Prominent pathologist speaks out on HPV vaccines and cervical cancer
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
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
Milford Medical Laboratory's (MML) molecular diagnostics department has
introduced the nationís 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 womenís 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
- 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
- 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
- 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
- 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.