Ethnopharmacologists suggest that while the human genome project has shown that humans are 99.9% alike genetically, the remaining one-tenth may cause drugs to be metabolized differently. They seek to advance this understanding and incorporate their findings into the manner in which we select subject groups for clinical trials, and how we interpret that data, and eventually use the medications.
They note that the current state results in the declaration of drug side effects and indications for use that were developed largely due to test results and interpretations of data that have been ‘normed’ for the entire population.
- There are ethnic differences in how people process blood thinners, like warfarin
- Many African-Americans tend to be more responsive to diuretics
- Whites of European ancestry are less responsive to beta blockers and ACE inhibitors
- African-Americans and Hispanics have higher rates of:
- Asian-Americans suffer higher rates of Hepatitis B
- Ethnic groups suffer disproportionately from cancer
- Rates of Lactose Intolerance are higher in Hispanics and African Americans than other groups, inhibiting the metabolism of any product that uses a lactose based filler
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- Are diversity proportional trials enough, or should we run ethno-specific trials?
- Will we be suggesting ethno-specific dosages?
- Do physiological differences require that we evaluate different bio-markers during clinical testing?
- To what level of ethnicity do we attempt to recruit? Is Hispanic enough, or do we need to differentiate between the geographical origin of the subject (e.g., Hispanic or Puerto Rican Hispanic, Mexican Hispanic, South American Hispanic)?
- How do we categorize people into complex sub-groups? Are ethno-specific groupings enough, or do we need to consider cultural habits and environments? The very rich? The very poor? Rural? Urban?
- If minority populations prove difficult to recruit, do we prohibit trials from starting?
- To what extent will additional and more complex Clinical Trials increase the cost of drug development?
- What about drugs that are developed outside of the US, in countries that do not have access to the same ethnic subgroups that are present in the US?
- Will increasing the requirements for Clinical Trials slow the pace of drugs to market?
- If the cost of development increases, and the pace to market decreases, will private sector organizations reduce their efforts to develop treatments for drugs that disproportionally effect minority groups?
- Will policy changes require that treatments whose studies did not reach a desired level of ethnic diversity limit the ability to use them only for the groups represented in the trials?
Currently many high profile organizations are attempting to introduce Ehnopharmacology into the Clinical Trial conversation:
- United States Food and Drug Administration (FDA) – In 2010, the FDA created an Office of Minority Health, working to increase the number of minority subjects in clinical trials and studying genomic differences in minorities
- The National Medical Association (NMA) – Launched project I.M.P.A.C.T in order to encourage African Americans to become aware and seek participation in clinical trials
- The Intercultural Cancer Council (ICC)– Working to encourage minority participation in clinical trials for cancer treatments
- The Elimination of Disparities in Clinical Trials Project (EDICT)–are working to end disparities in clinical trials in the areas of asthma and cancer
- The National Institute of Health (NIH) – now requires government-funded research to include more women and ethnic groups