When a man gets a worrisome PSA result, his doctor is likely to schedule him for a prostate biopsy. It’s the standard of care.
But if he goes on the Internet and looks around, he may get very different advice. He may find a YouTube video starring a Sarasota urologist who says biopsies are old-fashioned. Barbaric, even.
“Hi, I’m Dr. Ronald Wheeler, author of the book ‘Men at Risk: The Dirty Little Secret - Prostate Biopsies Really Do Spread Prostate Cancer Cells,’” says the man hawking a 600-page book on the video channel for $39.95.
The book, “Men at Risk,” lays out Wheeler's philosophy: that biopsies of the prostate gland are dangerous and unnecessary. Instead, he uses imaging – MRI-spectroscopy, which produces a “roadmap” of the inside of the prostate.
Another outmoded medical practice that harms patients, in Wheeler’s view, is the standard treatment for prostate cancer: radiation or surgical removal of the entire gland, which can damage the nerves that control urination and erections.
A number of less-invasive procedures have been tried for partial-gland tumors, including radiation pellets (brachytherapy) and freezing (cryotherapy). But for whatever reason, they haven't pushed aside the so-called "gold standard," full-gland prostatectomy.
Wheeler rejects that. He prefers a procedure called High Intensity Focused Ultrasound, or HIFU. Wheeler does HIFU in Mexico because it hasn’t been 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, but here it cannot be used outside clinical trials.
A patient who decides on Wheeler and HIFU must come up with $32,000 cash up front. Insurance doesn’t cover it.
Health Department Files Complaints
All of this has brought Wheeler under the scrutiny of the Florida Department of Health, which over the past two years has been investigating him. He faces three administrative complaints for practicing outside the standard of care. Also mentioned in two of them is financial exploitation of patients.
The Florida Board of Medicine is to consider all three cases in early June. (The administrative complaints can be found online on this site by clicking "Link to Complaint.")
The cases involve men from Alabama, Tennessee and Michigan who found Wheeler on the Internet or heard about him from friends. The Alabama and Tennessee patients scheduled HIFU with Wheeler, but changed their minds after talking to their home-town urologists.
The Michigan patient, identified as GP, went ahead with the procedure in Cancun. According to the complaint, that patient suffered scarring that made it hard for him to urinate and required follow-up surgery.
In all the complaints, Wheeler is accused of failing to provide appropriate care - a biopsy - before he concluded that they had prostate cancer and needed HIFU. Reflecting the language of the Florida statutes, the complaints say: "A reasonably prudent physician practicing within the prevailing professional standard of care...would have obtained a biopsy of the patient's prostate before diagnosing and recommending treatment for prostate cancer."
Wheeler’s state online profile says he attended medical school in Guadalajara, Mexico, and did residencies at Akron City Hospital and Louisiana State University Medical Center in New Orleans.
He has not obtained certification in a specialty recognized by the Florida Board of Medicine.
Wheeler, through an employee, declined a request from Health News Florida for an interview. So did his attorney, Paula Willis, in Tallahassee. She said negotiations are under way to settle the case. If they reach agreement, the settlement will be presented to the board, which can accept it, suggest revisions or reject it. If it is rejected or substantially changed, Wheeler may decide to skip the settlement and file for a formal hearing by an administrative law judge.
The state takes the position that Wheeler is violating the law by practicing outside the standard of care, and that doctors who do that place patients at risk. According to his videos, Wheeler's position is that he’s just ahead of his time – or that others have fallen behind.
“I urge you to buy at least two books; one for yourself, obviously, the other also for the most arrogant urologist you know,” Wheeler says on YouTube. “Doctors don’t intentionally want to be arrogant, but they’re stuck in a rut and they are unwilling to learn."
Biopsies Carry Risks
A prostate biopsy, usually ordered after a blood test that shows a high level of prostate specific antigen (PSA), captures tissue samples that can be analyzed to see 1) whether there is cancer, and if so, 2) how aggressive the tumor is. If it's a slow-growing cancer and the patient is old, it may be appropriate to just watch it.
A prostate biopsy is no walk in the park, judging from comments on men’s health message boards. It involves needle jabs through the rectum into the prostate gland, emerging with tissue samples. WebMD describes the process as “a brief, sharp pain” each time the biopsy needle is inserted, and that’s usually six to 12 times -- more for an enlarged prostate.
Prostate biopsies can have side effects, beyond bleeding. Infection can set in even though antibiotics are usually given ahead of time, said Dr. Julio Pow-Sang, chairman of genitourinary oncology at Moffitt Cancer Center. Pow-Sang says studies have found infections in 1 to 6 percent of post-biopsy patients. Occasionally a man will die of sepsis., he said.
Then there is the possibility of missing the cancer cells altogether, having jabbed the wrong spot.
But according to Wheeler, there is a greater danger: “needle-tracking.” As needles are pulled out of the prostate, they bear tissue samples. The samples 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, he says.
“We can’t be treating patients or men specifically as if they’re pin cushions and we’re putting all these needles in,” Wheeler says in a video on his website.
He suggests that MRI-spectroscopy is as good at finding cancer in the prostate as a biopsy, and can be accomplished without needles.
Dr. Rafael Carrion, associate professor of urology at the Morsani College of Medicine at University of South Florida, called MRI instead of biopsy “a hot topic” in urology.
Moffitt's Pow Sang said that while biopsies are still being used at Moffitt to find and evaluate primary prostate tumors, MRIs will be substituted for biopsies on cancer survivors when they come in for recurrence checks.
But will private urologists try it? Wheeler doubts it. “In this community I believe the physicians are not going to give up their biopsies easily,” he said. Urologists cling to old-fashioned methods that hurt patients but make doctors a lot of money, he said. He maintains that his only interest is patient safety.
"It's not about making money," he says on a video. "It's about changing medicine."
'Knee-jerk' Approach to Medicine?
Most of Wheeler’s patients aren't local.
“We see patients from all over the world here in this clinic,” he said in his video, “and 70% of our practice actually comes from outside the state of Florida.”
Wheeler said that removal of the prostate is “the knee-jerk” approach to the disease. “That’s what we’re taught to do as urologists: If you see cancer, cut it out.”
The HIFU that Wheeler employs in Mexico is described as 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.
According to Wheeler's websites, his HIFU procedure is done at a clinic in a deluxe resort. The surgeon inserts a probe in the rectum. It has an ultrasound scanning feature for positioning the device correctly, and a focused, intense sound-wave generator to heat the targeted tissues – to “cook” them, as Wheeler puts it.
Two manufacturers make these treatment systems, one in France and the other in the U.S. (See a 3-D animation of the HIFU procedure by Ablatherm.) Wheeler says he has used both with spectacular results.
“No patients are incontinent that I’ve taken care of over the last 2 years, and all of our patients are potent,” he said in the video.
In a press release a year ago, Wheeler claimed a 95 percent cure rate from HIFU, with no side effects. Academic urologists say it's highly unlikely that Wheeler's results are that good.
“I myself have seen two patients with severe erectile dysfunction – or problems with erection -- and leaking urine from HIFU,” said USF’s Carrion, who makes the point that all prostate cancer treatments have complications. “There is no magic treatment that’s foolproof without risks.”
Online, Wheeler 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 in the testimonial.
FDA officials declined to discuss the status of HIFU. But the agency appears ready to hear from an advisory panel in coming months.