The Avodart® - Proscar® DebateDecember 2013
By William Faloon
Worst Case Scenario: Assume We Are Wrong?
We have provided solid evidence that Avodart® (dutasteride) or Proscar® (finasteride) do not increase high-grade prostate cancer risk. But what if we are wrong?
Here is what would happen under such circumstance using the Prostate Cancer Prevention Trial (PCPT) study for reference:
- More than 238,000 men will be diagnosed with prostate cancer in 2013.34
- If all these men had taken Proscar®, about 57,120 of them (24%) would avoid it.
- Based upon the results of the PCPT study, if none of these men took Proscar®, 52,598 would have high-grade (Gleason score ≥ 7) disease as opposed to 65,840 who would be diagnosed with high-grade disease (assuming Proscar® somehow causes high-grade disease).32
- So each year, 57,120 men would avoid prostate cancer altogether, but 8,720 more men would be diagnosed with high-grade disease (assuming Proscar® (or Avodart®) really cause it).
- Under this worst case scenario, one could argue there would be greater numbers of beneficial outcomes (as opposed to adverse ones) if all men took Proscar® (or Avodart®).
We at Life Extension® don’t recommend these drugs for all men. They appear effective for reducing risk of low-grade prostate cancer and helping to better diagnose high-grade prostate cancer by shrinking prostate gland volume and better enabling the PSA marker to identify high-grade malignancy.
Our opposition might state that most men over age 69 with low-grade prostate cancer don’t have to be concerned because they are likely to die of something else before their prostate cancer spreads to other parts of the body.
While this may be the case for typical men over age 69, it’s a far cry from the longevity objectives of Life Extension members. And low-grade prostate cancers do kill some men and are the most prevalent form of prostate cancer diagnosed.
With all due respect to Patrick Walsh, MD, who is advocating that urologists change the medical classification of low-grade prostate malignancy to remove the word “cancer” so as not to create psychological stress in aging men, and to avoid overly aggressive medical procedures, pretending low-grade malignancies are something else will not make them go away.
The documentation presented in this issue of Life Extension magazine® that low-grade prostate cancers may be reversible in some men using a variety of inexpensive drugs, nutrients and dietary changes mandates that aging men have annual PSA blood tests and other diagnostics needed to assess the health of their prostate gland. If high-grade disease is detected, it is curable in its early stages, whereas the more prevalent low-grade prostate cancers are often controllable or reversible without requiring side effect-prone treatments.
New 18-Year Study Confirms Benefits of Finasteride
As we were finalizing this article, a new study was published in the New England Journal of Medicine that further verified the safety and efficacy of finasteride in the prevention of prostate cancer.35
This study meticulously followed all the men in the original Prostate Cancer Prevention Trial for up to 18 years.35
The findings showed that long-term prostate cancer risk was reduced by about 33% in men who had received finasteride compared to the placebo group.35 This approximate 33% reduction in prostate cancer incidence was greater than the original study findings that looked at these same men over a shorter (7-year) time period.3,35
Of men who did develop prostate cancer, those in the finasteride group had a 17% greater chance of high-grade disease, yet long-term mortality data was virtually identical in both groups.3 This adds a tremendous weight of evidence as to the safety of finasteride since if it really caused an increase in high-grade disease, more men in the finasteride group would be expected to have died sooner.
In addition, the 17% greater chance of high-grade disease seen in this long-term follow up was far lower than the 25.5% seen in the early phase of the Prostate Cancer Prevention Trial.3,35 The authors of this new study emphasized that the reason that more men in the finasteride group were found with high grade disease was “detection bias.” As we stated earlier, 5-alpha reductase inhibitor drugs like finasteride (Proscar®) and dutasteride (Avodart®), markedly shrink prostate gland volume, thus making detection of tumors much more efficient.14 Proscar® or Avodart® do not appear to cause high-grade tumors, they just make finding them much easier, which is of significant importance in obtaining curative treatment before these aggressive cancer cells escape from the confines of the prostate gland.
