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Winters Group Inc
False Hope: Promising 'Racial' Heart Drug Fails to Reach Blacks
Compiled by the DiversityInc staff

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October 17, 2006

Many blacks were optimistic that BiDil would lower the disproportionately high incidence of heart disease in their community when the drug came on the market last summer. But now the prognosis is bleak.

 

High co-payments and inadequate healthcare coverage are preventing blacks from accessing BiDil, which made history as the first drug designed for their benefit.

 

In 2005, the hospitalization rate for black heart-failure patients ages 65 to 74 was more than double that of whites—19.2 versus 8.3 per 1,000 people, according to the Agency for Healthcare Research and Quality.

 

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But only 1 percent of the 750,000 blacks (subscription required) with heart disease use BiDil, which the Food and Drug Administration approved 16 months ago, reports The Wall Street Journal (WSJ).

 

Fighting with health plans

 

The disparities have become so drastic that BiDil producer NitroMed is threatening to take legal action unless insurers start allowing the drug to be covered. The biotech company sent letters to more than 12 health plans advising of its intentions after efforts to reduce consumer costs through wholesale discounts proved ineffective.

 

"We'd much rather have the plans as our customers and we don't want to be litigants," NitroMed spokesperson Jane Kramer told the WSJ. "But if it becomes necessary to fight for our intellectual property, we will."

 

Health plans argue that there is no evidence to suggest BiDil's superior effectiveness compared with generic brands and thus no reason for its high cost, which the Department of Veterans Affairs estimates to be between $1,382 and $2,675 per patient per year.

 

NitroMed CEO Jerry Karabelas maintains that BiDil's benefits surpass the generics. He cites a clinical trial that showed BiDil reduces mortality by 43 percent within a year of use for black heart-disease patients who had tried alternative treatments.

 

The Centers for Medicaid & Medicare Services (CMS) sides with the insurers.

 

CMS commissioned the American Heart Association and the American College of Cardiology to investigate the matter a few months ago. They concluded that use of generic brands was suitable to treat heart disease and did not breach patient rights. But it's not that simple.

 

Heart-disease patients have to take one generic pill and one and a half tablets of a different generic pill three times daily to obtain the same benefits as one BiDil pill.

 

This easily could be confusing, particularly for older people, the primary intended beneficiaries of CMS's controversial Medicare Part D. The policy stripped BiDil coverage from tens of thousands of blacks suffering from congestive heart failure, reports the WSJ.

 

"If that were white patients, nobody in America would tell them, 'Excuse me, I want you to go buy a drug for angina and another for hypertension, and I want you to go home and cut them, and I want you to take multiple pills a day on top of all the [other drugs] you got," National Minority Health Month Foundation Executive Director Gary Puckrein told the WSJ. If the healthcare system "were doing it to whites there would be an uproar."

 

Still, CMS senior officer Jeffrey Kelman says every Part D plan covers BiDil, generic alternatives, or both. If that's true, why the discrepancy in access?

 

The underlying problem is the historically stratified nature of the healthcare system along economic and racial/ethnic lines. Lower socioeconomic status compounds healthcare-access and quality-related problems for blacks, whose household income is nearly half that of whites—$36,076 and $62,300, respectively—according to the Census Bureau. In 2005, 21 percent of blacks ages 65 and older were uninsured, outnumbering the percentage of whites (0.7 percent) in that situation by 30 to 1.

 

Medicare Part D has done little to expand drug coverage for blacks. According to managed-care consultant Amundsen Group, about 70 percent of blacks ages 45 and older either have to pay high co-payments or do not have coverage for BiDil, reports the WSJ.

 

To learn more about the unique challenges facing communities of color, read DiversityInc®'s May issue on healthcare disparities.

 

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