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The DOH (Department of Health) comes under fire as Dr. Wheeler questions their integrity and their intent.
Dr. Ronald E. Wheeler, a Prostate Cancer Specialist and an Advocate for Patient Rights intends to prove the Department of Health (DOH) has accused him wrongly without proper foundation or due process.
Many men interested in the services of Ronald E. Wheeler, M.D. have inquired about the disposition of 4 complaints filed by the State of Florida’s DOH regarding our position of diagnosing prostate cancer without a biopsy as well as the use of High Intensity Focused Ultrasound (HIFU) for men determined to have prostate cancer. Anyone reading this message should know that all 4 complaints, albeit similar, are being vigorously disputed to ensure public confidence relevant to the integrity and reputation of Dr. Wheeler (personally) and HIFU Centers of America, LLC (Corporately). While we are expecting resolution of all 4 cases without guilt, the merit of the facts are noted herein without discussing specifics that may prejudice this case. Dr. Wheeler’s thoughts follow.
I am a Board of Medicine, Certified physician of more than 25 years. During this time, I have had the privilege of treating and/or assisting thousands of patients. My career goal has always been to honor the “Hippocratic Oath” by first doing no harm. It is amazing to me how many patients know this health care directive while equally amazing, yet ironic, how many doctors fail to openly adhere to this directive. Health care is an incredible field where doctors are entrusted to do special things for men, women and children by informing a patient fully and doing what is right … first and foremost. In the field of medicine and surgery, imaging is the most significant diagnostic tool we have regardless of organ studied.
In the field of Urology, prostate cancer is the most prolific cancer that men acquire. It is also the number two killer of men with prostate cancer trailing only lung cancer. The diagnosis of prostate cancer has been most commonly (but not exclusively) associated with patients undergoing a biopsy as the “standard of care”. History tells us that often time diseased organs are treated without a biopsy including Kidney cancers. While I admit a biopsy of the prostate is the “Standard of Care”, it is by no means the only approved diagnostic tool. Urologists, who have taken the initiative to learn a more balanced approach diagnostically, are now totally on board while understanding that imaging with a 3.0 T MP-MRI scan has become a “game changer” allowing their intended biopsy to find prostate cancer with greater predictability. This is a win-win scenario for patients and doctors who remain enthusiastic about biopsies and the need for such.
So to be sure, there are alternatives to a biopsy when a patient refuses a biopsy for whatever reason including but not limited to: personal or religious beliefs, personal experience, the experience of others, an issue with an artificial heart valve, limb or hip, bleeding disorders or even the fear of death. Fortunately, the threat of death from Septic Shock is less than 1-2%, however, upwards of 8% of prostate biopsied men will be hospitalized for sepsis referencing Johns Hopkins’ “state of the art” research analysis. Beyond sepsis, the threat of “needle tracking” has been documented in the Journal of Urology for all Urologists to understand for more than 14 years. Unfortunately, despite what the literature states, the vast majority of Urologists will tell a patient that “needle tracking” or seeding of prostate cancer cells is an “old wives tale”. This is a measure of ignorance at the highest level when doctors should be all knowing or at least knowledgeable about “needle tracking” in a procedure they perform. Due to the detractions (including adverse events) to a biopsy, the patient “Bill of Rights” in most States support an alternative to a biopsy. Diagnostically, United Healthcare has stated in January 2015 that either a biopsy or a 3.0 T MP-MRI are equally diagnostic for prostate cancer. It is not surprising, therefore, that men who choose an alternative to a biopsy are given the opportunity to undergo imaging with a 3.0 Tesla Multi-Parametric Magnetic Resonance Imaging (3.0 T MP-MRI) scan.
I first learned the benefits of a 3.0 T MP-MRI scan in early 2004 prompting me to enter into a research study as a PI (Principal Investigator) with General Electric from 2006-2011. During this time our center scanned more than 1600 men. Since then I have been involved in evaluating more than 2500 scans. The information gathered and opportunity to learn enabled me to become expert and/or equivalent to the very best of prostate MRI reading Radiologists.
In an allied issue, tied to their complaint, High Intensity Focused Ultrasound (HIFU) is a procedure typically performed when men are believed to have prostate cancer. HIFU, available throughout the world for more than 27 years had been used by myself and other treating Urologists from the USA in various countries including Bermuda, Bahamas, Mexico, England, Argentina and the Dominican Republic. The complaint levied by the DOH suggests that without a biopsy, how could a doctor possibly know if cancer is present? Apparently, in their failure to research the case carefully they did not know of my research experience with General Electric nor are they aware of the findings of the Food and Drug Administration (FDA) for approving HIFU as a device to ablate (destroy prostate cells) without any mention that men had to have a biopsy showing the presence of Prostate cancer. In effect, the FDA statement regarding HIFU was “they (Urologists in Clinical Trials) had not convinced anyone with their expertise in ridding a patient of prostate cancer”. Correctly, the FDA Ruling allows a doctor and a patient to come together on a topic with or without a biopsy to discuss the relevance of treating with HIFU. Clearly, we all know that a rising PSA (in the majority of cases) indicates prostate cancer, while a rising PSA without a positive finding of prostate cancer on biopsy suggests highly that a prostate cancer was missed. A clinical false positive would be a cancer that is found to be low grade without any real chance of long term harm to the patient. The very mention of or finding of cancer can be very disturbing emotionally to men who develop prostate cancer. Clearly, this is further reason for scanning a patient pre-emptively (prior to a biopsy), or if at all. To be sure, with the FDA ruling, men are not required to have a biopsy prior to having a HIFU procedure. To take this idea a step further, maybe the FDA also believes imaging makes more sense than an intrusive biopsy with complications noted above and merely trying to protect the integrity of the Hippocratic Oath.
The third issue of concern with the DOH relates to the prescribing of cancer type drugs. The state claims in their case against me that I used cancer type drugs (not typical chemotherapy) inappropriately. To be sure, I used the drugs appropriately to suppress a presumptive cancer due to an excessively high PSA at a time when the patient had to have his risk lessened or his chance of cure would be lessened. The FDA has always stated that a physician may use any FDA approved drug if the drug has value to a patient regardless of its primary indication. One would think the “expert(s)” at the DOH would know this but it is not the case here.
So in conclusion, 4 patients out of more than 2000 patients made complaints after another health care provider suggested they had the right to file a complaint. In every case, it was a health provider who failed to see my vision or understand how to properly take care of a patient in need but thought a well-trained intelligent doctor needed to be reined in. In the one case where HIFU was performed, the patient had received a negative biopsy previously, become septic and then subsequently hospitalized. This individual also had a family history of prostate cancer, so therefore avoiding a secondary biopsy was consistent with the other 3 patients who did not want another biopsy as well. The HIFU patient’s procedure went quite well despite an issue with a stricture that was later addressed and remedied.
Instead of the DOH supporting the “Patient Bill of Rights” and one of their own physicians (me) they found concern even though there was “no harm and no foul” related to any patient. I appreciate your understanding that there has been no wrong doing in any of the four cases and invite your comments and/or consultation so you can make the best decision for yourself.
I look forward to the opportunity in the near future to defend my actions and results before the Board Of the Florida Department of Health. As stated it is expected that with a full and impartial hearing of the evidence these four complaints will be resolved.
I am a patients’ healthcare freedom fighter and will always do what is in the best interest of any given patient without prejudice or self-serving intentions.
Respectively, Ronald E. Wheeler, M.D. March 4, 2016