Why Prostate Cancer Testing and Treatment is a Public Health Disaster--How the herd mentality created a false prostate cancer narrative.

(Editor’s note: Dr. Bert Vorstman, the “uro-heretic,” is well-known to the readers of TheActiveSurveillor.com. His controversial columns have been among the most read in this newsletter—often to the dismay of his critics. He’s teaming up with Ron Piana, co-author with Richard Ablin, PhD, of “The Great Prostate Hoax,” the classic expose of the approval of the PSA blood test. Grab a cuppa of Java, buckle up, and be prepared for a wild ride. If you disagree with Vorstman and Piana, please feel free to comment or email to mailto:pros8canswers@gmail.com but be civil and do check with your urologist about the authors’ views.—Howard Wolinsky)

By Bert Vorstman MD, and Ron Piana

Patients expect their medical care to be delivered on the basis of brutal honesty, irrefutable scientific evidence and in their very best interests. However, about half of all medical treatments are unknown for effectiveness while only about a third are proven to be beneficial or likely to be beneficial. Although prostate cancer recommendations are presented very convincingly by medical “experts” as beneficial, are they trustworthy?  

Are all prostate cancers a danger to health?

For years, the urology community has claimed that about 1 in 8 men will be diagnosed with prostate cancer in their lifetime, that all prostate cancers are potentially deadly and that early detection and treatment save lives. But are these claims really true?

Certainly, the word cancer is a frightening label that not only sounds potentially deadly but the mere mention of the word instantly floods your brain with mind-numbing fear, helplessness and doubt. And, in that same scary moment, all sorts of chilling questions pop up. Is it true? How bad is it? What do I have to do? How long do I have? And so on. Breathless, overwhelmed and desperate, the word cancer can bring you to your knees and make you very vulnerable to misinformation, false hope and false promises.

(Bert Vorstman, MD, (top) and author Ron Piana.)

In sharp contrast, however, the prostate cancer label is much more of a frightening mental assault for both patients and many doctors than the tag actually deserves. In fact, not only are prostate cancers very common with an incidence approximating one’s age from about 50 years on (so that about 50 percent of 50 year-olds and so on can have areas of cancer) but most men with prostate cancer do not die from it because of two major reasons. First, one of these so-called cancers fails to behave as cancerous and second, many prostate cancers grow incredibly slowly and are outlived. Therefore, is having your prostate “checked” a danger to health?

Which prostate “cancer” fails to behave as cancerous? 

The very common grade 3 “cancer” (as in the Gleason 3+3 = 6 “cancer”) does not behave as cancerous. This grade 3 disease was initially believed to be a low-grade, low-risk or “mild” cancer purely on the basis of its low-power microscopic appearances. Years later however, it was determined by several investigators that the genetic pathways for cancer development and spread in the grade 3 were inactive. Therefore, with inactive genetic pathways for cancer development and spread, the grade 3 is not a cancer. Additionally, there’s no evidence that the grade 3 genetic pathways can routinely activate and transform into a higher grade or meaningful cancer.  

Why does the grade 3 disease still have a cancer label? 

The cancer label for the grade 3 should have been dropped years ago when evidence demonstrated that its genetic pathways for cancer development and spread were turned off. Despite solid data, there are at least three self-interest groups that have lobbied strongly against the removal of this false cancer label. First, urologists because of the misguided notion that those diagnosed with the Gleason 3+3=6 “cancer” and on active surveillance (AS) will quit this monitoring program - despite the facts that the grade 3 is not a cancer (or even a low-risk cancer) and, that there’s no scientific evidence that AS saves significant numbers of lives; second, prostate cancer “support” groups because of their reprehensible concern that if the grade 3’s “cancer” label is removed that some of their funding sources may dry up; third, the medical-industrial-insurance-complex because this group answers primarily to shareholders with a profits-before-patients mentality. This Big Money group are the original influencers in healthcare. By providing money to medical groups for “studies” they can manipulate the information and treatment narratives for financial gain - and, at patient expense.

As a consequence of these various groups’ shameful unwillingness to drop the fake cancer label from the grade 3 disease, the grade 3 is still labeled as a cancer; prostate cancer statistics are inflated; the life insurance industry can cancel or deny the life policies of individuals diagnosed with the grade 3 pseudo-cancer and, urologists can continue to hoodwink men into believing that they have a cancer that needs “careful” monitoring and or, “treatment”. Clearly, these grade-3-treated victims are survivors of an unnecessary treatment and not cancer survivors. 

