Part 2: Up yours. The case against DREs.

(Can you answer the anonymous questionnaire on your thoughts on DREs? Go here: https://forms.gle/QVXTXmuTrHjTppKq8 )

(Uro-heretics Bert Vorstman, MD, and Ron Piana are back at The Active Surveillor. They are readers’ favorites. Not all doctors or patients will agree with them. But I believe it’s important to air differences of opinion in hopes that the truth will emerge. Last week, Dr. Christian Pavlovich made the case for Digital Rectal Exams (DREs). And I heard from a dcotor who said his prostate cancer was detected early with a DRE at age 48.

(So discuss amongst yourselves and with your doctors. Feel free to comment, or write to Dr. Vorstman directly at bert@healthdrum.com Also seee below for a link to Part 1. HW)

Is a prostate check for cancer good or bad?

Is prostate cancer screening and treatment helpful or not?

By Bert Vorstman MD and Ron Piana

Is a prostate check for cancer good or bad? Doctors believe that this digital rectal exam (DRE) is useful for detecting prostate cancer and consider it to be a standard of care. Although the standard-of-care label sounds trustworthy, does the prostate check have proven benefits, or does it simply open the door to a pile of scare tactics, false promises, and health dangers?  

What is the prostate check for cancer?

The prostate check or touch is a clinical test to judge whether the prostate feels normal or not. An area that feels firm (induration) or hard (nodule) may suggest cancer. The prostate can be easily evaluated using a gloved and lubricated finger to enter the anus and gently press the gland through the rectal wall to feel its texture. The examination can be performed with the patient standing and bent over or lying on their side with legs drawn up. And, although the check takes only a moment, it can be uncomfortable or even painful for those who have an anal fissure, hemorrhoids, or have some anal stenosis after hemorrhoid surgery. 

Urinary symptoms are NOT associated with early prostate cancer. Instead, urinary symptoms are due to the benign enlargement of the prostate and not the possible cancer within. Also, there are several concerns that make the prostate check unreliable; the examination depends on a subjective judgment by the practitioner as to whether the prostate feels abnormal or not; small nodules may be missed as a prostate bulge needs to be about 0.5 to 1 cm in diameter before being detectable (depending on its depth within the prostate); most prostate nodules are benign (due to BPH or diseases such as chronic prostatitis, granulomatous prostatitis, tuberculous prostatitis or prostatic calculi) and, only some prostate nodules are cancerous. However, the biggest concern by far with the prostate check is that a “suspicious feeling” prostate almost always sets the patient up for more unreliable tests such as the PSA (prostate specific antigen) and risky, undependable prostate biopsies. 

(Dr. Vorstman is above and author Ron Piani is below.)

The highly erroneous PSA.

PSA testing is highly unreliable and FAILS to save significant numbers of lives. These results are hardly surprising given that the specific label for the PSA is a blatant lie as it is NOT specific for the prostate or even for prostate cancer; the PSA has a false positive rate of about 78 percent; its 0-4 n g/ml limits of “normal” are arbitrary and meaningless; the PSA is easily raised or lowered by numerous benign processes; an “elevated” PSA doesn’t mean you have prostate cancer; a “normal” PSA doesn’t mean you don’t have cancer; the lowering of a PSA doesn’t mean you have less or no cancer and the PSA cannot distinguish between aggressive and non-aggressive cancers. Even more of a letdown, the 10-15 percent of aggressive and potentially deadly prostate cancers can go undetected as they may produce little or no PSA. Yet, despite the fact that the PSA test fails to meet the criteria necessary to be an effective marker, the urology community labeled it as a standard of care and even helped engineer an FDA approval in 1994. 

Thankfully, one healthcare agency in the U.S. is concerned about patient welfare. The USPSTF (the United States Preventive Services Task Force), an independent evidence-based organization of highly respected physicians gave PSA-based screening a D grade in 2012 as the benefits did not outweigh the harms. However, this important healthcare safety ruling was quickly challenged by physicians and others in the business of prostate cancer and the rating was watered down to an ineffectual C grade in 2018. 

As for the many other prostate cancer markers available (whether for detection or prognosis), there’s no indisputable and reproducible data that any of them have saved significant numbers of lives. These include PSA derivatives such as the free PSA and percent free PSA, PSA density, PSA velocity/kinetics/PSA doubling time, age-related PSA, Pro PSA, PCA3, PTen, genome tests, urine markers, indexes, scores and others. Yet, when these undependable tests (often costly) and the severely flawed PSA test come back elevated or abnormal, patients are almost always pressured into having unsafe and highly subjective prostate biopsies.

The unreliable and unsafe prostate needle biopsy. 

