FDA advisory panels reject the use of two separate prostate cancer prevention measures yet approve cervical cancer preventive shots using virtually the same criteria. What is wrong with this picture?
November 2010, an FDA advisory panel soundly rejected the proposed use of two drugs, Avodart from GlaxoSmithKline and Proscar by Merck, as a potential preventive measure for prostate cancer. It seems that although the two drugs showed promise in preventing low-grade cancer cells, they were linked to a risk of a higher incidence of high-grade cancer.
For those who have been following the HPV vaccine controversy, this sounds all too familiar. The following excerpts (visit http://www.medpagetoday.com/HematologyOncology/ProstateC ... for details) from a December article in MedPage, titled, “FDA Panel Rejects Prostate Drugs for CA Prevention” by Emily P. Walker:
• How to handle low-grade prostate cancer is controversial in the urology community, in part because it is unknown if the low-grade tumors would ever develop into high-grade tumors, and also because the method used to originally detect prostate cancer -- the PSA test -- is inexact.
• The panel agreed that a reduction in the less-risky tumors -- which may never even turn into serious cancers -- is not a big enough benefit if the drugs may actually lead to life-threatening cancers. In addition, the standards need to be much higher for a chemopreventive agent.
• "If you're going to give normally healthy people a drug, there need to be no side effects," said Walsh, who was brought in by the FDA as a guest speaker.
• If approved to prevent cancer, the drugs could potentially be given to hundreds of thousands of otherwise healthy men with elevated PSAs who are concerned about dying from prostate cancer.
• That means "we [would] use this to treat men -- not patients -- men who don't have a disease," said Richard Padzur, MD, director of oncology drugs at the FDA.
The SaneVax Team applauds the FDA advisory panel for their decision on these two drugs. We are sure it will save many men from suffering not only the potentially higher risk of prostate cancer, but also any potential adverse effects from mass administration of drugs to healthy individuals.
However, the SaneVax Team wants to know where these ‘wise’ advisors were when HPV vaccines came up for review. We want to know why the same standards were not applied to the world’s female population in regard to cervical cancer prevention that were taken into consideration when the world’s male population was reviewed for potential prostate cancer prevention. This double standard of ‘care’ is not acceptable.
• Handling low-grade cervical cancer is just as controversial as prostate cancer. It is also not known if low-grade cervical pre-cancerous lesions will ever progress to invasive cancer. Currently approved HPV tests are inexact, just as the PSA test.
• Less risky cervical cell changes (CIN1/2) may never turn into cervical cancer, just like less risky prostate tumors. The standards, therefore also need to be much higher for a preventive agent, such as HPV vaccines.
• Clinical trials for both HPV vaccines also indicated a potentially higher risk of developing invasive cervical cancer when the recipients had prior exposure to HPV vaccine relevant genotypes.
• The SaneVax Team wholeheartedly agrees with Mr. Walsh, if you are going to give normally healthy women a drug there needs to be no side effects.
• Nevertheless, Gardasil and Cervarix were approved for use as a preventive measure for cervical cancer and are currently being administered to hundreds of thousands of previously healthy girls, with apparent total disregard for any potential adverse effects.
• Men who didn’t have a disease would have been treated should the advisory panel have approved the two prostate medications listed above. Unlike those men, your daughters, neighbors and friends - healthy women – NOT patients - are currently being ‘treated’ despite any potential risks.
The SaneVax Team wants to know why the FDA came to opposite conclusions in the prostate cancer versus cervical cancer prevention decisions. Is it because the prostate cancer drugs were not ‘vaccines’ and thereby liability issues would exist? Or, is it simply that the advisory committees at the FDA feel men are more important than women?
Either way, it is abundantly apparent that female medical consumers must be even more cautious and well-educated than their male counterparts. It is time for the FDA, and pharmaceutical/medical industries to stop treating women like second-class citizens.
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