Which prostate cancers grow very slowly? 

The slow-growing prostate cancers are mostly the low-grade, low-risk group such as the 3+4s. These cancers have extremely sluggish growth rates with a mean cell doubling time of 479+/56 days. This rate of cell division means that it can take 40 years or more for the growth to reach one centimeter (about half an inch) in diameter from the time of cell change (mutation). 

Which prostate cancers are potentially deadly? 

Clearly, not all prostate cancers are equal as only the 10 to 15 percent of high-grade prostate cancers are responsible for the 30,000 or so U.S. deaths annually. This number may actually be dropping somewhat because of better treatment of comorbidities such as heart disease. Yet, these deaths are used to promote another scare tactic - that prostate cancer is the second leading cause of cancer deaths (after lung cancer). In contrast, however, most prostate cancers do not lead to death. And, even the natural history of high-grade metastatic prostate cancers is unpredictable as some patients may live 10 years or more. 

Additionally, Black men seem to have a 67 percent higher risk of developing prostate cancer than White men. A greater incidence of aggressive cancer may explain the 2.3 times increased risk of mortality compared to that of White men.

Is the call for early detection and treatment of prostate cancer credible?

Given that the Gleason 6 is not a cancer and that most prostate cancers can be outlived, what is the truth about early detection and treatment? Certainly, publicizing celebrity prostate cancer diagnoses gives testing and treatment an air of believability. But, is the testing and treatment journey safe and save many lives? Or, is it a hard slog that only harms countless men? Let's follow in the footsteps of a typical patient entering the prostate cancer testing and treatment arena and see what the evidence shows. 

Why the prostate exam is undependable.

The digital rectal examination (DRE) Is one of the first tests a patient will be subjected to in a routine “check” for prostate cancer. The prostate sits at the base of the bladder and is easily felt by putting a finger in the rectum. Because prostate cancer can feel firm or hard to touch (but not always), the physician tries to judge whether the prostate feels “abnormal” and if so, to what extent. However, this simple test is based on a judgment or estimate of what the practitioner “feels” and is not specific. Additionally, other diseases like chronic prostatitis, granulomatous prostatitis and prostatic calculi (stones) can feel hard like cancer making the DRE undependable. Not only is the DRE unreliable but, subjecting patients to 6 monthly DREs is absolutely illogical when most prostate cancers grow very slowly, taking 40 years or more to reach one centimeter in size. Two good reasons why some physicians have abandoned this test. 

Why the PSA blood test is highly unreliable.

The PSA (prostate specific antigen) is promoted by physicians as a simple and reliable blood test to screen for prostate cancer. The sad truth, however, is that this test is highly unreliable and has simply steered countless men towards risky and inaccurate prostate needle biopsies. This process and the shameful manner in which the untrustworthy PSA became a standard-of-care test for prostate cancer has been well detailed by Ablin and Piana in their book, “The Great Prostate Hoax”. The approval of the PSA blood test for prostate cancer screening in 1994 by the FDA (Food and Drug Administration) was a gigantic agency misstep as the PSA test had already been proven to be highly ineffective. In fact, the PSA test has a false-positive rate of 78 percent because it is neither specific to the prostate or specific to prostate cancer (the specific label for the PSA is simply a naked lie); its so-called cut-off value of 0-4 n g/ml (“normal” range) is an offhand and misleading metric; a PSA above 4 does not mean a diagnosis of prostate cancer; large prostates commonly and normally generate high PSAs; many “cancers'' are detected by chance during testing for an elevated PSA because the PSA was generated by the benign prostatic enlargement and not the cancer within; the PSA value can be artificially raised or lowered without a cancer being present or progressing; the PSA cannot distinguish between aggressive and non-aggressive cancers; lowering the PSA does not lower a risk of developing a cancer and, the subset of high-grade, aggressive and potentially deadly cancers may produce little or no PSA and go undetected. The bottom line is that a high PSA doesn’t mean you have prostate cancer (or to what degree) while a normal PSA doesn’t mean that you don’t have prostate cancer. On the other hand, PSA monitoring of your status after a diagnosis of prostate cancer can be more reliable.

