Note from SaneVax: Citizens, medical professionals, scientists, and vaccine safety advocates around the world are getting the same message from those in control of vaccination policies and practices. Health ‘authorities’ respond to legitimate concerns as if citizens, no matter how extensive their background, are either incapable of reading and analyzing scientific data, or just frightened by false information. It does not appear to matter how many peer-reviewed scientific studies are presented when concerns are voiced. They are either ignored or answered with sufficient medical/legal jargon to completely obfuscate the issue or circle around the questions asked.
When elected representatives are questioned there are typically two responses. Either they were not aware of the issues or, they have not heard from enough of their constituents (particularly medical professionals) to raise the level of concern to one demanding action.
This page is dedicated to posting letters written by concerned citizens, medical professionals and vaccine safety advocates to either their elected representatives or health officials around the globe.
All letters posted will read exactly as they did when they were sent. If a reply was received, it will also be posted. Any letter that was ignored will state that fact. When the author of the original letter has granted permission for others to use their letters, there will be a printable pdf file linked to the bottom of the letter.
If you have written a letter you wish to have posted here, please email a copy to email@example.com.
WHAT TO DO ABOUT HPV VACCINES
Although there are many areas of concern regarding HPV vaccines, the only way to get affirmative action is for everyone to raise their voice and demand the same thing. Unless we are willing to wait decades to see whether HPV vaccines actually have an impact on cervical cancer, everyone concerned (victims, families, medical professionals, scientists, and vaccine safety advocates) must demand the FDA, CDC, NCI and all other government sponsored health agencies follow their own rules and regulations. The following letters were created by a team of concerned health advocates from around the United States to help everyone get the message circulated to those in charge of making health care decisions.
Since Gardasil was approved under the fast-track designation by the FDA, the manufacturer was allowed to use a surrogate endpoint to determine projected efficacy. FDA guidelines for industry clearly state that when a surrogate endpoint is used to gain approval, post-licensure monitoring is required to verify the drug’s clinical benefit.
If there is no reliable method of monitoring HPV vaccinations for disease impact, there should be no marketing of HPV vaccines. There is no benefit to paying for a vaccine that is not effective – only risk.
If you are concerned about HPV vaccine risks, here’s how you can help:
- Read the letter below that was sent to Dr. Markowitz at the CDC. If you agree, write a short cover letter, either print a copy of the letter below or attach the pdf copy, and send both to Dr. Markowitz. Let CDC officials know you are aware the rules currently in place to protect public health and safety are not being followed. Let those responsible know that as a medical professional/medical consumer you will not accept marketing HPV vaccines without reliable post- licensure monitoring. (Please note, it does not matter what country you live in, officials at the CDC need to know this is a global issue.)
- Put your elected officials on notice. Let them know you are aware that current rules and guidelines put in place to protect the public health and safety are being ignored. Let them know it is their responsibility as public servants to ensure the rules are followed by federal health agency employees or conduct investigations to find out why the rules are being ignored. (Again, it does not matter what country you live in. Your government representatives also need to be aware of the facts.)
- A draft letter to elected officials is below the letter to Dr. Markowitz for your convenience. You may use it as a cover letter to your elected representatives, or compose one of your own. Please note, if you use the one below, there is a section for you to include your personal story should you wish to do so. If you do not wish to include a personal story, you will need to delete the words printed in red. Either print a copy of the letter to Dr. Markowitz and send with your cover letter, or attach the pdf copy to your cover letter depending on whether you are mailing them, or emailing them. Find your Congressman’s address here and your Senator’s address here. Email addresses for Senators, Congressmen and State Officials are here.
Letter of Concern to Dr. Markowitz, CDCLauri Markowitz, M.D. Centers for Disease Control and Prevention MS E05, 1600 Clifton Rd Atlanta, GA 30333 Email: firstname.lastname@example.org
Dear Dr. Markowitz:
As we all know, Gardasil is a vaccine approved for prevention of cervical cancer caused by two specific HPV genotypes under the Fast Track Drug Development Programs. The Guidance for Industry, Fast Track Drug Development Programs-Designation, Development, and Application Review stipulates:
“Where an accelerated approval is based upon a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity, postmarketing studies are ordinarily required “to verify and describe the drug’s clinical benefit and to resolve remaining uncertainty as to the relation of the surrogate endpoint upon which approval was based to clinical benefit, or the observed clinical benefit to ultimate outcome” (57 FR 58942, December 11, 1992).”
