Rebel Urologist Faces Trial; FDA Panel to Review Device

Jul 3, 2014

A Sarasota urologist who diagnoses prostate cancer in an unusual way and treats U.S. patients at a clinic in Cancun will not agree to a suspension from practice.

Dr. Ronald Wheeler
Credit YouTube.com

Dr. Ronald Wheeler has rejected an offer from the Florida Board of Medicine to let him keep his medical license if he agrees to a year of suspension and an $80,000 fine, according to the Department of Health.

Instead, Wheeler intends to present evidence at a formal hearing about the benefits of his style of practice. He uses imaging rather than biopsy to diagnose prostate cancer; for patients who have malignancies, he meets them in Cancun to perform high-intensity focused ultrasound, or HIFU. It is legal in Europe, Canada and other countries, but not approved for use in the United States outside clinical trials.

In a stroke of good timing for Wheeler, an advisory committee to the Food and Drug Administration has scheduled a July 30 meeting to discuss the HIFU procedure and a device used in performing it. If the committee votes to recommend approval, the FDA would be likely to follow the advice.

Approval would mean Wheeler would be able to perform HIFU at an ambulatory surgery center in Sarasota. And it would give him  more hope for absolution at his hearing.

"Nobody's heard Dr. Wheeler's side of this," said his practice manager John Frye. "A judge is going to hear this and say, 'Geez, where's the beef?'"

No date has been set for a trial by the Division of Administrative Hearings. It is up to DOH to request one, and DOH spokeswoman Pamela Crain said she does not know when the agency will file it.

A month ago at a meeting in Tampa, the state medical board rejected a settlement proposed by DOH and Wheeler that called for fines and probation but not a suspension.

Members of the medical board, particularly cardiologist Zach Zachariah from Fort Lauderdale, used strong language in denouncing the settlement and Wheeler.

"It looks like he's board-certified in medical fraud," Zachariah said. "He's one of the most dangerous doctors I've seen in a long time...He's a menace to society."

A Health News Florida profile of Wheeler in May drew from his online videos to describe his views, since he declined to be interviewed.  Wheeler describes his methods as more advanced than those of mainstream urologists. In a YouTube video touting his $39.95 book called "Men at Risk: The Dirty Little Secret," he says prostate biopsies are outmoded and can spread prostate cancer cells as the needles are withdrawn.

The complaints against Wheeler involved three prostate cancer patients from other states who were attracted to his Diagnostic Center for Disease through Internet ads and message boards.

He used a specialized MRI to diagnose and pinpoint the tumors, rather than the usual biopsy, and recommended HIFU, DOH records said. After patients paid $32,000 cash, Wheeler told them, he would
perform HIFU at a clinic in Mexico. Records show he serves as a consultant for the clinic.  

Two patients got a second opinion in their home towns and backed out. Another had the treatment but suffered serious complications, records said.

The treatment uses sound waves of such a high frequency that they burn up the cancerous tumor, ideally without harming surrounding tissue.

Two companies -- SonoCare Medical and EDAP -- make the devices used in HIFU. EDAP's device is to be considered at the July 30 meeting, and SonoCare is scheduled for Oct. 2.

Frye said Wheeler has used both devices but prefers the one from EDAP, a French company.

--Health News Florida is part of WUSF Public Media. Contact Editor Carol Gentry at 813-974-8629 (desk) or e-mail at cgentry@wusf.org. For more health news, visit HealthNewsFlorida.org.