If I were to tell you that there is a drug that has been approved for
a specific race, probably many of you would not believe me. In 2005, a drug
named Bidil had become one of the first pharmaceutical to be approved by the
FDA for the specific treatment of heart failure in African Americans. Nitromed,
the biotech firm, presents Bidil as an opportunity to address the disparity in
outcomes for black Americans with heart failures. Particularly, it combines
hydralazine and isosorbide dinitrate to vasodilate blood vessels to ease heart
strain. For the record, these are individual, generic drugs that were combined
for easier administration.
Furthermore, they cite the differential rates of heart failure and
nitric oxide levels between blacks and whites. Unfortunately, the statistical
research done on this has some alarming flags. To begin, there were many
external factors that were not controlled for. Specifically, socioeconomic
disadvantages, education levels, and financial stress are important factors in
considering causes of cardiovascular diseases.
While on the surface this does seem like a noble cause, Bidil’s
development has depended on the appropriation of race to justify its approval. The
researchers themselves note that skin color is only a crude marker of
underlying genetic differences yet it has been able to establish property
rights, garner approval, and form marketing campaigns based off of this. These
are huge issues because this promotes the idea that medical research can be
swayed by law and commerce rather than focus on actually addressing the
biological and social issues that are at hand. Not to mention, this brings
about issues of racialized notions concerning biology. Given our troubling
history of oppression based on racial misunderstandings, this is not a path we
should be going down again. Do you think Bidil has strong enough empirical
research to be backed up using these claims? If someone like this can be
approved by the FDA, how must trust can we really put into the FDA in regards
to their approvals?
Kahn, Jonathan D., How a Drug Becomes 'Ethnic': Law,
Commerce, and the Production of Racial Categories in Medicine. Yale Journal of
Health Policy, Law, and Ethics, Vol. 4, pp. 1-46, Winter 2004. Available at
SSRN: https://ssrn.com/abstract=515942
It is interesting that you mention that African Americans have some of the higher rates of cardiovascular disease because they also have some of the highest rates of some other diseases, including cancer. According to the American Cancer Society, African Americans are more likely to die from cancer than any other racial or ethnic group. Because we know that African American men are more likely to die from prostate cancer , do you think it is different to "target" African American populations in certain types of cancers, whether it be for screening, treatment, etc.?
ReplyDeleteIn addition, you mentioned that there are other factors that predict cardiovascular disease risks, and these risks also exist in cancer and can determine survival outcomes. How much should drug researchers and drug companies take these other factors into consideration when they are developing their products? I agree that the cause or motivation behind developing the drug was most likely noble and had good intentions, but it should make drug developers think more carefully about how they are specially targeting certain populations and marketing towards those populations.
Your post reminded me of a TEDMED talk I listened to earlier this year by Dorothy Roberts titled “The problem with race-based medicine.” In her talk she speaks about the shortcomings that following race-based medicine has and how it impairs the quality of care that patients can receive when medical professionals follow said techniques. She specifically talked about BiDil in her talk, beginning with the FDA failing the African- American community by only doing clinical trials with African- American patients for BiDil. She stated that by testing only in a specific community, the FDA portrayed the African- American as substandard because it implies that the drug is unable to work for any other race. She made a very good point about race being a social grouping that is clouding evidence based medicine and overwhelming clinical measures that offers no relevant information to patient care. There was a lot more that she spoke about that I invite you to see for yourself, I have included the link below.
ReplyDeletehttps://www.ted.com/talks/dorothy_roberts_the_problem_with_race_based_medicine