The pharmaceutical company Schering-Plough is excluding African-American patients from the Phase II trial of its new Hepatitis C (HCV) anti-viral drug. Activist groups are denouncing this exclusion as racist. For its part, Schering-Plough argues that it has valid scientific grounds for limiting the research at this stage to other racial groups. Company researchers point out that for unknown reasons, black people do not respond as well to HCV treatments as do members of other racial groups. One prominent activist, Judith Dillard, told the Newark Star-Ledger, "The bottom line is that African-Americans have been left out of this study to make the drug look good." Which is precisely the point.
In the past, drug trials would generally include members from diverse racial and ethnic groups. If the drug being tested was effective in all groups, then that was great; the company testing it had a potential blockbuster. If, however, some groups in the trial did not respond well to a treatment, then it would appear to be ineffective compared to placebo, and it would not be approved. Eventually researchers began to notice that not all groups respond the same way to the same medicines.
For example, researchers at the pharmaceutical company NitroMed ran clinical trials testing a combination therapy of two drugs on patients suffering from heart failure. The idea of the treatment was that the drugs together would boost nitric oxide in patients' bloodstreams. This would dilate their arteries and veins, allowing for more blood flow. In the company's initial trials NitroMed researchers were disappointed to find that their treatment seemed relatively ineffective. But they went back to the data and noted that black patients appeared to respond well to it.
So NitroMed decided to run a drug trial using just African-American heart patients. It was a success. Black patients taking the combination therapy called BiDil have a 43-percent reduction in death and a 39-percent decrease in hospitalization for heart failure. Researchers suspect that BiDil works well in black patients because they tend to have lower average amounts of nitric oxide. This may be the result of an evolutionary adaptation that helped their African ancestors retain scarce salt in tropical climates.
NitroMed encountered opposition when it asked the U.S. Food and Drug Administration to approve BiDil as treatment for blacks suffering from heart failure. Some objected to approving BiDil for blacks only on the grounds that all racial and ethnic distinctions are invidious. Nevertheless, the FDA, focusing on real patient benefits, brushed those objections aside and approved BiDil for use by African-American patients last year. Resistance to BiDil continues and sales have not met NitorMed's expectations.
Now, other drugs are turning out to have differential effects in patients from diverse racial and ethnic groups. For example, this month researchers at the University of Alabama at Birmingham are reporting a study of the effects of ramipril—an angiotensin converting enzyme (ACE) inhibitor medicine to treat high blood pressure and prevent kidney failure—in black patients. The study found that ramipril treatment is associated with a significantly lower rates of diabetes in African Americans with hypertensive kidney disease than conventional treatment with other drugs. Interestingly, an earlier study found that one side effect of ACE inhibitors in many Asian women is a persistent cough so bad that it often drove them to stop taking the medication.
So is the Schering-Plough HCV anti-viral study "racist"? Not really. The researchers have identified a patient subpopulation that they believe is more likely to benefit from the new treatment. If Schering-Plough can demonstrate that the medicine does work for whites, then the company can get it approved for sale by the FDA for that patient population. Admittedly race is a crude biomarker, but it would surely be bowing to political correctness about race to deny patients the benefit of treatments that are more likely to help them. In any case, the use of race to identify and classify patient subpopulations will doubtless be superseded by tests for more selective genetic markers before long.
Journalist Andrew Gumbel, a BiDil critic, argued, "Now, there may well be some genetic predisposition to respond to BiDil that shows up in a large number of people who happen to be African-Americans. But in that case it is the genetic predisposition which should be identified, and tested in all patients regardless of skin color." Clearly that day is coming. Researchers are forging ahead with the HapMap project which is sequencing the genomes of people drawn from a diverse mix of racial and ethnic groups. The goal of the project is to identify "genes that affect health, disease, and individual responses to medications and environmental factors."
As genetic biomarkers associated with various diseases are identified and tests devised to detect those differences in individual patients, race and ethnicity will fall away as a treatment biomarker. Therapies will then go beyond "whites only" or "blacks only," and become personalized: "Joe only" or "Julie only." In the meantime, it would be stupid and immoral not to take advantage of the crude genetic knowledge that racial and ethnic differences provide in making current treatments more effective.