January 16th, 2013 at 11:00 am
Earlier this week, we posted on BiDil, the first FDA-approved drug with a race-specific indication on its label. In the following interview with Columbia University Press, Jonathan Kahn, author of Race in a Bottle: The Story of BiDil and Racialized Medicine in a Post-Genomic Age, places BiDil in context. He provides some compelling examples of how “personalized” medicine is being “racialized” and makes an argument for why this needs to be stopped.
CUP: Generally, can genetics be reliably used to determine the efficacy of a drug?
JK: Using genetics to determine the efficacy of a drug is very different from using race. A lot of progress has been made in using genetics to identify how a person may metabolize a particular drug. This is not quite the same thing as efficacy, but it is important. There are several steps to using a drug to treat a disease. Once you decide that a person needs a drug, you then need to determine what the appropriate dose is for that person. Many factors can influence this – height, weight, age, and, of course, genetics. You would not want to give an infant the same dose of Tylenol that you would give an adult. Similarly, some people have genetic variations that make them metabolize certain drugs more quickly or more slowly than others. If you are a slow metabolizer, then the drug is going to present in your system for a longer time, and you may not need as a high a dose as someone who is a faster metabolizer, and so forth. Many of these variations have been identified and can be tested. In some circumstances this can improve treatment outcomes; in others, it does not seem to be significantly more effective than the old-fashioned way of having your physician monitor your response to a particular dose and adjusting as needed.
Some significant advances have also been made in targeting drugs to treat some cancers based, not on the genetics of the person, but of the cancer itself. Thus, for example, there are certain types of breast and lung cancer that respond particularly well to certain drugs. To determine whether the drug will work, doctors test the cancer cells to see if they have certain genetic variants that will make them susceptible to the drugs. In all cases, whether drug metabolizing genes or cancer genes, the relevant genetic variants are not specific to particular racial groups.
CUP: Could you define your use of the term “unstated white norm” in the book?
JK: In the realm of biomedicine, the “unstated white norm” is the common practice of thinking about the health status or conditions of white people as the normal state of affairs from which people of color are seen somehow to deviate. It becomes manifest in such practices as algorithms that use race as a variable in calculating the proper dose of a drug for a given patient. Some of these – even those using genetic information – include values for being “African American” or “Asian American” but not for being white. The idea here is that if you are white you get the “normal” dose that does not have to be adjusted for race. It is similar to the idea that somehow whites do not “have race” – only people of color do.
In the case of a drug like BiDil, the idea of the unstated white norm becomes manifest in the logic of its approval by the FDA. The approval was based primarily on data from a drug trial that enrolled only self-identified African Americans. The FDA approved BiDil with a race-specific label based on the idea that since it was only tested in African Americans it should only be approved for African Americans. But the fact of the matter is, most of the drugs on the market today were approved based on data from similarly race-specific trials – trials conducted only with white people – but these drugs were not designated as “white” drugs, nor should they be. One unfortunate implication of this dynamic is the FDA sending a message (unintentionally to be sure, but a message nonetheless) that drugs tested in black people are only good for black people but drugs tested in whites are good for everybody – that is, that whites are somehow more fully representative of humanity than are blacks.
CUP: What are your views on the future of racialized and personalized medicine?
JK: I consider racialized medicine to be the inappropriate use of racial categories in medical practice and drug development. It often involves constructing practices around mistaken assumptions of some innate genetic difference among racial groups. For me, the important issue is not whether to use race in biomedicine, but how to use it – and when. There are very real health disparities in the country that are based on a long history of social, economic, and legal practices that have consistently and deliberately subordinated groups of people based on their race. As a social and historical phenomenon the health impacts of race are very real and can only be addressed by taking race into account. The key is to recognize that in these contexts it is the social and historical practices of racism that have become manifest in racialized bodies as the very real biological differences of health disparities. That is, it is history and culture that has created these biological differences in the incidence of disease across racial groups – not genes.
The future for personalized medicine should be to focus on specific genes for disease and drug response and use new knowledge to develop more effective therapeutics. My hope is that a better understanding of the relationship between race and race-based health disparities will lead to rejection of racialized medicine and an embrace of broad-based approaches to addressing the persistent social and historical determinants of health in our country.