P A A C T, I N C. PROSTATE CANCER COMMUNICATION PROSTATE CANCER COMMUNICATION NEWSLETTER вЂў VOLUME 20, NUMBER 2 вЂў June 2004 FOUNDER: LLOYD J. NEY, SR. вЂ“ FOUNDED 1984 President and Chairperson: Janet E. Ney A STRATEGY OF SUCCESS - IN THE TREATMENT OF PROSTATE CANCER By Stephen B. Strum, MD, FACP PART II Board of Directors: Edwin Kuberski Treasurer Newton Dilley Helen Mellema Peter Noor Jr. Richard H. Profit Jr. Anthony Staicer After counseling thousands of men and their families from all over the United States and abroad for over the last twenty years, a strategy associated with a successful campaign against cancer became apparent. What are the necessary ingredients of this successful strategy? There are six essential steps in this вЂњroadmapвЂќ to a successful outcome for the man with prostate cancer (PC): 1. LISTENING TO THE BIOLOGY OF CANCER. 2. VALIDATING CRITICAL DATA INPUTS. Honorary Board Members: 3. ESTABLISHING A BASELINE. Donald F. Mellema Russell Osbun Frank Perry 4. INTEGRATING ANALYSIS. Medical Advisory Board: 5. SYNTHESIZING ALL OF THE ABOVE DATA TO REPRESENT A вЂњREFINEDвЂќ ANALYSIS. Richard J. Ablin, Ph.D. V. Elayne Arterbery, M.D. Robert A. Badalament, M.D. Duke K. Bahn, M.D. Israel Barken, M.D. E. Roy Berger, M.D. Michael J. Dattoli, M.D. Fernand Labrie, M.D. Fred Lee Sr. M.D. Robert Leibowitz, M.D. Mark Moyad, M.P.H. Charles E. Myers Jr. M.D. Gary M. Onik, M.D. Haakon Ragde, M.D. Oliver Sartor, M.D. Stephen B. Strum, M.D., FACP Donald Trump, M.D. Steven J. Tucker, M.D. Ronald E. Wheeler, M.D. INFORMATION WITH COMBINED VARIABLE 6. PRESENTING STRATEGIES TO THE PATIENT WITHIN THE CONTEXT OF HIS SITUATION. In Part I of this three-part series published in the December 2003 issue of the PAACT Prostate Cancer Communication, I introduced the reader to many foundational concepts involved in PC and covered Step 1 of the 6 steps listed above. A concise review and embellishment of the contents of Part I will add to your understanding of Part II. Out of the crisis of having a life-threatening illness such as PC comes the opportunity to focus on the integrity of your biological systems. The term Integrity is an important one. This relates to knowing the truth about the status of a biological system as well as heightening our attention to the fact that every system integrates with other systems to allow for coordinated biologic actions. This is the ultimate goal of medicine: to realize the holistic nature of health and the unity of all biological systems at every level of life. This is the heart and soul of integrative medicine. LetвЂ™s Conquer Cancer in OUR Lifetime In our approach to the treatment of PC, the determination of the extent of the cancer (staging) is our greatest weakness. In the year 2004, the staging of PC equates with doing a bone scan and a CT scan of the pelvis and abdomen. These tests are too crude to appreciate small volumes of PC outside the prostate gland and therefore they grossly underestimate the extent of disease. Thus, many patients are led down the proverbial garden path to selections for local therapy that are not appropriate to their biological status. Too often, after the failure of one local therapy, the patient is again led to another local therapy. The realization is missing, or is being denied, that a local therapy cannot eradicate disease whose extent is greater than the scope of the surgeonвЂ™s scalpel, beyond the field of the radiation oncologistвЂ™s portals of treatment, or beyond the borders of an iceball created by the cryosurgeon. Therefore, we must use our healthcare dollars wisely to make advances in technology that lead to the development of more accurate staging tools. We have effective methods to eradicate PC, but the selection of a particular treatment is often not appropriate to the stage or extent of the disease. Step #2. Validating Critical Data Inputs The Gleason Score (GS) The process of validating key biological вЂњinputsвЂќ involved in the prognostic equation is important. The GS is one of the most important biologic clues relating to the aggressiveness of prostate cancer. An accurate reading of the GS is not to be taken for granted. Medicine has become more complicated, and the levels of skill of community pathologists and even academic pathologists vary significantly. Some pathologists are highly competent in evaluating a specific disease(s), while others are not. Observer disagreement occurs even among experts, although not usually to a major extent.37 Disagreement on GS between community pathologists and recognized experts in the field, however, is significant.37 Therefore, validating the Gleason score with an acknowledged expert in the field of PC is a critical portion of successful strategy.37-40 Certainly, we should optimize our evaluation of the biologic process by understanding the variable talents that exist everywhere and in every field. Obtaining a second opinion from an acknowledged expert in the field of PC pathology is a worthwhile investment. A listing of some of the USA- and European-based recognized experts in prostate cancer pathology is shown in the tables. Name of Pathologist or Lab Europe Helmut Bonkhoff Burkhard Helpap Nicolas Wernert Location or Telephone Center Name bers Num- Frankfurt, Ger- 069/951 447-90 many Singen, Ger- 07731/892100 many Bonn, Germany 0228/2875030 C A N C E R C O M M U N IC A T IO N P a tie n t A d v o c a t e s f o r A d v a n c e d C a n c e r T r e a t m e n ts 1 1 4 3 P a r m e le e N W G r a n d R a p id s , M I 4 9 5 0 4 D ir e c t o r вЂ¦ . R ic h a r d P r o f it E d it o r вЂ¦ R ic h a r d P r o f it & S t a f f W e b m a s t e r вЂ¦ A r t S c h le f s t e in P o stm a s te r: S e n d a d d re ss c h a n g es to : P r o s t a t e C a n c e r C o m m u n ic a t io n P .O . B o x 1 4 1 6 9 5 G r a n d R a p id s , M I 4 9 5 1 4 P h o n e : 6 1 6 /4 5 3 - 1 4 7 7 F a x : 6 1 6 /4 5 3 - 1 8 4 6 E - M a il: p a a c t @ p a a c t u s a . o r g P A A C T W e b P a g e : h t tp : //w w w .p a a c t u s a . o r g N e w s le t t e r : h t t p : //w w w . p a a c t u s a . o r g E d it o r : A r t ic le s a u t h o r e d b y o t h e r t h a n t h e e d it o r m a y n o t f u lly r e f le c t t h e v ie w s o f t h e c o r p o r a t io n b u t a r e p r in t e d w it h t h e u n d e r s t a n d in g t h a t t h e p a t ie n t h a s t h e r ig h t t o m a k e h is o w n in t e r p r e t a t io n o f t h e e f f ic a c y o f t h e in f o r m a t io n p r o v id e d . I n a n e f f o r t t o c o n s e r v e s p a c e a n d b e a b le t o in s e r t a s m u c h m a t e r ia l a s p o s s ib le in t h e n e w s le t t e r , r e f e r e n c e s f r o m v a r io u s a r t ic l e s a r e in t e n t io n a lly o m it t e d . I f y o u w o u ld lik e t o o b t a in t h o s e r e f e r e n c e s , p le a s e c o n t a c t P A A C T , w e k e e p a ll o f t h e o r ig in a l a r t ic l e s a n d th e r e f e r e n c e s u s e d o n f ile . INDEX Page 1. A Strategy of Success in the Treatment of Prostate Cancer (Stephen B. Strum, M.D., F.A.C.P.) 8. Early Hormonal Therapy Works Ridiculously Well (Robert Leibowitz, M.D. and Steven Tucker M.D.) 12. What The Heck Has Been Going On In My World вЂ“ Part IV? (Mark A. Moyad, M.P.H.) 17. Media Release 18. LAC-PAACT UPDATE (Gregory H. Teufel, Esq.) 20. Board Certification What Does It Mean? (Stephen Barret, M.D.) 21. Acknowledgements 23. Financial Summary Report 24. PAACT Dues Notification for 2004 Name of Pathologist or Lab USA David Bostwick Francisco J. Civantos Dianon Laboratories Jon Epstein David Grignon John McNeal Jon Oppenheimer UroCor Laboratories Location or Cen- Telephone ter Name Numbers Virginia U of Miami 800-214-6628 305-325-5587 Connecticut John Hopkins U U of Michigan Stanford U Tennessee 800-328-2666 (select 5) 410-955-2162 313-745-2520 650-725-5534 888-868-7522 Oklahoma 800-411-1839 A second opinion on the pathology is usually covered by insurance but if not, runs about $300-$500 depending on what is done. A copy of the original pathology report with the actual slides or recuts from the tissue block are sent to the outside reviewer. A copy of the insurance information is usually sent along with this. Your primary care doctor or specialist can initiate a 2nd opinion but you need to request this and ask for a specific physician or lab to be used. Additionally, other prognostic tests such as p53, p27, BCL2, Ki 67, and DNA (ploidy) analysis can also be done by some of the above pathologists and labs using the tissue blocks. There are extra charges for these services. Call the phone numbers shown in the tables for more information. Step #3: Establishing a Baseline A truer picture of the patientвЂ™s status evolves when we (1) listen to the biology of PC and employ the valuable tools of PSA and its dynamics, (2) understand the use of the clinical stage and its limitations, (3) obtain the prostate gland volume and use the appropriate calculations to determine cancer-related PSA, and (4) keep in mind that the Gleason score, one of the most important biologic expressions of prostate cancer, must be validated by an expert in PC pathology. The patientвЂ™s medical вЂњstoryвЂќ becomes clearer as more and more clues are revealed to help us solve his problem. This is M.D. (medical detective) work and it is the crux of outstanding medical care. This information is our baseline, or starting point. Years ago, the baseline would have been limited to the findings of DRE and a pathology report. Now it has evolved to incorporate biological manifestations that allow us to tell so much more, or as Paul Harvey used to say, вЂњand now for the rest of the story.вЂќ These baseline studies are valuable because they depict the biologic reality of the individual patient, and because they act as critical observation or comparison points to evaluate the patientвЂ™s course of illness. This applies to periods of observation as well as when active therapy is underway. We have to be able to objectify the results of our therapy. How can we know how much we have helped the patient if we have no basis for comparison? Core Percentage The number of biopsy cores that exhibit PC at the time of the diagnosis of this disease is an additional baseline input of significant importance. Dividing the number of cores that show prostate cancer by the total number of cores sampled gives us the core percentage. The core percentage relates to tumor density. It also provides a sense of tumor volume. A core percentage involvement of 50% or higher is an adverse prognostic finding that is reported in many publications.41-51 DNA or Ploidy Ploidy, in the context of PC, relates to the amount of DNA present in the PC cell population being studied. A normal ploidy status, or вЂњdiploidвЂќ state, occurs when the amount of DNA within the tumor cell is normal. This is equated with the tumor cell having the full complement of chromosomes e.g. 46, since the DNA or genetic material is found within genes that are arranged on each chromosome. Cells are either вЂњdiploidвЂќ or normal in their DNA amounts or abnormal i.e. вЂњaneuploid.вЂќ Diploid status is more commonly associated with tumors of a low to moderate Gleason score, whereas abnormal ploidy (aneuploid) status is more commonly associated with tumors of a higher Gleason score. The actual data involving the evaluation of 35,931 biopsies is shown in the accompanying table. As can be seen from this data, ploidy analysis would be especially helpful in patients with Gleason scores ranging between 6 and 8. Gleason Score vs Probability of Diploid vs Aneuploid *** Gleason Diploid Aneuploid Number of BiScore opsies Evaluated 2-5 85% 15% 564 6 62% 38% 15,999 7 33% 67% 12,768 8 22% 78% 4,433 9-10 13% 87% 2,167 Total 35,931 *** Table from PCRI Insights, Vol 4, No.1 Jan 2001, page 4, table 2. Data from UroCor, Inc. Although DNA analysis or ploidy is often criticized as not being a useful prognostic factor in prostate cancer, there are far more compelling studies that would suggest that the DNA status of the tumor cell population tells us much about the aggressiveness of the individual patientвЂ™s PC. 5280 Ploidy analysis can be done on the diagnostic biopsy or from PC tissue obtained at the time of RP. Normal DNA or diploidy is associated with a better prognosis and a better response to therapies involving androgen deprivation therapy. Abnormal DNA or aneuploidy is associated with PSA recurrence after RP in a large series from the Mayo Clinic. 