PSA-testing fails to save significant numbers of lives.

Unsurprisingly, because the PSA test is so highly unreliable when used for prostate cancer screening, urologists' own clinical studies in 2009 determined that PSA testing failed to save significant numbers of lives. Years later, another review of PSA-based screening for prostate cancer also concluded that PSA testing failed to extend life significantly. As well, there’s no evidence that the use of other PSA-type markers such as PSA derivatives - the free PSA and percent free PSA, PSA density, PSA kinetics/PSA doubling time, age-related PSA, Pro PSA and PCA3 have led to significant life-extension. 

Why prostate cancer biomarkers are unreliable.

Biomarkers are measurable indicators of some biological state or condition. Aside from the undependable PSA there are many other urinary and blood genetic and molecular markers such as the PTEN that are used to try and detect early prostate cancer or to try and predict which ones could progress. There are also some tests that compile weighted scores of several variants (polygenic testing and risk scores). These tests are commonly recommended to better understand the biopsy results and try to prevent over-testing and over-treatment of low-grade cancers. However, there's no evidence that any of these markers are accurate enough to estimate which prostate cancers are potentially deadly or may become deadly so as to alter care and save significant numbers of lives.

Why the prostate needle biopsy is risky and unreliable.

An abnormal DRE, PSA or other type of marker, although totally unreliable for prostate cancer screening and early detection of disease, almost always leads to an untrustworthy prostate needle biopsy. Irresponsibly considered a standard-of-care, the ultrasound-guided 12-core needle biopsy of the prostate is uncomfortable and risky. Predictably, the passing of a needle through a dirty rectum into the prostate (as in the trans-rectal technique) can result in bleeding (sometimes needing treatment) and life-threatening septicemia. And, although the biopsy is ultrasound-guided, the ultrasound can’t “see” a cancer and its only use is to steer the needle into six different areas of the prostate. Even more concerning is the fact that both the trans-rectal and trans-perineal biopsy techniques are associated with huge sampling errors. When the volume of the 12-cores is measured against the volume of the prostate, these biopsies sample only about 0.1 percent of the prostate. A situation made even more embarrassing by the fact that prostate cancer is typically multifocal (often occurring in some 1-5 areas) so that a 0.1 percent sampling of your prostate can easily miss cancers that may be located in the 99.9 percent rest of the prostate. As well, prostate tissue is often impacted by field effects. A condition where prostate tissue has been triggered (by some unknown agent) to become cancerous at some point in the future. 

Not only does the grossly unscientific 0.1 percent random sampling technique miss prostate cancers but it also explains why “progression” or “upgrading” is far more likely to reflect only an appearance of progression and upgrading because of the detection of a previously missed cancer. As well, it explains why additional cancers are found after radical prostatectomy specimens are examined and why annual biopsies for those electing AS is insultingly inaccurate. And, as for upgrading, there’s no reproducible scientific evidence that a lower grade of prostate cancer can routinely “upgrade” to a higher grade. 

Why MRI screening of the prostate can be more reliable.

The non-contrast MRI by a radiologist with expertise in prostate MRIs has almost put an end to the embarrassingly risky and unscientific ultrasound-guided 12-core needle biopsy for prostate cancer detection and AS. Although not all prostate MRIs are equal, the right machine in the right hands can evaluate 100 percent of the prostate for high-grade disease while ignoring low-grade disease which is invariably non life-threatening. The MRI study is particularly helpful for detecting the 10-15 percent of high-grade prostate cancers that are potentially lethal. These prostate cancer MRI findings are categorized according to the PI-RADS scoring (1-5) system with high-grade areas classified as PI-RADS 4 or 5. But, like the complex Gleason pathological classification system for prostate cancer, the PI-RADS radiological classification system for MRI changes in the prostate is complex, prone to observer error and associated with false negatives and false positives. Therefore, getting a second opinion from a radiologist who does several hundred of these studies per year is highly recommended. However, although the MRI can minimize the risk of unnecessary biopsies and the detection of irrelevant low-grade disease there’s no scientific evidence that MRI-based detection of high-grade prostate cancer has led to management that saved significant numbers of lives. 

