I am on fire today! I think that @Deleted User will love this paper. "Tradition and toxicity: Evidential cultures in the kava safety debate" Jonathan D. Baker
Abstract:
"This paper examines the debate about the safety of kava (Piper methysticum Forst.
f., Piperaceae), a plant native to Oceania, where it has a long history of traditional use.
Kava became popular as an anti-anxiety treatment in Western countries in the late
1990s, but it was subsequently banned in many places due to adverse reports of liver
toxicity. This paper focuses on the responses to the bans by scientists involved in kava
research, contrasting their evidential culture with that employed by clinicians and
regulatory officials. Cultural constructions and social negotiations of risk are shown
to be context-specific, and are shaped by professional, disciplinary, and organizational
factors, among others. Though the science of hepatotoxicity is uncertain enough to
allow for multiple interpretations of the same data, the biomedical/clinical narrative
about kava remains dominant. This case study explores the influence of these cultural,
social, and political factors on the production of scientific knowledge and the assessment
of benefit/risk posed by comestibles."
A couple of interesting fragments:
"In essence, kava underwent a translation, from natural medicine to pharmaceutical analogue, as it moved from approval/evaluation to post-marketing surveillance. This
translation had significant consequences, because the assumptions underlying different types of medicines were not identical. Approval of natural medicines specifically relies upon traditional history of use as part of the evidence, at least in the initial stages. By contrast, new pharmaceuticals are evaluated under the assumption that they have no history of human consumption. By the time of post-marketing surveillance, kava products had been incorporated into the larger category of pharmaceuticals. Consequently, case reports of toxicity were treated similarly to reports about medicines for which there was no history of human consumption. Despite the role traditional knowledge and history of consumption play during approval, such information is not considered in pharmacovigilance contexts.
(...)
[By contrast] Plant scientists are aware that kava has been used safely by Pacific Islanders for thousands of years. From their perspective, it is not a novel drug lacking history of human consumption. Ethnobotanists point out that kava is not recognized as toxic in traditional contexts (Balick and Lee, 2002; Tavana et al., 2003), and in places such as Fiji and Hawai’i, scientists are immersed in a context in which safe traditional kava use is
commonplace. To them, this is important evidence that must be addressed in any explanation of how kava might be toxic. The plant scientists’ reliance on statistically significant evidence influences how they interpret case reports. At best, they view clinical observations as preliminary, but generally find them deficient. Case reports do not address traditional history of use or previous trials demonstrating safety, and do not elucidate mechanisms of action underlying hepatotoxicity. These scientists view the bans as unwarranted, since to them it seems that regulatory authorities ignored evidence indicating kava’s safety, while relying on statistically
insignificant, poor quality data indicating toxicity. Their responses make sense from this perspective – by and large, laboratory scientists involved with kava research
have set out to determine specific mechanisms by which kava might cause toxicity, seeking to fill the gap in evidence by conducting experiments that will produce statistically significant results. This reaction – suspicion of findings based solely on clinical observations, and searching for underlying mechanisms of action – is common among disputes between laboratory scientists and clinicians (Marks, 1997). The hypotheses they have developed about how kava may cause toxicity are based on the assumption that some difference between traditional and non-traditional use is responsible."
Conclusion:
"Let us return to a consideration of ‘traditional’ kava drinking, and Pacific Islanders’ assessments of kava’s safety. This context also is an evidential culture, and it makes logical sense that people would rely on their own experience when evaluating the safety of kava. As mentioned earlier, the frequency of toxicity from any kava-containing substance is exceedingly low; low enough that it can be difficult to ever observe it in the relatively small populations in which kava is traditionally consumed. Add to this that there have only been three documented cases of toxicity associated with the traditional drink, despite extensive observation over long periods of time in diverse regions of the Pacific. The larger question then remains: How safe is safe enough? How frequent does a toxic reaction have to be before something is deemed unsafe? Clearly, the evaluation by regular kava consumers that kava is safe enough is well-supported by their own contextual
observations, as well as by evidence gathered by researchers studying traditional consumption. Their assessments are grounded in extensive experience and evidence.
Introducing traditional kava drinking into the discussion helps highlight the ways kava is transformed when it is introduced into new contexts. It is physically modified,
and the manner in which it is used and understood is also radically changed. In essence, two (or more) different kavas end up being evaluated, and evidence about one does not directly apply to the other. In this sense, it is reasonable to question the applicability of evidence that the traditionally prepared drink is safe when assessing the risk posed by kava supplements. But this is true of the other side of the equation as well: just because cases of toxicity have been linked to supplements does not mean traditionally prepared kava poses the same risk. The political and social power of the biomedical perspective and regulatory authorities simplifies this debate, conflates all kavas as the same, and obscures the processes underlying kava’s transformations. In a broader sense, assessment of benefit/risk from comestibles is best understood as relative: it is context-dependent and strongly shaped by social and cultural factors. It is also a process in which humans engage regularly, indeed daily. One need look no further than alcohol to find an example of continued use of a known dose-dependent liver toxin, and many medicines that continue to be used are also implicated in hepatotoxicity. By following substances such as kava through different evaluative contexts, the various influences shaping how they are perceived, and in turn used, can be better apprehended."