We wholeheartedly agree with your statement on HPV vaccines that, ”Post-licensure evaluation of vaccines plays an important role in monitoring the progress of immunization programs, demonstrating population impact of vaccines, and providing data for ongoing policy decisions.”  A vaccine without a science-based post-licensure monitoring system to evaluate its impact on the population should not be allowed to be marketed to the consumers.
The currently available HPV vaccines, Gardasil and Cervarix, are designed to prevent infection by two genotypes of HPV that may cause cell changes, which if persistent and not properly treated may lead to cervical cancer in 10-30 years. Therefore, we also agree with you that “…it will take decades before the impact of vaccine on cervical cancer is observed. More proximal measures of vaccine impact include outcomes such as prevalence of HPV vaccine types, incidence of cervical precancers and genital warts.” 
Monitoring the prevalence of HPV vaccine types is the most practical meaningful approach to analyze the impact of HPV vaccines, including Gardasil because cervical precancer CIN2 and CIN3 lesions are not irreversible morbidity even though these cellular changes were used as the surrogate endpoint in the clinical trials for evaluation of Gardasil as a vaccine for prevention of cervical cancer. Prevention of genital warts has never been the purpose for developing HPV vaccines.
However, we are disappointed to find no provision for implementation of an effective system to survey the prevalence of HPV vaccine types in your monitoring report . The only relevant statement in the report – “Some states, such as Florida and Connecticut have made some HPV-related outcomes reportable…” seems to be just a token gesture concealing the lack of CDC efforts to formulate a meaningful post-licensure surveying system.
We suspect the reason the CDC has delayed a genuine monitoring system is that it does not want to introduce a reliable DNA-sequencing-based HPV genotyping method for post-licensure monitoring. HPV DNA sequencing may reveal many post-vaccinated women are actually developing cervical precancerous lesions and cervical cancer caused by vaccine-relevant HPV genotypes which may include HPV-16, HPV-18, HPV-31 and HPV-45. This would be a fact the vaccine manufacturer, the CDC, the FDA and the NCI would not want to face.
On record, the CDC , FDA , NCI  and the standard textbooks [5, 6] all recognize that DNA sequencing is the gold standard for HPV genotyping beyond a reasonable doubt.
As informed consumers, we do not believe that the DNA sequencing technology is too complex or too expensive for HPV genotyping in order to ensure safe and effective vaccination. In the very CDC report authored by you and your associates , a quoted reference states:
“… HIV genotype DNA sequence has been made reportable as part of a Centers for Disease Control and Prevention-funded multistate surveillance system to monitor trends in HIV drug resistance.”
This document confirms that the CDC has made HIV genotype DNA sequence in electronic file reportable to monitor trends in HIV drug resistance.
Cervical cancer initiated by persistent infection of certain genotypes of HPV is at least as life-threatening as infection by drug resistant HIV. For this very reason, the FDA approved the HPV vaccines under the fast track drug programs and allows the vaccines to continue to be marketed in spite of its potential serious harmful side effects to the consumers.
According to Section 112 Expediting Study and Approval of Fast Track Drugs of the Food and Drug Administration Modernization Act of 1997 cited in Appendix 1 of the Guidance for Industry, Fast Track Drug Development Programs-Designation, Development, and Application Review, under the provision EXPEDITED WITHDRAWAL OF APPROVAL, The Secretary (of HHS) may withdraw approval of a fast track product when a post-approval study of the fast track product fails to verify clinical benefit of the product.
Therefore, the CDC post-licensure surveys on the prevalence of HPV genotypes which cause cervical precancer or cancer among women who have already been immunized with the HPV vaccines plays a pivotal role in determining if the benefit of the vaccine outweighs its potential risk to medical consumers.
Based on available science and law, we hereby request that the CDC issue a directive to the vaccine manufacturers, vaccine distributors, state health departments and health care providers as follows:
“Any female patient who has been vaccinated with HPV vaccines who subsequently is diagnosed with Pap cytology results positive for cervical precancer or cancer, the electronic file diagnostic of the HPV genotype DNA sequence derived from the cervicovaginal cell suspension in the cytology sample is now reportable to the CDC.”
We believe this format of post-licensure surveys will not need any special funds from the government and require little effort to implement. The cost of continued post-vaccination cervical cancer screening is already part of the routine health care expense for all women. In this manner, the CDC will have the data for analyses to determine if Gardasil has indeed reduced the percentage of cervical precancers and cancers caused by the vaccine-targeted HPV genotypes.
