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Well, the verdict is in. On May 21, 2012, the U.S. Preventive Services Task Force (USPSTF) announced its final recommendation about PSA screening - IT SHOULD NOT BE OFFERED TO ASYMPTOMATIC MEN OF ANY AGE! There have been many responses... *New PSA Recommendations from U.S. Preventive Services Task Force are a Disservice to Men* Washington, DC, May 21, 2012– The Prostate Cancer Roundtable expressed deep disappointment today as the U.S. Preventive Services Task Force (USPSTF) issued its final recommendation statement against the use of prostate-specific antigen (PSA) testing in the detection of prostate cancer. “A 'D' grade from the USPSTF will discourage many healthcare providers from using PSA testing at all; will justify non-coverage of PSA testing by many payers; and will also discourage men and their doctors from even beginning conversations about individual risk or the need for the test,” explained Scott Williams, Vice President of Men’s Health Network. This decision has been taken despite authoritative research by Andrew Vickers, Hans Lilja, and others, published in the Journal of Clinical Oncology and elsewhere, that shows that even a single PSA test administered between the ages of 44 to 50 can project risk for the future diagnosis of prostate cancer.1-3 Research by the National Cancer Institute’s Cancer Modeling Network has also shown that as much as 70 percent of the drop in age-adjusted prostate cancer mortality since 1975 can be attributed to PSA screening.4 “The USPSTF continues to ignore the benefits of screening for men known to be at high risk, including African American men, men with a family history, veterans exposed to Agent Orange, and men with an above-average baseline PSA in their 40s” stated Thomas Farrington, President of the Prostate Health Education Network. Currently Medicare and Medicaid and most insurance companies continue to cover PSA tests. And in 37 U.S. states there are mandates in place that require insurance companies to pay for the test. However, the “D” grade will likely lead many health insurance companies to stop paying for the test, thus cutting off access to many men. “Men should still be encouraged to talk to their healthcare providers about whether PSA testing is right for them. PSA testing can help predict future diagnosis of prostate cancer and can also help men who have been diagnosed determine which treatment path, if any, might be right for them,” stated Prostate Conditions Educational Council President Wendy Poage. The above statement has been issued on behalf of and endorsed by the following Prostate Cancer Roundtable’s member organizations. Ed Randall’s Fans for the Cure Malecare Prostate Cancer Support Men’s Health Network National Alliance of State Prostate Cancer Coalitions Prostate Cancer Foundation Prostate Cancer International Prostate Conditions Education Council Prostate Health Education Network The Prostate Net Us TOO International Prostate Cancer Education and Support Network Women Against Prostate Cancer ZERO – The Project to End Prostate Cancer This response is from Tom Kirk, President and CEO of Us TOO International Prostate Cancer Education and Support Network and is supported by Us TOO Florence. I believe a “D” grade from the USPSTF will discourage men and their doctors from even beginning a conversation about individual risk of prostate cancer or whether PSA screening may be right for them. We know that certain categories of men are at increased risk of developing prostate cancer—including African American men, men with a family history, veterans exposed to Agent Orange and men with an above-average baseline PSA in their 40s—and the USPSTF does not address the benefits of PSA screening for me in these groups. It’s also important to remember that prostate cancer doesn’t just affect men—the disease can have a serious impact on their partners, families and even on society. Research from the National Cancer Institute has shown that as much as 70 percent of prostate cancer deaths since 1975 can be attributed to PSA screening. And research based on data from Sweden and Denmark, published in the Journal of Clinical Oncology and elsewhere, shows that even a single PSA test given between the ages of 44 to 50 can help predict the future diagnosis of prostate cancer. it is about education, informed decision making, and self-empowerment. While the PSA test is certainly not perfect, it is the best we’ve got at our disposal right now. Now more than ever, in this period of confusing messages as the media reports surface, we along with the other member organizations of the Prostate Cancer Roundtable encourage men to continue to have educated discussions with their healthcare providers about whether PSA testing is right for them. What can you do? Take action to educate yourself and speak up to educate others. Use your passion on this issue in a constructive manner to reach out to help others determine what step is best for them. I, like many, believe that every individual has a right to know if he has cancer