Patients have a right to expect only scientifically proven healthcare, for it to be delivered with expertise and, only when truly needed. However, although the cutting out of a prostate cancer sounds reasonable, definitive and possibly, even curative – what is the objective evidence that this controversial surgery is good or bad health advice?
This question is especially important since, not only is there considerable disagreement amongst physicians regarding the benefits of various treatment options available (from radical surgery, radiation and proton beam to focal therapy options using laser, HIFU and cryoablation), but PSA-based screening is very controversial, while the deceptive, all-inclusive prostate cancer label covers both pseudo-cancers and potentially deadly cancers. So what do you do when the evidence says NO, but your Urologist says YES?
Receiving a Prostate Cancer Diagnosis
Receiving a prostate cancer diagnosis can bring you to your knees. In total disbelief you may feel terror, confused, vulnerable and desperate. It’s difficult to think about anything else. You just don’t know where to begin, who to turn to, or who you can trust. Slowly, you begin your information gathering only to find out that there is no emergency, no standard way of managing your particular diagnosis, little time to ask questions, and perhaps pressured by scare-tactics to choose a course of action. At every turn there is a different story. Shockingly, even the prostate cancer support groups and online forums can’t always be trusted. Before long, you learn that the prostate cancer arena is filled with misconceptions, assumptions, and distortions. Dissatisfied and frustrated, you just want to get it all behind you, but take your time and get a second opinion regarding your biopsy results. Ultimately however, you will have to make a difficult decision based upon what type of prostate cancer you have, whether or not it seems contained and what you believe is right for you. Still, you’re left with a feeling that the acceptable is really unacceptable.
The Origins of Prostate Cancer Surgery
So, how did prostate cancer surgery get started and, how did it become entrenched as a treatment? The concept for a radical surgical treatment of prostate cancer came about in the early 1900’s because of a convergence of ideas about two other procedures – and at a time when doctors were free to experiment with trial and error surgery. First, at Johns Hopkins, William Halstead was undertaking experiments with breast cancer treatment by removing the cancer with large amounts of surrounding tissue and muscles – radical breast surgery (radical mastectomy). Secondly, bladder stones had been removed since ancient times via an in front of the anus incision, and since the prostate is located at the base of the bladder, hopeful surgeons used this approach to try and remove parts or all of the prostate. It was this marriage of the “cutting for stone” technique with Halstead’s experimental radical breast cancer treatment (now abandoned) that led Young, also at Johns Hopkins, to refine a radical operation for “treating” prostate cancer.
In the 1905 Bulletin Johns Hopkins University, H.H. Young published his technique for treating prostate cancer, “The Early Diagnosis and Radical Cure of Carcinoma of the Prostate“. Despite the enthusiastic title, Young’s paper offered NO evidence for early diagnosis of prostate cancer and ZERO evidence for cure. Furthermore, Young’s conclusion that, “The four cases in which the radical operation was done demonstrated its simplicity, effectiveness and, the remarkably satisfactory functional results furnished” stands in very sharp contrast to his published results where he noted the deaths of his first two patients. One, in the postoperative period and the other after an attempt to correct a postoperative complication. The remaining two men were left with significant urinary problems after prolonged hospital stays. Furthermore, three of the four men were left with areas of residual cancer so that their cancer removal was incomplete – a problem common today after robotic surgery. Additionally, although not discussed in Young’s paper (since the subject was taboo in those times), impotence in the survivors was a very likely additional complication.
Horan MD, The Big Scare. The Business of Prostate Cancer
The Quest For Perfection – More Trial and Error Surgical Experimentation
It was Young’s description of a technique for removing a cancerous prostate along with his claims of early diagnosis, radical cure and effectiveness that led to decades of more human experimentation with trial and error surgery.
Trying to find ways to control the many dangers associated with radical prostate surgery, surgeons eventually veered away from Young’s original perineal, or in front of the anus approach, to try other surgical entry points such as ischiorectal, sacroperineal and ultimately, Terence Millen’s retropubic or, an in-front and above the pubic bone technique. This soon became the preferred approach and, although removing the prostate this way seemed less deadly, its many nasty complications including incontinence and impotence persisted. Years later in 1982, Walsh tried to address the inevitable post-op erection troubles by suggesting that potency could be maintained if the operation was slightly less radical so that the nerves lying close to the prostate could be “saved”. However, this “nerve-sparing” technique wasn’t perfect, as other urologists went on to develop a battery of counseling programs for both preoperative “outcome expectation” and postoperative, penile and continence rehabilitation programs to deal with the many “limp and leaking” troubles. Even more telling about the harm that prostate cancer surgery caused and the inadequacy of these counseling programs, was the fact that a whole prosthetic industry took root to make implantable urinary control devices and implantable penile erection devices.
