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FDA approves first racially targeted drug

Sickle cell anemia (L), Tay-Sachs (R; conditions that are commonly known to occur more frequently in certain racial/ethnic groups, and are recognized as such.

Clearly this drug is effective in a group of people that share similar traits, but I’m sorry, this is a slippery slope of medical confusion. How in the hell can you target a medicine at an artificial construct? How “black” do you have to be to benefit from the drug? What if you are biracial? What if you are black, but light-skinned/have facial features that allow you to “pass” – will you still get the drug? Will a doctor’s biases get in the way of prescribing the appropriate medication for the patient?

This ruling by the FDA opens a Pandora’s box of problems.

The heart failure drug BiDil was approved Thursday by government regulators for use by blacks. It will be the first medication marketed for a specific racial group. The Food and Drug Administration called the approval a step toward “the promise of personalized medicine.”

Studies showed that blacks benefited from the drug while the general population did not. The drug is marketed by NitroMed Inc. of Lexington, Mass.

“The information presented to the FDA clearly showed that blacks suffering from heart failure will now have an additional safe and effective option for treating their condition,” said Dr. Robert Temple, the agency’s associate director of medical policy. “In the future, we hope to discover characteristics that identify people of any race who might be helped by BiDil.”

A study indicated that the drug led to a 43 percent reduction in deaths from heart failure among the blacks who took it. Research was stopped early after scientist realized the benefits of the drug so the data could be presented for the drug’s approval.

BiDil is a combination of two older drugs, hydralazine and isosorbide dinitrate, neither approved for heart failure. Some common side effects with the drug are headache and dizziness.

Temple said the success of the drug in blacks was a “striking example of how a treatment can help some patients even if it does not help all patients.”

In addition to the reduction in deaths, the FDA cited a 39 percent decrease in hospitalizations for those who took the drug compared with those who took a placebo.

While the favorable results of the study is good news for blacks, some health care experts said the company won’t have financial incentive to do larger trials for the general population now that they have a product patented for blacks only. While, others worry that blacks will automatically be prescribed the pill based on their skin color, even if it may not be the best choice.

I blogged about this topic back in November, when the clinical trials were stopped because of the disparity in results with blacks:

My racial/ethnic background is extremely varied, but I do know, for instance, that type II diabetes exists on both sides of my family, for at least two generations, and I am one of the few in my family on either side to receive the kinky hair gene. My gene pool represents the multi-culti phenomenon that is part of the colorful history of the United States. It’s nearly impossible to easily pigeonhole someone like me into any clear category, though I do, when I feel like it, check the African-American box to make someone else comfortable with clerical matters. The truth is that checking the box denies all the pieces of genetic history that makes me who I am — I have white American, West Indian (Barbados), white European, American Indian (Shinnecock, Lumbee), and possibly Chinese ancestors in my family tree. It’s harder for people in my boat to trace things like this back too far, but there are folks on both sides of my family trying to do so. What does that make me (other than a proud “mutt” — and a white supremacist’s embodiment of what is wrong with America)?

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Pam Spaulding

Pam Spaulding