Is Robotic Prostate Cancer Surgery Bad Health Advice?
When physicians say yes but the evidence says no
Patients have a right to expect only scientifically proven healthcare, for it to be delivered with expertise and, administered 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 there is considerable disagreement amongst physicians regarding the benefits of the various treatment options available for treating prostate cancer. These include radical treatment choices using surgery, radiation, radioactive seeds or proton beam to focal therapy choices using laser, HIFU or cryoablation. Even more debate surrounds PSA (prostatic specific antigen) testing while the deceptive all-inclusive prostate cancer label covers both pseudo-cancers and potentially deadly cancers.
Getting hammered with cancer label
Getting a prostate cancer diagnosis can bring you to your knees. In total disbelief you feel terrorized, confused and very unskilled to handle such dreadful news. You start thinking about dying and have all sorts of other crazy thoughts. It’s difficult to concentrate on anything. Is it true? What do I have to do? You just don’t know where to begin, who to turn to or, who you can trust. Getting appointment times and waiting for the various consultations is an agonizing experience. Slowly, you begin your information gathering only to find out that there is no emergency, no standard way for managing your particular diagnosis, little time to have questions answered and, pressured by scare-tactics to choose a course of action. Shockingly, even the prostate cancer support groups and online forums seem confused and, there’s a different story at every turn. Before long, you learn that the prostate cancer arena is filled with misconceptions, assumptions, and distortions. Only some prostate cancers are potentially deadly and, any urinary symptoms you may have are because of the benign enlargement of the prostate and not the cancer. Dissatisfied and frustrated, you may even be tempted by a “minimally invasive” quick fix to get it all behind you. However, since all treatments come with potentially significant complications, be very careful. Take your time and do your homework. Get opinions about your particular cancer and, another opinion on your biopsy results. It’s a tough road but eventually you will make a difficult decision about whether or not you need any treatment, what type of treatment maybe best for your particular kind and stage of cancer and ultimately, what you believe is right for you. Still, this horrible exercise will leave you with a very strong feeling that the acceptable is really quite 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 or, radical mastectomy. Second, bladder stones had been removed since ancient times via an in front of the anus incision and, since the prostate is located here 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 cancer treatment (radical breast surgery has since been abandoned) that led H. H. Young also at Johns Hopkins, to refine a radical operation for “treating” prostate cancer.
In the 1905 Bulletin Johns Hopkins University, 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 or life extension. 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 common postoperative complication. Furthermore, the remaining two men were left with significant urinary problems after prolonged hospital stays. Even worse, three of the four men had incomplete removal of their cancer with a positive margin — a problem seen frequently now after robotic surgery. And, 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 as it is today.
A. Horan, The Big Scare. The Business of Prostate Cancer
The quest to perfect— more trial and error prostate cancer surgery
It was Young’s description of a technique for removing a cancerous prostate and 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 methods to control the many dangers associated with radical prostate surgery, surgeons eventually veered away from Young’s perineal or, the in front of the anus approach to try other surgical entry points before adopting Terence Millen’s retropubic or, the 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, Patrick Walsh addressed the inevitable postoperative erection troubles by suggesting that potency could be maintained if the operation was slightly less radical so that the nerves for erection that lie 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 the nerve-sparing technique and counseling programs was the fact that a whole prosthetic industry took root to make implantable urinary control devices and implantable penile erection gadgets.
Regrettably, this seven decade 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 regulations. 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 “standard of care”. However, despite the public’s perception that standard of care suggests that 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 to be safe or effective through evidence-based studies.
Patient protection policies to safeguard human subjects
Independent ethics and scientific oversight panels to protect patients and ensure that what a surgeon had in mind was safe and effective only came into play in the 1970’s. Prior to this time, 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 modify various surgical procedures as they saw fit.
