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Cervical Intraepithelial Neoplasia (CIN) and Failures of LEEP
CIN, also known as cervical dysplasia, is characterized by the presence in the cervix of abnormal cells that can precede and develop into cervical cancer. The primary cause of such abnormalities is infection with HPV types 16, 18, 31, 33 and 35. Experts recommend screening all sexually active women for HPV.
In the U.S., Pap screens are used to help detect HPV, and are estimated to cost up to US$6 billion per year. An estimated 1.2 million women each year are diagnosed with low grade cervical dysplasia in the U.S. Another estimated 200,000 to 300,000 women are diagnosed with high grade cervical dysplasia in the U.S. each year. There are no FDA-approved drug therapies for CIN.
Typically, high grade CIN is treated with a type of surgery called LEEP (Loop Electrosurgical Excision Procedure), estimated to cost from $400 to $1,450 per treatment in the US. The incidence of residual disease after LEEP varies from 20 percent to 30 percent. Potential complications include bleeding and the excessive removal of healthy tissue. LEEP is not recommended for lesions that are too deep to view with medical instruments. In those cases, widely used treatments include surgery, the cost of which varies depending upon the site of the lesion, or cold-knife cone biopsy, estimated to cost $3,700 per treatment in the US. These treatments are not always effective in removing all abnormal cells. The recurrence rates of CIN have been estimated at 19 percent of patients treated with cryotherapy and 13 percent of patients treated with laser surgery or LEEP. Market research indicates that physicians are eagerly looking for an alternative to LEEP, which does not treat the underlying HPV infection.
Recently, there has been much media attention paid to HPV as a result of the approval of the first preventative vaccine for the types of HPV that cause CIN. What this attention highlights, for those carefully watching the field, is that roughly 630 million people worldwide are already infected with HPV and many are in need of treatment rather than prevention. None of the new vaccines treats this infected population, nor do any address the various HPV-related diseases that result.
Serious HPV-related diseases
(*) Sources: World Health Organization;
National Institute of Health, Center for Disease Control; National
Cancer Institute; National Institute of Allergy and Infectious Diseases.
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