Regrettably, this 70-year period of trial and error prostate cancer surgical experimentation was possible only because of a mix of strong-willed surgeons, the weight of institutional authority and the absence of patient protection measures. An era that allowed urologists to continue their “quest to perfect” and claim that not only was radical prostate cancer surgery “effective”, but that it was actually the “standard of care”. However, despite the public’s perception that standard of care suggests a treatment has been proven to be of health benefit, in reality standard of care is covered loosely in a legal explanation as “actions or procedures another reasonable physician of similar training and experience as well as in good standing, would undertake in similar circumstances”. Surprisingly, standard of care does NOT equate with perfect care or, that your care is “standard” because it has been proven objectively through evidence-based studies to be safe or effective.
Patient Protection Policies To Safeguard Human Subjects
Independent ethics and scientific oversight panels to protect patients and ensure that what the surgeon had in mind was safe and effective really only came into play in the 1970’s. Prior to these formal patient protection regulations, the only physician-guiding principles for the “art-of-healing” was the ancient Hippocratic Oath and its edict “but from harm or injustice I will keep (them)”. Principles that were often at variance with surgeons long-held beliefs that they had a license to develop and “improve” various surgical procedures as they saw fit.
It was after the horrific medical experiments conducted by physicians on concentration camp victims during the Second World War that formal rules for conducting new procedures and treatments on patients were found necessary. In fact, the Informed Consent (IC) which detailed a proposed healthcare intervention and, which a patient had to understand and agree to was first used in a U.S. malpractice case in 1957. Further, although the laudable process of Shared-Decision-Making to promote patient-centeredness came about in the early 1970’s, it also was not foolproof since patients could still be incompletely informed, plus not truly share in the decision-making process. Subsequently in 1974, Institutional Review Boards (IRBs) or, panels were formed to determine whether a new procedure/treatment met ethical guidelines, was safe and, had voluntary patient participation. These protocols were based upon the post-war Nuremberg trials and the Declaration of Helsinki whereas, the Federal Policy For The Protection Of Human Subjects Subjects (aka the “Common Rule”) was introduced only relatively recently in 1991.
Miles, The Hippocratic Oath and the Ethics of Medicine
The Origins of Robotic Surgery
When robotic assisted surgery entered the healthcare arena, patient protection policies to shield patients from experiments with new devices were already in place. However, to escape rigorous local IRB and ethics scrutiny, the initial human experiments using robotic assisted surgery were conducted across the border. Despite this low-level clinical study in Mexico recording zero benefit for the robotic device in gallbladder and fundoplication surgery, the FDA (U.S. Food and Drug Administration) still gave the tool a stamp of “FDA approved” in 1999. Surprisingly, the FDA panel voted to approve the robotic device NOT because there were clinically significant beneficial differences between laparoscopic and robotic assisted gallbladder and fundoplication procedures but that, “it (the robotic device) demonstrated potential for future enhancements to surgery”. Despite this majority approval, another panelist offered his take on the data presented and added, “safety perhaps; efficacy not even close; equivalence not always close” – and, this panelist would not support the robotic device as effective or, equivalent (to conventional surgery).
From Gallbladders to Robotic Prostate Cancer Surgery
By the time the robotic device for robotic assisted gallbladder surgery was FDA approved, conventional radical prostate cancer surgery was already firmly accepted by urologists as standard of care treatment. However, this standard of care label was a stretch since, radical prostate cancer surgery was developed during an era when patient protection regulations did not exist and, other than urologists declaring that the surgery was “effective”, there was no objective evidence to support these claims – physician-conducted clinical studies with self-serving definitions of success just don’t count. An issue underscored by Ioannidis who determined that, “most published research findings are false” – because, physicians assume their treatment philosophy to be valid and then design their studies around this extraordinary but unfounded bias. Nevertheless, because radical prostatectomy was always assumed by urologists to be “effective”, they simply assumed by extension, that the robotic prostatectomy would also be effective.
Soon after the FDA approval of the robotic tool for use in gallbladder surgery however, the device-maker realized that there was no lucrative market for robotic cholecystectomy (gallbladder removal). Undeterred, the robotics company went on the hunt to find a suitable disease to create a need for the “minimally invasive” gizmo and, quickly locked on to impressionable urologists still mesmerized by the illusion of “effective” and “curative” radical prostate cancer surgery. With the FDA approval for gallbladder surgery in hand (although no benefits demonstrated), it was but a simple matter to use the FDA’s 510(k) process as a backdoor maneuver to be granted an FDA approved label for the robotic device to assist in removing a cancerous prostate – the 510(k) is a premarket submission made to the FDA to demonstrate that a device to be marketed is at least as safe and effective, that is, substantially equivalent to a legally marketed device that is not subject to an FDA premarket approval (PMA). By using the phony claim that the device to be used for robotic prostate cancer surgery would be essentially similar to that already used in robotic gallbladder surgery, urologists were given an automatic FDA “approved” label for the robotic device in prostate cancer surgery in 2001. This process occurred despite the enormous differences between prostate and gallbladder surgery and, without the robotic device ever being tested for safety or benefits on even a single case of prostate cancer.