If areas of high-grade cancer are detected in the prostate MRI, the disease can be confirmed with an MRI-guided biopsy. However, although MRI-guided biopsies are superior to ultrasound-guided biopsies, most prostate biopsies are still conducted in urology offices employing a controversial fusion of MRI to ultrasound-guided biopsy technique. And, because the fusion process requires two different imaging modalities (MRI and ultrasound) undertaken at different times from each other, using software of varying capabilities and requiring a number of steps for completion, the accuracy of the fusion technique compared to that of the MRI-guided method is in question. Certainly, fusion studies incorporating senseless random biopsies of the prostate devalues the benefits of prostate MRI evaluation. And, if the fusion technique leads to a diagnosis of mainly low-risk cancers it will simply confirm the inaccuracy of this fusion technique and or, the inexperience of the physicians. 

Why are prostate biopsy reports undependable? 

After the prostate biopsies have been taken they are prepared and examined by a pathologist under low-power microscopy. If a cancer is thought to be present it will be identified by a certain pattern of growth. For prostate cancer there are normally two or more patterns of growth seen on the slide. According to the Gleason grading and scoring system the two most common patterns of growth seen are each estimated according to a 1 to 5 degree of abnormality with five being the most abnormal. The most common pattern or grade of growth seen is given as the first number. The second number represents the estimated degree of abnormality for the second most common pattern of growth. These two grades are then combined to give a Gleason score or sum. For example, if the most common pattern seen was judged to be consistent with a grade 3 and the second most common pattern a grade 4, you would see on the report a 3+4 for a Gleason score of 7. As well, other confusing details may be recorded such as perineural invasion, atypical small acinar proliferation (ASAP), prostatic intraepithelial neoplasia (PIN) and so on. However, by far, the most important details in the prostate biopsy report are the Gleason grades.

The Gleason classification system used to grade and score these various growth patterns of prostate cancer is complex. And, because it relies on a pathologist’s knowledge and interpretive skills for estimating the pattern of cancer seen, grade misclassifications and disagreements between pathologists are not uncommon. Therefore, to get a reliable report and minimize the chance of Gleason grade over-reads and under-reads, requesting a second opinion by a pathologist with expertise in prostate cancer is highly recommended. Yet, whether a prostate cancer diagnosis is reliable or not there’s no reproducible scientific evidence that shows that an accurate diagnosis leads to better treatments that save significant numbers of lives. 

Is prostate cancer staging reliable?

Prostate cancer staging is an unreliable process that uses imaging (and possibly pelvic lymph node sampling) to try and estimate whether a cancer is localized (organ-confined) or has spread. Not only is staging unnecessary for the Gleason 6 pseudo-cancer but the common imaging techniques (ultrasound, bone scans and CT scans) are recognized as being relatively insensitive for detecting small-volume cancer spread. Underscoring this concern is the fact that prostate cancer cells have been found in the bone marrow of patients with high-grade disease when it was believed that their cancer was localized to the prostate. In fact, metastases (spread) may begin when high-grade cancers are as small as 0.25 mm in size and barely detectable within the prostate. Unexpectedly, these metastatic cells can lie dormant in the bone marrow for many years before some activate and spread. Little wonder that treatments often deliver a temporary semblance of cure till metastases appear years later.

Currently, staging is done using whole body MRI to detect bony spread and the PSMA PET (prostate-specific membrane antigen positron emission tomography) scan (using either CT or MRI) to detect soft tissue or lymph node spread. Additionally, the MRI is able to indicate whether the prostate cancer is locally advanced and outside the prostate or invading the seminal vesicles. And, although requiring expertise to read, these studies are far more accurate than conventional imaging techniques and have eliminated the need for invasive pelvic lymph node sampling. However, PSMA PET scans are not foolproof as some prostate cancers do not express PSMA leading to false negatives while other cancers and non-cancers can express PSMA leading to false positive scans. And, although often described as a patient benefit to help understand potential outcomes and assist in decision-making for treatment options, there’s no scientific evidence that these MRI and PSMA tests for staging have led to disease management that was curative in the long term.

Are prostate cancer treatments effective?

