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HEALTH NEWS

FDA's Black-and-White BiDil Decision

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 26 June, 2005  17:39 GMT

bidil blacks FDA heart failure
The results of the BiDil trial were so striking, so good, that FDA approval was inevitable. Blocking access to a drug that helps some people live longer and better would have been immoral.
BiDil worries some, but its potential is promising. When a person is diagnosed with heart failure -- and 5 million Americans have been -- it means the heart is unable to beat forcefully enough to propel adequate amounts of blood through the body. That can cause congestion and swelling, and, ultimately, a backup of fluid into the lungs or other organs.

There is weakness. There is shortness of breath. There is fatigue. There is no cure. Within five years of a diagnosis, more than half will get worse and die. So when a pill -- added to dietary improvements, exercise, lifestyle changes and other medications -- decreases the death rate of some heart-failure patients by 43 percent and reduces their chances of needing to check into a hospital by 33 percent, such promise cannot be ignored. Thus it is with blacks and a pill called BiDil.

Last summer, researchers conducting a study of 1,050 black heart-failure patients noticed such remarkable progress that they stopped their clinical trial months early, so as not to deny the life-saver to those unwittingly taking a placebo.

To have withheld the drug would have been unethical, much like the government's 40-year Tuskegee syphilis study that left black men untreated and unaware of the available cure while researchers watched the disease paralyze and blind them.

Pervasive Racial and Ethnic Disparities in Health Care

It is in the shadow of that experiment (which ended in 1972) and the government's decision to alter a report to downplay this country's pervasive racial and ethnic disparities in health care (which happened just last year) that BiDil is both criticized and praised as the first "race-based" drug.

Critics fear that the stereotype that can result from a drug being marketed to people who say they're "black," as those in the study identified themselves, could give credence to ulterior motives for linking race to biology.

America struggles enough with a legacy of legitimizing mistreatment based on faulty race-based claims of inferiority that have nothing to do with genetics. Some using medicines also are distrustful: If a drug is tailor-made to fit a specific "race," couldn't it be tailor-made to harm a specific race?

In fact, BiDil did not start out as "a drug for blacks." Neither does BiDil give blacks a license to overindulge in high-salt diets, fried and fatty foods, smoking or other behaviors -- even those born out of poverty -- that, if avoided, could help prevent heart disease in the first place.

More study is needed to determine how well BiDil will affect people of other ethnicities, but researchers believe that countless others could benefit. After being rejected by the Food and Drug Administration in the 1990s, the makers of BiDil expanded studies among veterans, reviewed the data and found that blacks responded better than whites. The Association of Black Cardiologists joined in the largest and most recent study, known as A-HeFT, the African American Heart Failure Trial.

'Precedent-Setting' Case

Cardiologists have known for some time that most of the 725,000 African-Americans who have been diagnosed with heart failure can blame hypertension, as opposed to repeated heart attacks, which is often the cause for whites. And blacks and whites respond differently to some conventional medicines; ACE inhibitors, for example, have been shown to be less effective for blacks than whites.

But there has been limited study on African-American and women heart patients. Why do African-Americans suffer from heart failure at a rate nearly twice that of whites? Why are African-Americans more likely to die from it at a younger age? Support for A- HeFT -- by the government and patients -- gives hope that more research will be done in populations that historically have been underserved.

The American Heart Association ranked BiDil second among last year's top 10 major gains in heart disease and stroke research. The president of the International Society of Hypertension in Blacks called it "the most important advance in the treatment of black people" that he has seen in his lifetime. An FDA advisory panel last week unanimously recommended approval in what the chairman called a "precedent-setting" case.

The results of the BiDil trial were so striking, so good, that an FDA approval should be inevitable. Blocking access to a drug that helps some people live longer and better -- in 2005, as in 1972 -- would be immoral.

Elisa Cramer is an editorial writer for The Palm Beach Post. Her e-mail address is elisa_cramer@pbpost.com




Related Articles
FDA Advisers Give Nod to Race-Specific Heart Drug (17 Jun 2005)
FDA Okays BiDil to Treat Heart Failure in Blacks (24 Jun 2005)
FDA to Review Heart Drug for Blacks Only (13 Jun 2005)
BiDil Could Become First Drug Approved for One Race (17 Jun 2005)
Bottom Line in BiDil Debate: It Saves Lives (19 Jun 2005)
BiDil Is Not a 'Black' Drug, Say Advocates (15 Jun 2005)
 
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