The Many Complications From Prostate Cancer Surgery
The fact that prostate cancer surgery and its robotic cousin had established itself as “standard practice” but, without the benefit of patient protection scrutiny or, independent objective data for safety and effectiveness, is probably why the robotic prostatectomy comes with a trove of potential complications.
From deaths within 30 days of surgery to suicidal depression, deep vein thrombosis and, many other general surgical complications have been recorded. As well, there are complications specific to robotic surgery such as insufflation embolism, trochar injuries and positioning injuries and, injuries that are particular to prostate removal itself. From every possible sexual problem imaginable (damaged or lack of erection, lack of emission, lack of ejaculate and or, ejaculating urine, pain on orgasm, infertility and lack of libido); penile issues (shortened penis, penile pain, numbness, curvature, wasting and, a general loss of manhood); testicular pain; bladder problems (urinary leakage, bladder neck scarring, bladder stones, infections). Furthermore, an even greater list of complications can be expected in those “advised” to undergo “salvage” prostatectomy because of residual or recurrent cancer after another form of treatment. And, if you ever wonder whether fiction trumps truth, talk to the wives, partners or, girlfriends of the patients to get a more realistic report on outcome results for robotic prostatectomy.
Additionally, there are several other important concerns. First, many men operated on for Gleason 6 disease never needed treatment of this pseudo-cancer and are survivors of the treatment and not the bogus cancer. Second, whereas men with small “apparently localized” high-grade prostate cancer do demand treatment, there may only be a semblance of cure since aggressive cancer cells often have the genes to metastasize and may have already spread to the bone marrow prior to surgery when tumors can be as small as 2 millimeters. Lying dormant and undetectable by imaging studies, these cells may spread years later. Third, studies have shown that the handling of the prostate during surgery causes the release of cancer cells into the bloodstream. Although cancer-cell seeding has been recorded after surgical manipulation, this form of blood dissemination of prostate cancer cells appears not to accelerate cancer evolution. However, although this study was only taken out over a short 5 years, metastatic disease can appear 15 years or more after surgery. Fourth, radical prostate surgery often removes the tumor incompletely to leave cancer at its cut margin (positive margin occurs in some 11-48 percent of cases). Surgeons will then recommend a course of radiation to try and treat this residual cancer – with or without a course of testosterone suppression or androgen deprivation therapy (ADT) which comes with its own list of toxic complications. A nasty process like salvage surgery that simply adds to the complications and costs.
What About the Costs of Robotic Surgery?
The robotic device costs 1-2 million dollars along with maintenance contracts and expenses of about $150,000.00 dollars annually; disposable supply costs; specialized instruments costs; upgrades; staff training; surgeon cases needed for proficiency; longer anesthesia time; cost of operating room and turnaround time between cases; cost of conversion to open surgery when the robotic approach fails and, the costs of treating the many probable complications listed. Sadly, with this background of complications and uncertainty about benefits, the expenses associated with robotic prostatectomy simply represent a burden on precious healthcare dollars.
The Many Warnings About Radical Prostate Surgery
Concerns about the effectiveness of prostate cancer surgery were noted by urologists in their PIVOT study (Prostate Intervention Versus Observation Trial) published in the New England Journal of Medicine. As to whether radical prostate surgery saved significant numbers of lives, this review concluded that; “Among men with localized prostate cancer detected during the early era of PSA testing, radical prostatectomy did not substantially reduce all-cancer or prostate cancer mortality, as compared with observation (active surveillance), through at least 12 years of follow up. Absolute differences were less than 3 percentage points (statistically insignificant)”. In other words, despite undergoing this invasive surgery, it offered zero protection against dying from prostate cancer and, according to Horan, “without proof of life-extension in man or animal that would satisfy the committee on medical experimentation at Nuremberg”.
In step with this stunning conclusion that prostate cancer surgery failed to save significant numbers of lives, Robert Aronowitz, an internist and medical historian, “Screening for Prostate Cancer in New York’s Skid Row: History and Implications”, underscored once more the many concerns about prostate cancer screening, treatment safety and effectiveness and, determined that “our screen-and-treat paradigm in prostate cancer is evidence-challenged”.
