Of politics, prostate cancer, screening, and editorial opinions


We don’t often refer to articles in what are primarily political publications like The Hill, but an OpEd in that journal this week did catch our attention, and not in a particularly good way either.

We should begin by being very clear that we are absolutely not “fans” of the decision, in 2012, by the US Preventive Services Task Force (USPSTF), to give use of the PSA test a “D” rating — effectively suggesting that there were no good data whatsoever to suggest that PSA testing had any value as a screening test for prostate cancer.

The “New” Prostate Cancer InfoLink is, in fact, of the opinion that the value of the PSA test is considerable for many men known to be at elevated risk for prostate cancer, but that its value as a mass, population-based screening test remains unproven — primarily because the two large trials completed to date were not well conducted. Indeed, one of those two trials, the European Randomized Study of Screening for Prostate Cancer (ERSPC)  trial, was really just a meta-analysis of multiple slightly different trials carried out in different countries according to different criteria at the same time. The other trial (the so-called PCLO trial, here in America) was simply a botched job and the only thing it proved is that it was badly designed (which many of us knew from day 1).

We are trying to be optimistic that the current, ongoing review of the available data will lead to the USPSTF issuing a revised rating that is either an “I” or a “C”. There are reasonable arguments to justify either of these two ratings for use of the PSA test as a screening tool. (Click here for the implications of each of the five available ratings issued by the USPSTF regarding preventive health care services, including screening tests for various forms of cancer.) We would also note that the senior investigators responsible for the ERSPC trial have themselves said, multiple times, that the data from this trial do not justify the use of the PSA test as a “screening” test (see here for an example).

Having said that, we wish to discuss the OpEd in The Hill, which is published over the name of Dr. Gary Kirsh, a urologist who — among other things — is the current chairman of the Large Urology Practice Group Association (LUGPA). The title of the article is “Prostate screenings are a cornerstone of men’s health“.

Unfortunately, for starters, the author doesn’t explain clearly what is meant by this title. If his intent is to argue that “access to PSA testing for initial assessment of possible risk of prostate cancer should be available for all appropriate men with the guidance of an appropriately knowledgeable clinician,” then we absolutely would agree with him. Conversely, if his intent is that, “all men should have regular, annual, screening PSA tests for risk of prostate cancer,” then we absolutely disagree with him.

The author attempts to bolster his arguments against the USPSTF by re-presenting information about a rise in the risk for metastatic prostate cancer that has already been discredited and by utterly misusing the recent data from the ProtecT trial in the UK.

With respect to the article suggesting that “rates of metastatic cancer climbed 72 percent between 2004 and 2012”, we have already noted that another much more sophisticated analysis has shown that this is not the case, and an article published just the other day appears to show that, at one large referral center, the use of PSA testing for risk of prostate cancer by primary care physicians has remained unchanged since the issuance of the USPSTF guidance.

With respect to the comments on the ProtecT trial, the data from this trial had nothing to do with PSA testing at all. Indeed, the ProtecT trial is just one part of a much larger effort to assess risk for prostate cancer in the UK — a trial in which > 400,000 men were initially randomized to receive or not receive PSA screening tests for risk of prostate cancer. We are still awaiting the results of that trial — which might actually tell us whether mass, regular PSA testing really does or really doesn’t “save lives”. The ProtecT trial, by comparison, was designed to evaluate whether men already diagnosed (as a consequence of participation in the screening study) with lower risk forms of prostate cancer could be successfully managed on active surveillance. It showed that many of them could; that some men could but still preferred to have definitive therapy; that some men really needed to be taken off active surveillance and given definitive treatment; and that some men placed on active surveillance in that trial should probably never have been given that option (because they weren’t well enough evaluated in the first place or because they didn’t meet what would be considered, today, as reasonable criteria for management on active surveillance).

