June 2007 - Honoring Black Men With Good Science

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How timely is this? June is Men's Health Month and someone sends me an article about Thomas Farrington, Founder of Prostate Health Education Network (PHEN ) and his efforts to get FDA approval of Provenge-the first ever prostate cancer vaccine. It is understandable that Mr. Farrington would have great interest in seeing such a drug approved (as would we all), given the high incidence and mortality rate of prostate cancer experienced by Black men-where mortality is nearly two and half times higher for Black men than white men. The thought of a vaccine seems like a life-raft that would rescue Black men from a sea of treatment options for the disease-none of which are without their shortcomings.

According to the article*, in Farrington's testimony before the FDA advisory committee, he stated, "During its deliberations, we also ask that the committee strongly consider the urgent needs of a segment of the U.S. population that is suffering from prostate cancer at epidemic levels. If the entire U.S. population was enduring the same prostate cancer death rate as black American men, would there not be an all out urgency to quickly bring to market treatments that could help reduce suffering and extend life?"

My guess is yes, there would be increased urgency. But a more serious question looms large, "do we want Black men-or any men for that matter, to be administered a drug that fails to answer all of the FDA committee's concerns or questions?" I don't think so.

While the FDA advisory committee voted overwhelmingly to recommend that Provenge be approved, on May 8th, 2007, the FDA did not immediately approve Provenge and requested more data on its effectiveness. The scientific data presented on Provenge failed to convince the FDA that it reduced suffering and/or extended life. Safety was also an issue, as there appeared to be an increase in the number of strokes (5) experienced in the test group (those receiving Provenge) when compared to those receiving the placebo (0). I view the FDA's failure to grant approval as a need for a more critical review of the scientific and clinical data, not an attempt to drag their feet because the disease disproportionately affects African-American men. After all, white men also suffer from prostate cancer.

Recently, the FDA has been under heavy fire for not examining drugs more closely before they go to market. The most recent case in point is Avandia, an FDA-approved drug prescribed to treat type-2 diabetes. Avandia was most recently in the news because this widely prescribed drug was found in one study to actually increase users' risk for heart attack by 43%. The FDA has been accused of not monitoring drug performance in the marketplace once a drug has been approved and of being slow to issue warnings or recalls once a problem has been identified.

The FDA's decision to request additional data could possibly delay the availability of Provenge for years. As a result, Mr. Farrington has formed a patient advocacy group and is calling for prostate cancer patients and especially African-Americans to petition Congress to have the FDA approve Provenge immediately.

While I believe that efforts to get Provenge approved immediately are well intentioned, I hate to see the issue of race interjected into the approval process before all of the scientific data is in. I say "thank goodness" the FDA is being cautious with Provenge. Our African-American brothers, fathers, sons, and husbands, deserve to have the best scientific research and most thorough data analysis possible on any drug. In our eagerness to protect Black men from a known killer-prostate cancer, let's not let emotion or racial positioning take a back seat to good science and that wonderful dictum of Hippocrates, "As to diseases, make a habit of two things - to help, or at least to do no harm."

With you on your journey to wellness...
Dr. Mary S. Harris

* DID THE FOOD AND DRUG ADMINISTRATION (FDA) TURN ITS BACK ON BLACK MEN WITH NON-APPROVAL OF FIRST-EVER PROSTATE CANCER VACCINE?, May 30, 2007, BlackNews.com

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