66,67 These landmark papers substantiate the value of the ploidy analysis, although others dispute its significance. In this paper, Lerner et al clearly demonstrated the importance of ploidy as an independent prognostic factor. The 5-year relapse rates in patients undergoing RP and having "apparent" OCD were analyzed with respect to PSA, GS and ploidy status. A significantly higher rate of disease relapse was seen in patients with non-diploid (aneuploid) tumors. This is shown in the accompanying table. Risk Factors for Progression in Patients with Prostate Cancer Treated with Radical Prostatectomy with Apparent Pathologically Organ-Confined Disease (after Lerner, et al.) PSA Level Prior to RP Percent Progression Within 5 Years of RP Ploidy Status at RP PSA < 10 ng/ml > 10 ng/ml Gleason Score Diploid at RP Aneuploid 5 8% 15% 6 15% 30% 7 30% 42% 8-10 42% 61% 5 15% 30% 6 30% 61% 7 42% 61% 8-10 61% 61% Using the PSA prior to RP, the Gleason score at the time of RP and the ploidy status of the RP specimen, the risk of any kind of disease progression (biochemical or clinical) was significantly correlated with ploidy status. Recent DNA analyses have shown an excellent correlation between ploidy analysis obtained from biopsy specimens and the subsequent RP specimens. Therefore, in the setting of what appears to be organ confined PC, the use of DNA analysis is a valuable tool for the PC patient and physician. Modified after Lerner, et al.66 Pyrilinks-D (Dpd or deoxypyridinoline) This is an important baseline assessment. Pyrilinks-D quantitates the amount of bone breakdown or resorption. It measures a fragment of the bone matrix that is excreted into the urine. Therefore, in situations of excessive bone resorption or breakdown, the Pyrilinks-D or Dpd is elevated. In men, this is greater than 5.4 nmoL Dpd per nmoL urine creatinine. Increased Dpd is also commonly seen as a result of the use of androgen deprivation therapy since a lack of testosterone favors osteoclast activity, which promotes the breakdown of bone. Excessive bone resorption is associated with a greater risk of osteoporosis. However, at the time of diagnosis, prior to any therapy, elevations in Dpd have been associated with metastatic disease to bone. This is not an absolute, but it is a risk factor that is put into the equation of how we assess patients and how we counsel them to treat the entire disease process.81-83 Nationwide laboratories for two patient service centers doing the Pyrilinks-D urine test include Quest Diagnostics and LabCorp. The URLs for these labs are: http://www.questdiagnostics.com/patient/index.html) and (http://www.labcorp.com/locator/). Information for additional laboratories may be obtained by emailing [email protected] Please note that the Pyrilinks-D urine test requires a sample obtained from the second-voided urine specimen upon arising out of bed; it does not require a 24-hour urine specimen. The cost of the Pyrilinks-D or Dpd test is approximately $30 and is covered by Medicare. Remember to remind the laboratory NOT to confuse the Dpd (deoxy-pyridinoline) test with the older pyridinoline test. We now have tools to improve the bone environment. These are the class of compounds called the bisphosphonates of which Fosamax, Actonel, Aredia and Zometa are examples. Used in combination with bone supplements such as Bone AssureВ® (Life Extension Foundation) and Bone UpВ® (Jarrow Inc), and with exercise, we can stop bone resorption and hopefully decrease the spread of PC to bone. If we do not use tests such as Pyrilinks-D (Dpd) prior to, and during treatment with bisphosphonates plus bone supplementation, we have no objective means to ascertain that treatment has accomplished its goal. Therefore, obtaining a baseline Pyrilinks-D is an important starting point to correct what needs to be fixed within the health of the patient. These are the five major available bisphosphonate compounds in the world today. Clodronate, Alendronate (Fosamax) and Risedronate (Actonel) are oral agents. Their bioavailability may be affected by gastrointestinal absorption. However, using the Pyrilinks-D test the effi- cacy of any bisphosphonate compound can be assessed. Pamidronate (Aredia) and Zoledronate (Zometa) are administered intravenously. Detailed discussion of the bisphosphonate compounds and information regarding administrations can be found in вЂњA Primer on Prostate Cancer, The Empowered PatientвЂ™s GuideвЂќ by Stephen B. Strum and Donna Pogliano. This is available via www.amazon.com or through Life Extension Foundation at 1-866-820-7457. QCT Bone Densitometry Not only does the status of the bone environment appear to be important in the potential spread of PC, but also it appears that bone loss is an epidemic disease in men with PC prior to the initiation of any type of PC treatment. Using the superior technology of quantitative CT bone mineral density to assess bone loss, Smith et al showed that 95% of men diagnosed with PC had either osteopenia (32%) or osteoporosis (63%). In the same patients, the current вЂњstandardвЂќ of DEXA bone densitometry, indicated that 29% of men had osteopenia but only 5% had osteoporosis.84 Establishing a baseline using the superior technology of QCT bone density scanning prior to any kind of therapy may not only enhance the outcome of the PC patient if abnormality is detected and corrected, but also it may prevent the complications associated with osteoporosis. Information on QCT bone density testing sites can be obtained from Mindways Software, Inc. (1-877-646-3929 or www.qct.com) and at Image Analysis, Inc. (1-800-5484849 or www.image-analysis.com) Testosterone Levels An additional area that is critical to an understanding of PC as it relates to treatment with androgen deprivation therapy (ADT) is obtaining a baseline testosterone level. 95% of the time we see men receiving ADTвЂ“вЂ“therapy targeted to deprive androgens such as testosterone, DHEA-S and androstenedioneвЂ“вЂ“and note that the patient never had a baseline testosterone level or one obtained after initiating ADT. PC patients presenting with low baseline testosterone levels at diagnosis have been found to have higher Gleason scores. Schatzl determined that the mean Gleason score averaged 7.4 in such circumstances versus 6.2 when the baseline testosterone levels were normal.85 Other investigators have found a correlation between low free serum testosterone at diagnosis and more extensive PC as well as a higher percentage of PC that shows a GS of 8 or greater.86 Prostatic Acid Phosphatase (PAP) Prior to the advent of PSA testing, the major blood marker reflecting prostatic cancer activity was the prostatic acid phosphatase, or PAP. This is an enzyme level that is obtained from the patientвЂ™s serum. Many physicians have discounted the PAP, while many others still use it as a differential tool in their strategic analysis of the patient. In their experience, the PAP is an important baseline test since it has predictive value regarding the success or failure of RP or RT.87-89 In the study by Moul, et al., values of PAP at baseline of 3.0 or higher were associated with more than a two-fold risk of PSA recurrence after RP, even if the baseline PSA was 10 or less.88 In the study by Han, et al., a striking relationship between baseline PAP using the enzymatic method of Roy and PSA recurrence post RP was seen. Clearly, the importance of this baseline biomarker must be emphasized and utilized in an intelligent strategy to maximize a successful outcome for the PC patient. Baseline Freedom from PAP (Roy Biochemical Recurrence After RP assay) At 10 U/liter At 5 Years (p value) Years 87% (84- 77% (73- p = <0.4 89) 81) 0.0001 79% (75- 65% (59- p = 0.4-0.5 83) 70) 0.0001 63% (52- 44% (30- p = >0.5 72) 57) 0.0001 PAP and Freedom from Biochemical Recurrence after RP In a study from the Johns Hopkins Medical Institutions involving 1,681 men, PAP levels obtained prior to RP were predictive of patient outcome.89 In this study spanning the years 1982-1998, the PAP methodology employed was based on an enzymatic assay described by Roy, et al.90 in contrast to present-day methods which use immunoassays.88 In the original paper by Roy, the mean PAP for normal healthy men was 0.28 В± 0.09 U/liter with a range from 0.11 to 0.60. In the Hopkins study, freedom from biochemical recurrence at five and 10 years after RP was 87% and 77% for those men with normal pre-RP PAP levels defined as <0.4. However, this dropped to 79% and 65%, respectively, in men with preoperative PAPs of 0.4 to 0.5 U/liter and even further to 63% and 44% in those with baseline PAP levels of > 0.5 U/liter. This is the 3rd study to show the significance of baseline PAP testing in the outcome of men with PC. In current times when translational medicine is emphasized so often, such findings should be routinely incorporated into the clinical care of men diagnosed with PC. After Han, et al. 89 Step #4. Integration of Information Using a Combined Variable Analysis Integrating and analyzing clinical and/or pathologic data to enhance the generation of information that is more statistically significant has been termed вЂњcombined modality analysisвЂќ by Anthony DвЂ™Amico, M.D. Such an approach incorporates various biological evaluations of the patient in order to project outcomes to be used as guides for further evaluation and treatment purposes. In essence, this is a deductive process of вЂњGiven these biological facts of known significance that are unique to the patientвЂ™s situation, what we can deduce is the reality for this patient insofar as the extent of his disease and the probability of success of various treatments that may be suggested.вЂќ to look for patterns associated with a specific outcome are very important advances. Some of the algorithms and neural nets that we have found helpful in integrating information (baseline and validated information) were discussed in the PCRI Insights issue of May 2001. These are available from the PCRI website. To recap, we have listened to the biology of this illness called PC to obtain basic inputs of information such as the PSA, DRE, GS, gland volume and core percentage. We have invoked important principles of medical detective work such as baseline studies, and validation of key bits of information. We have integrated such data using tools based on the vast experience of others. Such tools are now conveniently used as software programs. These take the form of nomograms, algorithms, and neural nets (see www.pcri.org under the menu heading of вЂњPC ToolsвЂќ and then вЂњSoftwareвЂќ). The outputs of such analyses become вЂњStatus Level I.вЂќ These basically relate our assessment of the extent of disease in the patient being studied. This first level Risk Assessment is the first stage of our rocket that we must achieve to optimize a successful outcome in the care of the man with PC. The output of these mathematical analyses provides a refined risk assessment. This logically leads your doctor to obtain additional studies to exclude PC spread to areas reflecting a significant risk of involvement, or on the contrary, to forgo such studies where the yield of finding abnormalities will be negligible (< 3%). The results of this objectified risk assessment enables the patientвЂ™s physician to fine-tune further evaluation and management of the patient. This formalizes the analytic process. It forces those involved in the patientвЂ™s care to look at вЂњthe facts MaвЂ™am, just the facts.