Hybritech was determined to get its PSA test approved by the FDA for expanded uses; rather than continuing to have physicians to use the test “off label.” Remember the first Hybritech (Tandem R PSA test kit) was approved in February of 1986; but was approved for a very limited use. It was approved for use as a clinical tool in the management (read monitoring) and following of men who HAD been treated for Prostate cancer. Not enough money in that so this must change!
Remember the goal of the PSA test was to be able to use it to test all men. Now we are talking about a nice sized market to exploit! But how do we get from here to there? We start by getting physicians to use the test “off label” until we can get the test usage expanded by the FDA to include all men as our target population.
In 2009, 2 much anticipated and important PSA studies, one from the US and 1 from Europe were published. These studies did not do any favors for the growing Prostate Industry. The studies concluded with the same answer: “ PSA-based screening results in small or no reduction (italics mine)in prostate cancer-specific mortality.” (Ablin, Richard J., Piana, Ronald). (2014), The Great Prostate Hoax. New York. Are you really stupid enough to pay attention to peer reviewed scientific studies rather than letting us help you understand what we want you to understand?? Just give us some time!
Carry all of this a step further and in 2011 the U.S. Preventative Task Force issued a policy recommendation against the use of PSA testing as a routine screening tool. Talk about a fire storm. You might as well be a news agency in 2024 saying President Biden is not physically fit to be the U.S. President. But I digress.
The argument over the use of PSA testing continued. To test or not to test, and why?? According to the then chief medical officer of the American Cancer Society, Otis Brawley, M.D. said, “We in medicine need to look into our soul and we need to learn the truth. If your income is dependent on you not understanding something, it is very easy to not understand something.” (Ablin, Richard J., Piana, Ronald). (2014), The Great Prostate Hoax. P.43. New York. Ouch, how mean…and honest! Another prescient statement from Dr. Peter Bach: “If a man has a PSA test today (2009) that leads to a biopsy and a diagnosis of Prostate cancer that he is treated for, there is a 1 in 50 chance by 2019 or later, he will have been saved from a death from a cancer that would otherwise have killed him. And there is a 49 in 50 chance that he will have been treated unnecessarily for a cancer that was never a threat to his life.”
You can see from the above that in the early 2000’s there was a great debate about Prostate cancer, how best to detect it and how best to treat it. PSA screening found itself in the middle of the controversy. The Prostate Industry was determined to find more and better ways to extract a commission for every breathing man in the world. Oops, my bad. I mean a way to create better and more robust testing tools to save men from death due to Prostate cancer, even if it does normally grow very slowly!!
It is time for our friends from Hybritech to reenter the picture from stage left! Remember their original 1986 approval did not fit their ambition at all. Why have a test for a limited market to monitor men who had already been treated for Prostate cancer when you can have a test to screen millions of men a year in the U.S. alone? Now we are talking some serious Benjamins, Jack! The Prostate Industry is ready to listen!
If you have ever had a PSA test, and if you are a man over 21, trust me you have whether you know it or not, then you know it is a painless blood test! Thus, it is a test that does not draw much attention and is easily charged to insurance! It is a perfect test to monetize for the Prostate Industry. So from the late 80’s to the mid 90’s’s there were millions of off label uses of the PSA test as simply part of “routine” screening.
That is all well and good if you have a bottom line to meet and every company in the Prostate Industry and every doctor’s office in the U.S. has a bottom line to meet or exceed. A lot of patients, physicians and others do not like the idea of testing off label. Thus this PSA test stuff needs to be legitimized so we can make money with a clear, or at least an uncluttered conscience. Now we need the FDA to make its magic in the name of good health.
As mentioned above Hybritech reentered the room from stage left, but now known as Beckman Colter/Hybritech, cause in the world of Big Pharma, the big‘uns always eat the little’uns. Much better for the bottom line you know to be able to buy rather than create! In June of 1993 the Immunology Devices Panel met to consider approving or not, Hybritech’s PSA test for the early detection of Prostate cancer. The debate raged back and forth during the hearing to approve or not to approve. Dang it, sorry, my bad again. The soft spoken and polite conversation carried on for a few hours.
As in the panel discussion in 1985, the positive data was hard to find and those pesky facts kept getting in the way. Peter Maxim. PhD and the NCI representative said, “There is currently no data showing that early detection of Prostate cancer by PSA…reduces mortality or morbidity from this disease.” Dr. Catalona, the Hybritech presenter also added that the World Health Organization’s calibration for the PSA test yielded lower PSA numbers that Hybritech’s calibrations yielded. I am not sure why he added that to assist the discussion, but PowerPoint slides are what they are! Dr. Catalona also let the cat out of the bag that Hybritech’s test produces a lot of false positives. The test was wrong more than it was right!
In the concluding remarks, Dr. Catalona stated that there was no evidence that the PSA test he was advocating for had any mortality benefits. In other words, there is no data indicating that using this test extends men’s lives!! By the end of the Q&A and with Dr. Catalona’s strange comments and date, it was obvious that the presentation and discussion created more questions than it answered.
So is this Approval DOA as we assumed it would be in 1985? Are you kidding? On August 25, 1994, the FDA notified Hybritech that its PSA test was approved as an aid in the early detection in men 50 and older. One last WTF. As of this FDA approval to make the PSA test an early detection tool for men over 50, there is still no discussion or proof that PSA can detect Prostate cancer.
But don’t worry, we are nowhere near the end of this story and the obscene profits that can be extracted from the Prostate Industry. In our next post we will move to the 2000’s and look at how the FDA has allowed the circus to grow to three or maybe four rings!!
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