HERBAL CRISIS

The Decision To Make Some Herbal Medicines, Including St John's Wort,
Prescription Only From January 1st Has Angered Many. But, As Kathryn
Holmquist Discovers, The Ruling Effectively Outlaws These Herbal
Medicines, As They Are Not Authorised For Prescription

The health food industry is angry at the Department of Health's
decision to place St John's wort - whose botanical name is hypericum -
on the Irish Medical Board's prescription-only list from January 1st,
2000. What many have yet to realise is that St John's wort, and other
herbal medicines on the list, will not be legally available even with
a prescription because they do not have product authorisation which is
required to sell drugs on prescription.

Also on the list are blue cohosh, or squaw vine, used to support women
during labour, and gingko, the most widely used herbal remedy in
Europe and a scientifically proven remedy for memory loss related to
normal ageing. Europe's largest manufacturer of gingko is in the
Republic, yet ironically, from January 1st, people here will not be
able to buy the herb.

The prohibition of St John's wort, gingko and other herbal medicines
has come about as a result of EU legislation that 13 of 15 EU states
are choosing to ignore in favour of their own legislation governing
the sale of herbal medicines. Only the Republic, by placing herbal
medicines on the prescription-only list, is following the letter of
the EU law, which says that any substance with a pharmacological
effect is a medicine, says Michael McIntyre, chairman of the European
Herbal Practitioners' Association.

"It's a total farce," says Dr Ellis Clare, a GP and
university-trained medical herbalist, who arrived in Galway from
London two weeks ago to open a new practice combining "orthodox" and
traditional medicine. Without St John's wort and gingko, two of the
most important remedies in her herbal apothecary, Dr Clare says that
she might as well close up shop and return to London, where these
herbal remedies remain freely available.

The hype about hypericum - St John's wort - has clouded the real
issue, which is that consumers have a right to avail of herbal
medicine, which has a 2,000-year-old tradition, and they also have a
right to be protected. The EU and the Government need to develop a
system whereby safe, quality-controlled herbal medicines are
prescribed by informed experts under a system of regulation, asserts
McIntyre. A university-trained medical herbalist (there are five
university programmes for medical herbalists in Britain), he believes
the Republic should introduce a system of training and regulation
which would limit the use of herbal medicines to licensed
practitioners. The Irish Herbal Practitioners' Association has been
talking to the Department of Health about this possibility, so far
without success.

Herbal medicines have scientifically proven pharmacological effects
that can be potentially damaging in the wrong hands. The Department of
Health has particular concerns about Internet traffic in herbs and has
placed two on the prescription-only list requiring product
authorisation and licensing. They are tribulus terrestrix, which
raises testosterone levels and is being marketed on the Internet as
the herbal alternative to Viagra, and caulophyllum thalictroides,
which has many uses and abuses, including one as a potential
abortifacient.

The only legal means that the Department of Health currently has of
protecting the consumer is the product authorisation system. But this
can cost pounds 40 million for one drug alone, because it requires
expensive studies on carcinogenicity and doubleblind control medical
trials. Herbal medicines manufacturers, distributors and practitioners
argue that the authorisation system designed for synthetic drugs is
too rigorous and costly for herbal medicines, which cannot be patented
like synthetic drugs. However, Dr Des Corrigan of the Department of
Pharmacology at Trinity College Dublin, points out that the herbal
medicines business in Europe is worth six billion dollars annually and
can well afford to ensure the safety, quality and efficacy of its products.

In late September, these issues were discussed by the pharmaceutical
committee of the European Commission, which concluded that the EU
should look at the possibility of assessing herbal medicines in terms
of "traditional use", rather than the standard criteria of product
authorisation. This approach is widely supported by people on both
sides of the debate.

Frank Hallinan, chief executive of the IMB, attends the EU
pharmaceutical committee. "We are open to discussions on how to solve
the problem. This is an evolving and developing situation and we are
not fixed in a particular position," says Hallinan. The IMB has been
painted as the villain of the piece by the health food industry, but
Hallinan points out that the IMB did not "go after" St John's wort. It
came to the attention of the IMB because someone wishing to
manufacture hypericum extract (the IMB will not reveal who) applied
for a product licence which requires a product authorisation.

After investigating the herbal medicine's properties, the IMB
immediately became concerned that St John's wort, which is effective
against mild, clinical depression, would be self-prescribed by
depression-sufferers, thereby putting them at risk of not getting the
necessary medical help. John's wort also has side-effects that, in the
experience of one psychiatrist who prescribes it - Dr Patrick McKeon
of St Patrick's Hospital, Dublin - are as significant as the
side-effects of prescription anti-depressants.

The consumer needs to realise that "natural" does not mean "safe", Dr
Corrigan points out. "Quality control is important. There have been
too many disasters," says Dr Corrigan. In Belgium, 90 women got kidney
failure - leading in many cases to kidney cancer - when they were
treated with a poisonous Chinese herb, aristolochia that had been
mistaken for a safe herb, stephania. This happened again in Britain
last year, when two people were affected. Measures have been taken to
ensure that this could not happen here, says Kerry McBride, chairman
of the self-regulating Register of Irish Chinese Herbal Practitioners,
which has a record of using medicinal herbs responsibly.

In the interest of protecting the consumer, the IMB and the Department
of Health are concerned about unscrupulous cowboys selling adulterated
products and using false advertising. In Britain, an Irishman was
prosecuted for selling a "herbal" cream for eczema which secretly
contained potentially harmful steroids. Believing the cream to be
"natural", consumers were covering themselves with it from head to
toe. In another case, a remedy marketed as natural, contained
phenylbutazone, an anti-arthritic synthetic drug that causes aplastic
anaemia, a blood disease that can be fatal.

The IMB does not want to put reputable health food stores and herbal
practitioners out of business. "Chasing after herbalists who are doing
a reasonable job would not be on our list of priorities," Hallinan
says. Nigel Griffiths of Nature's Way says that all his staff who
advise on herbal remedies are fully trained and know when to refer a
customer to a medical doctor.

McIntyre explains: "The health food stores have pioneered the
availability of over-the-counter herbal remedies to the public and
many have real expertise and integrity, but because there are no
regulations it leaves the business open to shenanigans." In the
absence of a coherent European policy on herbal medicines, the public
must rely on the honesty and intelligence of sellers practitioners. On
January 1st next, health food shops may decide to ignore EEC/6565 by
continuing to sell herbal medicines. The Department of Health is
understood to be considering prosecutions as a means of focusing the
health food industry's attention on the seriousness of the EU
legislation. However, the IMB has yet to hire the promised enforcement
officers who would go into health food stores and inspect, with powers
to prosecute. And so we may have yet another Irish solution to an
Irish problem.