вЂќ This methodological process is of paramount importance since the nomograms, neural nets and similar tools that have been available utilize the inputs and outcomes of over 20,000 human lives in their generation of new data. This is not mouse, rat or hamster data, but the experiences of men with prostate cancer that can guide other men who come after them. Thus, Level 1 embodies the philosophy of Santayana: вЂњThose who cannot remember the past are condemned to repeat it.вЂќ Physicians have actually been using a lower intensity form of this kind of approach when they observe individual variables such as the PSA, Gleason score, etc. What scientists like Partin and DвЂ™Amico and others have done is to combine these variables and define risk-groups that relate to particular outcomes for various therapies. In other words, what treatment will be most successful for your given biological profile. The outcomes may relate to the findings at RP such as the probability of organ-confined disease versus the presence of extra-capsular extension, seminal vesicle or lymph node involvement. The outcomes may be expressed as the risk for PSA recurrence after RP, RT or seed implantation. Many scientists are also using additional statistical methods that go beyond analysis of multiple variables. Their analytic approaches are now being published in large numbers of papers.91-94 Approaches such as artificial neural nets that can be taught This refined risk assessment profile, now developed specifically and individually for a particular patient, becomes a custom profile. Rather than pigeonhole patients into broad categories, it has presented the individual patient as the unique biologic entity that he is. In addition, as mentioned previously, the patient is now taking advantage of the past history and performances of other men in similar prognostic risk categories. This historical data is the essence of what Partin, et al. first presented in 199395, updated in 199796 and again recently updated; this is what we call the Partin Tables.97 The Partin Tables are the prototype of combined modality analysis. This ends Part II in A Strategy of Success in the Treatment of Prostate Cancer. In the next issue of Prostate Cancer Communication, steps 5-7 will be discussed. 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Erbersdobler A, Hammerer P, Huland H, et al: Numerical chromosomal aberrations in transition-zone carcinomas of the prostate. J Urol 158:1594-8, 1997. 57. Forsslund G, Esposti PL, Nilsson B, et al: The prognostic significance of nuclear DNA content in prostatic carcinoma. Cancer 69:1432-9, 1992. 58. Gauwitz MD, Pollack A, el-Naggar AK, et al: The prognostic significance of DNA ploidy in clinically localized prostate cancer treated with radiation therapy. Int J Radiat Oncol Biol Phys 28:821-8, 1994. 59. Greene DR, Rogers E, Wessels EC, et al: Some small prostate cancers are nondiploid by nuclear image analysis: correlation of deoxyribonucleic acid ploidy status and pathological features. J Urol 151:1301-7, 1994. 60. Greene DR, Wheeler TM: Clinical relevance of the individual prostate cancer focus. Cancer Invest 12:425-37, 1994. 61. Hawkins CA, Bergstralh EJ, Lieber MM, et al: Influence of DNA ploidy and adjuvant treatment on progression and survival in patients with pathologic stage T3 (PT3) prostate cancer after radical retropubic prostatectomy. Urology 46:356-64, 1995. 62. Henke RP, Hammerer P, Graefen M, et al: Interphase cytogenetic study of preoperative core biopsies for the prediction of early serum prostate specific antigen recurrence after radical prostatectomy of clinically localized prostate carcinoma. Cancer 83:977-88, 1998. 63. Hussain MH, Powell I, Zaki N, et al: Flow cytometric DNA analysis of fresh prostatic resections. Correlation with conventional prognostic parameters in patients with prostate cancer. Cancer 72:3012-9, 1993. 64. Khoo VS, Pollack A, Cowen D, et al: Relationship of Ki-67 labeling index to DNA-ploidy, S-phase fraction, and outcome in prostate cancer treated with radiotherapy. Prostate 41:166-72, 1999. 65. Lee SE, Currin SM, Paulson DF, et al: Flow cytometric determination of ploidy in prostatic adenocarcinoma: a comparison with seminal vesicle involvement and histopathological grading as a predictor of clinical recurrence. J Urol 140:769-74, 1988. 66. Lerner SE, Blute ML, Bergstralh EJ, et al: Analysis of risk factors for progression in patients with pathologically confined prostate cancers after radical retropubic prostatectomy. J Urol 156:137-43, 1996. 67. Lerner SE, Blute ML, Zincke H: Risk factors for progression in patients with prostate cancer treated with radical prostatectomy. Semin Urol Oncol 14:12-20; discussion 21, 1996. 68. Miller J, Horsfall DJ, Marshall VR, et al: The prognostic value of deoxyribonucleic acid flow cytometric analysis in stage D2 prostatic carcinoma. J Urol 145:1192-6, 1991. 69. Phillips JL, Hayward SW, Wang Y, et al: The consequences of chromosomal aneuploidy on gene expression profiles in a cell line model for prostate carcinogenesis. Cancer Res 61:8143-9, 2001. 70. Pollack A, Zagars GK, el-Naggar AK, et al: Near-diploidy: a new prognostic factor for clinically localized prostate cancer treated with external beam radiation therapy. Cancer 73:1895-903, 1994. 71. Pollack A, Zagars GK, el-Naggar AK, et al: Relationship of tumor DNAploidy to serum prostate-specific antigen doubling time after radiotherapy for prostate cancer. Urology 44:711-8, 1994. 72. Ross JS, Figge H, Bui HX, et al: Prediction of pathologic stage and postprostatectomy disease recurrence by DNA ploidy analysis of initial needle biopsy specimens of prostate cancer. Cancer 74:2811-8, 1994. 73. Ross JS, Figge HL, Bui HX, et al: E-cadherin expression in prostatic carcinoma biopsies: correlation with tumor grade, DNA content, pathologic stage, and clinical outcome. Mod Pathol 7:835-41, 1994. 74. Scrivner DL, Meyer JS, Rujanavech N, et al: Cell kinetics by bromodeoxyuridine labeling and deoxyribonucleic acid ploidy in prostatic carcinoma needle biopsies. J Urol 146:1034-9, 1991. 75. Shankey TV, Jin JK, Dougherty S, et al: DNA ploidy and proliferation heterogeneity in human prostate cancers. Cytometry 21:30-9, 1995. 76. Song J, Cheng WS, Cupps RE, et al: Nuclear deoxyribonucleic acid content measured by static cytometry: important prognostic association for patients with clinically localized prostate carcinoma treated by external beam radiotherapy. J Urol 147:794-7, 1992. 77. Stege R, Tribukait B, Lundh B, et al: Quantitative estimation of tissue prostate specific antigen, deoxyribonucleic acid ploidy and cytological grade in fine needle aspiration biopsies for prognosis of hormonally treated prostatic carcinoma. J Urol 148:833-7, 1992. 78. Tinari N, Natoli C, Angelucci D, et al: DNA and S-phase fraction analysis by flow cytometry in prostate cancer. Clinicopathologic implications. Cancer 71:1289-96, 1993. 79. van den Ouden D, Tribukait B, Blom JH, et al: Deoxyribonucleic acid ploidy of core biopsies and metastatic lymph nodes of prostate cancer patients: impact on time to progression. The European Organization for Research and Treatment of Cancer Genitourinary Group. J Urol 150:400-6, 1993. 80. van der Poel HG, Oosterhof GO, Schaafsma HE, et al: Intratumoral nuclear morphologic heterogeneity in prostate cancer. Urology 49:652-7, 1997. 81. Berruti A, Dogliotti L, Bitossi R, et al: Incidence of skeletal complications in patients with bone metastatic prostate cancer and hormone refractory disease: predictive role of bone resorption and formation markers evaluated at baseline. J Urol 164:1248-53, 2000. 82. Koga H, Naito S, Koto S, et al: Use of bone turnover marker, pyridinoline cross-linked carboxyterminal telopeptide of type I collagen (ICTP), in the assessment and monitoring of bone metastasis in prostate cancer. Prostate 39:1-7, 1999. 83. Takeuchi S, Arai K, Saitoh H, et al: Urinary pyridinoline and deoxypyridinoline as potential markers of bone metastasis in patients with prostate cancer. J Urol 156:1691-5, 1996. 84. Smith MR, McGovern FJ, Fallon MA, et al: Low bone mineral density in hormone-naive men with prostate carcinoma. Cancer 91:2238-45, 2001. 85. Schatzl G, Madersbacher S, Thurridl T, et al: High-grade prostate cancer is associated with low serum testosterone levels. Prostate 47:52-8, 2001. 86. Hoffman MA, De Wolf WC, A M: Is low serum free testosterone a marker for high-grade prostate cancer? J Urol 163:824-7, 2000. 87. Dattoli M, Wallner K, True L, et al: Prognostic role of serum prostatic acid phosphatase for 103Pd-based radiation for prostatic carcinoma. Int J Radiat Oncol Biol Phys 45:853-6, 1999. 88. Moul JW, Connelly RR, Perahia B, et al: The contemporary value of pretreatment prostatic acid phosphatase to predict pathological stage and recurrence in radical prostatectomy cases. J Urol 159:935-40, 1998. 89. Han M, Piantadosi S, Zahurak ML, et al: Serum acid phosphatase level and biochemical recurrence following radical prostatectomy for men with clinically localized prostate cancer. Urology 57:707-11, 2001. 90. Roy AV, Brower ME, Hayden JE: Sodium thymolphthalein monophosphate: A new acid phosphatase substrate with greater specificity for the prostatic enzyme in serum. Clin Chem 17:1093-1102, 1971. 91. Batuello JT, Gamito EJ, Crawford ED, et al: Artificial neural network model for the assessment of lymph node spread in patients with clinically localized prostate cancer. Urology 57:481-5, 2001. 92. Han M, Snow PB, Epstein JI, et al: A neural network predicts progression for men with Gleason score 3+4 versus 4+3 tumors after radical prostatectomy. Urology 56:994-9, 2000. 93. Bostwick DG, Burke HB: Prediction of individual patient outcome in cancer: comparison of artificial neural networks and Kaplan--Meier methods. Cancer 91:1643-6, 2001. 94. Babaian RJ, Fritsche H, Ayala A, et al: Performance of a neural network in detecting prostate cancer in the prostate-specific antigen reflex range of 2.5 to 4.0 ng/mL. Urology 56:1000-6, 2000. 95. Partin AW, Yoo J, Carter HB, et al: The use of prostate specific antigen, clinical stage and Gleason score to predict pathological stage in men with localized prostate cancer. J Urol 150:110-4, 1993. 96. Partin AW, Kattan MW, Subong EN, et al: Combination of prostatespecific antigen, clinical stage, and Gleason score to predict pathological stage of localized prostate cancer. A multi-institutional update. JAMA 277:1445-51, 1997. 97. Partin AW, Mangold LA, Lamm DM, et al: Contemporary update of prostate cancer staging nomograms (Partin Tables) for the new millennium. Urology 58:843-8, 2001. EARLY HORMONAL THERAPY WORKS RIDICULOUSLY WELL By Robert Leibowitz, M.D. and Steven Tucker, M.D. Compassionate Oncology Medical Group Los Angeles, CA 310/229-3555 Traditionally, patients with prostate cancer were offered only three treatment options: observation (no treatment), radical prostatectomy (the alleged gold standard), and standard radiation therapy. A fourth treatment option, brachytherapy or seeds, has been increasingly offered. Since 1991, the only treatment we have recommended is primary androgen deprivation therapy without any radical local treatment. We call triple hormone blockadeВ® the вЂњPlatinum and Diamond Standard,вЂќ because we believe it is far superior to any вЂњgold standard.вЂќ At the European Oncology Conference, September 22, 2003, Abstract 328 was presented and discussed. In a press conference held afterwards, Sir Richard Peto, Ph.D., Professor of Medicine Statistics at the University of Oxford, United Kingdom, was interviewed. Dr. Peto has gained international recognition and fame with his analysis of the adjuvant therapy for breast cancer (this refers to treatment given after surgery or radiation therapy to reduce the risk of cancer recurrence). We believe the following statement best describes Dr. PetoвЂ™s analysis. вЂњHormonal therapy as a whole works ridiculously well.