Deeply flawed process produces a dangerous and life-threatening recommendation
WASHINGTON, May 21, 2012 /PRNewswire-USNewswire/ -- Men's Health Network (MHN) and the Veterans Health Council are strongly opposing the U.S. Preventive Services Task Force (USPSTF) final recommendation against the use of prostate-specific antigen (PSA) testing in the early detection of prostate cancer. The PSA test, used with a DRE (digital rectal exam), is the only method currently available for the early detection of prostate cancer.
"Early detection saves lives," said MHN VP Scott Williams, "and this recommendation essentially eliminates access for patients and their healthcare providers to the only test available for early detection of prostate cancer."
The final recommendation, relying on an inadequate and deeply flawed decision-making process, downgrades PSA testing to "D", recommending against the use of PSA testing in healthy men that "do not have symptoms that are highly suspicious for prostate cancer." This in the face of strong evidence that use of the PSA test saves lives.
A "D" grade is defined as "moderate or high certainty that the service has no net benefit, or that the harms outweigh the benefits". This means that the USPSTF believes men should only be tested for prostate cancer using the PSA after they display symptoms of possible prostate cancer, meaning the cancer has spread and the prospects for a cure are remote.
There are repercussions beyond an individual's decision to be screened. The USPSTF is empowered by the Affordable Care Act to determine which screenings Americans receive. A "D" rating means Medicare, Medicaid and/or private insurers could choose not to cover PSA test for tens of thousands of men nationwide.
USPSTF placed heavy emphasis on the PLCO (Prostate, Lung, Colorectal and Ovarian) study, whose prostate arm was critically flawed. Approximately 50% of the control (non-screened) group received PSA testing one or more times as part of their routine care, while 15% of the screening group were never screened. In addition, African-American men, a group at highest risk of developing prostate cancer, constituted only 4% of the study. The USPSTF also failed to consider past and present data available at CDC, NCI, NIH, VA, CMS, and other agencies
In stark contrast to PLCO, the European Randomized Study of Screening for Prostate Cancer (ERSPC) has followed 182,000 men for 11 years. The latest data from ERSPC, released while the USPSTF was still considering the PSA, indicates a reduction in prostate cancer specific mortality of 29% at 11 years follow-up, a significant life-saving benefit. ERSPC is a much larger study than PLCO and compliance has been greater from the beginning of the study.
Also not considered is a study which found that Vietnam veterans exposed to Agent Orange were more than 2-times as likely to develop prostate cancer and that when diagnosed the cancer was more aggressive.
"If allowed to stand, USPSTF clearly abrogates its responsibility for the health and well-being of America's Vietnam veterans," stated Thomas Berger, PhD, Executive Director, Veterans Health Council.
The complete Veteran's Health Council statement is found at:
The USPSTF decision-making process shoulders the blame for this decision:
- The decision is reached without consultation with other federal agencies, such as the National Cancer Institute, Veterans Administration, other NIH agencies, or the Centers for Disease Control and Prevention – each of which can provide information and research that are critical to an informed recommendation.
- Medical specialists (i.e. urologists, oncologists, etc.) are excluded from membership on the USPSTF, eliminating the experts who know most about an issue.
- Patient organizations, with their vast patient resources and experience, are excluded from the process, allowed only to provide comments to a draft decision.
MHN pointed out these and other flaws in the decision-making process in an April 23, 2012 letter to HHS Secretary Sebelius, found at:
For example, not consulted was CDC which has found that men with a family history are 2- to 3- times more likely to develop prostate cancer.
Also not consulted was NCI, whose recent modeling studies "suggest that between 45% - 70% of the mortality decline…can be attributed to that stage-shift induced by screening." (presentation at the 7th Annual African American Prostate Cancer Disparity Summit, September 2011)
"The recommendation against PSA testing puts men's lives in jeopardy as they will be discouraged from getting screened for prostate cancer. This especially affects African-American men, men exposed to Agent Orange, and men with a family history, all of whom are at greatest risk of developing prostate cancer and dying from the disease. In the U.S. alone, 30,000 men die from prostate cancer annually, a staggering number. Early detection is key and PSA testing is the best available tool, reducing prostate cancer mortality by 40% since its inception," commented Ana Fadich, MPH, CHES, Director of Programs and Health Promotion at MHN.
MHN recognizes that a better test for the early detection of prostate cancer is desperately needed, however, the PSA is the best screening tool available today. Until a new test is found, the USPSTF should withdraw its current recommendation and initiate a new study that actively engages all relevant stakeholders, including federal agencies, professional organizations that advise patients and treat prostate cancer, and patient representatives.
About Men's Health Network
MHN is a national non-profit organization whose mission is to reach men and their families where they live, work, play, and pray with health prevention messages and tools, screening programs, educational materials, advocacy opportunities and patient navigation. For more information, please visit www.menshealthnetwork.org.
About the Veterans Health Council
The Veterans Health Council works to insure that veterans get the proper diagnosis based on the impact of their particular military service. For more information, please visit www.veteranshealth.org.
SOURCE Men's Health Network