Physicians have promoted PSA testing, prostate cancer detection and prostate cancer treatment to be safe, effective and potentially life-saving. A so-called standard-of-care favored with FDA approvals and “evidence-based” guidelines for managing localized prostate cancer. But is this prostate cancer narrative pushed by urologists supported by the clinical evidence?
Is PSA testing supported by the clinical evidence?
PSA (prostate specific antigen) testing for prostate cancer is not supported by the clinical evidence (the prostate exam is equally unreliable). A “high” PSA is not a cancer diagnosis and lowering the PSA doesn’t mean you have less risk of developing prostate cancer. The “specific” label is a hoax as PSA is not specific to prostate tissue or specific for prostate cancer. Moreover, the PSA test cannot distinguish between benign disease and cancer, the PSA is unable to distinguish killer prostate cancers from non-killer cancers, the 10-15 percent of high-grade prostate cancers responsible for most of the 30,000 or so deaths can escape detection as they may make little or no PSA (dedifferentiation – because prostate cancer cells have become more primitive), the rapidity of a PSA rise does not correspond with the aggressiveness of an underlying prostate cancer, the PSA fails to correlate with cancer volumes for levels below 8-10ng/ml, the PSA level commonly fluctuates from one test to another, the PSA limits of 0 to 4 ng/ml being normal are arbitrary and, PSA testing has a 78 percent false positive rate – according to the many clinical studies cited in the books by Anthony Horan MD, The Big Scare. The Business of Prostate Cancer and, Richard Ablin PhD and Ron Piana PhD, The Great Prostate Hoax. Additionally, the PSA level is easily manipulated.
- Conditions that can increase the PSA without cancer being present. Enlarged prostates, post ejaculation, prostate inflammation, urinary tract infection, prostate massage, testosterone administration, prostate biopsy, cystoscopy or TURP.
- Medicines and supplements that can lower the PSA even if cancer is present. Prostate medications such as finasteride/proscar or dutasteride/avodart, cholesterol lowering medications, thiazide diuretics, aspirin, certain “natural” products, certain herbal mixtures and some low fat and plant-based diets.
Is the FDA approval for PSA testing supported by clinical evidence?
Despite the PSA having a 78 percent false positive rate and no clear evidence of benefits the FDA approved PSA testing in 1994 to “help in the early detection of prostate cancer”. This event simply highlights the abject failure of the FDA to determine scientifically the safety and benefits of PSA testing.
Does the clinical evidence show that PSA testing saves lives?
A 2009 study by urologists showed that PSA testing failed to save significant numbers of lives, Mortality Results from a Randomized Prostate-Cancer Screening Trial
- And, there’s no clinical evidence that any other PSA-based test saves significant numbers or lives. PSA derivatives/percent free PSA, PSA density, isoPSA, PSA velocity/doubling time, prostate health index, PSA score tests, finasteride 3 month suppression test, “age-specific” PSA and urinary PSA.
Does the clinical evidence support the prostate needle biopsy?
The clinical evidence shows that the prostate needle biopsy is highly unreliable as it has a false negative rate of at least 30 percent (more if only potentially deadly high-grade cancers are counted). The study samples on average about 0.1 percent of the prostate – when the 12 core volumes of the standard biopsy are weighed against the volume of the whole prostate. Not only is the biopsy blind and random but the test leaves you with no knowledge of what’s going on in the 99.9 percent rest of the prostate. Making matters worse, this grossly unscientific examination is associated with the potential complications of pain, septicemia, death, bleeding, erection issues and depression.
Does the clinical evidence show that a prostate cancer diagnosis is reliable?
The clinical evidence shows that a prostate cancer diagnosis is unreliable. As well as errors of interpretation, there is the problem of diagnostic reproducibility between pathologists – studies indicate that different pathologists viewing the same slides may offer dissimilar Gleason grades and scores. More worrisome, the same pathologist may offer a different diagnosis when reading the same slides at a later date. Underscoring this profound lack of reproducibility and dependability with this subjective prostate cancer diagnostic system Swedish pathologists disagreed about Gleason grades a staggering 50 percent of the time.
Even more unsettling than the disagreement between pathologists concerning Gleason grades are the following facts:
- The clinical evidence shows that the Gleason 6 is a bogus cancer – The Gleason grade 3 in the 3+3=6 lacks the hallmarks of cancer on both clinical and molecular biology grounds. The disease is a pseudo-cancer and needs to be renamed in order to prevent unnecessary “treatments” and to prevent it from being tagged as a cancer statistic.
- The clinical evidence shows that prostate cancers are not all equal and that many are low-risk and likely to be outlived. In fact, no treatment has a similar 10-year survival to someone who did have treatment. Furthermore, prostate cancer appears to be a disease of aging with the chance of harboring some cancer approximately equal to one’s age. For example, 60 percent of 60 year old men have small areas of cancer in their prostate.
