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Clinical Trials: Should I Trust Them?

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Dr. Ernest Levister, Jr.
Dear Dr. Levister: My brother signed me up for a clinical trial on lupus treatment. He is employed by a large pharmaceutical company. He says more African-Americans should become involved in medical research. Are clinical trials trustworthy? B.Y. 

Dear B.Y.: Fear and mistrust of the medical establishment are two reasons why many African-Americans historically have not participated in clinical trial research. And most Americans know of the notorious Tuskegee Syphilis Study in Macon County, Ala. in which almost 400 African-American men with syphilis were denied treatment for as long as 40 years so doctors could learn more about the disease.

Today the urgent need for knowledge to lower African-Americans death rates and prevent disease is bringing changes. Federal law now provides safeguards for patients and requires researchers to make sure those in studies are informed of possible risks and benefits of the trial, and want to be in it.  Government agencies giving money for research now requires researchers to show proof that they will involve enough women and minorities to make their findings certifiable.  It’s really critical for African-Americans to take part in clinical trials if we’re going to reduce health disparities. There are certain diseases or cultural implications that make it important for us to be involved in trials. Take something like hypertension, which disproportionately affects us. The same drugs that may be effective in one group may not be effective in another. We have differences, in terms of how we break down a drug, how long the drug stays in our system and things like that.

If you don’t have a representative number of African-Americans in a clinical trial, you actually don’t know how the results apply to African-Americans. Drug manufacturers are coming out with new drugs – better drugs with fewer side effects – and it’s important that those drugs be appropriately tested in a representative population.

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