вЂќ Significant reductions in ten-year mortality rates have been identified in the United States and United Kingdom, as well as elsewhere in Europe. A meta analysis is a type of analysis that pools the results from all pertinent medical publications, hoping that by adding together all of the patients in each trial, it is more likely that you will identify statistically significant conclusions because of the larger sample size. Dr. Peto looked at early versus late initiation of hormonal therapy. His meta analysis concluded that early hormone blockade for prostate cancer is about as effective as it is for early breast cancer....вЂќ When asked why so many physicians are reluctant to prescribe early hormonal therapy when the survival benefits are so great, Dr. Peto primarily attributed this to tradition. I would interpret that as reluctance on the part of physicians to open their (sometimes closed) minds to change and allow themselves to learn about new and effective treatment options. вЂњMeta analysis provides strong evidence of benefit, and when you add them (the studies) all together, they are very clear, showing improved prostate mortality....вЂќ Early use of hormone blockade reduced the probability that you would die from prostate cancer in the next ten years by about one-third, and all other deaths were not increased. A very well known and internationally respected urologist, Dr. E. David Crawford, Professor of Urologic Oncology at the University of Colorado Health Sciences Center in Denver, in a telephone interview, stated вЂњEarly hormonal therapy saves lives, and can even be considered to be a cure of prostate cancer.вЂќ Although not involved in this study, he states, вЂњWe have been on this bandwagon for years. When I give a talk on this, I like to start by asking for a show of hands on how many people think early hormonal therapy can be a cure for prostate cancer. I do.вЂќ (Dr. Bob has never claimed early hormone blockade could cure prostate cancer, but he loved discovering that Dr. Crawford believes it can.) Dr. Crawford went on to state that вЂњearly signs of a drop in prostate cancer mortality in the 1990's could not have been accounted for by improved screening and detection with PSA testing because the test was too new to have an impact on death rates. At least some of the decline was likely attributable to the inhibition of cancer growth by hormone blockade.вЂќ Dr. Bob comments, вЂњIt is known that 80% of men in their 80's have prostate cancer, but only 2 - 3% of men die from prostate cancer. Most of us will die with prostate cancer; not from it. Therefore, for most men, it is not necessary to be cured of prostate cancer in order to enjoy a normal life span.вЂќ Treatment with 13 months of triple hormone blockade/Leibowitz protocolВ® is the least invasive treatment option for socalled localized prostate cancer, but still is a most potent and effective form of therapy. It is also the only non-chemotherapy treatment option that can kill prostate cancer cells that have escaped from the prostate and spread to places like your bones. Dr. Crawford had been one of my most vociferous critics in the past, stating that hormone blockade could never cure prostate cancer, and that patients should never consider primary hormone blockade as a viable treatment option. During a question and answer session following one of his L.A. area lectures, he literally took one of our patients to task when this patient asked, вЂњWhat about using hormone blockade as sole treatment for so-called, localized prostate cancer?вЂќ Dr. Crawford was extremely indignant and quite rude, stating categorically that hormone blockade is not an acceptable treatment option; period; end of discussion. Perhaps Dr. Crawford would be impressed (astonished) if he was told that this patient continues to remain in a clinical complete remission for more than six years in spite of the fact that he had aggressive, negative baseline prognostic factors. His only treatment was 13 months of triple hormone blockade/Leibowitz protocolВ®, followed by finasteride maintenance therapyВ®. It is amusing to hear Dr. Crawford say that вЂњ...weвЂ™ve been on this bandwagon for years.вЂќ He sure wasnвЂ™t on this bandwagon when he lectured in L.A. just a few years ago. However, we welcome company on the primary hormone blockade as sole therapy for prostate cancer bandwagon. We were the first to advocate this option more than 12 years ago, and remain a most vociferous spokesperson for this approach. CAPSURE data was presented at the American Urologic Association in May 2003, and reported that from 1989 through 2001, the use of primary androgen deprivation therapy as a treatment option had risen sharply. For low-risk patients, the use almost tripled to 14.2%. For intermediate risk, it more than doubled to approximately 20%, and for high-risk, it increased from 33% to 48%. Almost one-half of men with high-risk disease selected hormone blockade as their treatment option. They investigated and discovered how poor the results were from any form of radical local therapy. Obviously, more and more doctors are either prescribing or agreeing to prescribe hormone blockade as the first and only treatment for prostate cancer patients. High risk is defined as a PSA equal to or greater than 20, or a Gleason score of 8-10, or locally advanced disease. Low risk is a PSA less than 10, a Gleason score of 6 or less, and nonpalpable or only a small abnormal area identified on digital rectal exam. Intermediate risk includes everyone else. It seems ironic that when surgery or radiation therapy fails to control your prostate cancer, then your urologist or radiation therapist will inevitably prescribe the same type of hormone blockade that we prescribe initially. Why subject yourself to radical local therapies with the well-known, often permanent complications of erectile dysfunction (impotence) and urinary incontinence? One-third of men report they use a pad, diaper, or penile clamp after radical prostatectomy. More than 60% report that they drip urine. Eighty-five percent report the inability to achieve and maintain an erection firm enough to allow for intercourse. Seven percent suffer from fecal incontinence. Imagine how you would feel if you developed one or more of these complications, but in spite of this you later required treatment with hormone blockade because of a rising PSA? Skip the radical local therapies and start with triple hormone blockade/Leibowitz protocolВ®. We firmly believe that you never save your best prostate cancer treatment for later. The time to kill prostate cancer cells is now. Do not allow prostate cancer cells the opportunity to mutate and become more aggressive. If any therapy works well in more advanced disease, it essentially always works much better in earlier stage disease. Hence, give your hormone blockade early rather than late. When radical prostatectomy or radiation therapy fails to cure a man, the PSA doubling time shortens from three to four years pre-surgery or pre-radiation, to about four months after those treatments. Frightening, but true. Remember, no study has ever shown any form of radical local therapy to be both necessary and effective. Dr. Fernand Labrie reported in the early 1990's that for men who presented with one to five separate metastases identified on bone scan, their median survival was greater than eight years. These men didnвЂ™t have bone cancer; they had prostate cancer cells in their bones. Hormone blockade can kill prostate cancer cells in your prostate, lymph nodes, and bones as well. Patients with obvious metastatic disease to bones have much shorter survival than patients with normal bone scans, even though a normal bone scan does not exclude the possibility that occult metastatic disease exists. More than 10 - 15% of a bone must be dissolved before a bone scan is abnormal. It takes destruction of 40% or more of a bone before an x-ray becomes abnormal. There can be billions of cancer cells, with a normal bone scan. Men with abnormal bone scans have much more aggressive disease. Their prostate cancer cells have figured out a way to escape from the prostate, survive in the circulation, leave the circulation, вЂњnestвЂќ in bones, attract blood supply to them, and develop successful colonies or islands of metastatic cells. Only the most aggressive cells are able to accomplish all of these steps. It is reassuring that even in men with up to five identified metastatic deposits on bone scan, eight years after starting hormone blockade, more than half were still alive in the Labrie study. Dr. Labrie used continuous double hormone blockade. We are confident that intermittent androgen blockade is far superior to continuous blockade. We are also convinced that triple hormone blockade/Leibowitz protocolВ® is the most effective form of hormone blockade, and is much better than double blockade. We feel the best results are obtained using a single 13-month cycle of triple hormone blockadeВ® up front, rather than intermittent hormone blockade. Following that first cycle of hormone blockade, use all of your supportive treatments to avoid the need for a second cycle of hormone blockade. The longer you are off hormone blockade, the much longer you will survive. You cannot get hormone refractory unless someone puts you back on hormone blockade. Examples of these supportive therapies include finasteride maintenance therapy (a small percent of our patients take dutasteride [Avodart]). All of our patients are on either one or the other. Virtually all take a COX-2 inhibitor, preferably Celebrex. The other COX-2 inhibitors we sometimes use are Vioxx or Bextra. Calcitriol and/or PEENUTS may have some limited beneficial effects. We have found that thalidomide is the most successful treatment option that helps to postpone or avoid the need for another cycle of hormone blockade. In our experience, more than 85% of men will respond to thalidomide by showing a decline in PSA, usually within weeks of starting therapy. You can request a videotaped lecture that discusses and explains how to avoid getting hormone resistant or refractory. Request Video #2 which is a lecture given in August 2001. Dr. LabrieвЂ™s survival figures are from a 1992 report. These survival statistics occurred in the era before we identified modern, effective therapies that we use for those men who fail initial hormone blockade. This information should reassure any patient with low-risk prognostic factors that almost without exception we expect them to do well for an indefinite period of time, well beyond eight years, if they are treated appropriately. For those men who present with intermediate-risk factors, the protocol described below also confirms their excellent prognosis. The men who present with one or more high-risk factors almost always require treatment with 12 doses of mild, easily tolerated, low-dose chemotherapy in addition to 13 months triple hormone blockade/Leibowitz protocolВ®. None of these patients develop nausea or vomiting; hair loss is rare; most working men continue to work full time during therapy. Men are amazed at how nontoxic this treatment is, and how well it is tolerated. We have a list of volunteers who have been treated with this protocol and are happy to discuss this treatment with you. Video #4 from October 2002 has additional helpful information. Triple hormone blockade/Leibowitz protocolВ® refers to men who have never had any form of local therapy and have never had any form of prior hormone blockade. These men are treated with 13 months of triple hormone blockadeВ® utilizing Lupron or Zoladex, three Casodex per day, and one finasteride (Proscar) per