According to a report in The Tampa Bay Times this morning, the Florida Board of Medicine has imposed a one-year suspension and a significant fine on a relatively well-known urologist who has been diagnosing prostate cancer exclusively on the basis of magnetic resonance imaging (MRIs), without a confirmatory biopsy.
The physician in question had also recommended (to at least three of the men so diagnosed, who later filed complaints) that they go to Mexico for treatment “at a center where he serves as a consultant.” The recommended treatment “is not approved by the U.S. Food and Drug Administration and not covered by insurance,” which suggests that it would have been high-intensity focused ultrasound (HIFU).
Dr. Ronald Wheeler has been an aggressive advocate for both MRI in the diagnosis of prostate cancer and HIFU in the treatment of prostate cancer in recent years. And while The “New” Prostate Cancer InfoLink is of the opinion that MRI scanning absolutely has a place in the accurate diagnosis of prostate cancer, and that HIFU has a place in the treatment of prostate cancer, for appropriately informed patients, the actual treatment of men for prostate cancer without a confirmatory biopsy at this time is, at best, unethical and unsupported by the available data.
The report notes that Dr. Wheeler has 7 days to advise “the board whether he’ll accept the settlement. If he does not, there will be further board action.”
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THE "NEW" PROSTATE CANCER INFOLINK 
Sounds like he’s threatening the status quo and financial interests of the establishment. The identification of prostate cancer with MRI is pretty good, and definitely better than a 12-core blind biopsy. If you have a low-risk way to treat, why would you go through a biopsy which is more dangerous the HIFU?
Wow. Actual professional accountability in the medical world? How can that be? But there are some not so positive stories out there about Dr. Wheeler. I’m just impressed that the Florida Board of Medicine practices oversight.
Dear Doug:
If Dr. Wheeler’s MRIs are this good, then he would only need to take one or maybe two biopsy cores to confirm the cancer. And without doing this, there is no way that he can assure a patient of his Gleason score! He may well be threatening the status quo, but that doesn’t justify poor medical practice.
EXPERTS FAVORING MULTIPARAMETRIC MRI STILL HOLDING OFF ON SUBSTITUTING IT FOR A BIOPSY
A lot of us are aware of the growing enthusiasm for multiparametric MRI in assessing the prostate for cancer, but comments current at least as of September 2013 indicate that leading experts are not calling for a substitution for the initial biopsy. My take is that Dr. Klotz’s Toronto team is among those edging close to using MRI for follow-up assessment of men on active surveillance as a substitute for biopsies. However, as their algorithms are based on a follow-up biopsy at 1 year, and more spread out follow-up biopsies as warranted, I’m thinking they will at least want to run biopsies in parallel to MRIs for a time.
Has any study demonstrated that Gleason determinations from MRI are at least as good as biopsy determinations? I’m not aware of any.
Doug — I’m not seeing any persuasive evidence that HIFU is worthwhile. Do you know of any? It needs to have at least 5 years of median follow-up, because that is where international HIFU series (including Sonablate as well as Ablatherm), have converged in showing a striking fall off in success to a level clearly and substantially below the success of properly done surgery or radiation, HIFU research also needs to show success clearly above the level that we could have expected from properly managed active surveillance. I once was eager to see HIFU succeed, but now we have a lot of data.
I’m still hoping someone will figure out how to make HIFU really work. Maybe that data will come out at the FDA meeting on July 30. (To date that meeting has only been tentatively scheduled, and none of the supporting materials are available. I would be delighted if you could prove me wrong.)
As for Dr. Wheeler, I have found his comments and views interesting for many years, but I’ve always had the impression that he relied on his intuition more than evidence. I had a hunch from this report’s title that Dr. Wheeler would be the subject of the attention.
Jim,
The long-term HIFU results that I have seen are disappointing. But those are old studies. Emberton and Scionti, who are probably the focal leaders in the world, both use HIFU heavily, so I assume it works. My belief is that if you can accurately locate the tumor, FLA is the way to go, and if you can’t accurately locate it, the go with HIFU or maybe IRE. This is just my opinion … I have no medical training.
What makes MRI — especially fused with color Doppler ultrasound — exciting is that it can pinpoint the spot where the biopsy should be done, and hopefully eliminate blind biopsies, and reduce the number of cores taken.
Dear John:
Well — maybe. We’re still waiting for definitive data to confirm that idea. Most of the currently available data still suggest that the combination of a systematic 12-core biopsy together with targeted biopsies based on MRI/TRUS fusion guidance is the best way to ensure appropriate diagnosis, because either method on its own is associated with a non-insignificant risk for false-negative results.
John,
Where do they do an MRI fusion using color Doppler?
All the fusions I am aware of use standard grey-scale ultrasound.
There are many European studies that show HIFU to be an effective treatment with far fewer side effects. There can now be no doubt that MRI has greatly enhanced the accuracy of a biopsy when required. There is no doubt that blind (12-core) biopsies are 30 t 40 percent false negative depending on what study you believe. There is no evidence to support Dr. Wheeler’s claims of needle tracking causing cancer to spread. The rest of his claims are supported by studies.
Given the doctor that called him a menace to society <a href=http://miami.cbslocal.com/2011/06/03/rapist-sex-offender-gets-ok-to-practice-as-florida-md/>let a convicted rapist practice 3 years after the conviction, a 5-year suspension might seem like a witch hunt.
Bob
Well, I’ll bet there are no tears in the urology world for Dr. Wheeler. It seems his reputation has preceded him. But it is going to be fun to watch the October FDA recommendation on SonaCare.
Will SonaCare’s HIFU, too, be denied so all of focal therapy naysayers can gloat in the decision? Or will it be approved, opening up a new door of choices for those prostate cancer patients desiring a less invasive treatment. I wonder how many males want to increase their chances of coming out of prostate cancer treatment with an erection?
i would like to sue him and get my money back — a lame doctor and poor staff.