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HONORING BLACK MEN THROUGH GOOD JUDGMENTS



?Why Wait For A New Prostate Cancer Treatment In The Face Of An Epidemic??



By Thomas A. Farrington



Mary S. Harris, PhD, founder and president of Journey To Wellness, recently wrote the article*, ?Honoring Black Men With Good Science.? This was in response to my testimony before a Food and Drug Administration (FDA) advisory committee convened to consider the approval of Provenge, an immunotherapy vaccine treatment for prostate cancer. Had it been approved by the FDA, Provenge would have become the first such treatment for any type of cancer, signaling a new era in cancer treatments. FDA?s own advisory committee (experts selected by the FDA) recommended approval but the FDA did not follow this recommendation and chose not to grant immediate approval. Rarely does the FDA choose not to follow the recommendation of its advisory committees on drug approvals. Subsequent to the FDA?s decision I wrote an article* where I posed this question; ?Did the FDA turn its back on black men with non-approval of first ever prostate cancer vaccine??



Dr. Harris? article echo?s the FDA?s position of using ?good science? as the reason for their Provenge decision. However, this statement appears on FDA?s own approval process documentation; ?At the heart of all FDA's medical product evaluation decisions is a judgment about whether a new product's benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important.? Relative to Provenge, Dr. Harris is the only person that I have noted who seriously questions the drug?s safety. The advisory committee voted 17 to 0 that the drug was safe. For efficacy (drug effectiveness) the vote was a positive 13 to 4, and even the four negative voters agreed that there were no significant safety issues. In addition I have not seen anything written by any FDA official that denies Provenge safety. Provenge is a safe drug with minor side effects (little or no known risks) targeting terminally ill prostate cancer patients, many with no treatment options available to them.



I am a seven year prostate cancer survivor. I lost my father and both grandfathers to this ugly disease, and I view treatment options from a different perspective than Dr. Harris. Chemotherapy with all of its bad side effects is the only treatment available today for terminally ill prostate cancer patients. Even this was not an option for my father because of other health issues. This is true for many men, and other men simply choose to face death as opposed to undergoing chemotherapy treatments because of the severe side effects. There are millions of prostate cancer survivors that live in fear of their next PSA test which most of us take every six months. We know that the slightest increase could mean a cancer recurrence and another round of treatments with a further erosion of our quality of life. We hope and pray for treatments that can extend our lives without taking away our quality of life. Provenge demonstrated through clinical trials that it might be the answer to our prayers, and patients want this treatment available as one of their options now.



Dr. Harris, in a statement similar to one in the Wall Street Journal attributed to Dr. Howard Scher, one of the most outspoken Provenge critics on the FDA advisory committee, urges against letting ?emotion? take a back seat to good science. If the fears and hopes of prostate cancer patients are the emotions being referred to, then we are guilty of being emotional about living. But we do not apologize for these emotions. Prostate cancer patients were invited to present before the FDA advisory committee because of the human factors involved in the FDA judgments to approve or not. The committee understood these human factors when voting to recommend approval. The science purists would have the human factors totally eliminated. If the FDA?s charter was simply to consider only the scientific data without making judgments, then we could replace the entire FDA drug approval process with a cheap PC and save the taxpayers lots of money.



The FDA Provenge decision has mobilized the prostate cancer patient community unlike no other time in our history. Why? Because we believe the FDA ignored both good scientific data and the human factor in making its final judgment on a safe drug. This is the wrong judgment call for the wrong reasons, adversely impacting all prostate cancer patients, especially Black men who suffer a 150% higher mortality rate than other men. In a meeting with the FDA Commissioner, patient advocacy leaders and leading medical doctors let the Commisioner know that we clearly understood the FDA was not obligated to follow the advice of its advisory committee. However, we emphasized our belief that the final FDA decision was flawed and corrupted through an unprecedented public politicizing of the approval process by participants on the advisory committee who were out - voted. These parties also had appearances of conflicts of interests. Simply put, we question whether ?good science? is a camouflage for what really happened, and we are gravely concerned about being denied access to a safe treatment option because of a flawed approval process. In our opinion the FDA?s advisory committee, and not the FDA, properly weighed the scientific data and Provenge?s benefits against its risks and made the right judgment call.



I find it interesting that Dr. Harris, a black woman, has stepped into the heated Provenge debate siding with the FDA citing ?good science.? ?Scientific findings,? left unchecked through good judgments, were reasons used for dehumanizing blacks during an ugly part of this country?s history. Most all scientific data requires good judgments to both protect and to help. For drug approval we need always strongly consider the human factors as stated in the FDA?s own guidelines. To err on the side of science for Provenge means that 27,000 men a year will die without access to a safe drug as a treatment option. I asked the FDA to consider the urgent needs of African American men who are in the midst of a prostate cancer epidemic during its approval process, and to value our lives as it would value others in such a crisis. For the FDA not to make such a consideration would clearly seem to devalue our lives. Dr. Harris terms my request as ?racial positioning?, and with her being in lockstep with the FDA I have to wonder if this reflects the agency?s view as well. For the record, this is advocating on behalf of the most severely impacted of all prostate cancer patients. Also, strangely, Dr. Harris chose to ignore the good scientific data supporting Provenge?s safety as a basis of her support for the FDA decision.



In summarizing the case for immediate Provenge approval, the sense of the Hippocrates dictum used by Dr. Harris is most applicable; Provenge has a great potential to help ? or at least it will do no harm. Why wait?





*View this article on www.Provengenow.org

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Thomas A. Farrington is a seven - year prostate cancer survivor, the author of the books ?Battling The Killer Within? and ?Battling The Killer Within And Winning.? He is the founder and president of the Prostate Health Education Network, Inc.( www.prostatehealthed.org) which hosts the annual ?African American Prostate Cancer Disparity Summit? on Capitol Hill each September. You can email Mr. Farrington at Thomas@prostatehealthed.org



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