An outspoken Sarasota urologist, whose unusual practice style brought him under state investigation four years ago, has signed an agreement that includes suspension from practice.
Dr. Ronald E. Wheeler , who specializes in treatment of prostate cancer with ultrasound, vowed to fight a suspension two years ago when the Florida Board of Medicine insisted on it.
Ever since, Wheeler and the Florida Department of Health – which investigates and prosecutes health professionals -- have been in a standoff. It is not clear why Wheeler agreed to suspension at this point; he said in an e-mail he couldn’t be interviewed without consulting his attorney. But he vented about the health department.
“DOH is corrupt,” Wheeler said in an e-mail. “Doctors in the State of Florida are disenfranchised by the DOH and its ruthless draconian ways!!”
The settlement agreement, which both DOH and Wheeler signed last month, will be presented to the Board of Medicine in early October. By signing it, Wheeler is not admitting that he did anything wrong, but agrees to accept discipline to bring the case to an end.
The agreement includes a suspension for at least one year, to end only after independent evaluators say he can practice safely. The suspension would be followed by 10 years’ probation, under indirect supervision by a board-approved physician.
Also Wheeler would have to pay a fine of $40,000 and DOH’s costs of investigation and prosecution, already over $48,000. And he would be barred from treating a patient for prostate cancer unless the diagnosis has been confirmed with a biopsy of tissue.
Wheeler got into trouble in 2012 when he promoted his unconventional treatments on YouTube, and he drew patients from all over the United States. Some of the state’s concern was that Wheeler was diagnosing and treating prostate cancer without a biopsy confirmation of the disease.
The standard treatment for prostate cancer is radiation or surgical removal of the entire gland, which can damage the nerves that control urination and erections.
Wheeler used a procedure called High Intensity Focused Ultrasound, or HIFU. He did the procedure in Mexico because it wasn’t approved by the U.S. Food and Drug Administration for use in the United States. It’s well-accepted in Europe, Japan, Canada and many other countries.
Wheeler believed that needle biopsies of the prostate were unnecessary and even dangerous. He said that MRI-spectroscopy, an advanced form of imaging, could do just as good a job without needles.
He wrote a book “Men at Risk: The Dirty Little Secret – Prostate Biopsies Really Do Spread Prostate Cancer Cells.” The 600-page book is available online for $39.95.
Most urologists, while impressed with advances in non-invasive diagnostics, have not considered them sufficient proof of disease without biopsies.
Wheeler was also initially charged with financial exploitation, because he was sending patients to Cancun to undergo a procedure – high-intensity focused ultrasound, or HIFU – that had not been approved in the U.S. But that accusation was dropped when Wheeler said convincingly that he was doing HIFU in Cancun only because he couldn’t do it at home; studies came out showing good results in Europe and Japan.
In any event, the U.S. Food and Drug Administration approved HIFU late last year, freeing Wheeler and several other Florida proponents to begin offering it.