FDA Panel Says No; Docs Say Yes
Sarasota urologist Ronald Wheeler says he's going to continue doing a controversial prostate-cancer treatment, even though an FDA panel recently voted against it and even though the state could punish him for it.
Because the U.S. Food and Drug Administration has not approved the French device that Wheeler uses for high-intensity focused ultrasound, called HIFU, he has been treating his patients in Mexico.
Europe, Japan, Canada and many other countries have allowed HIFU for years. Wheeler hoped the device would win approval from FDA this year, but a medical advisory committee vote July 30 went the other way.
Panel members were well-intentioned, Wheeler said in online comments, but they didn’t know enough about HIFU to give it a fair hearing. He called the decision “outrageous, unconscionable and unacceptable.”
The FDA panel isn’t Wheeler’s only current problem. As Health News Florida reported in June, the Florida Board of Medicine is so suspicious of his style of practice that it voted to seek his suspension, calling him “a menace to society.” Wheeler invoked his right to an independent hearing examiner, a process the Department of Health has not initiated yet.
Despite the disdain from the FDA advisors and medical board, Wheeler is not the only American doctor using HIFU. He’s not even the only one in Sarasota.
Dr. Stephen Scionti, a urologist who has done hundreds of HIFU cases, moved his practice to Sarasota recently after many years in Boston and New York. He doesn't work with Wheeler, but the two practice groups are in touch.
"They sort of welcomed us to the neighborhood," said Scionti's administrative assistant Doug Knowlton.
Wheeler's practice manager John Frye said the two groups have talked. "There's a good chance we will work together" eventually, he said.
HIFU is a minimally invasive treatment that involves neither radiation nor surgery, and it can be done as an outpatient. But that's not possible in the United States except as part of an officially sanctioned clinical trial.
Both Wheeler and Scionti have to send HIFU patients to clinics outside the country where the doctors spend a few days a month. Wheeler works in Cancun, while Scionti goes to Nassau, his assistant said.
U.S. prostate-cancer patients find out about HIFU through the Internet when they seek alternatives to the traditional treatments of surgical prostate removal and radiation, which can result in incontinence or erectile difficulty.
"For us Baby Boomers -- and I'm now in that group -- quality of life is important," Scionti says in a YouTube video. "We're not ready to give up our sex lives. We're not ready to be back in a pad or a diaper."
Even though insurance doesn't pay for HIFU and it costs a lot -- in Wheeler's case, about $30,000 -- patients come for consultations from across the country.
The technology involves the use of high heat, narrowly focused and applied in rapid ultrasound bursts, to destroy cancer cells in the prostate gland after they are mapped through magnetic resonance imaging, or MRI.
Two manufacturers of HIFU devices have applications pending with the FDA. The one Wheeler uses, the Ablatherm from EDAP TMS, has been used in 40,000 patients over 15 years in other countries. The product that Scionti uses, Sonablate by the Charlotte, N.C. company SonaCare Medical, is scheduled for consideration in October.
The reason the Gastroenterology and Urology Panel of the FDA's Medical Device Advisory Committee voted against Ablatherm, according to Medscape, is that EDAP provided very little data showing the device was safe and even less demonstrating effectiveness. The company had been unable to recruit enough U.S. patients to conduct the kind of clinical trial that would meet FDA standards.
Wheeler and his staff, who watched the proceedings through an Internet link, were disgusted at the result. Wheeler wrote online that the FDA should look at results from U.S. doctors who are performing the procedure in other countries. He said he has a "99 percent cure rate" with low rates of side effects.
But Wheeler's claim drew criticism from some, including Medscape commentator and prostate cancer expert Dr. Gerald Chodak. He said such high rates of cure are likely the result of doing procedures on many men who didn't need them.
He wrote, "Thankfully, the FDA panel has not allowed another unproven treatment to end up getting covered by insurance."
Wheeler said in an interview that he's still smarting from the treatment he received in June from the Florida Board of Medicine, which threw out a proposed settlement worked out between Wheeler's attorney and the Department of Health that would have fined him but let him keep practicing.
The board said it wanted him suspended for a year, followed by five years' probation, not to mention an $80,000 fine. It was not an offer Wheeler was inclined to accept, so he took the other option: Forcing DOH to prove its case against him before a hearing officer. DOH has not yet filed the documents for that hearing.
Wheeler said he has never been so embarrassed as he was during the June meeting, especially when board member Dr. Zach Zachariah called him "dangerous" and "a menace to society."
Wheeler said, "It appeared to me they were gunning for me from the start."