day. After 13 months, they are treated with finasteride maintenanceВ® (Proscar maintenance therapy). For men who cannot afford three Casodex per day, we recommend Eulexin, 250 mg three times per day. We do not recommend using one or two Casodex per day. You need three for optimal results. You can request a copy of a videotaped lecture given by me [Dr. Leibowitz (some of my lectures are also available in DVD)] to further explain in detail this information regarding triple hormone blockadeВ®. A July 2001 lecture also describes all of the choices for local therapy as well as the side effects from each form of treatment. A lecture from May 2003 updates our triple hormone blockade/Leibowitz protocolВ® results, and may convince you to consider treatment with high-dose testosterone replacement therapy after your triple hormone blockadeВ® has been completed. The February 2002 lecture addresses subjects including our antiangiogenic cocktail; high-dose testosterone replacement therapy; as well as different approaches for achieving optimal management of all stages of prostate cancer. Call our office for a description of these lectures. Dr. Tucker has taped a lecture given in San Diego in October 2003. A copy of that lecture is also available. In September 2003, I (Dr. Leibowitz) presented our updated data at the Prostate Cancer Research Institute Symposium. I reported on 177 men, all with biopsyconfirmed prostate cancer. All men refused local therapy; all men were treated in a single practice, by myself or Dr. Steven Tucker. Their average age is 66. Their average baseline PSA is 11.5. Their median Gleason grade is 7. We had 71 patients with a Gleason 7; 24 with a 4+3, and 47 with a 3+4. Twenty-one of our men had Gleason scores of 8 to 10, and 85 had a Gleason score of 4 to 6, with a rare 4 or 5. The largest percentage of our patients were stage T1c or T2a; however, at least 20% were locally advanced. The first 134 men treated have a mean follow-up of 60 months. Their current mean PSA is 2.49. Ninety patients have been followed for a mean of six years, and their mean PSA is 2.8. Almost 50 men have been followed for a mean of seven years; their mean PSA is 2.678. Baseline testosterone was 388; on finasteride maintenanceВ® 530. Finasteride (or Proscar) raises your testosterone level. Through September 2003, we have only had to retreat 12 men. All 12 of these patients presented with at least one high-risk prognostic factor. As of September 2003, our disease specific survival is 99.4%. This means that only one patient in 177 died from prostate cancer. These results are superior to any reported surgical or radiation therapy series. Our results were published in the journal, The Oncologist, an international, peer-reviewed journal; see вЂњTreatment of Localized Prostate Cancer with Triple Androgen Blockade: Preliminary Results in 110 Consecutive Patients;вЂќ 2001; 6:177-182. Our article was referenced at the 2003 AUA convention in a course on androgen deprivation therapy. The syllabus, written by Dr. Eric Small, reads вЂњTriple androgen blockade employing simultaneous LH-RH agonist, antiandrogen, and 5-alpha-reductase inhibitor (finasteride) may offer additional benefit over stan- dard double hormone blockade, particularly in the context of intermittent treatment protocols.вЂќ Our work was also referenced in the Journal Cancer, published by the American Cancer Society. It is immensely satisfying to me (Dr. Leibowitz) personally that my work utilizing triple hormone blockadeВ® with finasteride maintenance therapyВ® has been so successful, is finally being recognized, and is increasingly accepted as an appropriate primary treatment option. Being the first to name and pioneer this approach that offers men a treatment option without incontinence and is the only treatment option whose side effects are almost always reversible, makes me proud and happy. Mayoclinic.com agrees that one of the treatment options commonly used by men with (so-called) localized prostate cancer is hormone blockade. This is your Fifth Treatment Option. We believe that our results confirm our opinion that triple hormone blockade/Leibowitz protocolВ® is the best treatment option (hence the name, The Platinum and Diamond Standard). It avoids any form of radical local therapy. Why take the risk you might need a diaper, pad, or (God forbid) penile clamp? Avoid the possibility of fecal incontinence or soiling. About one-quarter to one-third of men, after being treated with radiation therapy, report moderate to severe gastrointestinal complications including bleeding or fecal soilage after radiation therapy. Following radiation therapy, approximately 85% of men develop erectile dysfunction within four years of treatment. Erectile dysfunction was defined as inability to get and maintain an erection firm enough for intercourse. Start your treatment with triple hormone blockade/Leibowitz protocolВ®. This buys you the time needed to investigate all other options. Later, if you decide, you can add local therapy. You are not burning any bridges by starting with triple hormone blockadeВ®. We donвЂ™t recommend local therapy, but you have the option to add it at any time. Currently, about two-thirds of men treated with radiation therapy for locally advanced prostate cancer are told that they also need to take hormone blockade. No study has ever shown that radiation therapy adds to the benefit of hormone blockade. Prospective randomized trials have proven that radiation therapy plus hormone blockade statistically prolongs survival compared to radiation therapy alone. After all of these years, no study has shown an advantage from adding radiation therapy to hormone blockade. The value of using hormone blockade is proven. This is not just our opinion; this is proven medical fact. Simply stated, we do not believe in any form of radical local therapy. Seventy-three percent of men, prior to the start of their radical prostatectomy surgery, already have PSA-secreting cells in their bones (bone marrow). Most experts agree that these are malignant prostate cancer cells. Not all will grow into mature metastases, but it is sobering to realize that three out of four men have these cells in their bones at diagnosis. This is one of the major reasons we believe prostate cancer is a systemic disease. This means that prostate cancer cells have already spread to lymph nodes and/or bones by the time you are first diagnosed. Since triple hormone blockade/Leibowitz protocolВ® is systemic therapy, it can attack prostate cancer cells anywhere and everywhere in the body. No form of local therapy kills the prostate cancer cells that have already spread to your bones or other distant sites. Dr. Peto, after analyzing the worldвЂ™s literature, concludes how ridiculously well hormone blockade works. Dr. Crawford has admitted (? confessed) that hormone blockade kills prostate cancer cells. Let triple hormone blockade/Leibowitz protocolВ® help you, too. We have a very long list of patients who were treated with our triple hormone blockade/Leibowitz protocolВ® and now volunteer to answer any questions or concerns that you or your significant other may have. Please call our office for a copy of that list. Call them and hear what they have to say. Note: Triple hormone blockadeВ® is Dr. BobвЂ™s registered trademark. Triple androgen blockadeВ® is Dr. BobвЂ™s registered trademark. Finasteride maintenance therapyВ® is Dr. BobвЂ™s registered trademark. WHAT THE HECK HAS BEEN GOING ON IN MY WORLD - Part IV!!! By Mark A. Moyad, M.P.H. By Mark Anthony (yes I do know that there was a famous Roman emperor that was very intelligent and good looking and good-hearted and he was from Rome, but I share no similarities to that guy except for the good looking, good hearted and kind part but I am not from Rome) Moyad, M.P.H. (also keep in mind that this is the last PAACT issue that will show my M.P.H. alone credentials cause in the next issue it will say M.D., M.P.H. - yes I am graduating in June after 9 years which means I hope that you keep your graduation gifts to me under 1000 dollars for the most part - oh by the way I really like that George Foreman grill and I need a new washer and dryer and car if you get my driftвЂ¦.). FIRST THE REALLY GOOD NEWS BUT THIS IS A WARNING THAT THIS IS A SHAMELESS PROMOTION THAT I HAVE BEEN WAITING 5 YEARS TO DO! (PRETTY DRAMATIC SOUNDING DONвЂ™T YOU THINK BUT TRUE!!!) Here we go again. Buckle up because we have a lot to cover in this issue. First letвЂ™s start with my SHAMELESSS PROMOTION NUMBER 3063. I have been asked by some people what happened to my newsletter or journal and why we still do not publish it and my answer was that it was too much work for a staff of 1 or 2 people - we simply underestimated the response, but if a legitimate company wanted to help us I would continue to do the newsletter/journal. Well, the good news is that it is now official. One of the largest medical publishers in the world has decided to publish a version of this journal 4 times a year along with providing internet access to other articles, medical meetings, new drugs and supplements. We will also spend a heck of a lot of time telling you what not only seems to work, but what also seems to be worthless! I am happy to report that after 5 years we finally have a company that will handle the journal and the first issue will be published in the late fall of 2004. This journal will review articles in conventional and alternative medicine for chronic diseases from A-Z. In other words, from arthritis to breast cancer, cardiovascular disease to colon cancer, diabetes to osteoporosis to prostate cancer to erectile dysfunction to menopause to hot flashes to skin cancer to any of the chronic diseasesвЂ¦ it will simply keep you up-to-date every 3 months of what has occurred in the previous 3 months in these and other areas of medicine. Also, although I will be doing most of the writing in each issue - about 33% or more of each issue will be written by numerous objective researchers from around the world. For example, in the first issue we have a respected researcher from Harvard writing about cardiovascular disease, and a respected researcher from San Diego writing about prostate cancerвЂ¦ Also, I wanted to make sure that it was cheap and at the same time if you are interested in subscribing that your name and address are protected. In other words, I did not want you to receive 40 pieces of mail from this and other companies after you expressed interest in this journal. Therefore, the other guarantee that was made by the medical publisher is that by contacting or e-mailing the publisher and letting them know that you are interested in the journal Seminars in Preventive and Alternative Medicine (keep in mind that we will be talking about a lot more than just prevention of a disease but also preventing recurrence of a disease or preventing side effectsвЂ¦) that you would be protected. Therefore, if you are interested in subscribing - contact Catherine Bewick at Elsevier publishing in Philadelphia and leave a message with your name, phone number, address and express your interest in the Moyad journal called вЂњSeminars in Preventive and Alternative MedicineвЂќ Or you can send an email message. This is only to express interest and in the next month or two they will contact you and discuss further if you are still interested in subscribing after hearing more about the prices and the journal itself. Catherine BewickвЂ™s number is 215-238-7877 Her e-mail is [email protected] I REALLY HOPE YOU WILL INQUIRE ABOUT THIS JOURNAL BECAUSE I THINK IT WILL BE WORTH IT FOR ANY MAN OR WOMAN. THANKS FOR LETTING ME STAND ON MY COMMERCIAL SOAP-BOX FOR A MINUTE. 20) LET ME GET THIS STRAIGHT (PUN INTENDED) - EJACULATIONS ARE GOOD FOR ME AND MAY ACTUALLY REDUCE THE RISK OF PROSTATE CANCER?? There is an old philosophy in medicine known as the вЂњuse it or lose it theory.