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It has been nearly a month since I penned
the previous article in this seemingly endless series about
Kava, the rather wondrous plant from the South Pacific, the
extract from whose roots, in medicinal form, have become increasingly
popular in Europe and the US over the last decade as a natural
antidote to combat stress, anxiety and tension. Readers will
have to refer back to the previous five articles on kava in
this newsletter, and will note that there recently seems to
be almost a worldwide 'ban' (except in the South Pacific)
on sales of medicinal extract and tablets of kava in Europe,
the US, Canada and Australia. We have gone into the pros and
cons of this in the past articles and the reasons why we think
this 'ban' is wrong and mistaken. The evidence but forward
by German medical authorities indicating a possible connection
between medicinal kava intake and liver damage does not seem
to be conclusive nor of good quality (although, of course,
the medical authorities have done the correct thing by bringing
any suspected health threat to notice), and yet other countries
have taken these warnings at face value with almost no enquiry
and have recommended the withdrawal of medicinal kava and
tablets from pharmacy shelves. This 'problem' really came
to public notice in Germany from the end of last year and
newspaper reports fanned the flames of a 'kava panic' in Germany
where kava medicinal extract and tablets sales have been massive
over the last decade or more, and particularly from the late
1990s. Newspaper reports spreading out from Germany around
the world have, in effect, had the unfortunate result of destroying
the important kava export market from the South Pacific, causing
puzzlement, anger and hardship in certain Pacific Island nations.
Everyone in the pacific now believes that kava extracts are
completely banned throughout Europe. But this is not the case.
Although, as we pointed out, kava extract was officially banned
in France from mid-January, the only country in Europe now
where it is easily, openly and officially available from pharmacies
as before is Germany, the country which seemed to have begun
the whole furore in the first place. I confirmed this again
by phoning contacts in Germany on April the 29th and was told
the pharmacies were selling kava tablets as before, although
sales were lower than before the press furore, and that the
relevant German government ministry (the Bf Arm, the Federal
Institute of Drugs and Medicinal Devices, in Bonn) had not
made any announcement, in spite of what the world seems to
think.
So why all the problems? Why can't people
elsewhere in Europe get kava tablets if they want to and what
has led to this situation where most people assume there is
a 'ban' when there isn't (except in France). It has an awful
lot do with the way the press has dealt with this affair over
the last six months and is almost an accident of timing combined
with other rather dubious trends happening in the medical
and pharmaceutical world of Europe and the US at the moment.
In August 2001, at the height of a major
medical scandal, the German government forced the withdrawal
from use of the cholesterol-reducing drug Lipobay (called
Baycol in the US) produced by the Bayer Company. This particular
drug (nothing whatsoever to do with kava) had been widely
promoted and sold and was then found to have major side effects
which it seems had possibly been known for some time. By mid
- January 2002 even the Bayer company was forced to admit
that the drug had been responsible for an estimated 100 deaths
worldwide (from renal failure, etc), and it seems that over
1000 patients taking it may have been potentially crippled.
In the middle of 2001, though, the scandal was at its height
in Germany, and journalists dug out rather horrifying information
regarding certain activities of the Bayer Company and certain
German doctors in regard to this medicine. At one time it
looked as if the resulting furor and potential court cases,
some said, might bankrupt the company. German press reports
indicated that the Bayer company was alleged to have 'sweetened'
(some said 'bribed') certain doctors in Germany to persuade
them to prescribe the anti-cholesterol drug: the return for
prescription was said to be a luxury trip on the Orient Express.
This was said to be happening from spring of 1999. Doctors
were to use copies of the prescription forms to show to Bayer
that they had put patients on to the drug, and with every
25 patients the prescribing doctor was promised one of these
trips. When this 'arrangement' came out in the press, Bayer
countered by saying the luxury trips were only an "information
event for southern German doctors". Of course there was
a press frenzy, and rightly so. Information about possibly
slightly dubious arrangements between certain pharmaceutical/drug
companies and certain sections of the medical profession (not
just within Germany but almost worldwide) has been seeping
out for years, and this was just confirmation to certain journalists
of what some saw as a wider phenomenon. This led the ex-President
of the Berlin Medical Practitioners' Board to state that often
doctors' training costs or their medical journals were frequently
paid for by elements of the pharmaceutical industry. Whether
he said this in their defence, to show that such links were
normal practice, I am not sure. Almost the last straw for
the Bayer company came in the middle of 2001 when it was discovered
that a medical study done for the German Health Ministry,
dated 15th June 2001 and indicating serious side-effects with
the Lipobay drug, was held on to by Bayer and only passed
on by the company to the relevant government ministry at the
beginning of August 2001, after government withdrawal of the
drug.
