For medical devices (Class I and II), to gain FDA approval, the device must be deemed SAFE and EFFECTIVE. This is done via a 510(K)-approval process, designed to show the device has a “substantial equivalence” to a device that is already on the market. This is a fairly simple and straight forward process. Many products from wheelchairs to bed pans follow this process.
On the other hand, for class III medical devices, Implantable devices, scanning devices like MRI machines and DIAGNOSTIC KITS (my caps for emphasis) must go through a much more robust approval process called a “Premarket Approval” (PMA) for short. This process requires clinical trials to prove the device works as intended. It can be a much longer process and usually is!
In December of 1985, the Medical Advisory Committee, an FDA advisory panel of the Immunology Devices panel met to discuss a PMA of the Hybritech Tandem R PSA Test kit. But a strange thing happened on the way to get approval for Hybritech’s Prostate cancer early detection test to be used on men 50 and older to screen for Prostate cancer. The FDA executive secretary, Srikrishna Vadlamudi, PhD, stated that the purpose of the meeting was to “discuss tumor marker kits used as an aid in the management of patients with Prostate cancer.” Wait, what did he just say? How do you get from point A to point B here??
Apparently, Hybritech did not have the required clinical data to support their intended PMA (an early detection Prostate cancer test)! So why don’t we just change it to a monitoring test? So if this discussion has changed from a test kit to a monitoring test, what is it being compared to? Hybritech’s representative presented the test kit as a replacement for Prostate acid phosphatase (PAP). PAP is an enzyme also produced in the male Prostate gland. PAP was once touted as a potential early detection tool, but PAP is no longer used. Thus in this change of direction Hybritech was trying to compare its value as a marker to another marker that is no longer used! That should be an easy hurdle to clear! But remember, PMA approval requires clinical data. This was not simply a 510 (k) approval but a device that required PMA!
Let’s make this panel discussion even more interesting. Hybritech’s presenter, Paul Lange, MD, mentioned that a PSA level of 4.0 ng/mL was a threshold. As Dr. Lange continued with his presentation many questions arose around the numbers being presented. When Dr. Lange was further pushed to justify numbers like 4.0 ng/mL, he actually said to the panel, “If you want to know the truth, I did not pick 4.0, that number is… some kind of sacrosanct number. We could have changed the data, made it 6.0, 8.0, made it 10.0, anything we wanted. Heck, if you are making up the data as you go, why not?!
AS the presentation continued, one panel member asked Dr. Lange, “Exactly what clinical use does this test have for a doctor treating men with Prostate cancer?” Further alarming in this discussion is what Dr. Lange said when asked about the patient data. He was asked if he had been following patients with the PSA for several years, right?? Has it improved the 5-year survival rate for Prostate cancer victims? Lange’s response?? “NO, we have not been following PSA for years. This (data) is retrospective!!” Now the panel was intrigued. They had been misled to think that the data was prospective and now find out that it is retrospective?? Retrospective trials are looking back in history and are more prone to errors and suspicion (Ablin, The Great Prostate Hoax, p.30).
With this information above and in the public record, it is obvious that this request was DOA. But never underestimate the power of positive thinking! After a long, closed-door discussion and debate with the panel members, they reconvened the public hearing…AND??? Hybritech’s PSA test was FDA approved for a limited use!!! The Hybritech Tandem-R PSA test was approved for use as a clinical tool in the management, meaning monitoring and following of men who HAD been treated for Prostate cancer. That is a far cry from a diagnostic tool to detect Prostate cancer to an approval for a test kit to monitor men with Prostate cancer! Guess what, the market size just shrunk and shrunk a lot. No longer do you have a tool to monetize that could be used for all men!!
But don’t worry, remember the government, big Pharma and alphabetic soup government agencies are involved. The fight is never over until all the right people are enriched. In our next post we take this discussion to the logical conclusion: The FDA approval of a PSA test kit that can make some people very wealthy and open the floodgates downstream for more diagnostics and surgeries!!
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