Kava Court Challenge Unsuccessful - London High Court rejects review
CategoriesAs reported in The Times on 10 January, the case brought by the the UK National Association of Health Stores and actress Jenny Seagrove to force government re-consideration of a ban on Kava Kava was rejected by High Court Justice Crane. A traditional South Sea calming drink is made by fermentation from Kava Kava root and has been used for centuries on several of the South Sea Islands. It is sold in Western countries as Kava root powder or as an extract put into capsules for convenience.
Sales of this natural sedative have been cutting into pharmaceutical profits on such drugs as Prozac and Valium, liberally prescribed for even mild depression. Consequently, clouds started to gather over Kava's fortunes, but what sealed its fate what the discovery that Kava could - like the competing pharmaceutical drug Zyban - help people stop smoking. Sales of Kava went soaring as people preferred the natural alternative.
According to German and Swiss Health Authorities, some cases of liver damage have been linked to consumption of Kava products, but Kava advocates have charged that conclusive causal connection between the damage and the herb has not been shown in the vast majority of these cases. Nevertheless, Kava was 'voluntarily withdrawn' by the German drug manufacturer Merck, and was subsequently banned in a number of countries, both as a medicine and as a supplement.
Why Kava had to go off the market and not Zyban, which in the UK alone had killed more than 60 people, is everyone's guess. Certainly the official explanation of "consumer protection" does not make sense when a safer and less costly alternative to a pharmaceutical drug is banned while the pharmaceutical product continues to be sold and its killing of patients is overlooked in a cavalier way.
Here is an interview with Jenny Seagrove, who was surprised at the judge's decision in the case.
Article appeared in The Times
January 10 2004
Health alternatives
Complementary crusaders
Kava calm hits a storm
Joanna Bale finds Jenny Seagrove battling the ban on a Polynesian sedative
Bloodied but unbowed, Jenny Seagrove is still in fighting mode despite last month’s humiliating defeat at the High Court as she attempted to overturn a ban on kava, an ancient herbal remedy for anxiety.“The battle has been lost but the war continues,” the actress declares angrily. “It’s absolutely unjustified to ban it and just symptomatic of the nanny state that we now live in.”
The ban was imposed a year ago after reports that 70 users around the world suffered liver damage, including three in the UK. Seven cases required liver transplants and four died, including two of those who received new livers. So great is the concern that Germany, Switzerland, France, Canada and, most recently, the United States have taken action to limit its use or prohibit its sale.
Convinced that an outright ban was a gross overreaction in a world where all medicines carry risks, Seagrove joined forces with the National Association for Health Stores (NAHS) in challenging the Government, arguing that the dangers of kava have been greatly exaggerated.
“Kava is a 2,000-year-old remedy. Millions of people have taken it without any harm,” she says. “The problem is that there is a risk if it is used with alcohol. The people who died were very old and some already had cirrhosis of the liver, but that wasn’t taken into consideration. I’m not somebody who wants something on the market that’s going to be dangerous to people. All it needs is better labelling.”
The case became a cause célèbre for the herbal industry, which has lost a market worth £7.5 million. It boasted the support of several academics, including Professor Edzard Ernst of Exeter University, Britain’s only professor of complementary medicine, who argued that the risk of liver damage was no worse than that of Valium.
Seagrove, 46, became a celebrity figurehead for the campaign, insisting that she depended on the herb to help her sleep during stressful times in her career. Currently appearing in The Secret Rapture at the Lyric Theatre, in London, she says: “I have used kava for about five years. I even give it to my dog, Kizzy, on bonfire night. It’s very gentle, but it helps me sleep when I’m stressed, especially leading up to an opening night.”
Unlike some herbal remedies, kava has proven medical benefits: placebo-controlled trials have shown that it is useful for relieving anxiety. The Polynesian shrub, whose Latin name means “intoxicating pepper”, is the basis of the national drink of Fiji and Tonga. In its traditional form, it is prepared by grating or pounding the fresh root and mixing it with cold water or coconut milk.
Seagrove, who lives in Little Venice, northwest London, with the theatre impresario Bill Kenwright, and who once lived with the film director Michael Winner, adds: “Peanuts, tobacco and alcohol kill large numbers of people yet they are not banned. HRT has been linked to cancer, but it isn’t banned. The whole thing is out of proportion. The principle that I’m fighting for is to be allowed to choose, as long as I am aware of the possible risks.
“People are disillusioned with the medical profession which is why they are turning to herbal remedies. Problems sometimes arise when there are a small minority of herbal products which lack quality. If there was better labelling and spot checks, rather like the doping tests on footballers, it would help.”
She criticises new EU directives requiring licensing, registration and uniform manufacturing standards for herbal medicines which, many would argue, would achieve precisely the controls she deems necessary. “The EU directives are a catastrophe. We are going to lose so many products,” she insists, echoing the views of much of the complementary health lobby which is anxious to protect a market worth £130 million.
Estimates of the impact of this new legislation vary, but it will undoubtedly cause problems for small British supplement companies as they are forced to reformulate entire ranges and invest massively in applying for new product licences.
At the High Court last month, Mr Justice Crane agreed that the consultation process in deciding to ban kava had been “procedurally flawed” but this did not justify ordering fresh consultations.
Ralph Pike, director of the NAHS which represents 420 independent health stores, is anxiously awaiting a further hearing in March to decide whether his organisation will have to pay an estimated £200,000 in legal costs for both parties in the case. He says: “All we wanted was a rerun of the consultation process to explore the evidence more thoroughly. The judge agreed that the process had been done wrongly, but said the decision to ban still stands. We hope this will be grounds for an appeal.”
As she waits her next day in court, Seagrove — who also takes echinacea and gingko biloba but would never touch an aspirin — says that she has not found an effective replacement for kava. “Valerian never worked for me,” she sighs.
“I have had lots of wonderful letters of support from people. Some of them have even sent me their last capsules of kava — although I suspect that a lot of it, sadly, is well past its sell-by date.”
* Kava is not the only herbal medicine considered potentially harmful. St John’s wort, taken as an antidepressant, can adversely affect Aids drugs, birth-control pills and chemotherapy, says the New England Journal of Medicine
Update 24.02.05Government lawyers given hard time in Kava appeal
The natural products industry awaits the outcome of another landmark hearing following the Kava Kava appeal, heard earlier this month. A full report appears in the March issue of Health Food Business.
This time Government lawyers were given a tougher time on the key issue put by the National Association of Health Stores that the consultation process that led to the ban was flawed.
A year ago, the High Court judge dismissed the NAHS claim, despite agreeing that the consultation process was faulty. The NAHS Appeal argued that if the consultation process was flawed, then the decision to prohibit Kava Kava from sale was also faulty.
A further issue is whether a prohibition could be valid if a Minister signs the order in the absence of basic knowledge of the salient facts. If the three Appeal Court judges decide that the opinion of the UKs leading herbal expert, Prof. Edzard Ernst, was improperly represented to the Ministers, the industry may well get its favourite mood herb back. The outcome of this point could change case law, and be relied upon into the future to ensure that consultations are fairly carried out.
The courts decision is expected some time before Easter.
Co-incidentally, the MHRA has just begun a re-consultation on the prohibition. Information and reply forms can be obtained from Alison Daykin, MHRA senior herbal policy manager
See also related:WHO to Investigate Ban on Kava Herb
Liver damage - Kava or Acetaminophen?
Cropwatch: Kava-kava: Bans to be Reconsidered
posted by Sepp Hasslberger on Monday January 12 2004
updated on Saturday September 24 2005URL of this article:
http://www.newmediaexplorer.org/sepp/2004/01/12
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