Pubdate: 14 November 1999
Source: Sunday Independent (Ireland)
Copyright: Independent Newspapers (Ireland) Ltd
Contact:  http://www.independent.ie/
Author: Patricia Redlich

CONSUMER CHOICE HIJACKED BY HEALTH EXPERTS

St John's Wort Is A Safe And Inexpensive Herbal Treatment For Depression,
Claims Patricia Redlich. So Why Is The Irish Medicines Board Making It
Prescription-only?

Sometime earlier this year, a company made an application to the Irish
Medicines Board for a product licence. This is normal practice when a
company decides it might like to manufacture a health-related product in
this country.

The product in question was to contain St John's Wort, or some of the main
constituents of St John's Wort, a medicinal plant which has been used by
herbalists for over 1,000 years. In support of the application, the company
provided data which argued that the plant is effective in treating mild to
moderate depression.

On foot of this application, the Irish Medicines Board reviewed the
literature on St John's Wort and decided that the herb, in all its forms,
should become a prescription-only product. At the board's request, the
Minister for Health signed revised regulations which will see St John's
Wort available only through doctors from January 1, 2000.

This decision is questionable, not just in common-sense terms, or in the
context of the interests of the consumer, but in scientific terms.

Sometime in the so-called Dark Ages, monks began to document what
herbalists had learned as they carried out their task of minding the
community's health. So they talked of plants which had medicinal qualities,
described whether it was the leaf, root, or whole plant which was
effective, and detailed the processing which had already become
traditional, namely dried, juiced or liquid extract, producing a powder,
drink or tincture.

They also gave instructions on how much to take, how often and when. St
John's Wort or "Hypericum perforatum", to use the Latin, technical name is
part of that tradition.

These were the days before modern chemistry. The herbalists didn't know
what the actual active ingredient in the plant was. For example, modern
science believes that hypericin is the ingredient in St John's Wort which
actively affects depression. Traditional herbalists didn't even think in
those terms. They believed in the importance of the subtle interaction of
all elements of a plant, the method of treatment, and the constitution and
behaviour of the patient. For them it was a package deal.

Pharmaceutical companies today look for a single active ingredient. They
then extract it and manufacture it in concentrated form. In the context of
St John's Wort, it is no longer then the plant itself, simply dried or
boiled, but a particular constituent, isolated and basically made as potent
as the manufacturer decides is prudent, effective or desirable.

The bottom line is that this is then a different product. It is no longer
the herbal remedy which is called Hypericum perforatum, and which has been
known for a thousand years. It is a pharmaceutical remedy called hypericin.
And apart from being quite different, it is also much more potent, which
not only makes it potentially more effective but can also mean its
side-effects are more pronounced. It is no longer the product used by
herbalists working a life-time in their profession and claimed by them to
be quite safe.

There is, I believe, no scientific logic in banning St John's Wort herbal
remedies on the basis of any data relating to a concentrated extract from
the plant. The notion of extracting hypericin from St John's Wort and
manufacturing it as a pill is, of course, not new. Such tablets already
exist and are widely available.

In Germany, for example, they are seven times more likely to be used for
depression than Prozac. And a lot of research has been carried out into the
efficacy of the plant extract.

It is known, for example, to have certain side-effects such as
photosensitivity in other words creating sensitivity to sunlight in
patients who are taking it and certain gastrointestinal disturbances,
fatigue and nervousness. Several things need to be said about these
side-effects.

First of all, the literature to date suggests they are not serious, and
certainly not life-threatening. Certainly they are dose-related, and
smaller doses help the patient avoid the problem. And compared to other
medical remedies for depression, side-effects are almost insignificant.
Anyway, such side-effects are commonplace in medical remedies and could be
dealt with by simply signalling the possibility of such problems on the label.

The Irish Medicines Board argued that, besides the above-stated possible
side-effects, it was also concerned about St John's Wort because it is not
sure how it works.

In particular, the board argues that it is suspected of being similar to
some other anti-depressants and acting as an MAOI, a monoamine oxidase
inhibitor. Those are the drugs where patients have to avoid eating cheese,
red wine, pickles, certain cough mixtures and other medication containing
tryamine because of the danger of seriously raised blood-pressure.

At best we can only argue here that scientists disagree. The latest
research from the National Medicines Information Centre quotes 1999 data
which argue, with a very definitive voice, that the initial suggestion that
St John's Wort was a MAOI has now been shown to be untenable.

There are, apparently, no documented cases of MAOI-type responses from
anybody taking the remedy. On the basis of side-effects, therefore, the
Irish Medicines Board's decision to ban over-the-counter sales doesn't hold
much water either. For anyone who doubts that, think about paracetamol.
Paracetamol, as everybody knows, causes irreversible liver damage when
taken to excess. And while many, if not most, deaths associated with the
drug are the result of deliberate overdosing, the real problem with
paracetamol is what the trade calls its `low safety index'.

That means there is not a great discrepancy between the recommended dose,
or effective dose, and the amount which can cause potentially irreversible
liver damage. You are told you can take, say, eight tablets. Double that
dose and you're in serious trouble. Yet with paracetamol in so many
products, it is relatively easy when suffering from a bad cold, for
example, to come perilously close to the danger zone.

Despite this, the Irish Medicines Board, I think quite correctly, has not
made paracetamol-containing products prescription only. It has even
resisted pressure, again quite correctly, to confine them to pharmacies
only. When the consumer is in pain, he needs painkillers. So a balance was
struck between protecting consumers' health and responding to their needs.
You can buy paracetamol products in every petrol station.

In this context, it is inexplicable why the Irish Medicines Board should
argue that the reality of the Irish medical scene when it comes to herbal
remedies is not something they can concern themselves with.

If herbal remedies become prescription-only, that means that Irish
consumers will no longer be easily able to get them, for Irish doctors know
nothing about herbalism. It is not part of their training or their
tradition. When patients go to their doctors they will not be informed
about herbal remedies, but given some pharmaceutical product. Even if they
know what they want, it will not be a nice scene.

Benign enlargement of the prostate is something most men suffer from when
they reach a certain age. The plant 'saw palmetto' is quick and effective
and has no side-effects. Hands up how many doctors suggest to patients that
they take it.

The Irish Medicines Board should think again. Irish consumers certainly
want it to.

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MAP posted-by: Keith Brilhart