Mixed Race Studies

Implications of Genetic Diversity in Mexico

Biopolitical Times
Center for Genetics and Society
2014-06-25

Pete Shanks

The category Latino is a valid cultural artifact, and often self-identified. But it’s not really a race in any modern sense of the term, and the genetic evidence surely shows that it is far too broad a grouping to be scientifically appropriate without serious qualification. Yet it is used, even in some current peer-reviewed papers.

One that does not use the term is an article published in Science this month on the genetics of Mexico. The country’s population is large and ethnically, linguistically, geographically, economically and culturally diverse. It is also genetically complex, and this article by a large and distinguished team of scientists provides new details. It also suggests some important implications for genomic research and likely for personalized medicine in general:

The genetics of Mexico recapitulates Native American substructure and affects biomedical traits

The study included 511 Native Mexican individuals from 20 indigenous groups, and 500 mestizo (mixed-race) individuals from ten states; nearly a million SNPs were analyzed for each. The variation was striking…

Read the entire article here.

Race-Based Medicine: Déjà Vu All Over Again?

Biopolitical Times: The weblog of the Center for Genetics and Society
2012-09-18

Osagie K. Obasogie, Associate Professor of Law
University of California, San Francisco
Also: Senior Fellow
Center for Genetics and Society

Race-based medicine has been one of the more contentious issues in pharmaceutical research and development over the past few years. Some argue that drugs specifically labeled to treat particular racial groups offer an invaluable way to fight racial disparities in health by targeting at-risk populations. Others claim that race-based medicine inappropriately treats race as a biological cause of racial disparities when broader social and environmental factors may offer better explanations.

Much of this debate involves the FDA’s 2005 approval of BiDil, which became the first drug to be labeled for a specific racial group – African Americans with heart failure. The heat generated from this debate has largely faded due to BiDIl’s market failure.  But, it seems like a new drug may reignite a few flames.

Tradjenta was developed by Boehringer Ingelheim Pharmaceuticals and Eli Lilly to treat Type 2 diabetes. But results from a Phase III clinical trial recently showed that Tradjenta was particularly beneficial for controlling African Americans’ blood sugar levels…

…Is another BiDil on the horizon? It’s important to acknowledge that Tradjenta had already received FDA approval to treat type 2 diabetes in the general population prior to the announcement of these race-specific results. This is different from BiDil, where investigators sought a race-specific indication from the FDA because they could not otherwise win regulatory approval as a race-neutral drug. Despite these differences, treating racial disparities in diabetes as a naturally observed group difference that can be at least partially resolved with a pill shares some similarities with the BiDil saga. In both cases, there is a tendency to naturalize racial disparities as a function of group difference rather than having a deeper engagement with the social determinants of health.

This leads to an important question: if Tradjenta already received approval for use in the general population, why would it not be effective in African Americans? Put differently, why go through the time and expense of conducting a clinical trial to demonstrate efficacy in a particular racial group when the drug has already been approved for everyone regardless of race?

It’s unclear how these recent clinical trial results might be used. Perhaps this is another example of using a clinical trial as a marketing device in the hopes of capturing a larger share of the market…

Read the entire article here.

Slooooooow Sales for BiDil^®

Biopolitical Times: The weblog of the Center for Genetics and Society
2006-10-18

Osagie K. Obasogie, Associate Professor of Law
University of California, San Francisco
Also: Senior Fellow
Center for Genetics and Society

Today’s Wall Street Journal reports that sales for BiDil^®—the first drug to receive FDAapproval to treat a specific race—are unexpectedly slow. Marketed as treating heart failure in African-Americans, BiDil^® was expected to generate $130 million in sales this year; thus far, only a little over $5 million has come in. Estimates show that only 1% of the 750,000 Blacks suffering from heart failure are using it.

There’s no shortage of explanations for why Black people are about as unlikely to take BiDil^® as they are to name a newborn child Katrina…

…But, perhaps there’s another explanation that the Wall Street wing tips are missing: a sense of history.

During a conference I attended earlier this year on BiDil^® and race specific medicines, an older Black woman in the audience stood up and said “If I were sick and somebody told me that they had a drug just for Black people to help me, I’d say to them: give me what the white people are taking.”…

Read the entire article here.