and to make an informed decision about what is best for him. I also believe no one wants to be overtreated or undertreated. We are here to help others work through such decisions - that is what Us TOO is all about. As we say, "Someone to talk to, who understands…" And, there is more... A controversial new report that recommends against routine prostate screenings has sparked a wide debate among doctors, cancer survivors and patients. The U.S. Preventive Services Task Force issued its final report on Monday, recommending against prostate-specific antigen (PSA) screening for prostate cancer for men of any age. The reason? Very few men actually need treatment to survive and the side effects from prostate cancer treatment do more harm than good, the task force said. From the report: Prostate cancer is the most commonly diagnosed non-skin cancer in men in the United States, with a lifetime risk for diagnosis currently estimated at 15.9%. Most cases of prostate cancer have a good prognosis even without treatment, but some cases are aggressive; the lifetime risk for dying of prostate cancer is 2.8%. Prostate cancer is rare before age 50 years, and very few men die of prostate cancer before age 60 years. Seventy percent of deaths due to prostate cancer occur after age 75 years. It goes on to say: There is adequate evidence that the benefit of PSA screening and early treatment ranges from 0 to 1 prostate cancer deaths avoided per 1000 men screened. "Many men are harmed by prostate cancer screening," Michael LeFevre, co-chairman of the task force and professor at the University of Missouri School of Medicine, said. "Very few will benefit." Dr. Virginia Moyer, another member of the task force, told CNN that just one out of every 1,000 men screened for prostate cancer needs the exam, with side effects such as incontinence, impotence, stroke and death related to "overdiagnosis" of prostate cancer treatment far outweighing the benefits. "Your primary care physician shouldn't routinely offer the exam," Moyer said. Prostate cancer is the second deadliest cancer among men, according to the American Cancer Society. However, CNN noted, 91 percent of all men with prostate cancer will live for 15 years beyond the diagnosis, which is considered a high rate of survival. The American Urological Association immediately fired back. "We at the AUA still recommend the PSA, with its imperfections," Dr. Chris Amling told the network. "It's the wrong thing to deny a man if he wants to have this test. There is no other screening test for prostate cancer. It's clear that the only way to cure prostate is to detect it early." And many prostate cancer survivors disputed the task force recommendation to skip the PSA exam. "With my family history, the PSA was essential in monitoring my cancer," Bruce Stambaugh, who says his father died of prostate cancer and he and his brother were treated for it, wrote on the Houston Chronicle's blog. "Without the regular PSA tests ... I could only guess if I had cancer or not." Below are some of the October 2011 comments on the U.S. Preventive Services Task Force "draft" recommendation that men no longer be screened for prostate cancer. You will find two locally published Viewpoints on the subject, first by Dr. Thomas Kollmorgen, Urologist at Oregon Urology Institute in Springfield, Oregon and second, by Bob Horney, Facilitator of the Us TOO Florence Prostate Cancer Education/Support group in Florence, Oregon. Both men are strongly recommending, after reading their Viewpoints, that you take the time to send your comments to the USPSTF at the link provided and argue that this recommendation should be withdrawn and never adopted. Please feel free to use any of the information in the Viewpoints to support your argument. Following the Guest Viewpoints are some critical remarks that Bob Horney has sent to the USPSTF and, separately, to its Chair, Dr. Virginia Moyer. GUEST VIEWPOINT: PANEL IS WRONG: PROSTATE CANCER SCREENING SAVES LIVES By Thomas Kollmorgen Published: (Wednesday, Oct 19, 2011, Register-Guard, Eugene, Oregon) The U.S. Preventive Services Task Force (USPSTF) recently recommended that healthy men no longer receive prostate-specific antigen (PSA) blood tests as part of routine cancer screening. This decision is being made by a panel that does not include a urologist or medical oncologist and is the same task force that suggested mammograms were unnecessary for women ages 40 to 49 and recommended against teaching women to do breast self exams. I am a physician member of the Oregon Urology Institute, a local urological practice representing 15 physicians and more than 10,000 patients, and as a group we strongly disagree with the task force's latest findings. The scientific literature regarding screening is controversial and contradictory, with serious methodological flaws in even the largest studies. No new research has been cited that would call for this drastic change in prostate cancer testing recommendations since the USPSTF considered this issue in 2009. In fact, the most recently published study, the