← Autodidact Archive · Original Dissent · starr

race in medical trials

Thread ID: 18889 | Posts: 1 | Started: 2005-06-29

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starr [OP]

2005-06-29 01:51 | User Profile

this is all very confusing. I thought the only difference between the races was simply the color of our skin.:shocking: There must be some racism at work here.

[url="http://www.msnbc.msn.com/id/8283953/"]www.msnbc.msn.com/id/8283953/[/url] [QUOTE]

Just as scientists have found in recent years that certain medications may affect men and women differently, they're now discovering that the effects also can vary among racial groups — many of whom have long been excluded from drug studies. Last week, the Food and Drug Administration OK'd a controversial heart drug exclusively for blacks. The approval of the drug, BiDil, was based on data of more than 1,000 patients with congestive heart failure. Large drug trials aren’t unusual when it comes to heart disease, which affects millions of Americans, but this one was because all of the participants were black.

That’s a big change from business as usual in the pharmaceutical industry. Most drugs have only been tested in whites, and generally white men, at that. However, the FDA and the National Institutes of Health have recently stepped up their efforts to get drug manufacturers to include more minority and women participants in clinical trials.

This is important because trials involving white men only can’t take into account potential variations such as different metabolic rates and levels of enzymes in women and minorities that may impact how effective a drug will be and whether it might cause side effects. For example, East Asians, according to the National Pharmaceutical Council, a research group sponsored by drug companies, metabolize codeine differently than whites and need to be given higher doses for effective pain relief. BiDil, according to Nitromed, the drug's maker, seems to boost nitric oxide in blacks, many of whom may suffer worse heart failure than some whites, perhaps because of insufficient nitric oxide, a gas found in certain cells that line blood vessels.

Minority health care leaders say BiDil’s impressive trial results — participants had a 43 percent increase in survival compared to patients who took standard therapy but not BiDil — point to the need for more clinical trials that include significant numbers of minorities, or minorities only.

"The results of the [BiDil] trial provide the first step towards what must be a long-term commitment on the part of government, industry and organized medicine to … identify the … appropriate therapies for all conditions that compromise the health and well-being of America’s multi-ethnic population," says Gary Puckrein, executive director of the National Minority Health Month Foundation, based in Washington, D.C., a group whose mission is to improve the health status of racial and ethnic minorities.

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