The author is, of course, utterly correct in the stated opinion that:

Until such time as advanced tools and tests are able to identify which patients are most at risk for metastasized cancer there is no substitute for the urologist and patient working together to decide the best course of treatment.

What the author is not entitled to do is use inaccurate and irrelevant data to support the positions he has now publicly taken about the use of the PSA test as a “screening” tool.

In fact, however, we suspect that Dr. Kirsch did not write this OpEd himself at all. Rather, we suspect it was written in his name by someone with a significantly less sophisticated understanding of the nuances of the appropriate use of the PSA test and the enormous importance of men really understanding just what that test can and can not tell a man and his doctors. If that is the case, we hope that Dr. Kirsch will take the opportunity to make that clear.

Men do need to have access to the PSA test until something better is available to assess risk for prostate cancer in the average man in the street of 40 years and older (or perhaps 35 years and older among African Americans). Men also do need to appreciate that the PSA test is not a test for risk of prostate cancer. Rather, it is a test for risk of any one of several possible prostate disorders that range from the entirely curable (without any surgery or any other form of invasive treatment) to the most aggressive forms of prostate cancer than can indeed lead rapidly to the deaths of very small numbers of men within 3 to 5 years. Men also need to understand that current testing strategies for risk of prostate cancer may place than at massive risk for loss of erectile and sexual function, loss of good urinary continence, and other complications and side effects of forms of treatment for low-risk prostate cancer that may not have been necessary at all (so-called “over-treatment”).

Finally, men most certainly need those “advanced tools and tests” that are indeed “able to identify which men are at most risk for” metastatic prostate cancer. Furthermore, those new tests need to be affordable, which the PSA test certainly is — but which many of the newer tests that have reached the market in the past 5 years or so really are not — if they are going to have any value as first-line tests for risk of prostate cancer.

6 Responses

  1. So many of the comments on prostate cancer screening focus on “but it saved my life” — as if one person’s story readily applies to everyone. Ben Stiller recently wrote an editorial along that line. The Huffington Post printed this in response, which I thought was fair.

  2. @Clara … I have to disagree with you and The Huffington Post article that quotes many testing advocates’ nemesis, Otis Brawley.

    One person’s story may not apply to everyone, but it applies to many. The epidemiological argument made by USPSTF and many others ignores the situation of many of the 30,000 to 40,000 men diagnosed every year with high-risk prostate cancer. Many of those men are strong candidates for advanced disease that kills 20,000 to 30,000 in most years. And many of those men die because they never had a PSA test until diagnosis; or, as in my case and many men for whom I advocate, their primary care pohysician never ordered repeat PSAs.

    In my own case, thank God I had a kidney cyst that caused my urologist to order a PSA or perhaps I would not have survived the almost 10 years since diagnosis. The nomograms back in 2007 suggested I probably would not. Moreover, I do know that missing an interim PSA test resulted in several years of additional treatment. Where does that cost figure in to the epidemiological arguments?

    Before you say — well that’s just more anecdotal information, I for one can attest that is not the case amongst men with recurrent and advanced disease. Sitemaster may well know, I do not, whether studies have been done on how frequently men with advanced disease were tested prior to diagnosis. My experience speaking to hundreds if not thousands of men suggest many of these men were not tested regularly.

    Sitemaster and I have disagreed for a good part of the past 9 years and I suspect that will continue. … I will add that at this point I believe we respect each other’s position!

    While the PSA test is very crude and far from perfect, the problem is not the test. It only provides information — and information does not cause side effects, nor does it kill; on the contrary it may save lives. The problem is how that information is interpreted. That is where attention should be focused.

    While Dr. Kirsh’s — or whoever wrote the editorial — editorial may have large holes in its reasoning, relying on the epidemiological argument is just as bad a foundation to argue against annual screening.

  3. “effectively suggesting that there were no good data whatsoever to suggest that PSA testing had any value as a screening test for prostate cancer.”

    So where is this “good data”?