The prostate needle biopsy is a highly unreliable and risky test. How physicians can claim that the passage of a needle through a dirty rectum (trans-rectal method) for a hit-or-miss prostate biopsy is standard-of-care is beyond comprehension. Predictably, the test is associated with several potential complications such as sepsis (often requiring hospitalization), death from sepsis, abscess, rectal bleeding (sometimes requiring clipping), hematospermia (blood in the semen) and erectile dysfunction. And, although the trans-perineal technique for prostate biopsy is associated with fewer complications than the trans-rectal technique, both methods are equally undependable because of huge sampling errors. 

Typically, prostate cancers arise in some 1 to 5 different areas of the prostate and not necessarily at the same time or of the same grade. Yet, the 12-core biopsy randomly and blindly samples roughly six different areas encompassing only about 0.1 percent of the prostate - when the volume of these biopsy cores are measured against the volume of the prostate. Since 99.9 percent of the prostate is unsampled by this biopsy method, it’s little wonder that subsequent biopsies find “new” cancers, “cancer upgrading” or, “cancer progression”. And, this multifocal nature of prostate cancer easily explains why focal treatment options are associated with high recurrence rates.

Prostate biopsy results are imprecise. 

Your prostate biopsies are prepared in the lab and examined under low-power microscopy by pathologists who look for patterns of growth that could mean cancer. Using the complicated Gleason classification system, physicians judge whether the two most common patterns of growth seen on the slide have the appearances of prostate cancer and if so, to what degree. But, such estimations of cancerous changes are not always identical between pathologists as studies have shown that readings from different labs of the same sample have rendered different results. And, when pathologists don’t agree on a Gleason Grade, it’s obvious that your biopsy may be over-read or under-read. And, such differences of opinion may result in inappropriate treatment and potential health dangers.  

Are all prostate cancers a danger to health?

The term prostate cancer is not only shocking but highly inaccurate as it implies that all prostate cancers are equal and potentially deadly. In sharp contrast however, most prostate cancers do not cause death and your greatest concern by far is exposure to a vast amount of prostate cancer disinformation. 

> Prostate cancers are very common. The incidence of prostate cancer corresponds approximately to one’s age - that is, 50 percent of 50-year-old men will have some prostate cancer, 60 percent of sixty-year-old men and so on. However, most men will be diagnosed with the noncancerous Gleason 6 or low-risk cancers and will eventually die from something else.

> The Gleason 6 “cancer”. The Gleason 3+3= 6 is still labeled as a cancer (on the basis of some minor microscopic appearances) but FAILS to behave as cancerous because its biological pathways for cancer development and spread are INACTIVE. Not only is the Gleason 6 a bogus cancer but, there’s no evidence that this pseudo-cancer can ever become cancerous. Therefore, the Gleason 6 disease does not require detection, monitoring or treatment. And, because the bogus Gleason 6 is still conveniently mis-classified as a cancer by the prostate cancer industry, most prostate cancer statistics and treatment studies are false.

> Many prostate cancers grow very slowly and are not life-threatening. Many prostate cancers grow very slowly taking some 40 years from the time of mutation to grow to a size of one centimeter or so. Therefore, many low-risk prostate cancers  detected in 70-year old men would have started when they were in their 30s. And, given the very sluggish growth rate for most prostate cancers, six-monthly or even 12-monthly physician recommendations for the unreliable digital rectal prostate checks are clearly irrational.

> About 10 to 15 percent of prostate cancers are high-grade cancers and potentially deadly. High-grade prostate cancer (certain inherited gene mutations and African-American men may have a greater risk of having high-risk prostate cancer) is responsible for about 30,000 or so deaths of American men each year (in contrast, medical errors kill about 251,000 people annually). Although the death rate from prostate cancer seems to have fallen somewhat in recent years (causing considerable speculation as to cause), the fact that PSA testing leads to the detection and treatment of large numbers of those with non-lethal prostate cancers easily explains the apparent fall in prostate cancer deaths. As well, better treatments for comorbidities such as heart disease are also likely to contribute to an appearance of a falling death rate from prostate cancer.

Prostate cancer imaging and staging are unreliable.

Prostate cancer imaging for detection is unreliable by ultrasound-guided biopsy as  low-volume cancers are frequently missed. Compared to the ultrasound-guided, 12-core prostate needle biopsy sampling blindly and randomly only about 0.1 percent of the prostate, whole gland MRI prostate imaging is more reliable as it examines 100 percent of the prostate, can ignore insignificant low-grade cancer and fairly reliably detect the PI-RADS 4 or 5 changes seen with high-grade prostate cancers. However, because not all MRIs are equal or foolproof and not all doctors are skilled in the techniques of prostate MRI evaluation or with the interpretation of MRI findings, low-volume high-risk cancers may still go undetected. As well, most prostate biopsies are now done using the in-office “fusion” (a trans-rectal ultrasound image is “fused” to an MRI taken elsewhere at a previous time) technique. But, because this fusion process requires a number of steps, the detection of significant prostate cancer is less reliable than that with the MRI-guided biopsy undertaken by an expert.