Göteborg Randomized Population-based Prostate Cancer Screening Trial (The Lancet Oncology, July 2010), found that with screening, deaths from prostate cancer dropped 44 percent over a 14-year period, compared with men who did not undergo screening. Since 1994, even with screening, the incidence of prostate cancer has remained fairly stable, while simultaneously, the death rates from prostate cancer have declined by nearly 40 percent. Studies show we are now diagnosing prostate cancer at an earlier, lower stage. We are not detecting more cancers; rather, we are catching prostate cancers earlier, saving lives. Still, prostate cancer remains the second leading cause of cancer death in the United States, with the National Cancer Institute reporting that 33,720 men will die from this disease this year, more than one every 30 minutes. Particularly troubling is that the USPSTF extrapolates risks of treatment onto screening. But screening is not treatment, in fact, it is not even diagnosis; it is simply screening. There are essentially no risks to screening, and to deny patients the opportunity to participate in decisions regarding their own health care because of concerns regarding treatment they may never get is a scientific bait-and-switch of the worst order. This recommendation needlessly puts into harm's way the men who are most at risk: the underinsured, those who live in rural areas where health care is not readily available, those who have a family history of prostate cancer, and particularly African-American men (who have the highest incidence of and death rates from prostate cancer). Definitely, a subset of patients exists for whom prostate cancer is an indolent disease; the problem is that we cannot currently differentiate these men reliably from the tens of thousands for whom prostate cancer could be fatal. Responsible practitioners are working toward solutions, developing advanced testing and creating guidelines based on the best available literature to assist with making reasoned, informed decisions. Successful prostate cancer treatment depends on early detection, and studies demonstrate the screening efficiency for prostate cancer is similar to that for breast cancer. The USPSTF suggests that asymptomatic men not be screened, but every urologist knows this is a tragic error, as by the time prostate cancer has symptoms it is generally too late to cure. Adoption of these recommendations will undo more than two decades of progress, and result in the needless deaths of thousands of men. Join me and contact your local and federal elected representatives to demand that these recommendations not be adopted. Comment at http://www.uspreventiveservicestaskforce.org/contact-uspstf/ or e-mail the task force chairwoman, Dr. Virginia Moyer, directly at moyer@bcm.edu. Treatment decisions should be determined between a man and his own doctor. The government should not be able to deny a patient's ability and right to choose his own health care destiny. Dr. Thomas Kollmorgen is a partner of the Oregon Urology Institute, a 15-physician medical group with offices in Springfield, Florence and Roseburg. GUEST VIEWPOINT: UsTOO TAKES STAND FOR PSA TESTING! By Bob Horney, Us TOO Florence Prostate Cancer Education/Support Group Published: October 22nd, 2011, Siuslaw News, Page 4 At the Oct. 11 Us TOO Florence Prostate Cancer Education/Support group's meeting, attendees soundly rejected the U.S. Preventive Services Task Force (USPSTF) draft recommendation ending PSA screening for early detection of prostate cancer, which additionally includes eliminating the digital rectal exam (DRE) as well. Reading the report, there is little doubt that the USPSTF framed its recommendation by deliberately selecting and interpreting data from the two major randomized trials it reviewed, the European trial (ERSPC) and the National Cancer Institute (NCI) PLCO trial. The ERSPC trial showed 20 percent reduced mortality and 31 percent when comparing only the men who actually received the PSA test. Even more significant are the results of the Swedish Goteborg trial in which asymptomatic men between the ages of 50 and 64 were given PSA tests biannually and showed a 44 percent reduction in prostate cancer mortality after 14 years of clinical observation. Unlike the ERSPC and Goteborg trials, the PLCO reported no mortality benefit, and, according to NCI's own Cancer Bulletin for July 13, 2010, had a significant amount of "contamination." That's quite an admission! The level of "contamination" in the trial will likely preclude the trial from ever demonstrating a cancer-specific survival improvement, according to renowned urologists Dr. William Catalona and Dr. Patrick Walsh. Dr. Walsh also states, "Indeed, if the authors had set out to design a study to discredit PSA testing, it would have been difficult to do a better job." The USPSTF has shown its disregard for the clinical trial process by relying heavily on the flawed PLCO results to substantiate its prostate cancer screening recommendation. The ERSPC and Goteborg trials demonstrated a benefit of reduced mortality with PSA screening. The USPSTF took a look at PSA screening and determined that the "harms" of PSA screening outweighed the benefits. What "harms" are they talking about? 