It was only after the horrific medical experiments conducted by physicians on concentration camp victims during the Second World War that formal rules for performing 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 with 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 and not truly share in the decision-making process. Subsequently in 1974, Institutional Review Boards (IRBs) were formed to determine whether a new procedure or treatment met ethical guidelines, was safe and, had voluntary patient participation. These protocols were based upon findings from 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 approval of robotics for gallbladder 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 the 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 however, 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 robotic gallbladder surgery to robotic prostate cancer surgery
By the time the robotic device for robotic-assisted gallbladder surgery had been FDA approved, conventional radical prostate cancer surgery had already been firmly accepted by urologists as standard of care for many years. 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. Nevertheless, because radical prostatectomy was always assumed by urologists to be “effective”, they simply assumed by extension that robotic prostatectomy would also be effective.
Not long after the robotic tool was FDA approved for use in gallbladder surgery the device-maker realized that there was no lucrative market for robotic gallbladder removal since surgeons still preferred the laparoscopic technique. Undeterred, the robotic company went on the hunt to find a suitable disease to create a need for the “minimally invasive” gizmo. Quickly, they locked on to impressionable urologists still mesmerized by the illusion of “effective” and “curative” radical prostate cancer surgery. With the FDA approval for use of the robotic device in gallbladder surgery in hand (although no benefits demonstrated), it was but a simple matter to use the FDA’s 510(K) process and the phony claim that the robotic device to be used in prostate cancer surgery was “essentially similar” to the robotic device already approved for use in gallbladder surgery. Disturbingly, despite major differences between these two operations and, without the robotic device ever being tested objectively on even a single case of prostate cancer, urologists were given a rubber-stamped FDA approval to use the tool for robotic-assisted prostatectomy in 2001.
The many complications from prostate cancer surgery
The fact that prostate cancer surgery and its robotic cousin had established itself as standard of care without the benefit of patient protection scrutiny or, supporting objective data for safety and effectiveness is undoubtedly why the robotic prostatectomy also comes with a trove of potential complications. After-effects that commonly need even more surgery to correct. Not only is it medically impossible to cut out a prostate and live like you did before the surgery but, if you should wonder whether fiction trumps truth in terms of robotic prostatectomy outcome success, just talk to the wives, partners or, girlfriends of these men.
The complications are extensive. From general surgical problems including deaths within 30 days of surgery, suicidal depression, deep vein thrombosis and many other issues, there are complications specific to robotic surgery such as insufflation embolism, trocar and positioning injuries. As well, there are injuries that are particular to prostate removal. From every possible sexual problem imaginable including lack of libido and loss of manhood, damaged or lack of erection, lack of emission, lack of ejaculate, ejaculating urine, pain on orgasm and, infertility. Additionally, there are potential Penile issues such as, shortened penis, penile pain, numbness, curvature and, wasting and, testicular pain and bladder problems such as urinary leakage, bladder neck scarring, bladder stones and, infections. An even greater list of complications can be expected in those with locally advanced disease and “advised” (without objective evidence for life extension) to undergo surgery to remove as much of the prostate as possible (“de-bulking”) and, to “mop up” residual cancer with radiation and testosterone suppression. A similar list of troubles and also without evidence for life extension can be expected in those advised to have a “salvage” prostatectomy because residual or recurrent cancer was detected after another form of treatment.
As well, there are a number of other concerns. First, men who underwent treatment for their Gleason 6 “cancer” never needed it as the Gleason 6 is a pseudo-cancer. These men are simply 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 early and, can spread to the bone marrow when these tumors are as small as two millimeters in diameter. Lying dormant in the bone marrow and undetectable by imaging studies, these cells may spread further 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 tumor handling, the activity appears not to accelerate cancer evolution. However, studies taken out only over some five years or so are unreliable since metastatic cancer can appear 15 years or more after surgery. Fourth, radical prostate surgery often removes the tumor incompletely by leaving cancer at its cut margin — a positive margin occurs in some 11–48 percent of surgical cases.
And, what about the costs associated with robotic prostatectomy? The robotic device costs some one to two million dollars. Additional costs come from, maintenance contracts; disposable supplies; specialized instruments; software upgrades; staff training; longer anesthesia time (even more when surgeons are trying to gain experience); longer turnaround time between cases; conversion to open surgery when the robotic approach fails and, the treatment of complications. Sadly, with this background of drawbacks and doubts about benefits, the expenses associated with robotic prostatectomy are just another unnecessary burden on precious healthcare dollars.