The original “accepted” prostate cancer treatment was the risky open radical prostatectomy, which often confers life-altering side-effects. It entered the treatment landscape on the basis of a bare-faced lie. Johns Hopkins surgeon, H.H. Young MD claimed early diagnosis and radical cure with his “new” surgical technique and of its, “simplicity, effectiveness and the remarkably satisfactory functional results furnished”. In contrast, there was zero evidence for early diagnosis, no evidence for radical cure, two patients died and the other two were left with lifelong urinary incontinence. Shamefully however, not only did this debilitating procedure gradually become a standard-of-care but the radical prostatectomy (perineal or suprapubic approach) became a cornerstone for managing prostate cancer. 

Radiation treatment options for prostate cancer were first described a few years after the development of the radical surgical technique. Initially, these treatments were used for local control of advanced disease. Later, they were used as a primary treatment for what was believed to be localized prostate cancer. Various radiation techniques evolved beginning with radium applications (to the rectum, urethra and bladder), radium seeds and then seeds employing different radioactive agents. Subsequently, with the development of more powerful linear accelerators, external beam techniques (with and without testosterone suppression) became available. Proton beam (a type of radiation) was first used in an attempt to treat prostate cancer in 1979.

Years later, robotic prostatectomy became the preferred “cutting-edge” treatment. After a low-level clinical study in Mexico, the robotic device was FDA approved for use in gallbladder surgery in 1999 despite the robotic device failing to demonstrate clear benefits for cholecystectomy. Unsurprisingly, it soon became apparent that there was no market for robotic gallbladder removal so a search was undertaken to find a treatment that could be converted to robotics. In time, urologists were targeted as they were struggling with a new laparoscopic approach to cut out the prostate. Still mesmerized by the illusion of curative prostate cancer surgery, urologists needed little persuasion to see if the robotics tool could be used to remove the prostate. To the device-makers' relief, robotic prostatectomy was possible and they knew just how to use the FDA’s fallacious 510 K process to fast-track approval of the tool without the need for additional studies. By using the false claim that the device to be used for prostate cancer surgery was “substantially equivalent” to the device used in gallbladder surgery, the equipment was quickly approved for robotic prostatectomy in 2001 without any scientific evidence for safety or benefits. A sham approval that also ignored the great differences between gallbladder surgery and prostate cancer surgery.   

Focal therapy options for treating prostate cancer generally became available in the early 2000s. The development of these treatment options using cryoablation (freezing), HIFU (high-intensity focused ultrasound), laser and others was partially spearheaded by the realization that there were far too many complications associated with whole gland treatments using surgery, radiation or seeds/brachytherapy. As well, focal therapy was based on the idea that although prostate cancer was commonly multifocal there was usually a bigger index lesion that often contained the highest grade disease responsible for cancer progress and spread. However, because the index lesion does not always contain the highest grade cancer untreated lesions could progress making focal treatments undependable.

Curiously, there are multiple whole gland and focal options for treating localized prostate cancer. All have been described as effective or even as the gold standard. Clearly though, if there was one treatment that had been scientifically proven to be curative for treating localized prostate cancer every doctor would be using just that particular option.

The many prostate cancer treatment complications.

Both open and robotic assisted prostate cancer surgery are associated with probably more complications than any other surgical procedure. In fact, many men underwent  trial-and-error surgery so techniques could be developed to reduce the bleeding, leaking, erection and other complications. And, although robotics is marketed as “minimally invasive” because of its smaller incision and shorter hospital stay compared to open procedures, it doesn't decrease the list of potential complications. Instead, the robotic technique simply increased the number of possible complications with the addition of various trocar and positioning injuries.

Additionally, as for all procedures, there were the potential complications of deaths within 30 days of surgery, thromboses, embolism, depression and suicide. And, there were the complications specific to cutting out the prostate. These included loss of libido and manhood, incomplete or total loss of erections, lack of emission, lack of ejaculation or ejaculating urine, pain on orgasm, infertility, shortened penis, penile pain, penile numbness, penile wasting, penile curvature and testicular pain. As well, there were complications associated with the bladder such as, urinary leakage, bladder neck scarring, bladder stones and urinary tract infections. Worse still, some 11 to 48 percent of patients had positive margins or residual cancer because of incomplete removal of the prostate cancer. Unsurprisingly, the FDAs Maude (Manufacturing and User Facility Device Experience) site recorded a great uptick in adverse events for the robotic device in radical prostate cancer surgery. Bad results because robotic prostatectomy is unsafe even in “experienced” hands.

