Prostate biopsy study supposedly proves urologists not motivated by money

Dr. Deepak Kapoor

Yesterday afternoon I was sitting at my computer checking my Twitter feed and I came across a tweet from LUGPA (@USUrology), the Large Urology Practice Group Association, that touted a study LUGPA’s president, Dr. Deepak Kapoor, was presenting at the 2013 GU Cancers Symposium.  A little after that, a reader left a comment on one of my posts that included a press release (put out by LUGPA itself of course) that discusses the same study.  Needless to say, I have some questions about it.

Before I go further, I would just like to thank whoever it is that mans LUGPA’s Twitter feed, because as soon as I saw the tweet, I asked LUGPA for a copy of the abstract, and someone immediately provided me with a link.  I am sincerely grateful for that.

This study is called “Utilization and cancer detection by U.S. prostate biopsies (2005-2011)”.  Here is the link to the abstract.

There are three authors in addition to Dr. Kapoor— one is also a urologist in Dr. Kapoor’s practice, Integrated Medical Professionals (IMP), another is one of IMP’s in-house pathologists, and the last is Dr. David Bostwick of Bostwick Laboratories (BL).

Readers will recall a federal judge recently denied BL’s motion to dismiss a whistleblower lawsuit brought against it by Michael Daugherty.  The lawsuit alleges, among other things, BL violated the False Claims Act and Anti Kickback Statute.

The authors harvested data from LUGPA members with their own in-office labs and from BL.  They compared positive biopsy rates and the number of specimen containers used per biopsy procedure and found no significant difference between the two groups.  Additionally, they found the cancer detection rate correlated with the number of biopsy cores taken.

The authors conclude the utilization of 10-12 separate containers for prostate biopsies “…has been adopted by urologists across sites of service and can be considered the de facto national standard of care.”

Dr. Kapoor, in a video interview, further proclaimed these results prove prostate biopsies are being performed appropriately and not for the financial gain of the referring urologists.

I’m not sure I feel the same way the authors do, for several reasons.

First, the data from both the LUGPA practices and BL are, at this time, completely unverifiable, unlike Dr. Mitchell’s study, which relied on verifiable data (Medicare claims data).

Second, we do not know if they included patients with known prostate cancer on active surveillance.  If so, then the positive biopsy rate may be falsely elevated, as they would be including men multiple times in their statistics.

Third, it is my understanding a significant portion of BL’s business comes from urologists who engage in client billing, where the referring clinician can bill for and profit from the pathology service BL performs.  How much of the data BL contributed to this study came from the client billing business model?  We don’t know, because they don’t say.

This would be helpful to know, because if it is indeed a significant number, then I’m not sure one can use the findings in the manner in which the authors want us to.

This is because both urologists with in-office pathology labs and urologists who client bill would have the same incentive to submit each core from a prostate biopsy procedure in its own container.  Each container gets its own charge, which then of course leads to greatly increased profit.  This incentive would negate the significance of the lack of a difference between the two groups with respect to the number of containers used.

Along those lines, I am extremely curious as to why the good doctors did not compare in-office labs with academic centers, where the urologists have no financial incentive to use more containers than necessary.

According to Dr. Jonathan Epstein, the urologists at Johns Hopkins submit their prostate biopsies in 6 containers, with two cores in each.  I’m pretty sure the same is true for the University of Michigan urologists.  These are two of the best urology programs in the country.  Surely if it were necessary to put each core in its own container, they would do it.  But they don’t.

Dr. Epstein, who probably understands prostate cancer better than anyone in the world, further explained:

I feel that in general it is better to put 2 cores per cassette as opposed to 1 core as it with uncommon exception does not impact patient care.

As if further proof were necessary, the NCCN, which writes the exhaustive protocols clinicians follow for the diagnosis and treatment of prostate cancer, also does not feel each core needs its own container.

I believe the only reason to submit cores in this fashion is to maximize profit.

I know I harp on this a lot, but it is a very important point.  If we, as a society, can decrease the amount we spend on a particular medical intervention without impacting the quality of care, shouldn’t we?  We could literally save roughly half a billion dollars a year if prostate biopsies were simply submitted in six containers instead of twelve.

I do agree with the authors on one thing, though.  Previous studies have also shown prostate cancer is more likely to be detected with the 10-12 biopsy technique than with a fewer number of cores.  The NCCN agrees as well, and it recommends 10-12 biopsies per patient.

In conclusion, the submission of each prostate core in its own container is far from being the standard of care and there are several questions to be answered before this study can be properly analyzed.

Call me cynical, but I have to wonder whether the study was constructed in a manner that would allow a pre-ordained conclusion to be “proven”.