1) "Harms" related to screening: These include false-positive PSA tests causing psychological effects persistent worry; biopsies causing fever, infection, bleeding, transient urinary difficulty in some men (about 60 events per 10,000 biopsies), as well as pain. 2) "Harms" related to treatment: Death from surgery (up to 5 per 1,000) and 10-70 will have serious complications, but survive; surgery and radiotherapy result in adverse effects including urinary incontinence and erectile dysfunction in at least 200 to 300 of 1,000 men treated; radiotherapy is also associated with bowel dysfunction; androgen deprivation therapy is associated with erectile dysfunction (in about 400 in 1,000 men treated), as well as breast enlargement and hot flashes. There is no acknowledgement that early detection may save lives in the USPSTF recommendation despite the fact that prostate cancer deaths have declined over 40 percent during the last decade. The report states, "The common perception that PSA-based early detection of prostate cancer prolongs lives is not supported by the scientific evidence." It goes on, "The possibility is very small that death from prostate cancer is less likely in men whose prostate cancer is detected by PSA screening rather than waiting for clinical detection." Unfortunately, Us TOO Florence has observed that men who wait for clinical detection of prostate cancer have usually passed the "window of curability." The USPSTF is now receiving public comments on its recommendation (until Nov. 8). Us TOO Florence members are sending theirs and encourage the public to get involved, too. NOTE: The USPSTF sat on this recommendation for two years to let the furor over its mammogram recommendation die down, according to Dr. Michael LeFevre, co-vice chairman of the task force. The women fought back and won. Now, it is time for men to do the same. To email a comment (women, too), go online to: www.uspreventiveservicestaskforce.org/draftrec3.htm. To send a letter, address it to: Dr. Robert Cosby, c/o USPSTF, 540 Gaither Road, Rockville, MD 20850. COMMENTS TO THE USPSTF REGARDING ITS PSA-BASED EARLY DETECTION draft RECOMMENDATION USPSTF QUESTION: How could the USPSTF make this draft Recommendation Statement clearer? Oh, it's clear, alright - deadly clear. It is also misleading, deceitful and just plain wrong. It is wrong because you didn't really give honest consideration to "all" the evidence that is available. This evidence includes the more than 2 million men surviving prostate cancer - MOST of whom probably were not needlessly over-diagnosed and over-treated; the reduced mortality shown in the ERSPC and Goteborg trials; and the 40% reduced mortality during the last decade. You say, "The common perception that PSA-based early detection of prostate cancer prolongs lives is not supported by the scientific evidence." What you mean is it is not supported by the specific (PLCO) evidence you chose to use. Your strategy seems perfectly clear - you knew what conclusion you wanted to reach and found the worthless PLCO trial to support it. There appears to be no other reason you would base your conclusions on that trial to the exclusion of two credible ones. By the way, it isn't simply a common "perception" that PSA-based early detection of prostate cancer prolongs lives. That marginalizes the lives of the more than 2 million men mentioned above. Actually, there is one thing that would make the draft Recommendation Statement clearer. That would be abstaining from the use of "absolute risk." That term is Greek to the general population. I guess you expect us to be impressed with the miniscule numbers like 0.03 and 0.06 (absolute risk) and figure they represent insignificant occurrences. Why didn't you use numbers that have meaning for the average person? USPSTF QUESTION: What information, if any, did you expect to find in this draft Recommendation Statement that was not included? For starters, some word about the positive results of the ERSPC and Goteborg trials. I also would have expected some comments as to why the PLCO trial results COULD NOT BE USED. You sadly minimized the two credible trials to the point of obscurity and aggrandized the one trial that has no credibility. There are clear signs; too, that urology has greatly improved in all aspects of prostate cancer diagnosis and treatment. Those of us in support groups see it on a continuing basis. In just the last couple years, we are seeing more active surveillance happening along with more precise treatment techniques resulting in more rapid recovery with fewer side effects. Vastly improved over what you are reporting - no comparison. I would also have expected more attention paid to survival. All of your attention was paid to harms, harms, harms, ad nausea. To most of us, benefits (as in survival) outweigh anything you call harms. You call it over-treatment and harmed for no reason, but you can only "estimate" how many men that might be. You can't prove it in each specific diagnosis nor can anyone else. You would have us wait for clinical detection in which case we are usually giving up our very lives...