Abstract:
"This paper examines the debate about the safety of kava (Piper methysticum Forst.
f., Piperaceae), a plant native to Oceania, where it has a long history of traditional use.
Kava became popular as an anti-anxiety treatment in Western countries in the late
1990s, but it was subsequently banned in many places due to adverse reports of liver
toxicity. This paper focuses on the responses to the bans by scientists involved in kava
research, contrasting their evidential culture with that employed by clinicians and
regulatory officials. Cultural constructions and social negotiations of risk are shown
to be context-specific, and are shaped by professional, disciplinary, and organizational
factors, among others. Though the science of hepatotoxicity is uncertain enough to
allow for multiple interpretations of the same data, the biomedical/clinical narrative
about kava remains dominant. This case study explores the influence of these cultural,
social, and political factors on the production of scientific knowledge and the assessment
of benefit/risk posed by comestibles."
A couple of interesting fragments:
"In essence, kava underwent a translation, from natural medicine to pharmaceutical analogue, as it moved from approval/evaluation to post-marketing surveillance. This
translation had significant consequences, because the assumptions underlying different types of medicines were not identical. Approval of natural medicines specifically relies upon traditional history of use as part of the evidence, at least in the initial stages. By contrast, new pharmaceuticals are evaluated under the assumption that they have no history of human consumption. By the time of post-marketing surveillance, kava products had been incorporated into the larger category of pharmaceuticals. Consequently, case reports of toxicity were treated similarly to reports about medicines for which there was no history of human consumption. Despite the role traditional knowledge and history of consumption play during approval, such information is not considered in pharmacovigilance contexts.
(...)
[By contrast] Plant scientists are aware that kava has been used safely by Pacific Islanders for thousands of years. From their perspective, it is not a novel drug lacking history of human consumption. Ethnobotanists point out that kava is not recognized as toxic in traditional contexts (Balick and Lee, 2002; Tavana et al., 2003), and in places such as Fiji and Hawai’i, scientists are immersed in a context in which safe traditional kava use is
commonplace. To them, this is important evidence that must be addressed in any explanation of how kava might be toxic. The plant scientists’ reliance on statistically significant evidence influences how they interpret case reports. At best, they view clinical observations as preliminary, but generally find them deficient. Case reports do not address traditional history of use or previous trials demonstrating safety, and do not elucidate mechanisms of action underlying hepatotoxicity. These scientists view the bans as unwarranted, since to them it seems that regulatory authorities ignored evidence indicating kava’s safety, while relying on statistically
insignificant, poor quality data indicating toxicity. Their responses make sense from this perspective – by and large, laboratory scientists involved with kava research
have set out to determine specific mechanisms by which kava might cause toxicity, seeking to fill the gap in evidence by conducting experiments that will produce statistically significant results. This reaction – suspicion of findings based solely on clinical observations, and searching for underlying mechanisms of action – is common among disputes between laboratory scientists and clinicians (Marks, 1997). The hypotheses they have developed about how kava may cause toxicity are based on the assumption that some difference between traditional and non-traditional use is responsible."
Conclusion:
"Let us return to a consideration of ‘traditional’ kava drinking, and Pacific Islanders’ assessments of kava’s safety. This context also is an evidential culture, and it makes logical sense that people would rely on their own experience when evaluating the safety of kava. As mentioned earlier, the frequency of toxicity from any kava-containing substance is exceedingly low; low enough that it can be difficult to ever observe it in the relatively small populations in which kava is traditionally consumed. Add to this that there have only been three documented cases of toxicity associated with the traditional drink, despite extensive observation over long periods of time in diverse regions of the Pacific. The larger question then remains: How safe is safe enough? How frequent does a toxic reaction have to be before something is deemed unsafe? Clearly, the evaluation by regular kava consumers that kava is safe enough is well-supported by their own contextual
observations, as well as by evidence gathered by researchers studying traditional consumption. Their assessments are grounded in extensive experience and evidence.
Introducing traditional kava drinking into the discussion helps highlight the ways kava is transformed when it is introduced into new contexts. It is physically modified,
and the manner in which it is used and understood is also radically changed. In essence, two (or more) different kavas end up being evaluated, and evidence about one does not directly apply to the other. In this sense, it is reasonable to question the applicability of evidence that the traditionally prepared drink is safe when assessing the risk posed by kava supplements. But this is true of the other side of the equation as well: just because cases of toxicity have been linked to supplements does not mean traditionally prepared kava poses the same risk. The political and social power of the biomedical perspective and regulatory authorities simplifies this debate, conflates all kavas as the same, and obscures the processes underlying kava’s transformations. In a broader sense, assessment of benefit/risk from comestibles is best understood as relative: it is context-dependent and strongly shaped by social and cultural factors. It is also a process in which humans engage regularly, indeed daily. One need look no further than alcohol to find an example of continued use of a known dose-dependent liver toxin, and many medicines that continue to be used are also implicated in hepatotoxicity. By following substances such as kava through different evaluative contexts, the various influences shaping how they are perceived, and in turn used, can be better apprehended."