And, although less debilitating than surgical treatments, radiation, proton beam, brachytherapy/seeds and focal therapy also have associated complications that included rectal and bladder burning, urethral strictures, urinary leakage, erection issues and other troubles. In addition, testosterone suppression which was often given to shrink the size of the prostate before radiation or focal therapy was also associated with many possible side effects such as hot flashes, impotence, hair loss, breast enlargement, depression and so on.

Preparing patients for bad prostate cancer treatment outcomes.

Incredibly, instead of urologists taking a hard look at whether surgery (open or robotic) had any place in treating prostate cancer, they focused on a couple of schemes to manage expectations. First, was a discussion about “patient preferences” and “risk tolerances”. This is an event where a physician shares with the patient the “evidence” that supports the recommendations for various tests and treatment options - balanced against their possible risks. However, since there is no reproducible scientific data showing treatments to be safe or curative these discussions simply made a mockery of  prostate cancer awareness, shared decision-making, informed consent, standard of care and the guidelines for managing localized prostate cancer. 

Second, was the strategy of preoperative and postoperative counseling and rehabilitation programs to mitigate against the many potential complications associated with prostate cancer treatments. A tactic so patients and their spouses could be mentally prepared for bad outcomes and less regret. 

Treatments to fix bad prostate cancer outcomes.

Despite the discussions with patients about risk tolerances, treatment preferences and the preoperative and postoperative penile and bladder rehabilitation programs, complications remained disturbingly common. Urinary leakage or incontinence often needed treatment with penile clamps, pelvic floor exercises, medications, pads, biofeedback, bulking injections, slings, catheters, electrical stimulation devices or artificial sphincters. Erection issues commonly required treatment with medications, suction or vibration devices, urethral suppositories, penile injections or penile implants. Many patients required repeat and or, alternative treatments to repair their complications. And, the breakdown of the various implanted devices often resulted in even more corrective surgery, costs and time-wasting while the patient and spouse struggled to maintain a relationship and retain some quality of life. 

Do prostate cancer treatments save lives?

Unsurprisingly, urologists’ own studies have determined that radical prostatectomy is not a lifesaver. Furthermore, whether the whole gland was treated with surgery or radiation or, untreated and monitored by AS, the 10-year and 15-year survivals were similar for each group. In other words, whether you had surgery, radiation or no treatment, survival was similar at 15 years. Amazingly, not only did these dismal results not stop urologists from recommending surgery, they even developed criteria for who would be an “ideal” candidate. And to boot, they continued to claim that if you chose radiation and then developed a recurrence that a subsequent salvage “curative” surgery would be difficult. The flaw with this witless argument is the reality that whether treated surgically or with radiation, there’s no evidence that either of these treatment options is curative. A conclusion that urologist Anthony Horan had already come to in 2009 with his publication, “The Big Scare. The Business of Prostate Cancer”. 

Mind-bogglingly, although urologists vilify radiation as a first line treatment for prostate cancer they quickly and irrationally recommend radiation to treat residual cancer. Such as in the prostatic bed and/or pelvic lymph nodes should the pathology show positive margins or postoperative PSA testing indicates a biochemical recurrence. A fancy term meaning that residual prostate cancer cells somewhere, are producing PSA. Shockingly, some 60 percent of patients undergoing “curative” prostate cancer surgery will develop a biochemical recurrence which will invariably be treated with radiation. Remarkably, not only will the surgery leave many men limp and leaking but, the addition of radiation commonly adds in rectal and bladder burning. A one two punch with no reproducible scientific evidence showing that either surgery or radiation after surgery is curative.

Proton beam therapy claims to be more precise and safer than standard radiation options with fewer second cancers and less rectal, bladder and penile complications. However, as for both external beam radiation and seeds, there's no long term scientific evidence that shows that proton beam therapy saves significant numbers of lives. A conclusion that Ablin and Piana had already reached in 2014 with their book, “The Great Prostate Hoax”.

Focal therapy options are marketed as providing “effective” treatment for localized prostate cancer with fewer sexual and urinary complications as compared to whole gland treatment with surgery or radiation. However, although these focal therapy options may provide a better post-treatment quality-of-life, there’s no long term scientific evidence that they are curative.

Does active surveillance save lives?