(to avoid being harmed). After watching men slowly die from prostate cancer, that is not an escape from being harmed. These men suffer greatly all the way to the ultimate harm...death. I expected you to be more understanding of the reasonableness of men pursuing PSA screening since the evidence shows clinical detection commonly leads to death. Evidence also shows that early detection leads to lives saved with a minimum of over-diagnosis and over-treatment. If I have a choice between early detection with a chance to be cured (with possible side effects) or waiting around until I am symptomatic before getting checked and dying (with absolute side effects - one being very long termed), I'll take my chances with early detection. USPSTF QUESTION: Based on the evidence presented in this draft Recommendation Statement, do you believe that the USPSTF came to the right conclusions? Please provide additional evidence or viewpoints that you think should have been considered. Let me put it this way: From the "evidence presented," aka PLCO, there was only one conclusion you could reach - no benefit. What happened to the 40% reduced mortality in the last decade, the ERSPC reduced mortality, and the Goteborg reduced mortality? Oh, yes, you had excuses for those unseemly results. You didn't look objectively at all the evidence and let that guide the recommendation. You, instead, let your recommendation (which I suspect was predetermined) define the evidence you selected. The PLCO trial was so contaminated you lost all credibility by clinging to its results for your recommendation. In addition, you give the urologists no credit for all the progress they have made over the years in utilizing the PSA test. Of course, with no one from urology on the task force, how could you be expected to know that. There is only one trial that in any way supports your conclusion and even the National Cancer Institute reluctantly admitted that it had contamination issues. We don't have to be statisticians to recognize that using such a contaminated trial as a basis for a recommendation will simply result in an invalid and worthless recommendation. What comes to mind is garbage in - garbage out. USPSTF QUESTION: What resources or tools could the USPSTF provide that would make this Recommendation Statement more useful to you in its final form? There are no resources or tools available to make this recommendation statement more useful to me in its final form. It simply needs to be DUMPED. The must useful thing you could do is WITHDRAW THE RECOMMENDATION. USPSTF QUESTION: The USPSTF is committed to understanding the needs and perspectives of the public it serves. Please share any experiences that you think could further inform the USPSTF on this draft Recommendation Statement. Stop trying to scare all of us that if we are diagnosed with PSA-detected prostate cancer, about 90% of us will be treated which will subject us to significant harms AND will not have our death prevented or lives extended from that treatment. I have been leading an Us TOO group for nearly 10 years and those are two simply ridiculous conclusions. First, that we will be subjected to significant harms. Have you people REALLY checked in on urology in the last 10 years to see the progress made in treating prostate cancer? Second, that we will not have our death prevented or lives extended from the treatment. What? You are coming to conclusions based on contaminated information up to 15 years old and then making your recommendation based on that information. And, worst of all, you expect everyone to believe it. We are currently being screened with a minimum of over-diagnosis and moving forward, in consultation with our urologists, with a minimum of over-treatment ending up with a maximum cure rate with a minimum amount of side effects. That is the true state of urology and prostate cancer today. Here's another thought - when we can be guaranteed that our prostate cancer is one of the indolent variety, you will see fewer of what you call over-treatments. But, until then, quit playing god with our lives. I have known too many men who heard their urologist say, "I'm sorry, but..." When we are dealing with life (early detection) and death (clinical detection), don’t even think of taking that screening decision away from us. USPSTF QUESTION: Do you have other comments on this draft Recommendation Statement? Yes, DUMP IT! It doesn't go unnoticed that your recommendation sets up a veritable roadblock at the primary care physician level, preventing many men from getting to a urologist in a timely life-saving manner. The last I knew, it was the urologists who are the specialists when it comes to prostate cancer. You are using the back door approach to tell the urologists how to do their job. I have had too many young men in my group who were diagnosed by clinical detection because