The Calamity of Mass Off-Label PSA Screening
Dr. Topol: In 1994 (8 years later), the FDA approved the PSA test for routine use in men aged 50 years and older. That is what the company was initially after. What created the big problem?
Dr. Ablin: The calamity was that right after its approval in 1986, people started to use the PSA test off-label. The only company that was permitted to produce the test kit was Hybritech, but several other biotech companies began producing it shortly after the approval. A tsunami began in the urology community when clinicians started to use the PSA test off-label between 1986 and 1994. This was a crime, because they were using a test that was approved as a harbinger of the recurrence of the disease for the detection of prostate cancer 8 years before it was approved for that indication.
Furthermore, it should have never been approved for that purpose, because at the advisory committee hearing in 1993 (before the 1994 approval), many members of the committee opposed it. For example, Alexander Baumgarten made the statement that because of the results that Bill Catalona was presenting, it was like Pontius Pilate; you won't be able to wash the blood (the guilt) off your hands because of the 78% false-positive rate.
Dr. Topol: How is a test with a 78% false-positive rate approved? As you wrote in the book, the PSA is wrong 80% of the time.
Dr. Ablin: Through the Freedom of Information Act, we obtained the transcripts of the 1985 and the 1993 meetings. A portion of the transcripts are reprinted in the book. The meeting had a circus atmosphere. Prostate cancer patient support groups were there. Lobbyists were there. Bill Catalona was saying that every few minutes, a man is dying of prostate cancer. The irony is that even Dr. Catalona said that the PSA test doesn't detect prostate cancer. It is a measure of risk. By his own admission, it wasn't a test for prostate cancer, but to determine the risk of developing prostate cancer. There was chaos.
We talked to some of the people who were present at the 1993 advisory board meeting and people from the prostate cancer advocacy groups. There was screaming and yelling: "Men are dying; you have to approve this test!" With the 78% false-positive rate, and being wrong 80% of the time, I don't know how the test was approved.
In the book, we also cover what it costs to go to the FDA. It costs a million dollars. Does that mean anything? I don't know. I can't say anything because I can't prove it, but something went on to lead to this approval.
Dr. Topol: Are you suggesting that there was a pay-off?
Dr. Ablin: How would they have approved a test with an 80% false-positive rate?
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Cite this: PSA Test Is Misused, Unreliable, Says the Antigen's Discoverer - Medscape - Aug 08, 2014.