We have explored the first 2 PSA Test FDA Approvals, as difficult as it may be to understand how they got an approval. But they did and here we are. It seems the next logical step in our journey is to follow the PSA Test and other FDA approvals.
Unfortunately, this is where it gets very murky, as in clear as mud! We should be able to simply input into a browser “PSA TEST FDA APPROVALS.” But that does not work so well. Nor does going to the FDA and asking for the tests they have approved and when they were approved. You immediately learn the meaning of the term, “crickets.” That is what you will hear.
I find that very puzzling as this should not be so difficult. It is here that we pivot and go in a different direction due to a lack of information, or intentionally hidden information. Remember the second Hybritech test approval expanded the PSA test from a monitoring tool for men already diagnosed and treated for prostate cancer to become a test to aid in the early detection of Prostate cancer in men over 50 years old. Never mind the fact that there is still no indication or data that shows PSA can detect Prostate cancer. But do not trust your lying eyes. No profit in that!
In my last post I concluded by saying we would explore how the FDA allowed the circus to grow beyond three rings. This was mainly achieved by just not paying attention to the market. Many tests were approved for some use and then used off label for PSA testing. The FDA wrote many “warning letters” but it appears most of them found their way into the circular filing cabinet, picked up nightly by the janitor.
At the same time, around 2008 a number of professional medical organizations began looking at the benefits and harms of PSA screening in general. Several organizations began cautioning against routine screening for PSA. They began recommending that any man considering PSA screening first consult their doctor about the risks and benefits of this test.
At the same time several organizations began recommending that men at higher risk of Prostate cancer begin having PSA screening at age 40 or 45. Those men include black men, men with germline variants in BRCA2 and possibly BRCA1. Also included in this group is any man whose father or brother have had prostate cancer (sorry little brother).
In 2018 the United States Preventive Services Task Force updated its earlier recommendation from a “D” rating (not recommended) to a “C” rating (selectively offering PSA screening based on professional judgement and patient preference). These recommendations are for men 55 to 69. Screening is not recommended for men younger than 55 or over 70. These recommendations are for both the general population and men at increased risk for the reasons mentioned above.
A very interesting aside in this whole story is how many times I keep finding the identical wording that the PSA test in question is approved to measure total PSA and often in conjunction with a Digital Rectal Exam (DRE)! It seems that the PSA testing story is on an endless tape loop. Same song, next verse! In other words, almost 40 years after the first FDA approval of a PSA test, not much has changed. PSA still cannot detect cancer in the Prostate. Even if one closes their eyes very tightly and hopes, PSA cannot prove much. Yes the FDA expanded the approval to be used as “a diagnostic tool to aid in the early detection of Prostate cancer in men over 50”, we could do about the same with the statistics of Prostate cancer for men over 50 and be even more of a Nostradamus when we expand that population to 60 or 65!!
I think it is time to move to the next topic. What are PSA measurements and what do they mean?
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