вЂќ In other words, exercising certain parts of the body can reduce your risk of certain conditions. For example, it seems that reading a lot or exercising the brain may reduce the risk of dementia or memory problems. Exercising the heart may reduce your risk of heart disease. Lifting weights can increase the size of your muscles and reduce the risk of osteoporosis. Therefore, researchers decided to look at the risk of prostate cancer in those men that exercise the prostate or men that have frequent ejaculations. Researchers from the Health Professionals Follow-up Study decided to analyze data on 29,342 U.S. men aged 46 to 81 years that provided information on the history of ejaculation frequency in 1992 and every 2 years until the year 2000. Interestingly, a high ejaculation frequency was associated with a reduced risk of total prostate cancer! There was an 11% decreased risk of prostate cancer in men reporting 21 or more ejaculations per month versus men reporting 4-7 ejaculations per month at the ages of 20 to 29 years, a 32% reduction in men ages 40 to 49 years, a 51% reduction in men reporting the highest number of ejaculations in the year before the final analysis, and a 33% reduction over an entire lifetime. In other words, more ejaculations were associated with a reduced risk of prostate cancer. Again, the reduction in risk was for the men that reported 21 or more ejaculations per MONTH compared to men reporting 4-7 ejaculations per month. My gosh - 21 or more ejaculations per month!!! I get tired and sleepy just reporting this data! Researchers are not sure that having a lot of ejaculations after a prostate cancer diagnosis actually can help or hurt, but I have to think that it is not necessarily a bad thing. However, be careful in how you report this data to your spouse, because some men may be insensitive and report to their wives that unless they have more ejaculations it is their spouses who are putting them at an increased risk of prostate cancer. Regardless, I am just the researcher here reporting the data and it seems that ejaculations are a good thing after all. Oh and that urban legend is not true that more self-ejaculations can lead to blindness! That is ridiculous but that was what my parents told me when my hormones were kicking in as a teenagar (whoops I spelled that wrong because I have trouble reading the keyboard on my computer. What I meant to type in there was the word вЂњteenagerвЂќ - anyone seen my glasses?). Finally, there is a rumor that a researcher in the future is going to find in a study that being more romantic and loving to your wife and providing her with expensive new jewelry every 4-6 months may reduce the risk of breast cancer or just asking for directions (if you are a man) while driving in the car with your wife when you get lost can reduce the risk of breast cancer or letting your wife use the TV. remote control once in a while can reduce the risk of breast cancer orвЂ¦. (Reference: Leitzmann MF, et al. JAMA 2004;291:1578-1586). 21) CAN EATING FISH REDUCE MY RISK OF PROSTATE CANCER RECURRENCE??? This data comes from the same study as the one referenced above (the Health Professionals Follow-up Study). However, 51,529 men were involved in this part of the study. There were 675 prostate cancer cases that had completed post-diagnosis follow-up data. A total of 171 cases of prostate cancer recurrence cases were reported. Interestingly, a greater post-diagnostic intake of fish was associated with a significant 27% reduction in the risk of prostate cancer recurrence. Therefore, eating more fish in your diet may not only reduce the risk of prostate cancer, but the risk of prostate cancer returning in men already treated for prostate cancer. The bottom line is that eating fish is a heart-healthy lifestyle addition, and in the worst case scenario may reduce the risk of sudden cardiac death or heart disease. So, why not eat more fish??? Well, some individuals are concerned about the mercury levels in fish. In addition, the FDA has warned that large predatory fish, especially shark, tilefish, king mackerel, and swordfish may contain high levels of mercury. Now, I do not remember the last time I asked my waiter or waitress for shark or tilefish, but I am not worried about our fish supply overall. It is important to remember that baking, broiling, or even raw fish (yes - sushi) can be healthy but fried fish is not healthy (sorry you Filet O FishВ® lovers out there). Also, we are not sure if fish oil capsules can also impact the risk of prostate cancer or the recurrence of this disease, but fish oil supplements have been shown to reduce the risk of sudden cardiac death in individuals at high risk for such an event. Several large heart disease organizations now recommend fish oil capsules for patients with a high-risk of a cardiovascular event. Fish oil supplements are also low in mercury because they mostly come from the small fish that contain less mercury. If you are interested in taking fish oil supplements please talk to your doctor. Fish oil supplements contain 2 compounds known as вЂњEPAвЂќ and вЂњDHA.вЂќ These 2 compounds are omega-3 fatty acids or heart healthy compounds. They can reduce triglyceride (a potential blood marker for heart disease that is a part of the fasting cholesterol blood test) levels in individuals with abnormally high levels of triglycerides. Past studies of fish oil have shown that about 1 gram a day of EPA + DHA may have the biggest benefit with the lowest rate of side effects. Again, talk with your doctor first because fish oil pills can thin your blood too much, especially when combined with other blood thinners like aspirin, coumadin вЂ¦ (obviously, it is best to first increase your consumption of dietary fish). Also, numerous companies now have enteric-coated fish oil supplements which significantly reduce the risk of having a bad fishy after- taste, so ask your doctor about these supplements. However, one big problem with supplements as you may or may not know is that there is no guarantee of quality-control. In other words, how can you be sure that what you are buying is actually in the supplement bottle? One way to do this is to log on to www.consumerlabs.com and they have a list of potential supplements that have quality-control because they were tested. Approximately once a week, I log on to consumerlabs.com to check the quality control of a variety of supplements and I think it would be wise for you to check it once in a while. Anyhow, I got off track here, but this finding from this recent study is very interesting and it could be that eating fish several times a week including tuna fish in a can in water or salmonвЂ¦ could reduce the risk of prostate cancer recurrence after treatment of prostate cancer. Regardless, letвЂ™s look at this in a different way. LetвЂ™s just say or pretend that researchers 10 years from now clearly find that fish does not reduce the risk of prostate cancer recurrence. Who gives a вЂњ______________вЂќ (insert bad word in that previous spot). What I love about fish is that it can or may: 1) Reduce your risk of sudden cardiac death 2) Reduce your risk of arthritis and other chronic conditions 3) Provide a large source of vitamin D 4) Provide a large source of selenium 5) Reduce the risk of depressionвЂ¦ The point is that fish consumption has already demonstrated numerous potential health benefits and that is why it just makes sense to consume more of this stuff. We are not sure if shellfish have the same potential impact, but we will keep you up-to-date and who gives a _________ anyway! Shellfish just taste good and have omega-3 fatty acids, so VIVA LA SHELLFISH!!! (Reference: American Urological Association Annual Meeting 2004; page 117, abstract #442). 22) CAN DUTASTERIDE (AVODARTВ®) REDUCE THE RISK OF PROSTATE CANCER IN MEN WITH BPH (PROSTATE ENLARGEMENT OR BENIGN PROSTATIC HYPERPLASIA)? We already know that taking dutasteride at 0.5 mg/day may reduce the symptoms of BPH. This dose reduces the blood levels of DHT (the more po- tent form of testosterone) by more than 93%. It seems that from previous BPH studies the use of 0.5 mg/day may reduce the risk of prostate cancer. This is now being tested more accurately in a large randomized trial. In the meantime, please continue to ask your doctor about the potential benefits and detriments of taking finasteride (ProscarВ®) or dutasteride (AvodartВ®) for BPH or after a prostate cancer diagnosis. It could be that these drugs have an effect, but we still are not sure. Regardless, they initially appear promising but we need more data. Now, the company that sells dutasteride and the company that sells finasteride are obviously competitors and you need to be careful not to get caught up in the competition. In other words, ask your doctor about the similarities and the differences between the two and ask your doctor if he/she gets paid by either company to do some speaking or to be an advisorвЂ¦ In other words, is there a conflict of interest? For example, one big difference between finasteride and dutasteride is their half-life or how long the drug is still active in the body. Dutasteride has a half-life of several weeks which means it is probably active for longer periods of time and if you miss a few dosages every week it is probably no big deal, but finasteride has a shorter effect that does not last as long. Now, if I worked for the dutasteride company I would probably sell you on the point that our drug works for a long period of time, which means you can miss a few dosages or days of taking it here and there and it may be no big deal and it reduces DHT to a greater degree so obviously we might be better... However, if I worked for finasteride and I wanted to sell this drug to you I would tell you it has been tested much more in humans and in a cancer prevention study and it has good safety data and although it does not stay in your body for a long period of time this is an advantage because any drug that stays in your body for a long time can be a problem if you start experiencing side effects because it will take a long time for it to go away. Anyhow, you get the point. Try not to get caught up in the competition between the 2 and if you are interested, just ask your doctor for an objective assessment of the 2 drugs. I just got back from our Annual Urology Meeting in San Francisco and there were so many studies and so much attention paid to weight gain and prostate cancer (made the front cover of the USA Today newspaper on May 11, 2004) that I thought it would be appropriate to repeat a section from the last issue of PAACT plus add a little more to it from the meeting. So here goesвЂ¦ 23) CAN LOSING WEIGHT OR MAINTAINING A HEALTHY WEIGHT BEFORE OR AFTER RADICAL PROSTATECTOMY OR OTHER TREATMENT BE A BENEFIT FOR ME? Here we go again and again. I am often asked what kinds of lifestyle changes or supplements are best after being diagnosed with prostate cancer. One of the best answers continues to be that maintaining a healthy weight is one of the best things that you can do for yourself. However, this is not an easy thing to do. Ask your doctor to continually monitor your body mass index (BMI), which is your weight in pounds divided by your height in inches squared mul2 tiplied by 704 (pounds/inches x 704). For example, I am 195 pounds on a good day and I am 6 foot 1 inches tall or 73 inches tall (which was an initially impressive height when I was asking my future wife out on a date). Thus, my BMI = 25.8 (my goal is to get to 25.0 or less - we all need to work on this). The higher the value the more we become concerned. In other words, a BMI of 25 to 29 is considered вЂњoverweightвЂќ and a BMI of 30 or more is considered вЂњobese.