An editorial accompanying this New England Journal of Medicine study stated:
“For men who choose regular prostate cancer screening, the use of finasteride meaningfully reduces the risk of prostate cancer and thus the morbidity associated with treatment of the disease.” 36
In maintaining the conventional party line that recommends against PSA screening, the editorial also stated:
“Men who are aware of and understand the benefits, risks, and uncertainties associated with the use of finasteride for prevention may make a rational decision to take the drug to reduce the potential harms of PSA screening. Of course, another way to reduce the harm of screening is to choose not to be screened.” 36
Said differently, the author of this editorial is stubbornly sticking to irrational conventional dogma that advises men to avoid prostate cancer screening because of side effects that may occur during needle biopsy or treatment. The data the author is reporting, however, clearly shows that by taking just finasteride alone for a relatively short time period, an aging man can reduce the risk he will ever contract prostate cancer (and thus the need for “harmful” diagnostics and treatment) by 33%!35
There is evidence to suggest that prostate cancer risk reduction would have been greater had these men continued taking finasteride. As Life Extension reveals in this month’s issue, there are many other steps men can take to slash low- and high-grade prostate cancer risk, and at the same time, reduce overall incidence of degenerative disease.
Medical Technology Is Regressing!
We are witnessing a lethal regression in the use of technologies that could spare tens of thousands of aging men from prostate cancer deaths each year. Instead of seeking to incorporate proven methods to reduce side effects associated with conventional treatment, doctors are telling patients today to avoid screening. While this will save Medicare and Medicaid big dollars in the short-term, the epidemic of metastatic prostate cancer that will manifest in 5-10 years will extract a horrific toll of human suffering, premature death, and catastrophic costs to government healthcare systems.
Treating metastatic prostate cancer is a prolonged and extremely expensive process. Death can be postponed, but the side effects of treating advanced disease are often harsh.
A Real World Example of What This Nation Faces
When taking on the federal government and medical establishment like Life Extension routinely does, we seek to be meticulously accurate in everything we publish. Our credibility is at stake in every one of these scientific debates.
A friend of mine used to have his blood tested annually using Life Extension’s comprehensive Male Panel that includes PSA. He retired 7 years ago at the age of 60 and received “free” healthcare from his union (and later Medicare). So he stopped using Life Extension’s testing and instead let his doctor prescribe annual blood tests.
Each year he would have his blood tested, and each year his doctor said his results were fine. What my friend did not know is that the doctor stopped testing for PSA. When my friend started developing health problems his wife contacted me and said his doctors could not figure out what was wrong. I suggested he have his blood tested using our comprehensive Male Panel.
His PSA came back at 31. He appears to have metastatic disease and is undergoing aggressive treatment. He wrote me that he was shocked his doctor had not tested for PSA.
What happened to my friend is occurring throughout the United States right now. Doctors are following federal government guidelines and are intentionally omitting PSA screening. This devolution in health care must be reversed.
Startling Statistic Reported by New England Journal of Medicine
In reporting on the long-term data showing that finasteride slashed prostate cancer risk, the authors of the New England Journal of Medicine editorial opened by stating:
“With the advent of prostate specific antigen (PSA) testing in the 1980s, the rate of diagnosis of prostate cancer rose dramatically…The timing and magnitude of the 44% reduction in prostate cancer mortality after the widespread adoption of PSA testing suggests that both screening and treatment improvements have contributed to this decline.” 35
The authors then go on to list all the side effects of treatment that prompted the federal government to suggest men should avoid PSA screening. Recommending against PSA screening will go down as one of the great travesties in medical history.
Prostate cancer is one of the most prevalent malignancies striking aging men. Technology developed four decades ago has resulted in a steep drop in prostate cancer-related deaths. Yet our federal government proclaimed in 2012 that this technology (PSA screening) should be abandoned.
Don’t be victimized by this nonsense.
- Andriole G, Bruchovsky N, Chung LW, et al. Dihydrotestosterone and the prostate: the scientific rationale for 5alpha-reductase inhibitors in the treatment of benign prostatic hyperplasia. J Urol. 2004 Oct;172(4 Pt 1):1399-403.
- Available at: http://www.cancer.gov/newscenter/qa/2008/PCPTQandA. Accessed October 1, 2013.
- Thompson IM, Goodman PJ, Tangen CM, et al. The influence of finasteride on the development of prostate cancer. N Engl J Med. 2003 Jul 17;349(3):215-24.
- Andriole GL, Bostwick DG, Brawley OW, et al; REDUCE Study Group. Effect of dutasteride on the risk of prostate cancer. N Engl J Med. 2010 Apr 1;362(13):1192-202.
- Available at: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258424.htm. Accessed September 28, 2013.
- Tewari A, Divine G, Chang P, et al. Long-term survival in men with high grade prostate cancer: a comparison between conservative treatment, radiation therapy and radical prostatectomy--a propensity scoring approach. J Urol. 2007 Mar;177(3):911-5.
- Available at: http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-diagnosis. Accessed September 28, 2013.
- Available at: http://prostate-cancer.org/the-gleason-score-a-significant-biologic-manifestation-of-prostate-cancer-aggressiveness-on-biopsy/. Accessed September 2, 2013.
