No License: HIFU Prostate Cancer Doc Arrested

Nick Mulcahy

July 25, 2017

A urologist who was once called "one of the most dangerous doctors" in Florida and who specialized in the treatment of prostate cancer with high-intensity focused ultrasound (HIFU) has been arrested by police in Sarasota, Florida, and charged with practicing medicine without a license.

The arrest took place on July 20 at the Sarasota offices of Ronald Wheeler, MD, whose medical license was revoked in late April. Dr Wheeler is 70 years old.

The arrest occurred after an anonymous complaint to the state's Department of Health that Dr Wheeler was still practicing medicine despite the revocation of his license.

Local police then went undercover at Dr Wheeler's HIFU Centers of America office in Sarasota. The undercover policemen, who posed as prostate cancer patients, were told that the office visit cost $3445 and that the recommended HIFU-based treatment plan started at $50,000.

Dr Wheeler has seen from four to 12 patients since his license was revoked on April 20, said Investigator Mike Harrell of Sarasota Police Department during a press conference last week.

There is "no question" that Dr Wheeler knew his license had been revoked by the state authorities because he was personally served with papers, said Harrell.

Harrell also said that Dr Wheeler was advertising prostate cancer diagnosis and treatment services but did not perform confirmatory tissue biopsies for patients with cancers diagnosed using MRI. Biopsy is required by law in the state of Florida. Harrell cited four complaints from patients related to that procedural violation, which are on file at the state's Department of Health.

In an online statement, Dr Wheeler's HIFU Centers of America said that the four complaints "are being vigorously disputed to ensure public confidence relevant to the integrity and reputation of Dr Wheeler (personally) and HIFI Centers of America LLC (corporately)."

The name HIFU Centers of America is misleading, because there is only one office, which is in Sarasota.

Furthermore, the center has not had an HIFU device for some time because the Ablatherm machine was removed by the manufacturer (EDAP) that leased it to Dr Wheeler, said Harrell.

EDAP's Ablatherm device received US Food and Drug Administration (FDA) market clearance in 2015 for the ablation of prostate tissue. However, no HIFU device has been approved for the treatment of localized prostate cancer in the United States, although this approach is approved and used in Europe and elsewhere. Nevertheless, other urologists are treating prostate cancer with HIFU in the United States, including in Florida.

At various times, Dr Wheeler has skirted his problems with Florida health authorities and in relation to the lack of FDA approval of HIFU by treating American patients in Mexico, Harrell said.

Additional charges for Dr Wheeler are expected, because the police have seized patient records. The arrest is "just the beginning," said Harrell. Dr Wheeler "has not been cooperative" with the police in their efforts to determine the number of patients inappropriately seen or treated.

Several patients have contacted Sarasota police and said they paid $45,000 for HIFU but have yet to receive the treatment, said Harrell, who added that this failure to provide treatment has not yet been categorized as fraud. An investigation is ongoing to determine whether Dr Wheeler received payment before his medical licence was revoked.

Dr Wheeler is well known both to authorities in Florida and to patients online.

In 2014, the Florida Board of Medicine ruled that Dr Wheeler be fined the maximum penalty of $80,000 and suspended from practicing for 1 year for practicing outside the standard of care. Such practices include his diagnosing prostate cancer via MRI alone, according to various news reports, including a report in the Tampa Bay Times.

"He was diagnosing patients as having prostate cancer without any kind of biopsy being done," said Harrell. His diagnoses of cancer were being made "strictly" on the basis of MRI results.

MRI is being investigated by urologists at major centers, such as the Sunnybrook Health Sciences Center, in Toronto, Canada, as a promising tool for the screening, evaluation, and monitoring of prostate cancer. The monitoring of prostate cancer is especially relevant for patients who undergo active surveillance. However, the imaging technique is not considered standard of care for diagnosis, which is determined by tissue biopsy and analysis.

The majority of Dr Wheeler's patients were not residents of Sarasota but came from other states, including Colorado and Kansas. These patients came to his practice via Internet promotions, said Harrell.

Dr Wheeler played on men's fears, which has prompted other complaints to the state's Department of Health, said Harrell, in answering a reporter's question at the press conference.

Dr Wheeler's modus operandi was to tell patients that they had aggressive prostate cancer and that HIFU "was probably their only option," said Harrell in reference to a number of complaints received by the state's Department of Health.

Last year, after being censured by the Florida Board of Medicine, Dr Wheeler was the subject of posts on the Us Too Prostate Cancer patient bulletin board under the headline of "Watch Out for Dr Wheeler."

Dr Wheeler is the author of the 600-page book Men at Risk: The Dirty Little Secret That Prostate Biopsies Really Do Spread Prostate Cancer Cells.

In an online promotional video, Dr Wheeler says the book explains that "imaging should precede biopsy, if a biopsy is ever done."

The idea that MRI could be used for prostate cancer screening is not far-fetched.

A Swedish pilot study found that screening for prostate cancer using MRI and employing a lower prostate-specific antigen (PSA) threshold could result in fewer men undergoing biopsy, with no compromise in cancer detection rates, as reported by Medscape Medical News.

Also, a Canadian study concluded that MRI was a "feasible" tool for screening men for prostate cancer, also reported by Medscape Medical News.

However, neither study proposed or concluded that MRI could be used to the exclusion of biopsy in diagnosing prostate cancer.

Follow Medscape senior journalist Nick Mulcahy on Twitter: @MulcahyNick

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