Racial profiling and prescription drugs

I've been missing commercials on t.v. lately because I now have a DVR and can pause during the first commercial on a program, walk off, return later and watch the rest of the program, skipping over commercials. So, until last night, I hadn't seen the ad targeting black Americans with high blood pressure.

This commercial is an insult to black Americans! First, it states that people in this category (how is this defined, anyway?) are twice as likely to have a stroke as people not in this category. Then, it promises a treatment that will solve the problem.

Are we back to "any drop of Negro = Negro"? Is the ad saying, "if you're white, you don't need to listen to this commercial"? Or, is it more sinister?

What happens after that in the ad is a mystery to me, because I got quite incensed hearing the ad--I actually didn't look at it so can't tell you what the visuals are. But, this is what I assume the ad is about:

There are data that say that black Americans have more strokes than do other Americans. I have no idea if the research encompasses countries other than the U.S. Generally, the news reports do not discuss why--generally lesser access to good health care, genetics, obesity, skin color, heritage from around the equator?

Then, there are data that say that one prescription drug lowers blood pressure better in blacks than in others. The FDA actually approved the drug with that comment in the labeling. Problem is, the studies supporting this contention didn't collect the data necessary to make this claim.

In study #1, the sponsor concluded that the people identifying themselves as black had fewer strokes than those identifying themselves as white or other. (Clinical studies have a number of "ethnic" groupings they can use to identify participants; I'm not including all the categories here.) However, the study was "powered" for the majority population (Caucasian)--that means the number of subjects enrolled was based on a plan to detect a change of X millimeters of mercury in either diastolic or systolic blood pressure (the upper or lower number of , for example, 120/60). Subdividing the population and claiming statistical significance of a difference between Group A (others) and Group B (blacks) is not sound statistical analysis.

In fact, the study did not meet its primary objective--the difference in blood pressure (and incidence of stroke) between all those treated with the drug and those not so treated was not statistically significant. Hmmmm, must rescue something from this multi-million-dollar study. So, work with the statistics and find something that appears to be statistically significant. Ah ha! blacks vs. others. Blood pressure lowering by the drug appeared to be more successful in blacks than in others.

Great, here's a possibility for the first drug target to an "ethnic" group!

Now, study #2. This study enrolled only subjects identifying themselves as black, and tested the drug against placebo. Now, the drug was better than placebo. So, the drug has been shown--in one study--to lower blood pressure. Because the subjects were black, the sponsor can apply to the FDA for approval (and get it) for a blood pressure lowering drug that works in blacks (and, implied, not in others).

What a bunch of hogwash!!!!!

When I was working with a drug to treat irritable bowel syndrome, we found that the drug worked in women, but not in men. The French medicines approval agency, not wanting to separate the genders for a drug not related to sex or gender, simply requested that the sponsor prove that men would not be hurt if they took the drug, and then the drug was marketed for the general population. It seems Americans took a different route. 

Wouldn't it be interesting if genetic testing became involved in all this targeting and they found that the "gene" responsible for all this actually originated in Europe, after Cro-Magnon overcame Neanderthal?

Now, did you say you're black? Are you so sure? If we as Americans haven't learned that there's generally a greater genetic difference between two people of the same ethnic background than there is between two people of different ethnic backgrounds, maybe it's time we geneticists get the word out.

Marie Godfrey, PhD

 

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