Gardasil Approval: FDA Apparently Does Not Follow Its Own Rules

Dec. 10, 2010 - PRLog -- 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?’

In addition to these two criteria, FDA guidelines say, if there are existing therapies for the disease a proposed drug/treatment is intended for a fast-track drug must show some advantage over available treatment(s), such as:

1.    Showing superior effectiveness – Gardasil will not be able to show that for at least 10-15 years.

2.   Avoiding serious side effects – there are no serious side effects to regular screening and appropriate follow-up.

3.   Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome – not applicable to HPV vaccines.

4.   Decreasing a clinically significant toxicity of an accepted treatment – again, not applicable to HPV vaccines.

Despite the fact that the only criteria Gardasil could have possibly met was the intent to combat a serious disease, the FDA granted fast-track approval for the product in June of 2006.

Now, American medical consumers have seen the post-HPV vaccination adverse events reports approaching 21,000 and there are 89 families who have ‘one less’ child. Perhaps, the FDA needs to study the rules.

Sources:
View http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegu... for more information on FDA fast-track approval guidelines.

View http://www.infectiousdiseasenews.com/article.aspx?id=37036 for more information on HPV clearing on its own.

View http://womenshealth.about.com/cs/cervicalcancer/a/hpvcerv... for more information on the HPV connection to cervical cancer.

Please visit our site at http://sanevax.org/.

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