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Did the Food and Drug Administration (FDA) Turn Its Back on Black Men with Non-Approval of First-Ever Prostate Cancer Vaccine?-Prostate Cancer Patients to Petition on June 4th, 2007, 10:00 a.m., at Upper Senate Park, in Washington, DC
PR Newswire
05-30-07
BOSTON, May 30, 2007 /PRNewswire via COMTEX/ -- Black men in the United States die from prostate cancer at a rate 140% higher than men of any other racial or ethnic group. This is the largest racial disparity for any type of cancer. On March 29th, 2007 US Congressman Gregory Meeks (D-NY) introduced legislation in the U.S. House of Representatives to designate prostate cancer as an epidemic among African American men; 100 members of the House signed as cosponsors to this legislation. On this same date Thomas Farrington, founder and president of the Prostate Health Education Network (PHEN), a nonprofit established to increase prostate health education and awareness among black men and others who are at high risk for prostate cancer, presented before an FDA advisory committee that was considering the approval of the first-ever prostate cancer vaccine, Provenge.
Provenge had completed phase III clinical trials and demonstrated that it was safe and prolonged life. This treatment was to initially target men who were late-stage terminally ill prostate cancer patients, whose only option between life and death is chemotherapy. The beauty of Provenge is that it had shown to be as effective as chemotherapy treatments without any of its side effects.
During 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? This critical condition in black communities today is real, and we are due the same valuation on our lives and urgency of action. We ask that the committee both understand and accept that another important reason for approval of Provenge immediately is because it is needed to help fight the ravages of an epidemic level condition in a segment of our nation's population ...."
The FDA advisory committee voted overwhelmingly to recommend that Provenge be approved (17 - 0 that it was safe and 13 - 4 that it demonstrated substantial efficacy). In an unprecedented and surprising decision on May 8th, 2007, the FDA did not immediately approve Provenge but requested more data on its effectiveness that could delay its availability for years. With this decision the FDA ignored the pleas of prostate cancer patients and patient advocacy organizations, including Farrington's own organization PHEN. The consensus of opinion is that the FDA caved to special interests at the expense of prostate cancer patients.
As a result of this ruling, Farrington has helped form a patient advocate initiative called ProvengeNow (ProvengeNow.org - Home) to petition Congress to have the FDA immediately approve Provenge. "The FDA's decision is inhumane for all prostate cancer patients and especially for African Americans, and we cannot accept it," says Farrington.
ProvengeNow has organized an assembly on June 4th, 2007 in Washington, DC as a part of its petition to Congress. Prostate cancer patients, family members and friends are asked to join the assembly at 10:00 am, located at Upper Senate Park (adjacent to the Russell Senate Office Building). The assembly is being coordinate by Jan Manarite of "Raise A Voice," member of the ProvengeNow coalition. For more information email [email protected] or visit ProvengeNow.org - Home.
PR Newswire
05-30-07
BOSTON, May 30, 2007 /PRNewswire via COMTEX/ -- Black men in the United States die from prostate cancer at a rate 140% higher than men of any other racial or ethnic group. This is the largest racial disparity for any type of cancer. On March 29th, 2007 US Congressman Gregory Meeks (D-NY) introduced legislation in the U.S. House of Representatives to designate prostate cancer as an epidemic among African American men; 100 members of the House signed as cosponsors to this legislation. On this same date Thomas Farrington, founder and president of the Prostate Health Education Network (PHEN), a nonprofit established to increase prostate health education and awareness among black men and others who are at high risk for prostate cancer, presented before an FDA advisory committee that was considering the approval of the first-ever prostate cancer vaccine, Provenge.
Provenge had completed phase III clinical trials and demonstrated that it was safe and prolonged life. This treatment was to initially target men who were late-stage terminally ill prostate cancer patients, whose only option between life and death is chemotherapy. The beauty of Provenge is that it had shown to be as effective as chemotherapy treatments without any of its side effects.
During 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? This critical condition in black communities today is real, and we are due the same valuation on our lives and urgency of action. We ask that the committee both understand and accept that another important reason for approval of Provenge immediately is because it is needed to help fight the ravages of an epidemic level condition in a segment of our nation's population ...."
The FDA advisory committee voted overwhelmingly to recommend that Provenge be approved (17 - 0 that it was safe and 13 - 4 that it demonstrated substantial efficacy). In an unprecedented and surprising decision on May 8th, 2007, the FDA did not immediately approve Provenge but requested more data on its effectiveness that could delay its availability for years. With this decision the FDA ignored the pleas of prostate cancer patients and patient advocacy organizations, including Farrington's own organization PHEN. The consensus of opinion is that the FDA caved to special interests at the expense of prostate cancer patients.
As a result of this ruling, Farrington has helped form a patient advocate initiative called ProvengeNow (ProvengeNow.org - Home) to petition Congress to have the FDA immediately approve Provenge. "The FDA's decision is inhumane for all prostate cancer patients and especially for African Americans, and we cannot accept it," says Farrington.
ProvengeNow has organized an assembly on June 4th, 2007 in Washington, DC as a part of its petition to Congress. Prostate cancer patients, family members and friends are asked to join the assembly at 10:00 am, located at Upper Senate Park (adjacent to the Russell Senate Office Building). The assembly is being coordinate by Jan Manarite of "Raise A Voice," member of the ProvengeNow coalition. For more information email [email protected] or visit ProvengeNow.org - Home.