Additionally, the many dangers associated with robotic prostatectomy have been clearly recognized by the legal fraternity as well Government oversight agencies. Not only are there numerous lawsuits linked to surgeons and hospitals regarding robotic prostatectomy and its complications but, the FDA’s MAUDE (Manufacturer and User Facility Device Experience) site has recorded numerous issues regarding robotic prostatectomy despite only about 8% of actual adverse events being listed there because of the websites’ complexity. Also, the USPSTF (United States Preventive Services Task Force) has expressed deep reservations about the PSA-based prostate cancer screening program and the treatment of screen-detected cancers because “the benefits do not outweigh the harms”. Furthermore, Dr. Otis Brawley from the American Cancer Society, A. Horan, (The Big Scare) and, Ablin and Piana, (The Great Prostate Hoax) have all recorded in glaring detail not only the many dangers associated with the surgical treatment of prostate cancer but, questioned its effectiveness as well as the impact of financial conflicts-of-interest involving the prostate cancer industry. Even the robotic device-maker is fully aware of the dangers of the robotic device for prostate cancer surgery as its list of disclaimers grows with every website revision.
Unfortunately, turbocharging the many dangers associated with the risky robotic prostate cancer surgery “treatment” has been the equally unreliable PSA-based (prostatic specific antigen) screening program used to funnel men towards this cut-to-cure ideology.
PSA-Based Screening – The Detection-to-Cure Myth
There are many valid concerns about the supposed benefits of PSA-based screening. First, the PSA is not cancer specific; has a 78 percent false-positive rate; leads to the detection of mainly benign and non-lethal diseases and commonly fails to detect the 15 percent or so of potentially deadly high-grade cancers as they often make little or no PSA and, if these are detected it’s because the benign portion of the prostate caused the PSA to rise – facts underscored by Ablin and Piana who stated, “the ill-use of a prostate cancer test has systematically ruined the lives of millions of American men”. Second, the prostate exam (DRE – digital rectal exam) is no more reliable than a coin-toss while the unscientific, ultrasound-guided needle biopsy of the prostate (also FDA approved) is blind and, samples randomly only some 0.1-0.3 percent of the prostate. Third, although appearing mildly cancerous under the microscope the Gleason 6 “cancer” has been misrepresented as a cancer because, on both clinical and molecular biology grounds, the Gleason grade 3 in the Gleason 3+3=6 “cancer” (Gleason 6 or, G6) LACKS the hallmarks of a cancer. A fact that brings doubt to the reliability of any prostate cancer statistics and studies that have embraced the bogus Gleason 6 as a “cancer”. Furthermore, some 50 percent of 50 year olds have Gleason 6 disease within their prostate. Fourth, not only are standard imaging studies insensitive for detecting microscopic spread of high-grade cancer but, imaging and pathology reports are not foolproof. In contrast, MRI imaging studies of the prostate by experts in prostate imaging seem to be the best screening tool for prostate cancer, almost foolproof and, with no need for random biopsies.
Ablin and R. Piana,. “The Great Prostate Hoax”
When the Evidence Says No But Urologists Say Yes
Getting a prostate cancer diagnosis and then finding out that much of the information and advice comes in a rich diet of misrepresentations colored with a few trivial truths to lend credibility is disturbing. Easily understood however, when one realizes that healthcare generally, has been infected with a process of orchestrated deception for the sole purpose of making money at patient expense.
According to Piana (The Great Prostate Hoax), RAND HEALTH has concluded that one third of all procedures are undertaken for inappropriate indications and, come with questionable benefits. This concern is particularly relevant for the prostate cancer arena where urologists have concluded from two studies, the “Mortality Results from a Randomized Prostate-Cancer Screening Trial” and their PIVOT study that “PSA-based screening results in a small or no reduction in prostate cancer specific mortality” and “radical prostatectomy did not substantially reduce prostate cancer mortality”. Never mind that it is medically impossible to cut out a prostate cancer and live like you did before this “treatment”.
Men only have a chance of dying from the 15 percent or so of high-grade prostate cancers and, according to Horan (The Big Scare), “only 3.6% of men have a tumor clinically significant enough to kill them”. Furthermore, not only do these numbers justify the concerns about over-diagnosis, over-treatment and, that the robotic prostatectomy is worse than the disease itself but, urologists have been deaf and blind to their own data. Therefore, because PSA-based screening fails to lead to the early detection of significant numbers of men with only high-grade prostate cancers and, the robotic prostatectomy not only fails to save significant numbers of those with high-grade prostate cancer but is associated with many significant complications, the weight of the evidence seems stacked against PSA-based screening and robotic prostate cancer surgery despite urologists saying yes. Accordingly, the robotic prostatectomy is bad health advice and, both the PSA and robotic device should have their FDA approvals pulled.
A Typical Miserable Patient Prostate Cancer Treatment Journey
As Albert Einstein is credited with saying, “The definition of insanity is doing the same thing over and over again but expecting different results” and, as Jonathan Swift observed, “Falsehood flies, and the truth comes limping after it”.
Bert Vorstman BSc, MD, MS, FAAP, FRACS, FACS