Monday, February 21, 2011
by: Rosemary Mathis, Director of SANE VAX, INC.
According to FDA rules, in order to obtain ‘fast-track’ approval a new drug or medical treatment, two criteria must be satisfied. The drug/treatment must be for a serious disease and it must fill an unmet medical need. According to the FDA, filling an ‘unmet medical need’ is defined as, “providing a therapy where none exists or providing a therapy which may be potentially superior to existing therapy.”
There is no doubt cervical cancer is a serious disease. However, one has to question how Gardasil met the second criteria of filling an ‘unmet’ medical need. Due to regular cervical cancer screening and appropriate medical follow-up when abnormal cervical cells are detected, cervical cancer rates in the United States have dropped over 74% and continue to decline. This is the case in most developed countries around the world. So, where is the ‘unmet medical need?’
Another problem arises when HPV is purported to be a cause of cervical cancer. Several high-risk genotypes of human papillomavirus (HPV) have been associated with cervical cancer, but not established as a cause of cancer. Persistent HPV infections occurring from the same genotype, increase the risk of cancer. No one has determined whether or not persistent infections actually cause cancer without other risk factors being present.
The truth is 90% of all HPV infections clear on their own without medical intervention. Of the 10% left, only 5% of these will ever develop into cancerous cells. Cervical cancer takes between 5 and 15 years to develop. 95% of cervical cancer is treatable and curable. Almost all fatalities from cervical cancer can be avoided with good gynecological care. Again, where is the ‘unmet medical need?’