Dr. Lee believes women the world over deserve only safe, effective and necessary medical treatments.

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, Neisseris gonorrhoeae opa gene DNA amplification assay, and Chlamydia trachomatis cryptis 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. Ony 4070 of these estimated deaths would be related to cervical cancer.
• 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 infestion 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 ony tool, nor a reliable tool, to prevent cervical cancer. Good gynecological care is.

PREVIOUS COMMENTS:

By Laurie:

Wow, this only confirms your last article that too many girls are being vaccinated without being tested for HPV prior to vaccination! I just want to know how this got past our government “protection” agencies prior to the release of Gardasil? In my personal opinion, this information itself, is negligence beyond explanation!!! Thank you for providing this evidence, proving even further, that you just can’t trust the things that are being recommended by the FDA or the CDC. It makes me literally sick!

By Denise Melton:

We certainly need more Dr. Lee’s to set the story straight. As he said, cervical cancer is not an epidemic so why is it being treated as one. Now they are including boys and young men in this guinea pig experience with not knowing the duration of the protection. As he also stated, the Pap test is the answer to women everywhere and that yearly exam we all look forward to, but is so necessary for our health and well-being.

Less and less is being said about the FDA and the CDC and how competent these organizations are to protect our health. More and more is being told of the GREED that follows these government officials and the incompetence in the name of guarding our health and well-being. I personaly have lost all confidence in the FDA and the CDC. They are not infallible they do make mistakes as we all do from time to time. Thank you again Norma for your tireless reporting.

By Phillip Castle:

There is so much misinformation in this column that it is difficult to know where to start. To begin with, Dr. Lee has a significant conflict of interest related to wanting people to use his services. He makes money from his services. To promulgate his business, he has attacks good science to his own benefit. The vaccines are not a panacea but are highly effective. They should be given before women become sexually active to gain the maximum benefit. It is not fact that giving the vaccine to women already infected increases the risk of disease. He is taken one selected number from a paper that could be attributed to a chance finding.

It is not correct that a very sensitive test is needed or useful. There is a well established clinical cutpoint of 5000 copies and below that identifies BENIGN infections that should not be found because it does not benefit the patient. One does not need to identify the exact HPV genotype. Pap smears don’t do it. It turns our that just knowing who is positive for carcinogenic HPV is good enough in most circumstances to provide the proper management. Not all cancers are preceded by a HSIL. Pap. And on, and on, and on. The arguments are not based on science.

By Dr. Lee (originally posted by Norma on behalf of Dr. Lee):

Philip Castle (P.C.) seems comfortable with $1.6 billion pocketed by a manufacturer of HPV test devices, but grossly disturbed at the prospect of offering a PCR/sequencing-based HPV genotyping test for safe, effective vaccination monitoring. He seems comfortable with the NCI spending $13.5 million for a Dutch laboratory to perform DNA sequencing on 375 cervical biopsy specimens, yet disturbed at the prospect of offering a similar option to medical consumers for $50.00 per test.

P.C. did not say what the vaccines are highly effective against. Cervical cancer was not used as an endpoint in clinical trials. The endpoints during clinical trials were CIN2 and CIN3, lesions which are poorly defined and often self-reversible.

There are already 29 reports of cervical cancer after HPV vaccinations. No one knows what HPV genotype(s) contributed because medical consumers have no access to reliable HPV DNA sequencing tests.

P.C. apparently does not want reliable HPV genotyping in laboratory medicine to avoid the potential revelation of post-vaccination pre-cancer/cancer cases due to acceleration of the carcinogenic process initiated by a vaccine-relevant HPV.

There are no benefits, only risks in getting HPV vaccination when infection with a vaccine-relevant HPV genotype is already present.

I hope P.C. and his associates will respond to my comments and continue this very useful open public discussion.