This affair 'went international', with the
use in the US of the same drug, there called Baycol. It seems
the potential court cases in the US are still piling up. At
the same time, however, in the US, another series of medical-associated
scandals were reaching their climax. For a number of years
it had been suspected that certain drug firms might have been
trying to assert undue influence on certain medical journals
to get positive reports about their new drugs published or
to get adverse studies dropped from publication. This came
to a head in the US in early September 2001 when representatives
of a dozen of the world's most prestigious medical journals
announced the adoption of strict uniform requirements to prevent
drug firms that fund studies from manipulating the results
or burying the publication of studies that are unfavourable.
This move was to stop the growing influence exerted by drug
firms over research findings, and was the result of several
major related scandals of this type over the last decade.
Knowledgeable journalists in Europe and the US moved in on
this series of affairs, producing articles with headlines
such as 'Drug scientists put profits before lives'. For those
with knowledge of some of the seamier aspects of this drug/medical
world, this was nothing new, but it was rather new for most
of the reading public. There have always been suspicions that
certain companies might use rather wily tactics to not just
get their new medicines/drugs approved, but also might use
other wily tactics to get certain doctors or government ministries
to promote them. This was put very well by Australian grief
counsellor, Mal McKissok, in an article in the 'Sydney Morning
Herald' on the 4th March 2002:" I think there's a conflict
of interest when drug companies are sponsoring research and
governments are responding to it". Well, there is not
just a potential conflict of interest but a potential situation
of danger for the public!
Readers should therefore view the press
furore last year about kava with all the above in mind: the
Bayer company scandal was winding down as was that related
to publication of medical results, but the public and journalists
were still 'primed', so to speak. And it is at just that precise
time that a mention about Kava and possible connection with
liver damage came to public notice. The media juggernaut,
sensing another major news item, shifted into high gear. Medical
authorities, terrified of the (health and) financial ramifications
of the Lipobay/Bayer company affair, almost immediately started
issuing cautionary warnings and the whole thing began to spiral
almost out of control with hardly anyone really bothering
to look in depth at the basis of the claims. Kava was damned
in the public eye before it even had a chance to speak up
for itself. Although an acetone-based kava extract ('Laitan')
had been pulled off the market in Switzerland as early as
October 2000, there was no associated media build-up as the
incident was minor, unproved, a precaution, and the media
were interested in other things at the time. It was really
only from September 2001, as the other above-mentioned scandals
started winding down, when a few minor medical reports about
kava came to the notice of the German press, that the media
there really began to move into action. No one was really
there to protect kava at her time of need from the increasing
barrage of insults. In January 2002, when my wife and I were
in Germany and I was speaking to pharmaceutical people all
over Germany by phone to try and get to the bottom of all
this, no-one I spoke to thought that the 24 cases of liver
damage mentioned by the German Bf ArM in their circular letter
of 8th November 2001 had anything really to do with kava extract,
it just so happened that kava extract intake was one of the
ingredients shared by these 24 individuals. There were, of
course, thousands of other cases of liver damage within Germany
over the same time period, but kava was not blamed for these.
The most serious cases were one death (politely called 'Exitus'
in some of the reports) from liver failure, and four, possibly
five, liver transplants. When one actually looks at the German
list, it looks 'set in concrete' and all set and sealed. But
it is not. The sad but famous 'Exitus' case, if one follows
up to find out who it actually was (there is, of course, no
information in the list), turns out to have been that of an
81 year-old woman with a long history of alcohol abuse and
possible other substances (I got this information over the
phone) who had also been taking 120mg/day of an ethanol-based
kava extract over a 9-month period. Half of the 24 listed
cases were people over 60.Long-term alcohol use was thought
to be common denominator in many of the cases. This rather
ties in with a general Ibicenco belief that all Germans really
seem to do is work, get drunk, and sleep.
This rather reminds me of a rather interesting
'joke' from Vanuatu, in the Southwest Pacific, the homeland
of the real kava. There, death is not really looked upon,
as something natural unless one is extremely old and one passes
away in a style that is obviously natural. Most other deaths
- of individuals not of a proper age to die naturally - is
attributed to sorcery, poisoning, or other such causes: i.e.,
someone else is involved. One old Vanuatu friend told me years
ago the following example: 'Well, what if you are 100 years
old, blind, deaf and crippled and walking with the help of
two sticks below a 100-foot high cliff during an earthquake
and a cyclone and a rock falls on you and kills you? Is that
a natural death or did someone make the rock fall?' There
was a certain amount of traditional Vanuatu poetic license
(there called 'putting sixpence on top') in that quote, but
it does, I believe, have relevance for these above suspected
kava-associated liver damage cases in Germany. Kava seems
to have been chosen as 'the rock'! And why would this be?
More next week.
Kirk W Huffman
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