Note from SaneVax: The following article was written several months ago. It has obviously sparked somewhat of a debate between an NCI (National Cancer Institute) official and the cancer pathologist the story was written about. The SaneVax Team believes medical consumers need to be aware of both sides of the current debate over HPV vaccines and cervical cancer prevention. The only way to be able to make sound decisions about your health care is to know all of the facts.
We have therefore decided to dedicate a special page to provide information on both sides of this highly controversial subject. We cordially invite everyone to participate in the discussion. All you need do to make a comment, or add information from your point of view is register and log in. The only thing we ask is that all parties participating keep it cordial. This page is for healthy, informative debate – personal attacks will not be tolerated.
The original article, along with comments is printed below in its entirety.
Prominent pathologist speaks out on HPV vaccines and cervical cancer prevention
By Norma Erickson, Vaccines Examiner
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, 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.
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.
Hilary Butler says
Exactly who is Philip Castle anyway? And why has he not returned to answer a few questions? Here’s another one: “What unstated nflicts of interest does Phillip Castle” have hidden under his bed? Got shared in Merck perchance?
Hilary Butler says
Exactly who is Philip Castle anyway? And why has he not returned to answer a few questions? Here’s another one: “What unstated conflicts of interest does Phillip Castle” have hidden under his bed? Got shares in Merck perchance?
Philip Castle says
Hilary, I have published approximately 200 papers on HPV and cervical cancer. My disclosures are that I serve on a data safety monitoring board for Merck (compensated) to make sure that the next generation of HPV vaccines are safe. I do not participate in the science of the HPV vaccines. And I have been a very vocal advocate of only cost-effective use of the HPV vaccines. You should familiarize yourself with PubMed.
Dr. Lee, I do not have a problem with you using PCR/sequencing-based HPV genotyping test for safe, effective vaccination monitoring. My concern is the use of your test for clinical management of women undergo cervical cancer screening, which you provide. I would like to see your data that shows your test has undergone vigorous validation to ensure patient safety.
You seem quite willing to line your pocket with the money rather than the commercial companies and testing labs. How are you better any than them? And you have not had a problem with the cytologists making the money. They are a business too. So it would be useful if you present a balanced view of the economics rather than a self-serving, inaccurate presentation of the so-called facts.
The NCI, for whom I used to work, did not spend $13.5 million on testing the biopsies. I know that with absolute certainty. I am not certain what the cost was for testing all biopsies and cervical specimens FROM ALL visits for 7500 women by one of the most highly regarded labs in the HPV research field. You should get the facts correct before presenting them as truth.
Of course there are cervical cancers among the vaccinated populations since the vaccine does not treat pre-existing infections and related precancerous lesions, the same lesions that you claim are clinically irrelevant (wrong—if these lesions are irrelevant, then why did Pap testing reduce the burden of cervical cancer.). I have been on record publicly since 2006 advocating for HPV vaccination only in women before sexual debut. I served on the American Cancer Society Vaccine Guidelines and fought to keep the guidelines to only 18 years of age and younger (unlike the CDC). I wanted under the age of 15 but lost. But at least I kept the ACS guidelines from going to 26 years of age. Dangerous and a huge waste of money.
I do not see how your sequencing test will prevent those cancers. Screening, and limiting vaccination to women before they become sexually active and exposed, is the correct approach. I suggest you do some reading of what I have published, including a NEJM commentary in 2005.
I highly recommend that you do a little more reading of the literature to understand the natural history of the disease, etc. And before you cast stones at me, you might actually look up what I have said and done. I have been transparent in my relationships with industry. I have even attacked industry when appropriate (e.g., See my commentaries on Cervista, the HPV test from Hologic, and my articles that are critical of vaccination of older women). I believe in cost-appropriate and safe use of proven, validated technology. I have no allegiances beyond what is best for the public’s health.
Bottom line there Mr. Castle is that the HPV vaccine is NOT needed. You need to understand as well the history of disease. If given the proper diets, HPV wouldn’t be a problem. Pushing toxic chemicals as prevention is not only insane, it causes more issues than cervical cancer ever would. This issue to me is more about nutritional deficiencies inner society and less about the need for more vaccines. Seems to me this vaccine is a slippery slope since with each new one, more and more genotypes and strains are added. What’s next….Gardasil 15? Give us all a break. The ore information people have the better and with you working WITH the industry doesn’t bode well for you whether you are transparent or not. Take your poison and go elsewhere. Women need to know WHY they are becoming susceptible, not what poisons they can take to kill things. You MUSt know that this is not a cure to anything but clearly making things worse.
So the vaccine does not stop cancer…as you have stated. Why take it? If women have precancerous lesions and current HPV infections its wont work and is actually contraindicated…so why are women getting these vaccinations in the first place??!! As a safety ‘monitor’ wouldn’t that be prudent!?
Vaccinating women before sexually active. The inserts clearly show that the vaccination waned after only 48 months….9 year olds are getting the series. Unbelievably useless and downright criminal to expose a young body to the toxin overload that is in these vaccinations as well as the contaminants. the Gardasil 9 is horrific in its adjuvant and mercury levels. the inserts are different too….love the smoke and mirrors.
If you really want to be an advocate for public health, stop vaccinating for diseases that can be treated with safer and more EFFECTIVE means. yearly PAPs, Vitamin A, D, and folic acid.
If CIN3 is cancerous, why did only 30% actually GET cancer…..seriously. they cleared it on their own. this is why it cannot be construed as ‘cancerous’ necessarily. What you should be exploring is why these women cleared it! Instead we focus on more vaccines to kill, kill, kill. Slow growing, easy to treat cancer.
Also in regards to the safety of this series, you should probably be sure every doctor in this country understands the issues before they all just give it to any woman or child. Contraindications are not being brought forward and many injuries are resulting including cancer. this vaccine has increase VAERS reporting by the thousands yearly.
Philip Castle says
Two points I forgot to make:
Dr. Lee, there was a person before you who thought that CIN3 was not precancer. His name was Dr. Green, from New Zealand, and he left women diagnosed with histologically-confirmed CIN3 untreated in the 1960’s-70’s. Guess what? 30% of those women developed cervical cancer over 30 years. I refer you to McCredie et al., Lancet Oncology, 2008. I am comforted by the fact that you do not manage patients and compromising their safety.
Second, I am more than happy to meet anybody in this discussion for a debate the scientific, medical, and public health facts in an open, public forum. Name the time and place. You can choose the audience so that it favors your viewpoint. I will pay out of my own pocket. I am confident that the truth shall set you free.
I would like to say that as early as 1992 I read that Folic Acid could reverse cervical dysplasia, and have recently read studies that indicate that cervical dysplasia occur when Folic Acid levels are inadequate. Could you please initiate more studies regarding this. Thank you.