their primary care doctors wouldn't give them a PSA test in their early 40s - you aren't 50 yet, don't worry about it. Or, as 60 year old men having only the DRE with the assurance - you're ok. Not so! Of course, you and I know that no one on the task force has to tell men that their cancer was detected too late to cure. You refer them to a urologist who gets to take over from your lack of screening. You all can simply see your next patient and possibly never see that "condemned" man again in your practice. I'm sure you are familiar with Dr. Otis Brawley's testimony before the House Committee on Oversight and Government Reform, March 4, 2010. Although his comments were in reference to uninsured cancer patients, your recommendation will put all asymptomatic men in the same situation. He told the committee, "Far too many cancer patients are being diagnosed too late, when treatment is more difficult, more expensive, and less likely to save lives." I concur with his statement and firmly believe there is no difference between being insured, under-insured or uninsured when men are systematically denied PSA-based early detection prostate cancer screening and told to wait for clinical detection. I'm sure when the death rate rises because men aren't being screened, you will have no accountability for your action because you were just interpreting the data - the specific data you chose to build your conclusions and support recommendation. You are good at over-emphasizing the "harms" at the expense of the "benefits." Well, by following your recommendation, the "harms" will be replaced by "deaths." We'll just be harmed for a shorter period of time. (I think that is in your Recommendation Statement). Death isn't harm - its just...a death. The vast majority of men treated after PSA-based early detection, have made the conscious decision to risk the "possibility" of side effects for the "probability" of life - not dying from prostate cancer. Surprised? Your task force seems to think we would choose waiting for clinical detection and death over suffering any incontinence or impotence, but you haven't spoken with us. Besides, both of those "harms" (as you call them) are generally treatable, which is very unlike death. Simply because the PSA test doesn't immediately tell us what it was never expected to tell us - that the cancer is indolent or aggressive - you are ready to throw all early detection out. Have you thought back to the days before PSA testing when all we had was the DRE and the mortality from prostate cancer was sky high? Does your task force understand that treatment for clinically detected prostate cancer is about as bad as it can get. I have men in my group who prefer to die from the cancer rather than suffer from the treatment that is simply meant to keep them alive as long as possible because nothing can cure them. And, you are making a recommendation that risks the certainty of putting even more men in that situation in order to prevent your so-called harms from over-diagnosis and over-treatment. That your recommendation will be the deciding factor whether more men survive or die from prostate cancer is unthinkable! For you to think that your evidence supports that conclusion is absolutely incomprehensible. To: Dr. Virginia Moyer, Chair, U.S. Preventive Services Task Force From: Bob Horney, Facilitator, Us TOO Florence Re: USPSTF PSA-based early detection draft Recommendation Statement Date: November 6, 2011 There is no way to put a positive spin on my following remarks about the USPSTF PSA-based early detection draft recommendation. The conclusions your task force reached defy logic! They do not even come close to stating the reality of PSA testing when we look at the results of credible trials and the state of urology today. Including the PLCO trial as "fair-quality" means any results based even in part on that trial is worthless. You list two instances of contamination with the trial, but that is hardly the "whole story." It is impossible to make any claim from that trial when the difference between the screened group that was supposed to receive PSA tests and the control group that shouldn't have received, but was permitted PSA tests as part of their "usual care," is only 33% (52% in the control group and 85% in the screened group). Yes, the design of the trial was flawed from the start when there was no PSA restraint on the control group. Nor was there any requirement that men with abnormal screening results get a biopsy and only about 30%-40% of men did, raising the question of how many men actually had undetected prostate cancer. The trial included men up to 74 years of age who are less likely to have a mortality benefit from screening (a point the USPSTF did acknowledge). Then, 44% of the men who entered the trial already had one or more PSA tests, thereby eliminating many men with high-risk prostate cancer from the study population and reducing the power to detect a mortality difference. (Prescreened men did have a 25% lower prostate cancer mortality rate, leading one to wonder how many prescreened men