Part 2: The Evolution of the Clinical Trial; Is Ethnopharmacology the New Frontier?

Last month, Part 1 of this series reviewed the history of some of the protections provided to the American consumer by Title 21 and the Food and Drug Administration.  Last month’s installment focused on the development of the controls designed to evaluate the impact of utilizing our medicines in clinical situations; the history of Clinical Trials.
In this installment, we will go beyond recapping how and why the system of modern Clinical Trials came to be, and look to the future.  Part 2 will evaluate what may be the next stage of evolution of the Clinical Trial System – Ethnopharmacology.
Future State: Clinical Testing – Should Results be Considered a Function of the Health of the Subject + the Nature of the Product + Ethnopharmacology?
Ethnopharmacology has been a practiced science since the early 60s and is generally thought of as the field of study that investigates the impact that culture, environment, genetics, biophysiology, and psychosocial factors have on the body’s metabolism of and response to medications.  While this emerging science has its roots in efforts to research the cultural use of medicines across the globe, it is quickly evolving into an effort to understand the correlations between race/ethnicity and how a person’s body metabolizes medications.
In short, the next step in the evolution of the clinical trial may be demonstrating how physiological and genetic differences between racial and ethnic groups may impact the effectiveness of pharmacological products.

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.

Leading Ethnopharmacologists point out that current data indicates that ethnic groups metabolize certain medications differently, and that they experience higher rates of some of today’s most serious diseases.
For example:
  • 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:
o   Diabetes
o   Hepatitis C
o   Obesity
o   Cardiovascular disease
  • 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

Evolution Can be a Painful Process

This stage of evolution will not however be accomplished with just an Act of Congress.  Developing a new way of matrixing clinical trial subjects, and evaluating the data generated will require scientific evaluation of the variations that are being purposely introduced.
The scientific community is already posing the following types of questions:
  • 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?
 In addition to the scientific questions that arise, many policy questions are also being posed:
  • 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?
While these questions may muddy the waters, one thing is clear; Ethnopharmacology is a newly emerging science and is a part of our ever evolving knowledge base.  And, if we have learned anything from past evolutionary stages of medicinal development and testing, it is that practices and policies adapt as new understandings present themselves.

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
Where these discussions take us as an industry can’t yet be known, but it is sure to be an educational trip.  We will be listening to them and keeping our readers informed.
We at Coda Corp USA believe that every stage of this evolutionary process has improved the safety and quality of the medicinal products available to the American public.  We have every confidence that this stage will do the same.
© Coda Corp USA 2013. All rights reserved.
Gina Guido-Redden, Chief Operating Office. [email protected]
Corrine R. Knight, Director of Business Initiatives, [email protected]
Coda Corp USA
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