Trying to determine if an early prostate cancer is still localized or has spread outside of the prostate is highly unreliable when using CT and bone scans because they are relatively insensitive for the detection of low-volume cancer spread. And, although MRIs and PMSA PET-CT scans are more reliable, they are not foolproof and may miss early metastases. In fact, some high-grade prostate cancers may have already spread before they are barely detectable within the prostate. In some subjects whose imaging studies suggested localized disease, bone marrow aspiration studies and the use of sophisticated staining techniques identified cancer cells already in the bone marrow. Surprisingly, these metastatic prostate cancer cells can lie dormant in the bone marrow for many years before some cells can activate and spread. This fact is the likely explanation for the semblance of cure in many men before these metastatic cells activate, start multiplying and generate a biochemical recurrence (rising PSA) years later. This rising PSA happens in about 60 percent of patients after surgery and in 30-50 percent of patients after radiation and means that these men have not been cured. 

Prostate cancer treatments are not life-saving.

Urologists’ own studies have determined that prostate cancer surgery is NOT curative. Shockingly, other studies have determined that whether the prostate cancer was treated with surgery, radiation or untreated and monitored by active surveillance the 10 and 15 year survivals were similar for each group. In other words, whether you underwent surgery, radiation, no treatment or active surveillance, survival was similar for all groups at 15 years. And, the fact that neither surgery or radiation are lifesavers makes absolute nonsense of surgeons’ claims that surgery is curative, that salvage surgery is an option if radiation fails and that radiation for residual cancer or recurrent cancer after surgery is “appropriate”. As well, there’s NO irrefutable and reproducible data that show that any other whole gland (brachytherapy, proton beam) or focal therapy option (cryoablation, HIFU or laser) saves significant numbers of lives. Yet, despite the lack of evidence for life-saving ability for any of these prostate cancer treatment options, physicians continue to label them all as standard-of-care in their guidelines.

Prostate cancer surgery’s very sketchy origins.

Prostate cancer surgery has a very sketchy past. In 1904 John Hopkins’ H.H. Young MD published a study entitled, “The Early Diagnosis and Radical Cure of Carcinoma of the Prostate”. Here, Young claimed the “simplicity, effectiveness and the remarkably satisfactory functional results furnished”. Disturbingly however, this claim was a barefaced medical lie. There was NO evidence for early diagnosis of prostate cancer, there was NO evidence of radical cure, two patients died and two were left with lifelong urinary incontinence after prolonged hospitalizations. Unfazed by this disastrous result, urologists continued experimenting with the radical prostatectomy technique and, despite failing to prove safety or benefits, labeled it as standard-of-care. 

Years later, robotic prostatectomy also recorded very dodgy beginnings. After a low-level clinical study in Mexico (the rules for experimental surgery are less rigorous there than those in the U.S.), the robotic device was FDA-approved for gallbladder surgery, although the tool failed to offer clear benefits. And, when the device-makers realized that there was no market for robotic gallbladder removal, the medical industrial complex got creative. They simply manipulated the FDA's fallacious 510 K approval process to create an automatic FDA approval for the use of the robotic device in prostate cancer surgery in 2001. A maneuver that bypassed any need for clinical testing to confirm whether the robotic prostatectomy was safe and effective. And although the FDA’s MAUDE (Manufacturer and User Facility Device Experience) division recorded a significant uptick in complications associated with robotic prostatectomy, physicians still gave it the stamp of standard of care.

Prostate cancer “treatments” lead to health dangers.

Not only is there NO undeniable and repeatable evidence that open or robotic surgery for prostate cancer saves significant numbers of lives but these procedures are associated with an incredible list of potential complications. Yet, fully aware of these catastrophic outcomes with prostate cancer surgery, physicians focused instead on developing devices that could be implanted to fix the many limp and leaking complications. In addition, they developed preoperative and postoperative counseling and rehabilitation programs to “manage'' patient expectations. Strategies that were designed to bolster physicians’ dishonest informed consent and shared decision-making agreements for prostate cancer surgery. Forget about the quality-of-life impacts on the wives, partners or girlfriends of these victims.