were peeled off the possible participants because they were already being treated for prostate cancer by a urologist). Dr. Patrick Walsh says this about the PLCO trial, "Indeed, if the authors had set out to design a study to discredit PSA testing it would have been difficult to do a better job." "The PLCO trial never reached the critical threshold necessary for reporting results and there is much speculation that the trial was published at this time to dampen the enthusiasm generated by the European trial." Before going any further, I know statistics can be manipulated to "prove" a certain point. Your task force's overwhelming use of the PLCO seems to substantiate that. From my reading, I have come to the conclusion that the only people who think the PLCO is a valid trial are those who like the results. I wonder, too, when I read that the studies were investigated using "predefined criteria" if those criteria were "predefined" to slant the results toward the recommendation you wanted to declare. I'm sure, to the reading public, "predefined criteria" was supposed to look like an unbiased strength which the USPSTF used to review the trials. However, many, if not most of us, know that no matter when the criteria are determined, they can be manipulated to result in very biased findings. Another concern is that you are ready to toss PSA-based early detection "out" even while mentioning that it may take 10 to 15 years to fully understand the effect of PSA-based screening. If that is even being thought of as a possibility (which others, too, have mentioned), then what sense does it make to throw the progress made during the last 2 decades using the PSA out the window instead of staying with your previous recommendation and coming back in 5 years and see what has happened? Your discussion also mentioned the number needed to treat to save one life in the ERSPC, but we know from the Goteborg trial that with longer duration that number comes way down, which you didn't mention. Are you so intent on doing away with PSA testing that you don't have the patience to let this all play out? The terrible consequence of this game you are playing is that you are dealing with human lives! Just so you know a bit about who is talking here, I was diagnosed with prostate cancer in December 2001, had a radical prostatectomy with extracapsular extension in January 2002, returned for radiation therapy from December 2007 to Valentine's Day, 2008 and currently have an undetectable PSA. Only because my primary care physician didn't like my 4.1 PSA at age 63 and my urologist felt a minimally abnormal prostate was my prostate cancer discovered before the extracapsular extension became metastatic disease. Since May 2002, I have been facilitating an Us TOO Prostate Cancer Education/Support group in Florence, Oregon. My group has had the privilege of having a urologist attending our meetings since 2004, not just presenting information, but actually getting down in the trenches with my guys and answering their questions and concerns, dealing with their ups and downs. I've had an absolutely marvelous in-service these 7 years and have come to greatly appreciate the thought and reasoning that urologists put into dealing with the results of PSA testing. It is this knowledge gained seeing and hearing urologists interacting with the group, in addition to being a personal recipient of their care as a prostate cancer patient, which has caused me to do what I can to set the record straight. As a prostate cancer patient, I don't want a task force or anyone else handing down any recommendation that dictates guidelines that even indirectly (through primary care physicians) prevents urologists from providing the most effective health care they can. I might add that especially goes for your task force which didn't have any urologist on it. As far as I am concerned, your task force failed to honestly present the results of the trials it reviewed and certainly did nothing to present the state of PSA testing as it exists today. I compiled a list of the "conclusions" your task force made on its way to the draft recommendation, and they show a definite disconnect with reality (and facts). Your conclusions are so biased and directed toward "harms," that your task force can't even acknowledge the "fact" that many men are given new, prostate cancer free lives, due to PSA testing. I know that is a particular strategy (stay on target, "harms," and you followed it well), even though I think it was a completely dishonest representation of the facts. You and your task force know very well that your recommendation, if adopted, will condemn many men to an early, untimely and needless death. These are men who would have been saved through PSA-based early detection. You will be throwing out two decades of progress in the detection and treatment of the second leading cause of cancer death in the U.S. All in the name of preventing supposed "harms" from PSA-based early detection. What a trade-off! My comments are intended to be harsh, because I operate at ground zero where men live