вЂќ This is a fast test but it is not a perfect test. For example, if you have a lot of muscle mass or lift weights there is a higher chance that your BMI is falsely elevated (as in my case because I have an incredible Hulk like body, in my dreams mostly). Regardless, BMI is still one of the fastest ways to determine how you are doing, because as the BMI approaches 30 or more it is a good indicator of a potential problem. Another good method I use to monitor a patientвЂ™s weight is by using the WHR or Waist-toHip ratio. This is as simple as it sounds. We measure your waist and hip (waist divided by hip = W/H) and the larger the number the more we become concerned. There are no magic numbers or cut off values for WHR. I just like to measure a patientвЂ™s WHR and compare his/her recent measurement to his/her past measurement. Simply put, if your number increases in time this means that your belly or abdominal fat tissue is probably increasing in size and this is not a good thing. So, letвЂ™s get to the scary recent research, which may change the way we treat patients being treated for prostate cancer. Two new studies in the February issue of the Journal of Clinical Oncology were actually released early by the journal itself. Researchers (Freedland SJ, et al. & Amling CL, et al. = 2 cool guys and good researchers) essentially found that out of 1000s of men being treated for radical prostatectomy there was a significantly increased risk of more aggressive prostate cancers and biochemical failure in the more obese men. In other words, it seems that obesity increases the risk of a man experiencing recurrence after being treated with surgery. The other scary finding was that the number of obese men having surgery for prostate cancer seems to have doubled in the last 10 years!!! What should be learned from these studies??? Men need to continue to discuss ways of losing weight or maintaining a healthy weight with their doctor after being diagnosed with prostate cancer. It is amazing to me that some men focus on some conflicting data that may suggest that obesity is slightly protective against getting prostate cancer. However, this is not the point because whether or not obesity increases or decreases your risk of getting prostate cancer is not the issue, because the research strongly suggests that obesity increases the risk of dying earlier from most diseases and this is the point that needs to be stressed. It is kind of like arguing whether or not seat belts increase the risk of bruising your chest in a car accident. The point is that wearing seat belts saves lives and not wearing seat belts increases your risk of dying in a car accident. Do not get overly obsessed at looking at the tree and forgetting about the forest all around you. Obesity is not a good thing for you if you have been diagnosed with prostate cancer. Discussing ways to reduce weight with your doctor is of primary importance after a diagnosis of prostate cancer. Again, I do not want to sit here and preach that it is easy to lose weight because it is not. In fact, 3500 calories is equal to 1 pound, which means that if you just cut your overall caloric intake by 500 calories a day (that is a lot) and do nothing else it takes about a full week to lose 1 pound!!! Man, that is slow and not very dramatic so it takes patience and commitment. However, being fit is also of primary importance because we see patients do better if they are fit first. In other words, do I think a man with a BMI of 30 that exercises 3 times a week and does not lose weight has a better chance of doing well versus another man with a BMI of 30 that doesnвЂ™t exercise at all??? You bet! Also, keep in mind that the most recent research from our Annual Meeting suggests that men with even higher BMIs of 35 or more actually may do even worse than the men with BMIs of 30-34. In other words, the higher the number the worse things can get for you. Talk to your doctor about the latest methods to lose weight from diets, weight watchersВ®, drugs, surgeryвЂ¦ 24) ARE OVER THE COUNTER ERECTILE DYSFUNCTION DIETARY SUPPLEMENTS SAFE??? A recent study from our annual urology meeting comes from a group of Canadian researchers that really had some scary results. These researchers found out of several dietary supplements for erectile dysfunction tested - it turns out that a few contained high dosages of ViagraВ® and CialisВ® - yes 2 prescription drugs that are used for erectile dysfunction. In fact, these companies sold dietary supplements that actually had a lot of prescription drug in the bottle. This is scary because some of these drugs are already a concern in men who are taking nitrate drugs or will be given nitrate drugs for heart disease because of the dangerous interaction (remember the recent Jack Nicholson and Diane Keaton movie where Jack was taking ViagraВ® and the doctor played by Keeanu Reeves asks Jack if he is taking ViagraВ® because he wanted to give him a nitrate drug for his heart attackвЂ¦), and it is a concern in men that are taking some of the alpha-blocker drugs for BPH because of the potential dangerous interaction or potential large drop in blood pressure. The point is that you may think you are buying a dietary supplement without prescription drugs in them, but some companies may secretly place prescription drugs in the bottle or may have herbal compounds that look similar to a prescription drug (Remember the PC-SPES mess from last year). Never take a dietary supplement for erectile dysfunction without first talking to your doctor! It is really that simple. (Reference: Fleshner NE, et al. American Urological Association Annual Meeting 2004, page 314, abstract #1190). 25) WHEN IS THE BEST TIME OF YEAR TO BUG MY DOCTOR ABOUT THE LATEST CLINICAL RESEARCH IN PROSTATE CANCER??? This sounds like a strange question but I have an answer to it. Patients need to realize that every year in May and June two of the largest prostate cancer meetings for researchers take place and we get a glimpse of the potential exciting and not so exciting research that will be published in medical journals in the next year or two. One meeting is called вЂњThe American Urological Association Annual Meeting or AUAвЂќ and it just took place for a week in San Francisco. The other meeting is called вЂњthe American Society of Clinical Oncology Annual Meeting or ASCOвЂќ and it will be held in June in New Orleans, LA. There are literally hundreds of studies presented at these meetings in less than a week. Again, the latest research on prostate cancer is presented, so the best time to either do your own research on these meetings or to talk to your doctor (because many doctors attend these meetings) is after the month of June. Now, of course I do not mean that you should call the office or your doctor at home or follow him/her around town. I just mean that if you have an appointment with your urologist or oncologist in June or after that make sure you ask about the latest research from the AUA and ASCO. In addition, later in the year one of the biggest radiation oncology meetings in the world generally takes place and it is called вЂњASTROвЂќ (yes, like the dog from the Jetsons cartoon), and you can ask your doctor about this meeting. In addition, after these meetings are concluded, most medical libraries contain a copy of the actual booklet from these meetings, which summarizes all of the latest research or the official web-sites of these organizations will post several research articles. Therefore, I cannot stress enough in taking some time to ask or research yourself the latest studies from these meetings. Anyhow, have a safe and healthy start to your summer and I look forward to the next issue where we will talk about more stuff. Also, I do not want to leave this issue without congratulating the University of Michigan Basketball team and the coach (Tommy A.) for winning the NIT basketball tournament this year - once again demonstrating that the University of Michigan is the most powerful academic and athletic program in the universe (and I never ever exaggerate). By the way, my next prediction is that in 2005 the University of Michigan will win the NCAA tournament in Basketball, Football, Hockey, Chess, and prostate cancer debateвЂ¦ 26) DO COX-2 INHIBITOR ARTHRITIS DRUGS SUCH AS CELEBREXВ®, VIOXXВ®, OR BEXTRAВ® HAVE ANY RECENT RESEARCH IN PROSTATE CANCER? The answer is yes and no. Yes, there is some preliminary exciting small studies that have suggested that men taking celebrexВ® for example for 1-year (200 mg twice a day) after experiencing a rise in their PSA after surgery or radiation treatment may have actually experienced a slowing of their cancer growth on these drugs as determined by their PSA change. The problem with this and other studies is that they are very small (in this case 12 patients and the article was published in the British Journal of Urology) so it is interesting but there are too few patients to draw any serious conclusions about adding one of these drugs to your program after experiencing a rising PSA. Some guys are already on these drugs for pain or for arthritis, and others are thinking about taking it. Regardless, work this thing out with your doctor or at least ask him/her about the latest data because we will see more very soon. Instead, they took simple steps proven to prevent infection вЂ“ they kept Adams warm during surgery, clipped his leg hair instead of shaving it, and administered antibiotics at the right time. MEDIA RELEASE Simple Steps Prevent Hospital Infections The Grand Rapids Press April 2004 By Rebecca Cook Not all hospitals practice them, and a surgical infection doubles a patientвЂ™s chance of dying. BELLEVUE, Wash. вЂ“ To prevent Scott AdamsвЂ™ knee surgery from getting infected, doctors at Overlake Hospital Medical Center didnвЂ™t need fancy new medicine or expensive equipment. ItвЂ™s easy, cheap and effective, but many hospitals fail to take these steps. Although fewer than 3 percent of the 30 million U.S. surgeries each year result in infection, the cost of treating it raises the cost of hospital care and insurance. And getting a surgical infection doubles a patientвЂ™s chance of dying. A national survey of 39,000 operations in 2002 found nearly half the patients did not get antibiotics at the correct time, which is one of the best ways to prevent infection. Health-care leaders are trying to reduce infection risk. By concentrating on simple preventive measures, 56 hospitals that took part in a government-sponsored project last year succeeded in cutting their overall surgical infection rate by 27 percent. The results were even more dramatic at Overlake Hospi- tal, a 337-bed community hospital in suburban Seattle. Overlake recently took part in a 13-month surgical infection prevention program run by Qualis Health, a Seattlebased health care quality improvement organization. The hospital cut its number of surgical infections by more than half, from 12 in 2002 to five in 2003. The hospital performs more than 14,000 operations annually. Adams, a jovial 31-year-old engineer who blew out his knee playing flag football, noticed the emphasis on preventing infection. вЂњPretty much anybody who put a needle in me talked about the risk of infection,вЂќ he said. His leg hair was clipped instead of shaved because shaving causes tiny skin abrasions that can let in infection. He got antibiotics exactly 20 minutes before his surgeon made the first cut, the optimum time for getting the most infection-fighting power from the drugs. And doctors and nurses kept him warm, which helped his body fight infection. Adams particularly enjoyed the вЂњbear hugger,вЂќ a comfortable puffy blanket filled with warm air, that he wore during surgery. вЂњIвЂ™ve got to get one of those for me at home,вЂќ Adams said. He was recovering comfortably and infection-free a few days after his anterior cruciate ligament (ACL) reconstruction surgery. вЂњIвЂ™ll be back playing football again next year,вЂќ he predicted. About 780,000 surgeries lead to infections in the United States each year, about 2.6 percent of the total. A 1992 analysis published in the medical journal вЂњHospital InfectionsвЂќ found a surgical infection adds an average of $3,152 to the patientвЂ™s hospital bill. Other studies estimate that 40 percent to 60 percent of surgical infections are preventable. The most powerful preventive medicine is antibiotics, given within an hour of incision. Give the drugs too early or too late, and they will wear off or wonвЂ™t get into the bloodstream fast enough to work. This isnвЂ™t new information. Studies dating to 1957 have told doctors about the need for well-timed antibiotics. So whatвЂ™s the holdup? вЂњThere are problems translating good research into actual practice,вЂќ said Dr. Dale Bratzler, principle clinical coordi- nator for the Oklahoma Foundation on Medical Quality and a leader of the national Surgical Infection Prevention Project. He is working with the authors of major antibiotic studies to set consistent national guidelines. With 10,000 studies published every year, вЂњthere is no physician that can keep up with all the publications,вЂќ Bratzler said. вЂњWe need to make it more systematic.