Cutting out the prostate is associated with huge list of potential complications including; deaths, thrombosis, embolism, depression, suicide, positive margins or residual cancer in 11- 48 percent of cases and the usual limp and leaking complications such as; loss of libido, partial or total loss of erections, lack of emission, lack of ejaculation or ejaculating urine, pain on orgasm, shortened penis, penile pain, penile numbness, penile wasting, penile bending, infertility, testicular pain, rectal injury and others. Additionally, there are several potential complications associated with the bladder such as urinary leakage, bladder neck scarring, bladder stones, urinary tract infections and urethral strictures. 

The other whole gland (radiation, brachytherapy, proton beam) and focal therapy treatment options for prostate cancer (cryoablation/freezing, HIFU/high-intensity-focused-ultrasound, laser) are also problematic for two major reasons. There’s NO unquestionable or replicable evidence that these treatments save significant numbers of lives and, they too are associated with many potential setbacks. Although the complications tend to be less severe than for surgery, rectal, bladder and penile complications are not uncommon. As well, radiation options may be associated with a small increase in secondary cancers. And, testosterone suppression, which is often recommended to shrink or downsize the prostate prior to radiation or focal therapy, is also associated with several significant side effects such as fatigue, hot flashes, impotence, hair loss, breast enlargement, mood swings, depression and others.

Active surveillance for prostate cancer is ineffectual. 

Active surveillance (AS) of prostate cancer is a program that monitors low-risk cancers  instead of recommending an immediate potentially debilitating treatment. The belief behind this proposal assumes that if a low-risk cancer appears to progress during monitoring then a timely “treatment” could still be undertaken. However, this program of “surveillance” is typically recommended for those diagnosed with the Gleason 6 (not a cancer so doesn’t need monitoring or treatment) or, those with low-risk cancers like the 3+4 (which commonly take 40 years to grow to 1 centimeter). Even more concerning, this monitoring program utilizes the undependable prostate checks, PSA tests that are associated with a false positive rate of 78 percent and ultrasound-guided biopsies that miss 99.9 percent of the prostate and or, imperfect MRIs. Compounding these concerns and questioning the benefits of AS is the fact that there’s no irrefutable and reproducible data that shows that any of the treatments for prostate cancer save significant numbers of lives.

Prostate cancer awareness month is a scam. 

Prostate Cancer awareness month is celebrated every September and markets the early detection and treatment of prostate cancer as a potential life-saver. However, despite insufficient evidence to support early detection and treatment, this physician-led program uses the same scare-tactics, false hope and false promises that are used to promote AS. The highly undependable prostate check, the highly unreliable PSA test and the grossly unscientific 12-core ultrasound-guided prostate needle biopsy. To boot, this “awareness” program detects mostly the bogus Gleason 6 cancers and the low-risk cancers that take years to grow. And, if potentially lethal cancers are detected, physicians recommend the same unsafe “standard-of-care” treatment options for prostate cancer that fail to save significant numbers of lives. In reality, prostate cancer awareness is a corrupt physician-led program that exaggerates risks, exploits false hope and only leads countless men to serious harm.

Intellectual dishonesty, orchestrated deception and unaccountability.

Patients are inherently trusting of their physicians and the term standard-of-care.  However, the evidence shows that much of what is termed standard-of-care in the business of prostate cancer is not only misleading but harmful and fails to save significant numbers of lives. Shockingly unaffected, physicians continue to recommend these unsafe and ineffective prostate cancer procedures, making a mockery of their practice guidelines. But, underscoring an even greater dereliction of duty, the American regulatory apparatus (FDC, CDC, NIH, AHRQ) and others such as the ASCO, ACS, NCCN and NCI have failed to protect patients by not ensuring that physicians recommendations for tests and treatments are supported by irrefutable and reproducible data. Unfortunately, brazen intellectual dishonesty is deeply embedded in the healthcare arena as most published research findings are false and only about 11 percent of medical treatments are of known benefit. Sadly, although physicians could find safe and effective treatments for the few potentially deadly high-grade prostate cancers, the recycling of prostate cancer misinformation is a much more lucrative $23.2 billion industry.

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.

Bert Vorstman BSc, MD, MS, FAAP, FRACS, FACS is the CEO and founder of HEALTHdrum.com - it’s a healthcare marketplace in south Florida that facilitates priority access to providers for cash pay office-based and outpatient services. Previously, Dr. Vorstman trained as a urologist in Auckland, New Zealand and at Jackson Memorial Hospital in Miami, Florida. Following these studies, he undertook fellowship training in adult and pediatric reconstructive urology at the Eastern Virginia Medical School, conducted NIH-sponsored research, and was awarded a master of surgery. He returned to the University of Miami as a faculty member and then went on to establish a private practice in Coral Springs, Florida.

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].