Does prostate cancer surgery save lives?
No. Prostate cancer surgery fails to save significant numbers of lives. There are two widely referenced studies that have been undertaken by urologists and, largely ignored by them. The PIVOT study (Prostate Intervention Versus Observation Trial) published in the New England Journal of Medicine 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 risky 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”.
The other radical prostatectomy study had a 29 year follow-up and claimed a mean of 2.9 years of “life” gained. However this study also, was hopelessly flawed and skewed towards a semblance of life extension because men with the Gleason 6 pseudo-cancer were included while others received arbitrary, additional interventions such as testosterone suppression (androgen deprivation therapy or, ADT). This therapy can extend life somewhat but also comes with a possible bucket-load of side effects.
The many warnings about prostate cancer surgery
In step with the concerns that prostate cancer surgery fails to save significant numbers of lives, Robert Aronowitz, an internist and medical historian published, “Screening for Prostate Cancer in New York’s Skid Row: History and Implications”. Here, troubled about prostate cancer screening and treatment effectiveness he made the observation 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 eight percent of actual adverse events being listed there because of website 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, R. Ablin and, R. Piana have all recorded in glaring detail not only the many dangers associated with prostate cancer screening and the surgical treatment of prostate cancer but, questioned its effectiveness as well as the impact of financial conflicts-of-interest surrounding the prostate cancer industry. Even the robotic device-maker is fully aware of the dangers of the robotic tool for prostate cancer surgery as its list of disclaimers grows with every website revision.
R. Ablin and R. Piana,. “The Great Prostate Hoax”
Does prostate cancer screening save lives?
No. Prostate cancer screening fails to save significant numbers of lives. Unfortunately, turbocharging the many dangers associated with the robotic prostate cancer surgery “treatment” has been the equally unreliable PSA-based screening program used to funnel men towards this cut-to-cure ideology.
Aside from the fact that urologists have already concluded from the study, “Mortality Results from a Randomized Prostate-Cancer Screening Trial” that “PSA-based screening results in a small or no reduction in prostate cancer specific mortality”, there are many other valid concerns about 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 usually because the benign portion of the prostate caused the PSA to rise. Facts underscored by Ablin (discovered the PSA in 1970) 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 or, 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 (commonly, in one to five areas) suggesting that this disease is simply part of the aging process. Fourth, not only are standard imaging studies such as bone scans highly insensitive for detecting microscopic spread and make staging very unreliable but, imaging and pathology reports are not foolproof as their analyses are subject to errors of interpretation.
In contrast, an MRI study of the prostate (but only by an expert) appears to be the best screening tool to detect and map out area(s) of significant high-grade prostate cancer. Unlike the ultrasound-guided biopsy which samples randomly only a very small percentage of the prostate the MRI is able to evaluate the whole of the prostate, ignore the Gleason 6 disease and, is without need for random biopsies. Any localized high-grade cancers detected and confirmed by realtime MRI-guided biopsy may then be treated with MRI-guided focal therapy options using HIFU or laser or, if these areas are larger, with whole gland radiation or proton beam. However, while the MRI is reliable (not perfect) for detecting high-grade prostate cancers, it is unable to say whether that particular cancer(s) will take your life and therefore demands treatment. Even tumor grades, risk groups, biomarkers, genomic testing and other predictive tools for estimating the risk of your cancer taking your life are unreliable and tend to overstate the need for treatment. Furthermore, rather than a particular cancer having a risk of becoming more aggressive, it are “field-change” effects that sometimes allows the development of a more aggressive cancer somewhere else in the prostate and why periodic MRI surveillance is reasonable. Additionally, it is unclear which of the radical or focal treatment options currently in play are truly safe and effective for these few high-grade prostate cancers since there are no longterm objective studies with patients stratified according to validated Gleason score and tumor volume.
