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FL Doctor in Trouble Over Prostate Procedure in Mexico

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A Sarasota prostate cancer specialist is in trouble with state health officials for doing a procedure in Mexico that hasn't been approved in the United States. Is he a danger to patients, or just ahead of his time?

Let’s say you’re a guy with a high PSA result on your prostate test. The doctor says you need a biopsy. But there's different advice on the Internet.

In this YouTube video, the Sarasota urologist promotes a book that has more than 600 pages and sells for $39.95.

It lays out Wheeler's philosophy: that biopsies of the prostate gland are dangerous and unnecessary. Instead, he urges the use of imaging - MRI's that can show what's going on inside the prostate.

“We can’t be treating patients or men specifically as if they’re pin cushions and we’re putting all these needles in”, said Wheeler.

Wheeler believes that as needles are pulled out of the prostate, bearing tissue samples, they can pull cells from a cancerous tumor out into clean areas of the gland, or into the rectal wall, the lymphatic system or the bloodstream. His “needle tracking” theory is controversial.

“In this community I believe the physicians are not going to give up their biopsies easily”, Wheeler said.

Wheeler says urology is using old-fashioned methods that hurt patients but make doctors a lot of money. Most of his patients aren't local.

“We see patients from all over the world here in this clinic, and 70% of our practice actually comes from outside the state of Florida”, said Wheeler.

It's not just biopsies. Wheeler also doesn’t like the standard treatment for prostate cancer.

"Maybe removing the prostate is not the best way to do it", said Wheeler. "It certainly is the knee-jerk way to do it. That’s what we’re taught to do as urologists: if you see cancer cut it out."

Instead, Wheeler uses an experimental sound-wave treatment to kill the cancer cells with heat. It’s a lot more intense than the diagnostic ultrasound that's become familiar. It’s called High Intensity Focused Ultrasound. HIFU.

The Food and Drug Administration has not yet approved HIFU, although it's been legal for years in Europe, Japan, and other countries. Dr. Wheeler flies with his patients to Mexico, where HIFU is legal. Cash up front, $32,000. Insurance doesn't cover it.

In a press release a year ago, Wheeler claimed a 95 percent cure rate from HIFU, with no side-effects.

"No patients are incontinent that I’ve taken care of over the last 2 years, and all of our patients are potent", said Wheeler.

Academic urologists say it's highly unlikely that Wheeler's results are that good.

According to Wheeler's websites, HIFU is done in an outpatient clinic. The surgeon inserts a probe in the rectum and positions the ultrasound tool over the cancerous area of the prostate beneath. The wand zaps the cancer cells with sound waves so intense they get cooked.

The doctor posted a testimonial from a patient named Jim Davis, who said he and his wife flew to Puerto Vallarta in August, 2007. Davis said he had HIFU at 11 in the morning and went back to the hotel at 4.

“It’s an amazing thing to think about being able to walk out and actually go out and have dinner and see the sunset after this was all done”, Davis said.

Sounds wonderful. But sometimes it isn’t, says Dr. Rafael Carrion at University of South Florida:

“I myself have seen two patients with severe erectile dysfunction – or problems with erection - and leaking urine from HIFU", Carrion said. "There is no magic treatment that’s foolproof without risks.”

FDA officials declined to discuss the status of HIFU. But the agency appears ready to hear from an advisory panel in the next few months.

Meanwhile, HIFU is not considered the standard of care outside a clinical trial. Neither is Wheeler's practice of using MRIs instead of biopsies, Dr. Carrion at USF said.

"But it's currently a hot topic", Carrion said.

The Florida Department of Health has three pending complaints against Wheeler, citing him for practicing outside the standard of care.

Dr. Wheeler, through an employee, declined a request for an interview. So did his attorney, who said negotiations are under way to settle the case.