- Shapiro RH, Johnstone PA. Risk of Gleason grade inaccuracies in prostate cancer patients eligible for active surveillance. Urology. 2012 Sep;80(3):661-6.
- Moreira Leite KR, Camara-Lopes LH, Dall’Oglio MF, et al. Upgrading the Gleason score in extended prostate biopsy: implications for treatment choice. Int J Radiat Oncol Biol Phys. 2009 Feb 1;73(2):353-6.
- Berglund RK, Masterson TA, Vora KC, Eggener SE, Eastham JA, Guillonneau BD. Pathological upgrading and up staging with immediate repeat biopsy in patients eligible for active surveillance. J Urol. 2008 Nov;180(5):1964-7.
- Nayyar R, Singh P, Gupta NP, et al. Upgrading of Gleason score on radical prostatectomy specimen compared to the pre-operative needle core biopsy: an Indian experience. Indian J Urol. 2010 Jan-Mar;26(1):56-9.
- Bostwick DG, Qian J, Civantos F, Roehrborn CG, Montironi R. Does finasteride alter the pathology of the prostate and cancer grading? Clin Prostate Cancer. 2004 Mar;2(4):228-35.
- Available at: http://www.medscape.com/viewarticle/705804. Accessed September 29, 2013.
- Available at: http://cancerpreventionresearch.aacrjournals.org/content/1/3/174.full. Accessed September 29, 2013.
- Kaplan SA, Ghafar MA, Volpe MA, Lam JS, Fromer D, Te AE. PSA response to finasteride challenge in men with a serum PSA greater than 4 ng/ml and previous negative prostate biopsy: preliminary study. Urology. 2002 Sep;60(3):464-8.
- Handel LN, Agarwal S, Schiff SF, Kelty PJ, Cohen SI. Can effect of finasteride on prostate-specific antigen be used to decrease repeat prostate biopsy? Urology. 2006 Dec;68(6):1220-3.
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- Krejcarek SC, Chen MH, Renshaw AA, Loffredo M, Sussman B, D’Amico AV. Prediagnostic prostate-specific antigen velocity and probability of detecting high-grade prostate cancer. Urology. 2007 Mar;69(3):515-9.
- Taira AV, Merrick GS, Galbreath RW, et al. Performance of transperineal template-guided mapping biopsy in detecting prostate cancer in the initial and repeat biopsy setting. Prostate Cancer Prostatic Dis. 2010 Mar;13(1):71-7.
- Cohen YC, Liu KS, Heyden NL, et al. Detection bias due to the effect of finasteride on prostate volume: a modeling approach for analysis of the Prostate Cancer Prevention Trial. J Natl Cancer Inst. 2007 Sep 19;99(18):1366-74.
- Kulkarni GS, Al-Azab R, Lockwood G, et al. Evidence for a biopsy derived grade artifact among larger prostate glands. J Urol. 2006 Feb;175(2):505-9
- Lucia MS, Epstein JI, Goodman PJ, et al. Finasteride and high-grade prostate cancer in the Prostate Cancer Prevention Trial. J Natl Cancer Inst. 2007 Sep 19;99(18):1375-83.
- Monga N, Sayani A, Rubinger DA, Wilson TH, Su Z. The effect of dutasteride on the detection of prostate cancer: A set of meta-analyses. Can Urol Assoc J. 2013 Mar-Apr;7(3-4):E161-7.
- Nelles JL, Hu WY, Prins GS. Estrogen action and prostate cancer. Expert Rev Endocrinol Metab. 2011 May;6(3):437-451.
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- Kristal AR, Till C, Tangen CM, et al. Associations of serum sex steroid hormone and 5α-androstane-3α,17β-diol glucuronide concentrations with prostate cancer risk among men treated with finasteride. Cancer Epidemiol Biomarkers Prev. 2012 Oct;21(10):1823-32.
- Available at: http://www.fda.gov/drugs/drugsafety/ucm258314.htm. Accessed September 6, 2013.
- Fleshner NE, Lucia MS, Egerdie B, et al. Dutasteride in localised prostate cancer management: the REDEEM randomised, double-blind, placebo-controlled trial. Lancet. 2012 Mar 24;379(9821):1103-11.
- Shelton PQ, Ivanowicz AN, Wakeman CM, et al. Active surveillance of very-low-risk prostate cancer in the setting of active treatment of benign prostatic hyperplasia with 5α-reductase inhibitors. Urology. 2013 May;81(5):979-84.
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