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Kava Fact of the Day Dr. Waller - An Unsung Kava Hero?

Kapmcrunk

The Kaptain (40g)
KavaForums Founder
Kava, as we know it, has been a poster child of demonization by regulatory authorities, however there has been a big question that has always sat in my mind. Why didn’t the United States follow the same path as Germany and the EU? How are we still able to purchase and enjoy kava for whatever purpose we see fit in the U.S. and other countries can’t?

I believe we have a specific doctor to thank for kava continuing to be available in the United States (and Canada) when it seemed like the rest of the world was quickly moving to remove it from the market. This person is Dr. Donald Waller, the Professor of Pharmacology and Toxicology at the University of Illinois at Chicago for 48 years. He is the Vice President of Research & Development at Yaso Therapeutics, Inc and has been for 6 years as well [1]. Dr. Waller has published over 90 works related to toxicology and drug therapy encompassing topics including novel male birth control methods, CYP metabolism, and medicinal plant pharmaceutical development [2].

During the time frame when the EU was banning kava, the US Natural Products industry began initiating a scientific engagement process with toxicologists to have them sit down and critically review the adverse event reports (AERs) that had arisen from the United States and the European Union. There was some pervading doubt about the validity of the conclusions made by BfArM (The German Pharmaceutical Agency). This task was then delegated to Dr. Waller to prepare a report.

The report given by Dr. Waller takes into consideration the 5 case reports in America and the 28 reported cases from the European Union that were marked as “likely” in regards to kava causing the issue. In the US his summary concluded “It is my opinion that there is no scientifically supported association of liver disease with the use of kava which can be found using the US FDA adverse reaction case reports”. He continues with “There is always a possibility of an individual hypersensitivity reaction to any food product, and such incidents must be expected when large numbers of subjects consume any food or drug product”. Waller's report on the EU events was even more stark. He brings up many issues with the EU reports lacking in details such as medical history, weight, diet, allergies, past and current alcohol use, viral infections, and occupational or environmental exposures. He verbatim calls BfArMs conclusions about kava “incomprehensible and arbitrary”. Some of these EU cases were also marked as “Clearly not attributable to kava”. In summary of the EU cases, and similar to the American cases he concludes that each of these that seem likely to be tied to kava were the effect of an extraordinarily rare hypersensitive idiosyncratic reaction of an immunologic type [3].

It seems that due to this individual's rigorous integrity his words were taken as cannon. Today we still have kava available on the market, and I believe this individual had quite a bit to do with why we can still get our hands on our favorite root.

Thank you Dr. Waller!


[1] Waller, D. (2016). Linkedin Profile. LinkedIn. https://www.linkedin.com/in/donald-waller-26378b7

[2] Donald WALLER | University of Illinois at Chicago, IL | UIC | Department of Biopharmaceutical sciences. (2013, December 9). ResearchGate. https://www.researchgate.net/profile/Donald-Waller

[3] Waller. 2002. “Report on Kava and Liver Damage to the American Herbal Products Association.” American Herbal Products Association. (Source Attached)
 

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Alia

'Awa Grower/Collector
Kava, as we know it, has been a poster child of demonization by regulatory authorities, however there has been a big question that has always sat in my mind. Why didn’t the United States follow the same path as Germany and the EU? How are we still able to purchase and enjoy kava for whatever purpose we see fit in the U.S. and other countries can’t?

I believe we have a specific doctor to thank for kava continuing to be available in the United States (and Canada) when it seemed like the rest of the world was quickly moving to remove it from the market. This person is Dr. Donald Waller, the Professor of Pharmacology and Toxicology at the University of Illinois at Chicago for 48 years. He is the Vice President of Research & Development at Yaso Therapeutics, Inc and has been for 6 years as well [1]. Dr. Waller has published over 90 works related to toxicology and drug therapy encompassing topics including novel male birth control methods, CYP metabolism, and medicinal plant pharmaceutical development [2].

During the time frame when the EU was banning kava, the US Natural Products industry began initiating a scientific engagement process with toxicologists to have them sit down and critically review the adverse event reports (AERs) that had arisen from the United States and the European Union. There was some pervading doubt about the validity of the conclusions made by BfArM (The German Pharmaceutical Agency). This task was then delegated to Dr. Waller to prepare a report.

The report given by Dr. Waller takes into consideration the 5 case reports in America and the 28 reported cases from the European Union that were marked as “likely” in regards to kava causing the issue. In the US his summary concluded “It is my opinion that there is no scientifically supported association of liver disease with the use of kava which can be found using the US FDA adverse reaction case reports”. He continues with “There is always a possibility of an individual hypersensitivity reaction to any food product, and such incidents must be expected when large numbers of subjects consume any food or drug product”. Waller's report on the EU events was even more stark. He brings up many issues with the EU reports lacking in details such as medical history, weight, diet, allergies, past and current alcohol use, viral infections, and occupational or environmental exposures. He verbatim calls BfArMs conclusions about kava “incomprehensible and arbitrary”. Some of these EU cases were also marked as “Clearly not attributable to kava”. In summary of the EU cases, and similar to the American cases he concludes that each of these that seem likely to be tied to kava were the effect of an extraordinarily rare hypersensitive idiosyncratic reaction of an immunologic type [3].

It seems that due to this individual's rigorous integrity his words were taken as cannon. Today we still have kava available on the market, and I believe this individual had quite a bit to do with why we can still get our hands on our favorite root.

Thank you Dr. Waller!


[1] Waller, D. (2016). Linkedin Profile. LinkedIn. https://www.linkedin.com/in/donald-waller-26378b7

[2] Donald WALLER | University of Illinois at Chicago, IL | UIC | Department of Biopharmaceutical sciences. (2013, December 9). ResearchGate. https://www.researchgate.net/profile/Donald-Waller

[3] Waller. 2002. “Report on Kava and Liver Damage to the American Herbal Products Association.” American Herbal Products Association. (Source Attached)
This is truly remarkable and an excellent theory as to US position.
The irony is not lost to Alfred Hitchcock fans as to whom the report is addressed to.
 

kasa_balavu

Yaqona Dina
Great post, @Kapmcrunk.
Impressive work by Dr. Waller, and also cool to see that he received the German data from Dr. Schmidt. I don't recall hearing of him before 2014 when he came to Fiji and Vanuatu to raise awareness about non-noble kava, but according to this document, he was fighting for kava even way back in 2002.
 
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