“The USA’s commonly employed medical practices for detecting Prostate Cancer are far Out of Date”
Medical practices have, and continue to follow the Healthcare Finance Association’s (HCFA) – now known as the Centers for Medicare and Medicaid Services (CMS) – guidelines. Unfortunately, it can often take 10 years or more before a life-changing or life-saving device or drug is approved for reimbursement by CMS. The problem is a symptom of good intentions – protecting the public from poor medicine or false claims – morphed into barriers that retard advancements.
Regarding the approval of a new drug or device, CMS relies largely upon the FDA device and drug approvals; yet is significantly more restricted than the FDA1. In order for a device or drug manufacturer to obtain FDA approval, significant investment in testing, validation, and verification of the product is made in addition to that the development time and cost. After receiving FDA approval, the product can legally be released for public use; yet no insurance reimbursement is allowed without CMS approval – meaning that most Americans cannot access this product without paying for it out of pocket.
It is during this period of pre-approval clinical testing and early post-FDA approval and market entry that most peer-reviewed clinical data are published, challenged, and eventually accepted by a growing body of physicians provided that the technology or drug withstands this high level of scientific scrutiny. Even then, it takes one or more various panels of experts – physicians and medical scientists – to advise, and possibly even lobby CMS for approval of the product. These panels often seem to take the most conservative approach of wait-and-see before acting to change old paradigms.
The undesirable side effect of this strategy is the significant time lag between new discoveries and their approval for reimbursement by CMS. Unfortunately for American citizens, this occurs despite the often abundance of clinical evidence presented through those peer-reviewed processes of scientific, engineering, pharmacological and medical journals. Such is the case with Prostate Cancer detection.
In the case of prostate cancer detection, it typically begins with the patient’s age (typically over 50), family history, and symptoms (frequent urination, incomplete voiding, erectile dysfunction, nocturnal urination, etc) related to his general practitioner (GP). Then a PSA blood test for free Prostate Specific Antigen is administered and if it is greater than 4ng/ml, the patient is referred to a urologist. OR not; because in many cases, the confusion amongst GPs regarding the merit of PSA may lead them to bypass this test and send them to a urologist. This is another irony of medicine because many more recent studies have clearly demonstrated that the inexpensive PSA test has assisted in early detection, not because of it being highly correlative to prostate cancer, but because it did lead to further tests that did detect cancer. Unfortunately, many of the later tests were just as non-correlative.
For instance, the typical urologist will perform the (DRE) digital rectal exam, and if he/she thinks that further testing is required the patient is prescribed a Transrectal ultrasound-guided (TRUS) biopsy or standard 12 or 20 core Transperineal biopsy. The former is a subjective test of feeling the size and stiffness of the prostate tissue – not that cancer could be detected. This would be like feeling a pea-sized lesion within a lemon-sized organ by exerting pressure with the tip of one’s finger – noting further than normal and cancer tissues have little discernable difference in tissue elasticity. The latter perforates the prostate with a pre-arranged grid of 12 or 20 (based upon the physician’s desire for sampling resolution) large gauge biopsy needles in hopes of hitting that same pea or even grape within the much larger organ. TRUS biopsies rely upon ultrasound (US) which has zero specificity to prostate cancer, so the purpose of the US is to guide the needle into some portion of the prostate, not hit a specified suspect target lesion.
Incredibly, none of the above tests, after being employed since the mid-1980s (Transperineal and soon after, TRUS) and before (DRE) have proven to be substantially over 50% effective; yet they are all reimbursed today.
MRI, and specifically, multi-parametric MRI (mpMRI) and bi-parametric MRI (bpMRI), have been shown to deliver very high accuracies in detecting prostate cancer; however, the results vary significantly within the US from the low 60th percentile to the low 90th percentile. An MRI doesn’t require a biopsy needle in the prostate with the inherent risk of infection and/or complications. In fact, bpMRI requires no needles at all whereas mpMRI does employ an intravenous injection of a contrast agent. Several recent studies have shown that bpMRI produces nearly identical results as does mpMRI for the detection of prostate cancer.
Why the big range of statistical outcomes with either MRI? Primarily it is the experience, not just training, of the interpreting radiologist. After consulting with many the leading experts (those with large numbers of MRI interpretations and patient historical data), they have stated that one has to have studied under an expert and reviewed hundreds of cases with an overview and clinical feedback such as biopsy confirmations in order to begin to reach accuracies north of 60%. Equipment and MRI operator training are also factors that can be more easily mitigated through upgrading old MRI equipment and better operations training for the MRI technologist.
The case in point about insurance is this. Today, despite a preponderance of evidence compiled over the past 10-plus years touting the benefit and accuracy of MRI over DRE, transperineal, and TRUS biopsies, MRI is not typically approved for insurance reimbursement until AFTER more than one negative transperineal or TRUS biopsy has been obtained and the symptoms persist.
One can research Prostate Cancer detection on the internet today and find the same tired old paradigm described to patients leading them like Lemings to their physicians to employ technics proven obsolete and bested long ago.