metacog said:
I thought the liver toxicity only happened because they used other parts of the plant that had those compounds?
That's a pretty good idea though Krunked.
I'm sure Kava Cola has some gnarly extraction trade secrets that he can't tell us ; )
There is a mad scientist in Vanuatu who keeps it so under wraps that even I don't know the full process.
There are questions over whether it was the extraction method or the use of stems and leaves which caused the liver damage, heres the notes of Dr. Mathias Schmidt from the International Kava Conference in Vanuatu last year, he is European Union funded and the worlds leading knowledge on Kava along with Dr. Lebot:
Was just typing this up for the site and thought you guys might want a copy:
EU Funded Kava Expert Dr. Mathias Scmidt PHD Key Notes from International Conference 2012 on EU Kava Legality, Effects and Safety:
The Kava Ban: A Scientific, Commercial or Political Issue?
The European Point of View
High Level Conference on Kava
Port Vila, Vanuatu, 12 March 2012
Dr. rer. nat. Mathias Schmidt
Team Leader Kava Project
HerbResearch Germany
Is Kava Banned in Europe?
Not exactly:
Preparations containing Kava extracts have been banned as medicinal products!
Important difference from the legal point of view!
History of the Kava Ban in Europe
1996-1998: "Boom of kava extract products. A German pharmaceutical company starts the cultivation of a 'Two-Day' variety.
1999-2000: First case reports of liver toxicity from Switzerland.
2001: The German drug regulatory authority questions the safety of Kava.
June 2002: Germany bans Kava-containing medications basedon 24 case reports of assumed liver damage, without discrimination of Kava quality.
But: The main argument is not the risk of liver toxicity, it is the supposed lack of efficacy - not of Kava as such, but of the licensed extract preperations!
Efficacy Versus Safety
Efficacy:
- To be demonstrated with a specific preparation in a selected indication, e.g., the treatment of stress-related anxiety.
- Study design must correspond to recent standards and guidelines.
Of Note: There were and still are no guidelines for the testing of drugs in acute stress-related anxiety!
- Kava efficacy is generally accepted in the scientific community.
- Based on this 'well-established use' marketing authorisations have been granted!
- But: By applying recent standards to older studies BfArM retrospectively discarded all single trials because of flaws in the study design.
With no 'valid' study available for the licensed formulations, Kava is by BfArMs definition not efficacious!
Safety:
- BfArM accepted that the risk of Kava Toxicity is minor.
- But: According to BfArM's new paradigm any safety issue will lead to a negative benefit-risk ratio when there is no efficacy making the risk acceptable!
BfArM declared Kava not to be effacious.
BfArM detects a risk, even if only minor.
The benefit to risk ratio becomes negative and Kava is banned!
History of the Kava Ban, Continuation:
2002 - The license holders of Kava products protest against the ban for being inappropriate: Other and less restrictive measures could have been applied.
2006 - After three years of consideration. BfArM accepts that the ban was inappropriate and converts it into a suspension of marketing authorisations.
The Kava companies are given time to present study data.
Efficacy Versus Safety - The Manufacturers Perspective:
- Kava efficacy is generally accepted, and has only been doubted based on the perceived risk.
- If there is no risk, then there is no reason to neglect the well established use.
- Toxicological studies on Kava extracts do not confirm any risk.
BfArMs perspective: The manufacturers did not look hard enough.
2006 - The manufacturers present BfArM a study plan for a clinical trial, as requested.
But: BfArM denies the manufacturers a permit for the trial.
BfArM sees the complete set of non-clinical examinations for new and unknown drugs as an essential pre-condition for a clinical trial permit.
The issue is thus suddenly shifted back to safety issues!
2007 - The manufacturers submit various toxicological examinations.
According to BfArM more work must be done, but BfArM does not detail what it expects. This situation has not changed to date.
BfArM returns to its original revocation of marketing authorisations, arguing that the manufacturers did not deliver the requested clinical trial results.
The manufacturers object to the decision.
November 2008 - Second EU/ACP project in Brussels and Berlin:
Contacts to the EU commission and the German government in the Kava issue.
The ministry is told that BfArM has still not detailed what kind of studies are to be performed to solve the Kava problem.
BfArM promises the South Pacific delegation a Scientific Advice and answers.
April 2009 - The Kava license holders formally apply for a Scientific Advice (which is usually given within 3 months post application). No answer from BfArM.
2009 - 2010 - Despite various reminders, no progress is made.
2011 - A meeting is finally scheduled for April 2011.
March 2011 - Only three weeks before the meeting BfArM cancels the Scientific Advice with a stunning argument: Even if BfArM told the license holders what is expected, they assume that the license holders would not consider performing these studies.
The license holders ask for a quick final decision to open the way for challenging the issue in court
December 2011 - As still no decision has been taken by BfArM, the license holders sue the authority for inactivity, and at the same time challeng BfArMs decisions.
Major Argument: BfArM recommends alternative medications, for which the known risk is even higher. BfArMs ban of Kava medications is effectively putting the consumer at a higher risk!
February 2012 - BfArM submits its statement to the court and at the same time uses this statement as its final decision: Confirmation of the 2007 decision and thus revocation of Kava extract product licenses.
The court case is still on-going, but will take years and several instances up to the European court of Justice to come to a result.
Was the Kava Ban A Scientific Issue?
Definitely not. The obvious questions have never been raised (Kava quality), the studies to be presented never having been defined. Calls for data were merely based on regulatory formalities.
Was the Kava Ban A Commercial Issue?
Probably not: There is no indication of foul play of competitors on the market of anxiolytic drugs.
Was the Kava Ban A Political Issue?
Obviously yes:
All seems to indicate that Kava became a victim of the precautionary principle: EU regulations give the responsibility of consumer protection to the authorities.
In such cases the authorities tend to overreact.
The decision was accompanied by a massive media campaign.
Background Information:
Shortly before Kava was banned, BfArM was accused of not having reacted in time in the Lipobay disaster. They learned their lesson:
Not deciding means to take the heat from the media.
Deciding against Kava meant 'selling' the decision to the consumer as a measure taken for his best.
Once taken, BfArM seems unwilling to correct its actions for fear of losing face.
Conclusions
- The situation of Kava extract products is currently discussed in court - results cannot be predicted and are likely to take many years.
- The situation with Kava as a commodity must be addressed by different means, such as challenging the consequences of the ban on the grounds of WTO regulations.
Final Remark
The issue of quality must urgently be solved:
Just the possibility that potentially dangerous Kava qualities are exported will give EU authorities sufficient arguments to defend the ban!
Dr. Mathias Schmidt
HerbResearch Germany
Wartbergweg 15
D-86874 Mattsies
[email protected]