Active surveillance (AS) is a monitoring program for low-risk cancers that withholds treatment unless, in the unlikely event, that it should “progress”. The basis for AS was that fact most prostate cancers grow very slowly and could be safely monitored and “caught” if they “upgraded” or “progressed”. However, the terms upgrading and progression have several definitions. And, while AS is best undertaken with a non-contrast MRI by an expert, most AS is still done using the same risky and unreliable tests as used for prostate cancer screening. That is, the inaccurate DRE; the unreliable PSA and, the inexact and risky 12-core, ultrasound-guided biopsy sampling only 0.1 percent of the prostate. This gross sampling error explains why cancers are easily missed and those found on a repeat biopsy can give an impression of “progression” or “upgrading”. 

Predictably, because AS is generally undertaken for patients with the Gleason 6 bogus cancer or low-risk cancers that take 40 years or more to reach one centimeter in size, the AS program seems to work very well. Yet, because studies have already concluded that the 15 year survival is about the same whether treated for prostate cancer or not, the value of AS is in question. 

Why most prostate cancer information is untrue.

The four principles of balance, randomization, control and repetition form the basis of sound scientific methodology. Unfortunately, most prostate cancer studies are not founded on these fundamental scientific principles. Instead, prostate cancer studies are invariably corrupted by opinions, approximations and assumptions. As well, there’s commingling of participants with various Gleason grades, scores, tumor volumes and the arbitrary treatment of some participants with testosterone suppression. A classic example of such a flawed study is the one that claimed surgery was associated with a reduction in prostate cancer deaths. 

A seminal study published in 2005 concluded that most published research findings are false. Because, researchers fail to conduct studies based on sound scientific methodology, and, since so many medical studies are flawed, it’s not surprising that some 50 percent of all medical treatments are of unknown effectiveness.

However, prostate cancer treatment is not in the category of unknown effectiveness, it’s known to be ineffective. Fortunately, there is a way to protect the public from ineffective medical care. Misguided FDA approvals can be rescinded while ineffective treatments can be rejected through the process of the de-implementation. Although surprisingly simple, it usually takes decades of harm to countless patients before principled physicians step up to throw out bad treatments. Till then, the history of medicine will continue to add to its ballooning list of bad and ineffective treatments.

Who’s accountable for ineffective prostate cancer treatments?

In addition to physicians being responsible for delivering effective, evidence-based medical care, various American regulatory agencies such as the FDA, CDC, NIH, AHRQ and other organizations such as the ACS, NCCN and NCI are supposed to offer an additional level of patient protection. Yet, it seems as though these agencies forgot to ask the most basic of questions concerning prostate cancer treatment effectiveness. Where is the undeniable and replicable data supporting urologists’ testing and treatment recommendations? Instead, it appears that these oversight agencies simply regurgitated the urologist's unproven recommendations for PSA testing and surgical treatment. A miserable pretense of oversight that easily explains why consumers are losing trust in our healthcare system.

The only agency that did challenge the dogma surrounding PSA-based testing and the treatment of screen-detected prostate cancer was the USPSTF (United States Preventive Task Force), a voluntary panel of national experts in disease prevention and evidence-based medicine. The USPSTF gave PSA-based screening a D grade in 2012 as the benefits did not outweigh the harms. This important ruling was quickly challenged by the urology industry and watered down to an ineffectual C grade in 2018. Incredibly, urologists already knew from their own studies in 2009 that PSA testing failed to save significant numbers of lives.  

Why prostate cancer testing and treatment is a hoax.

Prostate cancer information is like a lot of other so-called information these days, mostly a departure from the truth. A result that is underscored by the finding that only about 11 percent of medical treatments are known to be beneficial. Shamefully, urologists have known for many years that the Gleason 6 is a bogus cancer, that most cancers are not deadly and that both PSA testing and prostate cancer treatments are not only ineffective but commonly harmful. A medical hoax that underscores a stunning disconnect of physicians from their Hippocratic oath and its creed for keeping patients from harm and injustice. As well, it highlights the stupefying failure of the American regulatory apparatus to protect unwitting consumers. A jaw-dropping lack of unaccountability that allowed intellectual dishonesty and licensed medical malpractice to exploit a fear-driven ideology of prostate cancer misinformation to craft a $32.7 billion public health disaster. Until medical care is proven to be beneficial by irrefutable and reproducible facts, patients will continue to be exposed to deception and ineffective care. 