вЂќ He said the best thing patients can do to protect themselves is to ask their surgeons about antibiotic treatment and make sure to explain any drug allergies. Also, general good nutrition and health will help, he said. The healthier a patient is going into surgery, the smaller the chance of infection. LAC-PAACT 1UPDATE By Gregory H. Teufel, Esq., Chairman2 We have been in contact lately with an inmate in a Montana prison facing the unique challenge of seeking reasonable medical care for his prostate cancer over the resistance of an uncooperative warden and prison medical staff. We are providing him with some informal thoughts and guidance and will keep you updated on the status and hopefully the successful outcome of his struggle to obtain reasonable healthcare. We have also become aware of a patient of Dr. BahnвЂ™s in California who was recently denied coverage by Blue Shield for cryosurgery performed in November 2003. This is the first cryo denial we have heard of in quite a while. We wish him the best and will keep you updated on the status of that case as well. We have recently received a draft copy of a House Concurrent Resolution sponsored by Rep. Nathan Deal (R-GA), which states as follows: вЂњExpressing the sense of Congress with respect to the need to pro1 LAC-PAACT is PAACTвЂ™s legal advisory committee. Despite the name of the committee, for various reasons, we generally cannot give you legal advice or act as your personal attorney. Please do not consider anything in this article as legal advice. If you want legal advice, I encourage you to consult a lawyer in your state, so that your specific situation and local laws can be considered. 2 Gregory H. Teufel, Esq. is a partner in the Litigation Department of Schnader Harrison Segal & Lewis LLP's Pittsburgh office. The views expressed are those of Mr. Teufel personally and not of the firm. vide prostate cancer patients with meaningful access to information on treatment options, and for other purposes. Whereas in 2004, it is estimated that approximately 230,000 new cases of prostate cancer will be diagnosed in the United States, and nearly 30,000 men in the United States will die from prostate cancer; Whereas prostate cancer is the second leading cause of cancer death in men in the United States; Whereas over $4,700,000,000 is spent annually in the United States in direct treatment costs for prostate cancer; Whereas African American men are diagnosed with and die from prostate cancer more frequently than men of other ethnic backgrounds; Whereas increased education among health care providers and patients regarding the need for prostate cancer screening tests has resulted in the diagnosis of approximately 86 percent of prostate cancer patients before the cancerous cells have spread appreciably beyond the prostate gland, thereby enhancing the odds of successful treatment; Whereas the potential complication rates for significant side effects vary among the most common forms of treatment for prostate cancer; Whereas prostate cancer often strikes elderly people in the United States, highlighting the importance of balancing the potential benefits and risks of various treatments on an individual basis; and Whereas Congress as a whole, and Members of Congress as individuals, are in unique positions to support the fight against prostate cancer, to help raise public awareness about the need to make screening tests available to all people at risk for prostate cancer, and to provide prostate cancer patients with adequate information to assess the relative benefits and risks of treatment options: Now, therefore, be it Resolved by the House of Representatives (the Senate concurring), That it is the sense of the Congress that (1) national and community organizations and health care providers have played a commendable role in supplying information concerning the importance of screening for prostate cancer and the treatment options for patients with prostate cancer; and (2) the Federal Government and the States have a moral responsibility to ensure that health care providers supply prostate cancer patients with appropriate information and any other tools necessary for prostate cancer patients to receive readily understandable descriptions of the advantages, disadvantages, benefits, and risks of all medically efficacious treatments for prostate cancer, including brachytherapy, hormonal treatments, external beam radiation, chemotherapy, surgery, and watchful waiting.вЂќ We have written to Rep. Deal applauding his efforts to ensure patients are aware and understand the treatment options available to them for prostate cancer and, further to that purpose, we have asked that he consider including cryosurgical ablation of the prostate among the listed efficacious treatment options. We will let you know whether the final version of this resolution, which is non-binding and has no actual legal force, is amended to include mention of cryosurgical ablation of the prostate as well. Failure to mention that procedure would possibly hinder efforts of those who chose that treatment option and who have been denied coverage, while mentioning it might help them. We want to keep you aware that the LAC-PAACT is here to help you. We are particularly helpful in addressing insurance and Medicare coverage issues related to advanced cancer treatments. Please do not hesitate to contact us regarding any coverage or other legal issues related to advanced cancer treatments. We are creating another supplement to the LACPAACT kit. Expect the new supplement to be available soon. Sorry that we are long overdue on updating the kit. If you have been denied coverage for an advanced cancer treatment, be sure to let us know and we will see if there is anything we can do to help. Contact LAC-PAACT If you have any questions or comments, or any suggestions about how LAC-PAACT can best serve your needs, please do not hesitate to contact me. The preferred method to contact me is via email at [email protected] You can also call me at work at (412) 577-5289, home (412) 421-7123, or on my cell phone (412) 596-6316, or send me a letter at Schnader Harrison Segal & Lewis LLP, Suite 2700, Fifth Avenue Place, 120 Fifth Ave., Pittsburgh, PA 15222 or a fax at (412) 765-3858. Please note that requests for the LAC-PAACT kit should be addressed to PAACT. Contact information for PAACT is on page 2 of this Newsletter. Please remember that this article is not legal advice and I cannot generally give you legal advice or become your personal attorney. Board Certification What Does It Mean? By Stephen Barrett, M.D. December 5, 2000 Question I live in a Florida city that has a high percentage of retired people and as a consequence, a large medical services population. In their advertising it seems almost all the MD's are "Board Certified," but the board is never mentioned. Somewhere, I heard that there are a few boards considered to be "legitimate" that require a high level of experience and recommendation, and who have passed stringent exams in their specialty. Somewhere I learned there are boards whose main purpose is to allow the use of "Board Certified" after the name. Could you comment on this? Is there a way to tell the difference? Answer Because the scope of modern medical knowledge is vast, most medical school graduates take additional training before entering clinical practice. Those choosing to become specialists take at least three years of residency training during which they are designated as PGY 1 (postgraduate-year-one resident), PGY 2 (postgraduate-year-two resident), and so on. The recognized standard-setting organization is the American Board of Medical Specialties (ABMS), which is composed of 24 primary medical specialty boards and six associate members: the American Hospital Association, American Medical Association, Association of American Medical Colleges, Council of Medical Specialty Societies, Federation of State Medical Boards of the United States, and National Board of Medical Examiners. The American Osteopathic Association (AOA) sets standards for osteopathic physicians (DOs) who undergo residency training at osteopathic institutions. (ABMS also certifies DOs who train at MD-run programs.) Medical specialty boards require high standards of training and performance and ensure them by rigid examinations. Successful applicants receive diplomas and are considered "board-certified." They are also referred to as "diplomates" in their particular specialties. The number of ABMS-approved credentials has risen sharply during the past ten years. Certificates are now available for 37 specialties and about 75 subspecialties . Most certificates expire within seven or ten years and require reexamination for renewal. Physicians who complete all requirements for certification except the examination may be identified as "board-eligible." Although the American Board of Medical Specialties has officially abandoned the term, it is still in common use. In 1995, Medical Economics magazine reported that more than 75 boards not ABMS- or AOA-affiliated had issued certificates to thousands of physicians. Although a few of these self-designated boards are run legitimately and may eventually achieve ABMS or AOA recognition, most do not require residency training in their specialty. The author stated that "some physicians use fringe board certification to attract patients, who usually don't know the difference. . . . And only a handful of states restrict the advertising of board certifications or specialties."  Certification by any of the following suggests that a practitioner is involved with dubious methods: вЂў вЂў вЂў вЂў American Board of Chelation Therapy American Board of Holistic Medicine American Board of Environmental Medicine International Board of Environmental Medicine Most physicians identified as specialists in the Yellow Pages have completed accredited specialty training. However, telephone directory publishers rarely attempt to verify credentials, so self-proclaimed specialists may be listed also. The ABMS Verification Service provides a simple way to check whether a doctor has ABMS-recognized certification. The Board also has been placing lists of board-certified physicians in many telephone directories, but many board-certified physicians are not included because they do not wish to pay the required fee (over $200 per year). Reference 1. ABMS Web site, July 1998. The list spans seven pages. To navigate, use the "Next Page Down" link at the bottom of each page. 2. Terry T. Visit Vegas! Get your boards while you're there. Medical Economics 72(3):26-36, 1995.
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