Heart Pill for African-Americans Under FDA Review

BiDil, the heart pill marketed for use by African-Americans, is in the news again. Race-based drugs are considered by some to be a stepping stone to developing drugs tailored to patients’ unique genetic profile. BiDil, however, may not be the best representative of this new way of dispensing medicine. The U.S. Food and Drug Administration is re-evaluating BiDil after it was rejected for use in the general population. (LA Times, June 16, 2005)

Now is a good time to review my concerns about race-based drugs:

1. Most people cannot be easily categorized.
2. Some patients will either knowingly or unknowingly misidentify their race.
3. Doctors may be afraid to offer certain drugs for fear of incorrectly identifying the patient’s race and possibly offending the patient.
4. Patients may refuse appropriate but race-specific treatment because they do not want to be identified as that particular race.
5. Patients may not offered or may be denied treatment because it isn’t believed to be effective in their particular racial group.

Other scientists share my concerns:

“It is not like one group has all the bad genes,” said Neil Risch, a UC San Francisco geneticist. “They are pretty well distributed.”

Still,the drug is not without its supporters and some convincing evidence:

The company has won support from such influential groups as the Assn. of Black Cardiologists, whose members were among the doctors who conducted the trial, and leaders of the Congressional Black Caucus. Donna Christensen, a Democrat from the Virgin Islands, said she would appear before the panel on behalf of NitroMed because “African Americans are dying.”

“I commend NitroMed for stepping out on a limb, knowing alarms would go off,” she said.

NitroMed’s study, published in the New England Journal of Medicine last fall, demonstrated a 43% increase in survival of African Americans who took BiDil in combination with an existing drug compared with blacks in a control group who received only that existing medicine. In addition, the study of 1,050 patients showed that those who received BiDil had fewer hospitalizations.

As with most drugs, there is a strong financial incentive behind the drive to get BiDil approved.

Critics say BiDil is a case study in how the forces of commerce drive medicine. Jonathan Kahn, a medical ethicist at the University of Minnesota, said NitroMed proposed its study at a time when the FDA was eager to involve more African Americans in clinical trials.

NitroMed’s patent on BiDil as a treatment for African Americans expires in 2020, so the company could enjoy a long monopoly if the drug is approved only for blacks, Kahn observed. NitroMed’s patent on BiDil for general use runs out in 2007.

It appears that NitroMed may not reap as much profit as they would like. Because BiDil is made up of two pre-existing generic drugs, it’s possible to take those instead and save a substantial amount of money.

Even approval of the drug by the FDA for blacks only is no guarantee of success. SG Cowan & Co., an investment firm, predicted that insurers would require a high co-payment, perhaps $35 or more, for BiDil. That could drive half of all eligible patients to go to the trouble of taking the two generic drugs that make up BiDil. Co-pays on each generic would be $5 to $10, the investment firm said.

Doctors already prescribe the generic drug combination for patients of all races. BiDil’s biggest contribution may be to the race debate instead of to our health.