    “The “New” Prostate Cancer InfoLink is, in fact, of the opinion”

    OK, so your “good data” is just your opinion. At least that’s clear.

    “the value of the PSA test is considerable for many men known to be at elevated risk for prostate cancer, but that its value as a mass, population-based screening test remains unproven”

    You’re making a false dichotomy. For many men known to be at elevated risk for prostate cancer its value also remains unproven. You are simply making an unproven claim but then in the very same sentence denigrate something which is also unproven. You are not being consistent.

    “its value as a mass, population-based screening test remains unproven — primarily because the two large trials completed to date were not well conducted”

    There is another reason why it could be unproven. It could be unprovable. Claiming it’s unproven primarily because the trials were not well conducted is itself an unproven claim.

    “the only thing it proved is that it was badly designed”

    No. It has proven that more PSA screening, in spite of leading to more diagnoses, does not lead to the saving of more lives, not even from prostate cancer let alone overall survival. It showed that being picked up by screening just above the threshold in the screening arm makes no difference to the detection of high risk prostate cancer and actually increases the risk of prostate cancer mortality! http://scholar.harvard.edu/files/shoag/files/efficacy_of_prostate-specific_antigen_screening.pdf?m=1455222972

    “We are trying to be optimistic that the current, ongoing review of the available data will lead to the USPSTF issuing a revised rating that is either an “I” or a “C”.”

    “Optimistic” is a strange choice of word in hoping for an “I” rating which has no practical difference from the “D” rating for a strategy with serious harms.

  4. “information does not cause side effects”

    “Information” in the hands of a conflicted advocate is used to provide conflicted advice.

  5. Dear David:

    I don’t follow your logic at all.

    First you reprint the quotation,

    “effectively suggesting that there were no good data whatsoever to suggest that PSA testing had any value as a screening test for prostate cancer.”

    Then you ask,

    ‘So where is this “good data”?’

    But what I had said was that “there were NO good data …”, so your question makes no sense. Nor therefore, does your statement that, ‘OK, so your “good data” is just your opinion.’ Our opinion is not data. It is just an opinion.

    Because the two trials carried out were so poorly designed, it is impossible to use them to come to any conclusion at all about whether PSA screening either does or does not save lives. Your claim that they have “proven that more PSA screening, in spite of leading to more diagnoses, does not lead to the saving of more live” is completely inaccurate. No one in the PLCO trial was followed for long enough to be able to make meaningful decisions about the effect of a prostate cancer diagnosis on overall survival and the paper by Shoag et al. fails to even mention that.

    You also fail to recognize the care with which we have distinguished between the use of the terms “screening” and “testing”. Testing is something done to individuals, and reasonable decisions about the frequency of such testing can be made by those individuals and their physicians together based on risk. “Screening” is something done to populations regardless of risk and based largely on things like sex and age. Because we have carefully made that distinction, there is no “false dichotomy”.

    Our biggest problem with your entire comment, however, is that it is utterly unclear what you think a man who is at significant and known risk for prostate cancer should be doing. If we were to take your comments literally, then you are saying he should never get a PSA test. I can quite understand that, on the basis of the available information, some men may choose never to get tested. That is their choice. A consequence of that choice is that some of those men will definitely get diagnosed later with metastatic prostate cancer, which may then kill them.

  6. @David Cunneen … you state:

    “Information” in the hands of a conflicted advocate is used to provide conflicted advice.”

    First — most information is not in the hands of advocates; it is in the hands of medical professionals, some with questionable motives, and usually uneducated patients.

    Testing is about information, and information does not cause side effects; treatment causes side effects, so don’t blame the PSA test, … or the advocates, blame the medical community who all too frequently recommend treatment when it is not required.

    A quick search on this site will reveal recent evidence that active surveillance is on the rise as a treatment alternative; that is one remedy to minimizing side effects.

    I, for one advocate am rarely conflicted, and if my advice is conflicted, I do not offer it.

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