or die depending on when their prostate cancer is diagnosed. I've lost over 15 men to prostate cancer in the last 9 years because of "clinical" detection. I have too many young men in their 40s dealing with metastatic disease, because they, too, had "clinical" detection of their disease. (Talk about suffering "harms!") These men ran afoul of primary care physicians holding the line on the previous recommendation that men not be offered prostate screening until age 50. Now, you are taking the age lid completely off. I’m sure you are sticking with the "scientific evidence" and don't care about personal experiences like the men mentioned here, but you are going to cause pain, suffering and death for real men. Like it or not, these men have families who lose fathers, sons, uncles, grandfathers, brothers and more. This is what I see while you are buried in statistics. If you were just making a general recommendation, that would be one thing. Unfortunately, your recommendation translates into guidelines for primary care physicians, family physicians, internists and other first level doctors who will do their best to "hold the line." Those are some of the very doctors who caused deaths in my group with the comment, "Oh, you aren’t 50 yet, don't worry about it." These are the very doctors who think they can save men from your task force's exaggerated "harms" of over-diagnoses and over-treatment by keeping them away from the urologists - even though it means men will die as a result. Now, you are urging them on with a recommendation based on supposed "scientific evidence." This is a deadly combination - the USPSTF recommendation and the primary care physicians who will march to it. Many more men will needlessly die as a result. Your recommendation will effectively remove the only curative doctors from the prostate cancer scene. Since no one will be referred to a urologist without symptoms, too often meaning metastatic disease, the urologist's job will simply be to diagnose the prostate cancer and then pass the man on to the medical oncologist who will try to keep him alive as long as he can. Just over 2 years ago, the American Urological Association revised it's own recommendation from the widely accepted standard of offering the PSA test to men at age 50, to a more pro-active common sense recommendation of offering well-informed men a PSA/DRE at age 40 along with a comprehensive risk assessment. This would, in effect, catch the early cancers and individualize prostate cancer screening for all men, thereby reducing screening intervals for many men whose test results and risk assessment show them to be at low risk of developing prostate cancer. To those of us who have "walked the walk," this recommendation was an absolute "win-win." Yes, WE absolutely want to avoid the medical oncologists at all costs, because their treatments are loaded with far greater harms than any you declared in your statement and are rarely curative. Being diagnosed with prostate cancer, being treated by a urologist/radiation oncologist and not seeing a medical oncologist is about as good as it can get. That often spells c-u-r-e-d. There is so much more that could be said and is being said from the real experts in this controversy - the urologists. Dr. William Catalona, for instance, lists over 30 instances of failure on the part of your task force. Dr. Patrick Walsh also has much more to say that just the quote above. In a recent survey conducted by the U.S. News & World Report, 97% of the male urologists surveyed indicated they would be tested starting at age 50. Ninety-five percent felt that doctors should continue to advise men starting at age 50 to have PSA screenings as part of a routine physical exam. What do the urologists know that your task force didn't pick up by reading trial results? How about the fact that your "harms" were well over-stated; "clinical" detection is rarely curable; men receiving regular PSA screening are rarely diagnosed with metastatic disease; prostate cancer diagnosed using PSA screening usually results in early disease and a high cure rate. Those are just starters, but the important thing is, these are the facts urologists deal with every day. Fortunately, they are the ones diagnosing and treating us, not the USPSTF. Even 72% of the responding male internists indicated that they would also have the test starting at age 50. How come all these doctors still believe in PSA screening? They live in the real world of prostate cancer life and death...thank goodness! We are currently being screened with a minimum of over-diagnosis and moving forward, in consultation with our urologists, with a minimum of over-treatment ending up with a maximum cure rate with a minimum amount of side effects. That is the true state of urology and prostate cancer today. Fortunately, there many of us who have a clear understanding of what your recommendation will mean for the U.S. men and will do all we can to make sure this draft recommendation is never adopted. Respectfully, Bob Horney |
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