questions will be asked.
LEIGH SALES: How do you think
the drug companies are likely to react to this?
DAVID
HEALY: I don't know. They'll have a huge problem in one sense,
in that this is a group of drugs that have really come to the
end of their patent life and the pharmaceutical companies are
at a point soon where they're not going to make that much off
them.
So I don't think? they would have reacted much
more vigorously if it was a group of drugs early on in their
patent life and this is where the companies were going to make
their next billions from.
LEIGH SALES: Is this decision
likely to influence other countries to impose similar
restrictions on the sale and prescription of these
drugs?
DAVID HEALY: It's not that they're actually
trying to block the use of the drugs, they're just trying to
make sure that the drugs get used more safely and they are
trying to discourage what one or two have referred to as the
cavalier use of these drugs, the use of these drugs for a
range of things that they weren't made for.
So from
that point of view, the signal that does come from here will
have an influence elsewhere. Also, I think it will be heard
over with you in Australia and it will also be heard in
Europe.
HAMISH ROBERTSON: Professor David Healy, a
world renowned authority on depression and the drugs used to
treat it. He was talking to our Correspondent in Washington
Leigh Sales. |