Prominent pathologist speaks out on HPV vaccines and cervical cancer prevention

July 2010

http://www.examiner.com

Sin Hang Lee M.D., F.R.C.P. (C), FCAP has over 50 years' experience in general/surgical pathology and clinical microbiology. He is qualified to practice in the U.S., Canada, and the United Kingdom.

Dr. Lee is currently a practicing pathologist at Milford Hospital, in Milford CT, and the Director of Milford Medical Laboratory,  which is an industry leader in the development of molecular diagnostic procedures. One of their goals is to facilitate the transfer of advanced PCR/direct DNA sequencing technology into community hospital laboratories.

Milford Medical Laboratory's (MML) molecular diagnostics department has introduced the nation’s first routine DNA sequencing-based no-false positive HPV genotyping, Neisseria gonorrhoeae opa gene DNA amplification assay, and Chlamydia trachomatis cryptic plasmid DNA amplification assay for women’s health care management. MML also assists CLIA-certified laboratories establish their own in-house molecular sequencing programs.

Dr. Lee is also the president of HiFi DNA Tech, LLC, a biotechnology company providing cutting-edge molecular tests developed by pathologists and cytotechnologists for pathologists and cytotechnologists to serve gynecologists and their patients at sustainable cost.

During recent phone conversations and emails, Dr. Lee has expressed  several concerns for the health and safety of women, particularly in the United States. He would like to get these messages out to the general public so they can make informed decisions regarding their medical care and treatment options:

• Cervical cancer is not a major health issue for women under the regular care of a gynecologist, as most mainstream American women are. It may be a health issue among the underprivileged women and new immigrants in the U.S. According to SEER, a division of the National Cancer Institute, an estimated 269,800 women would die from various types of cancer in 2009. Only 4070 of these estimated deaths would be related to cervical cancer. (verify information here)
• Gardasil is reported to be effective against infection by HPV 16 and 18, and probably HPV 31 and 45 due to antigenic cross-reactions. But the duration of protection is not clear.
• There are about 13 known types of high-risk HPV which may induce persistent infection, a cancer promoter. Therefore, it is not safe to depend on vaccination alone to prevent cervical cancer. Periodic cancer screening is still necessary for sexually active women.
• Since Gardasil injections can increase the risk of developing precancer lesions by 44.6% if there is a prior infection by a vaccine-relevant HPV genotype, it is prudent to make sure that a sexually active woman is not infected by HPV 16, 18, 31 or 45 before receiving a Gardasil vaccination.
• Vaccinated women should still be followed by their gynecologist for periodic cancer screening.
• If HPV testing is used, instead of Pap cytology, for primary cancer screening, the test must be highly sensitive, being able to detect less than 100 copies of HPV DNA, and capable of identifying all clinically relevant HPV genotypes accurately.
• The sample for HPV testing must be collected from the cervicovaginal junction by a gynecologist, not by the patient with any self-collected device to be medically meaningful. A sensitive and specific HPV test should be performed. Any HPV-positive laboratory report should state the specific genotype of HPV detected, validated by DNA sequencing.
• Colposcopic biopsy is a traumatic and harmful procedure. It should be performed only when a high-grade intraepithelial lesion is observed, or highly suspected on Pap smear cytology with evidence of a persistent high-risk HPV infection.
• Persistent high-risk HPV infection means that the same (identical) high-risk genotype, or its variant, is demonstrated in the same patient on two or more occasions over a period of 6-12 months.
• Demand a DNA sequencing report from the gynecologist as evidence for a positive HPV infection, and ask the gynecologist why it is not just a transient infection. Ask the gynecologist what genotype of HPV is present.
• Do not agree to colposcopic biopsies unless there is a HSIL Pap cytology, or a really persistent high-risk genotype HPV infection associated with a borderline HSIL cytology.

Dr. Lee says,

As a pathologist, I have seen too many unnecessary cervical biopsies on young women with subsequent complications. Vaccination is not the only tool, nor a reliable tool, to prevent cervical cancer. Good gynecological care is.