Over-diagnosis, over-treatment, and “first, do no harm”

The potential problems associated with over-diagnosis and over-treatment that have been much debated in the world of prostate cancer over the past few years actually go well beyond prostate cancer.

There is an interesting article in this week’s issue of the British Medical Journal that helps to put the situation regarding prostate cancer into a larger context, along with the over-diagnosis and over-treatment of a variety of other disorders.

To give just one example among those described by Moynihan et al.:

Diagnostic scanning of the abdomen, pelvis, chest, head, and neck can reveal “incidental findings” in up to 40% of individuals being tested for other reasons. Some of these are tumours, and most of these “incidentalomas” are benign. A very small number of people will benefit from early detection of an incidental malignant tumour, while others will suffer the anxiety and adverse effects of further investigation and treatment of an “abnormality” that would never have harmed them.

The “New” Prostate Cancer InfoLink is extremely cognizant of the fact that early detection of aggressive forms of prostate cancer is the only currently available strategy that has a good chance of offering curative therapy for a man so diagnosed. However, we are also extremely cognizant of the related fact that for every one of those men who really needs such early diagnosis and treatment, we may be diagnosing and treating anywhere between a dozen and a couple of hundred men who really did not need such a diagnosis because they will never benefit from treatment and may indeed suffer irreparable harm to their quality of life.

In the case of prostate cancer, we, like others, have no “perfect solution” to the current problem. What we do understand, however, is that our technological ability to identify possible risk for disease now far outdistances our abilities to provide therapeutic care in an appropriate manner to those who actually need such care and to not over-treat those who will never actually benefit from such care.

If the Hippocratic principle of medicine that a physician should “first do no harm” is to be kept alive and well given the technological capabilities of the 21st Century, we all need to appreciate that the current debate about over-diagnosis and over-treatment is timely and highly appropriate — even if we have individual, personal opinions about exactly what the implications are for the diagnosis and management of early stage prostate cancer.

9 Responses

  1. I’m not sure who the royal “we” is here, Mike. I know YOU understand this, but there’s little in response from the AUA as an organization and from the rhetoric, research, and actions of most individual members of the prostate cancer advocacy and treatment community to indicate that you are anything but very, very alone.

  2. Tracy:

    The supposed “Royal we” in this piece is all of us, as a society, not just the prostate cancer community or the urology community or The “New” Prostate Cancer InfoLink.

    I also believe that there is a significant “change of position” going on within the AUA and led by a new generation of opinion-leaders in the world of prostate cancer who have been working behind the scenes to overturn the historic intransigence of some well-known members of the urologic oncology community.

  3. And a new test that differentiates between aggressive and indolent forms of PCa will end this discussion on screening.

  4. Tony:

    Well … only if it is a simple blood or urine test. Any test that is based on further analysis of biopsy specimens (like the genomic test being evaluated by researchers at the Cleveland Clinic) would leave the screening debate unresolved … although it might resolve the over-treatment issue.


    I too of course would love to see a simple test that could separate the sheep from the wolves.

    However, active surveillance (AS) is a now well accepted approach by leading medical organizations and is well supported by research. Why is AS not seen, for the purpose of reducing or eliminating over-treatment, as an extension of stagingthat is capable of largely ending over-treatment?

    I am aware that a large majority of eligible patients and their doctors still chose treatment, but I see that changing as the advantages of AS penetrate the minds of the medical community, media, and men who are at risk for prostate cancer and their loved ones.

    I have been puzzled throughout this screening debate why AS has been essentially overlooked. (Sitemaster: I have reviewed the USPSTF’s treatment of AS following your comment on another post, and I’m more convinced than ever that they do not really appreciate the role AS can play in prostate cancer. I hope to post about that.)

    Tracy, are you aware that the AUA endorsed AS in 2009?

    Tony, is there a reason you do not mention AS?

  6. Dear Jim:

    It is not the responsibility of the USPSTF to address issues about how using different management strategies might affect outcomes AFTER the use of mass screening for prostate cancer. The USPSTF’s recommendation is solely focused on one thing — that there is no good evidence to support the widespread recommendation of mass, population-based, annual screening of otherwise healthy men for risk of prostate cancer, that the currently available data suggest that for most of those men the current risk of harms outweighs any risk for clinical benefit, and they therefore do not recommend this. (This is not to say that individualized testing based on risk is not appropriate, but again, that is not what the USPSTF is responsible for making recommendations about.)

    The fact that AS may be able to significantly impact this equation is also still to be proven in any type of study that offers level 1 evidence of benefit. For those who make their decisions on this type of evidence-based medical process, an hypothesis is (rightly) not sufficient. The fact that the AUA has (somewhat tepidly) “endorsed” AS is far from the same as the AUA telling its members (as the NCCN has done) that AS is the only recommended form of first-line management for men with low- and very-low-risk prostate cancer and a life expectancy of 15 years or less.

    I have been consistently asking opinion leaders in the urologic oncology community if anyone can tell me what the rates of recommendation and rejection of active surveillance are at the present time. No one seems to have had the good sense to be accurately tracking this information. They all tell me that the rates of recommendation of AS are up significantly, but none of them can tell me what the actual acceptance and rejection rates are.

  7. No reason, Jim. I was directing my comment to the need for a better tool for determining who needs to be treated and who doesn’t.


    Mike I get the point. But it probably would not settle the over-treatment issue either to be honest. After all, 50% of all doctors are below average. … When we had Nick Vogelzang at our meetings he pointed out how, typically, 3 years after the conclusion of level 1 studies about 46% of doctors were still practicing the contrary to the study at hand. Not encouraging. He also pointed out that many doctors reject these studies regularly.

  8. A question: Is biopsy considered over-diagnosis or over-treatment? I find its invasive character unacceptable when based solely on a modest PSA result.

  9. Dear Chris:

    At this time, a biopsy is an essential component of a diagnosis of prostate cancer. There is no other way to know with certainty whether a specific patient actually has prostate cancer or not (unless he has evident metastatic disease on a bone scan in combination with other symptoms and an elevated PSA).

    The critical question is really “Who should and who should not get a biopsy?”

    I would argue that at the one end it was unethical to give a biopsy to any man over 85 years with a PSA of less than about 15 ng/ml unless there was a clear family history of men living to > 100 years of age. That would be a clear case of over-diagnosis. At the other end of the scale, it would be at least unwise not to give a biopsy to a man of 40 years with a normal-sized prostate (or smaller), a PSA of 3.0 ng/ml or higher, and no other signs or symptoms of a prostate condition. In between these two extremes, the water becomes muddy fast. What is “appropriate,” for example, for a man of 55 years with a PSA of 3.2 ng/ml and no other known risk factors? I don’t think we really know. We do know, however, that there is a significant risk that such a man has Gleason 7 prostate cancer.

    In other words, inappropriate use of prostate biopsy may well constitute over-diagnosis in individual, well-defined cases. Over-treatment may be a consequence of over-diagnosis, but that is based on a separate decision by men and their doctors about the management of prostate cancer that has already been diagnosed. It has nothing to do with the decision whether to have or not have a biopsy.

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