Does the clinical evidence support the reliability of prostate cancer staging?
The clinical evidence shows that prostate cancer staging with CT and bone scans is highly unreliable as they are insensitive for detecting small volume cancer spread. Underlining this fact are the findings from bone marrow aspiration studies and the use of sophisticated staining techniques. Here, micrometastases have been demonstrated in men with high-grade cancer despite staging studies being read as negative.
Does the clinical evidence show prostate cancer surgery to be safe?
The clinical evidence shows that prostatectomy or radical prostate cancer surgery (whether by robotic or conventional means) is highly unsafe and without objective benefits at any age.
- Dr. H.H. Young at Johns Hopkins told two bare-faced lies about prostate cancer surgery over a 100 years ago. He claimed early diagnosis and radical cure of carcinoma of the prostate and that “The four cases in which the radical operation was done demonstrated its simplicity, effectiveness and the remarkably satisfactory functional results furnished.” Yet, in the same paper and in stunning contrast, he gave no evidence for early diagnosis and radical cure of prostate cancer and admitted that his first two patients died from his surgery (one postoperatively and the other after being treated for a complication common to the procedure). In addition, his other two patients were left with lifelong urinary complications – impotence was not mentioned as the subject was taboo in those times. Shockingly, little has changed since that publication and prostate cancer surgery continues to be a disastrous cornerstone for prostate cancer management.
- The clinical evidence shows that the complications first recorded with prostatectomy continue today whether the surgery is conventional or robotic – see the studies cited by Horan, Ablin and Piana and others – lack of libido, loss of manhood, damaged or loss of erection, lack of emission, lack of ejaculate, ejaculating urine, pain on orgasm, infertility, shortened penis, penile pain, numbness, curvature, wasting, testicular pain, urinary leakage, bladder neck scarring, bladder stones and infections and, a positive margin or cancer left behind in 11–48 percent of cases.
- The limp and leaking complications were well recognized by urologists as they developed numerous techniques trying to overcome these troubles. From “nerve-sparing” techniques to a battery of counseling programs – both preoperative (outcome expectation) and postoperative. And, for a more definitive treatment of these persistent penile and continence complications despite “counseling” they developed a prosthetic industry to make implantable urinary control devices and implantable penile erection devices.
Does the clinical evidence show that prostate cancer surgery saves lives?
The clinical evidence shows that prostate cancer surgery fails to save significant numbers of lives – Radical Prostatectomy Versus Observation for Localized Prostate Cancer. Not only did this study confirm the high incidence of complications (21.4 percent) typically seen after surgery but, the definitions for various complications were self-serving. For example, a participant was recorded as being incontinent only when categorized as having moderate or severe leakage. And, like other treatment studies (whether whole gland or focal) this work was corrupted by the inclusion of patients with various cancer risk groups (a mixture of Gleason grades, scores and tumor volumes as well as those with the Gleason 6 pseudo-cancer). Not clear is whether any participants received arbitrary testosterone suppression treatment – a therapy which itself can extend life.
Is the FDA approval of the robotic device supported by the clinical evidence?
Despite the absence of clear benefits, gallbladder surgery received an FDA approval for use of the robotic device in the 1980s. Urologists subsequently used the FDA’s fallacious 510(K) process to rubber-stamp an approval for use of the robotic tool in prostate cancer surgery without any supporting data for safety and benefits. This shocking lapse of regulatory judgement is similar to the misguided FDA approval for PSA testing.
The clinical evidence says no to PSA testing and other prostate cancer advice.
The clinical evidence shows that PSA testing and other accepted prostate cancer advice is highly unreliable, exposes patients to many potential health hazards and fails to save significant numbers of lives. The clinical evidence also negates the AUA/Astra/SUO (2017) guidelines for localized prostate cancer (and their false labeling of the Gleason 6 as a cancer), the validity of FDA approvals and the stamps of standard-of-care, evidence-based and science-based. Tags that are commonly self-anointed since there is no regulatory agency that ensures the integrity of these labels.
Renowned meta-researcher John Ioannidis MD had recorded previously that most published research findings are false. Primarily, because healthcare studies are invariably corrupted by bad science, conflicts-of-interest, biases, assumptions and opinions. Not only does the prostate cancer industry draw from this well of junk science but it remains steadfastly indifferent to the clinical evidence that contradicts its narrative. Sadly, these half-truths are all too common in the circus called healthcare. A “science” that defies ethics, morality and reason, and lets intellectual dishonesty and accountability go unchecked.
Read more about how human health is sacrificed for profits.
Junk science, conflicts-of-interest and failed regulatory oversight by the FDA, CDC and others simply expose the public to financial and health robbery. Little wonder people are wary of healthcare guidelines and mandates.
This article is dedicated to our friend and colleague Anthony Horan, MD – The Big Scare. The business of prostate cancer – he was one of the first to expose the rotten underbelly of the prostate cancer industry.