When physicians say yes but the evidence says no — the power of myths and lies
Although the public assumes that healthcare information and advice is proven, trustworthy and, in their very best interest, in reality much of it is crafted to influence and exploit. This well-oiled prescription aims to profit from the unaware with a diet rich in distortions, selective presentation and emphasis and, a few trivial truths to make it all seem very reasonable. Even researchers and physicians stray from science into junk science to help themselves. Urologists did this when they assumed that their cut-to-cure treatment philosophy was valid and then designed all of their other prostate cancer studies around this extraordinary but unfounded bias. Such a fundamental study design flaw is surprisingly common in science and why Ioannidis determined that, “most published research findings are false”.
Along with the finding that most study results are unreliable, there are two other disturbing reports that lead one to question whether good healthcare information and advice even exists. First, RAND HEALTH (Ablin and Piana) has concluded that one third of all procedures are undertaken for inappropriate indications and, come with questionable benefits. Second, the Institute of Medicine (IOM) has determined that the U.S. Healthcare System wastes some $750 billion dollars annually and, a significant portion of this waste comes from unnecessary services. Disturbingly, unneeded services with over-diagnosis and over-treatment feature prominently in the prostate cancer industry because of a gaming of the cancer label. As discussed in the previous section Klotz has determined that the very common Gleason 6 prostate “cancer” although called a cancer, fails to behave like a cancer. Furthermore, since there is no objective evidence that the Gleason 6 turns aggressive, it doesn’t need detection and, doesn’t need treatment. Moreover, Horan determined that of all the men with so-called prostate cancer, “only 3.6% of men have a tumor clinically significant enough to kill them”. It is only these significant high-grade prostate cancers that are responsible for the 30,000 or so U.S. deaths annually.
The crime of being mislead and railroaded into unnecessary services and treatments is that not only do they expose you to possible harm from complications but, these “favors” may open you to additional harm from medical errors and, reactions to prescribed medications. Especially from generic drugs (Eban) because, many of these generics are unsafe. Yet, despite all of the players in our U.S. drug supply chain being well aware of the potential dangers that these imported generics pose to consumers, there is no mandatory quality control process to check their safety and effectiveness. Regrettably, consumer protection is generally deeply flawed because of weak American regulatory oversight and accountability. Even worse, lobbyists and lawyers can easily challenge and manipulate these rules for the benefit of foreign or local Big Businesses. Such was the case when urologists brazenly concocted a politically-based challenge on the USPSTF and had the highly unreliable PSA re-graded from a D to a C grade for men in the 55 to 69 year old age range. An underhanded action taken to protect the business of prostate cancer and fool the public that despite its 78 percent false positive rate, the PSA screening test could have some merit.
Although marketed as so-called standard practice, the fundamental reasons why the prostate cancer screening and surgical treatment agenda represents such a giant health hazard is because this program is based mostly upon feeble science, herd mentality, ineffective medical guidelines and, weak regulatory oversight. Unfortunately, this process fails to identify and cure reliably the few men with the killer-type prostate cancers. Instead, it captures and harms mostly those who have the non-lethal types of prostate cancer and, that never needed detection or treatment. Yet, despite the evidence that robotic prostate cancer surgery is bad health advice and burdened by false hope and false promises, urologists continue to say yes. Sadly, in order to cure this glaring healthcare disaster, a socially responsible and humanitarian public health approach is needed. An approach that should suspend not only health insurance coverage for both PSA-based screening and robotic prostatectomy but also, their FDA approvals. Once independent objective testing establishes safety and significant benefits for prostate cancer screening and surgery, perhaps insurance coverage and their FDA approvals could be reinstated.
https://www.nejm.org/doi/full/10.1056/NEJMoa0810696 https://www.theatlantic.com/health/archive/2012/09/how-the-us-health-care-system-wastes-750-billion-annually/262106/ https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0020124
K. Eban, “Bottle of Lies”
Bert Vorstman BSc, MD, MS, FAAP, FRACS, FACS
Originally published at https://urologyweb.com on June 10, 2019.