Saturday, December 4, 2010

PSA, CER, and The Health Care Bill

One should always observe how data is collected. In a visit to a colleague I had the opportunity to sit in a waiting room and observe how a survey was to be performed. It was a prostate cancer practice in a large teaching hospital. Many of the men were with their spouses, one suspects women will always last longer, and as they were waiting a young woman with a computer touch pad went from couple to couple asking them to fill out a questionnaire regarding their personal scoring on such things as their incontinence and sexual performance.

Now how does one suspect that a patient in such a circumstance will answer such questions as the wife looks over their shoulder and corrects their answers. "Of course they are happy with ..." whatever the question is. All too frequently the questionnaires are of a confusing form and conducted in less than ideal circumstances.

Now what does that have to do with CRE and the new Health Care plan. Well in the CRE, Comparative Effective Research, world, studies such as a recent one in JAMA. The study, authored by a group headed by a group of women, not surprisingly, makes the following statements:

In the era of prostate-specific antigen (PSA) screening, up to 60% of men diagnosed as having prostate cancer may not require therapy. Results of the European Randomised Study of Screening for Prostate Cancer demonstrated a 20% mortality reduction attributable to screening and treatment; however, 48 additional men needed to be treated to prevent 1 prostate cancer death. It is not currently possible to distinguish patients who require treatment to avoid prostate cancer morbidity and mortality from those who will die with but not because of their cancer. Active surveillance is an alternative to initial treatment for men with low-risk, clinically localized disease that has the potential to mitigate overtreatment. 

Now read this a bit:

First, the European study was fatally flawed as we noted at the time and as we have documented in our PSA Study. We have recently also provides what we believe could be a substantially improved PSA test as well. The main problems with the European study were the less than frequent performance of tests, the use of the old 4.0 threshold and the failure to include temporal data. They were in effect random point tests taken at random periods with great intervals in between. In my opinion it was like doing mammograms every few years and only following up if half the screen was occluded.

Second, they state that it is not currently possible to distinguish the roughly 10% with PCa who will die quickly from PCa from the other 90%. Yes ladies that is true, so let them all die! Are they insane, we want this as part of health care rationing! Just because 10% will die if not operated on in a timely fashion, that is almost 20,000 per year, or 7 World Trade Center attacks per year, just because it is not yet know definitively. You cannot make this up.

The oxymoron of this statement is that watch and wait works for those at low risk but she already admitted we have no idea who is at low risk! How can you say something like this!

Then to the data ... the data. Remember the waiting room, the wife's eyes correcting the poor guy's answers to what she would like to see, well that is probably what was used. So junk in - junk out.

The solution here is better treatment, earlier treatment, and continued research on cell markers to determine if PTEN is lost and the like. It is not making suggestions like this.