Prostate cancer has long been one of the most common types of cancers in American men. Our Curious Dr. George asks retired urologic surgeon Bert Vorstman, MD, and freelance science writer Ronald Piana about the quality of prostate cancer information available to U.S. patients and doctors.
Curious Dr. George: Most people with prostate cancer live a long and healthy life. But some die, with or without treatment. It can be a confusing disease. To what extent are American men and physicians receiving trustworthy information about prostate cancer?
Bert Vorstman and Ron Piana: For men entering the prostate cancer arena, the terms “standard-of-care,” “medical practice guidelines,” and “FDA-approved” are very reassuring. But are they trustworthy? Let’s see if the evidence supports the stamp of standard practice:
- In 1994, the U.S. FDA (Food and Drug Administration) approved the PSA (prostate specific antigen) test, despite the fact that it had a false-positive rate of 78 percent because it is neither specific to the prostate nor to prostate cancer. As well, its so-called cut-off value of 0 to 4 ng/mL is an arbitrary and misleading metric that can lead to unnecessary and potentially harmful therapies. Along with a host of other PSA inaccuracies, the 10 to 15 percent subset of prostate cancers that are high-grade and potentially deadly can be missed as they often produce little to no PSA—a major problem, since it’s essentially these aggressive prostate cancers that are responsible for the 30,000 or so U.S. prostate cancer deaths annually.
- The 12-core ultrasound-guided prostate needle biopsy samples only about 0.1 percent of the prostate blindly and randomly. Along with this egregious sampling error, the biopsy exposes men to the risk of significant complications of sepsis and bleeding.
- Examination of a prostate biopsy under low-power microscopy overly relies on the pathologist’s knowledge and interpretive skills of the complex Gleason grading and scoring system. Because of potential errors of judgment, grade misclassifications and disagreements about a given patient’s diagnosis amongst pathologists are common.
- The Gleason grade 3 (in the 3+3=6) was judged initially to be consistent with a low-grade, low-risk cancer under low-power microscopy. However, clinical evidence—and the discovery that the genetic pathways enabling cancer development and spread are inactive—mean that grade 3 has features inconsistent with a cancer.
- The safety and benefits of prostate cancer surgery were always in doubt. In 1904, H. Young MD claimed early diagnosis, cure, and remarkably satisfactory functional results from radical prostate surgery. However, he gave no actual evidence for early diagnosis or cure, two patients died, and the other two were left with lifelong urinary leakage. And, when robotics entered the business of surgery, not only was this approach given an FDA approval without demonstrating clear benefits, but the FDA’s fallacious 510(K) process was manipulated to permit use of the device for radical prostatectomy—again, without sufficient evidence of safety or benefits. Unsurprisingly, robotic prostatectomy, like open surgery, had a similar rate of residual cancer, incontinence and impotence problems. These complications were managed with radiation, pre- and post-operative counseling and rehabilitation programs, or implantable devices for ongoing limp and leaking issues. The breakdown of these gadgets resulted in even more surgery, costs, and suffering.
Warning: Prostate cancer testing and treatment are unreliable, unsafe, and fail to extend life. Since most men outlive their prostate cancer, and prostate cancer information is untrustworthy, vulnerable and unwitting men are in great jeopardy of being harmed.
For more invaluable information for patients and physicians on the unreliability of prostate cancer testing and treatment, readers can consult the books The Great Prostate Hoax by Ronald Piana and Richard J. Ablin, PhD, and The Rise and Fall of the Prostate Cancer Scam by A. Horan M.D.
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