Required reading.

The Rise and Fall of the Prostate Cancer Scam by A. Horan M.D.

The Great Prostate Hoax by R. Ablin and R. Piana.

Reach author bert@healthdrum.com                                                                                                       

HEALTHdrum.com is a healthcare marketplace for routine medical services.

Dedication.This article is dedicated to Anthony Horan M.D., a urologist, truth-seeker and author (“The Big Scare”) ,who fearlessly challenged the culture and the business of prostate cancer. 

An earlier piece by Dr. Vorstman:

Bert Vorstman BSc, MD, MS, FAAP, FRACS, FACS went to medical school after receiving a BSc in microbiology in Dunedin and then on to surgical and urology training in Auckland, New Zealand. He undertook a chief residency position at Jackson Memorial Hospital in Miami and then completed a fellowship in pediatric and adult reconstructive urology at the Eastern Virginia Medical School in Norfolk. He also conducted NIH-sponsored pioneering research on urinary bladder innervation earning him the honor of a Masters of Surgery diploma. He returned to Miami to become a board-certified faculty member in the department of urology, Jackson Memorial Hospital, University of Miami. Subsequently, he established a private urology practice in Coral Springs, Florida. Now retired, he spent nearly 40 years in medicine and remains active in the healthcare arena.

Ronald Piana is a freelance science journalist who has published more than 400 articles in major medical journals during his 25 years covering the oncology sector. His article “Dying Without Morphine” appeared in the New York Times. Piana is the co-author of the 2014 book—which received a starred review from Kirkus Reviews—”The Great Prostate Hoax: How Big Medicine Hijacked the PSA Test and Caused a Public Health Disaster” [Palgrave Macmillan, 2014].

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Could 2024 be the Year of Active Surveillance going mainstream?

The Wall Street Journal (subscriptions required) took the AS discussion mainstream in this article “The Cancer That Doctors Don’t Want to Call Cancer/Renaming the lowest-risk prostate cancer would cut down on overly aggressive treatment, some doctors say” : https://www.wsj.com/health/wellness/prostate-cancer-low-risk-treatment-rename-185b6e3f TheActiveSurveillor.com summarizes:

When is a cancer not a cancer? Wall Street Journal asks as the Gleason 6 debate goes mainstream

Jan 25

By Howard Wolinsky The idea of renaming Gleason 6 as a noncancer has been knocking around for more than a decade. I first explored it in 2013 in Chicago Medicine Magazine as part of a broader discussion of renaming what one of my doctors calls “lame cancers” that don’t act like cancers. The idea wasn’t brand-new then.

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TheActiveSurveillor.com editor Howard Wolinsky appeared on Vox.com’s “Today Explained” on NPR to talk about AS and also Defense Secretary Lloyd Austin and his secret prostatectomy. The podcast is entitled "The Prostate of the Union" and appeared on NPR on “Today Explained”: 

A Wayne State University researcher talks in the Conversation about how active surveillance is gaining greater acceptance, but there are geographic differences in uptake and also how there is lower uptake in Black men. The article is entitled “Treatment can do more harm than good for prostate cancer − why active surveillance may be a better option for some”: https://theconversation.com/treatment-can-do-more-harm-than-good-for-prostate-cancer-why-active-surveillance-may-be-a-better-option-for-some-221485

Plus Health Day reports on a Eur

opean study questioning the value of digital rectal exams based on an Austrian study
"Digital Rectal Exam Has Low Diagnostic Value for Prostate Cancer
Low diagnostic value seen as independent test and supplementary measure to PSA for detection of prostate cancer"
in this article ": https://www.healthday.com/healthpro-news/men-health/digital-rectal-exam-has-low-diagnostic-value-for-prostate-cancer

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Register for ZERO’s March AS webinar

By Howard Wolinsky

For the past three years, colleagues and I have run a special Active Surveillance support group for ZERO. We need your support to stand up for the AS clan.

Be there, or be square.

Please sign up for the program at 11 a.m. Eastern on March 12, 2024.

Register in advance:
https://us02web.zoom.us/meeting/register/tZUsfuqgrjIoG9AWf7voMhzT_UjdqbQQbQPA