Gardasil is known to be associated with high frequencies of anaphylactic reactions. It is estimated the rate of anaphylaxis reaction after Gardasil vaccination is 5 to 20 times higher than those identified in comparable school-based vaccination programs . Anaphylactic reactions may be the cause of syncope (fainting) commonly reported after Gardasil injections, and may lead to serious permanent disabilities or deaths as listed on the CDC record.
Therefore, we urge the CDC to institute a reliable science-based post-licensure monitoring system nationwide immediately to determine if the benefits of mass vaccination of young women against HPV infection for cervical cancer prevention in fact outweigh the risks of the vaccine.
Recently, the fast-track cancer drug Mylotarg was withdrawn after post-marketing studies raised new safety concerns and failed to confirm its effectiveness. Medical consumers need post-licensure survey data on Gardasil to be reassured that they are not receiving the risk of HPV vaccination for no confirmed benefits.
The SaneVax Team believes any drug approved via Fast-Track procedures using surrogate endpoints must be adequately and accurately monitored post-licensure – or not be marketed.
We are looking forward to receiving your answer to our questions and our request.
Norma Erickson, President
cc.Director of CDC- Thomas R. Frieden – email@example.com FDA commissioner – Margaret Hamburg – Margaret.Hamburg@fda.hhs.gov Secretary of HHS – Kathleen Sebelius – Kathleen.Sebelius@hhs.gov
 Markowitz LE, Hariri S, Unger ER, Saraiya M, Datta SD, Dunne EF. Post-licensure monitoring of HPV vaccine in the United States. Vaccine. 2010; 28:4731-7.
 Vernon SD, Unger ER, Williams D. Comparison of human papillomavirus detection and typing by cycle sequencing, line blotting, and hybrid capture. J Clin Microbiol 2000; 38:651-5.
 Draft Guidance for Industry and FDA Staff
 HPV Genotyping
 Molecular diagnostics: techniques and applications for the clinical laboratory, By Wayne W. Grody, Robert M. Nakamura, Frederick L. Kiechle
 Brotherton JM, Gold MS, Kemp AS, McIntyre PB, Burgess MA, Campbell-Lloyd S; New South Wales Health HPV Adverse Events Panel. Anaphylaxis following quadrivalent human papillomavirus vaccination. CMAJ. 2008;179:525-33.
Copy of letter for printing.
Draft Letter to Political Representatives
The following is a suggested draft letter intended for political representatives. Feel free to modify as needed to fit the circumstances in your state and/or country. Please note, if your country uses Cervarix instead of Gardasil, all references to Gardasil need to be changed. There is also a spot (indicated in red) for you to insert your personal story, should you wish to do so – if you do not wish to, please delete the words in red:
Dear Senator/Congressman/or appropriate title,
I am writing to your office because of my personal concern over the trail of tragedies left in the wake of people making decisions to follow CDC guidelines regarding the FDA approved quadrivalent HPV (qHPV) vaccine, Gardasil. We were led to believe that Gardasil “can prevent most cases of cervical cancer….” and “it can also prevent vaginal and vulvar cancer…”  Millions of trusting people around the world submitted to the administration of the qHPV vaccine believing it to be “very safe” and effective . However we now learned that in clinical trials, the efficacy of Gardasil to prevent cervical cancer was never validated under the FDA fast track drug program.
Furthermore, post-licensure monitoring of Gardasil as required by law to determine if Gardasil indeed reduces the incidence of cervical cancer or precancer caused by relevant HPV genotypes has also not occurred.
I have attached a copy of a letter to Dr. Laura Markowitz at the CDC which documents the concerns in detail. Validation of the efficacy of Gardasil would require a reliable, science-based DNA sequencing test to properly analyze HPV genotypes. Although this reliable method of analysis is the gold standard, it has not been implemented.
Consequently, there is no valid scientific evidence that Gardasil can prevent cervical, vaginal or vulvar cancer. While that is a shocking statement it is clearly explained and documented in the letter.
Gardasil is known to be associated with a high incidence of potentially serious side effects which are also documented in the letter. (insert your personal story if you wish)
It is imperative that the CDC institute a reliable post-licensure monitoring system nationwide immediately to determine if the benefits of mass vaccination of young women against HPV infection for cervical cancer prevention do in fact outweigh the risks of vaccination. We request that your office follow up to ensure that the CDC acts immediately to comply with the law in the interest of public health and safety. There is no benefit to paying for a vaccine that is not effective, only risk.
If there is no reliable method of monitoring HPV vaccinations for disease impact, there should be no marketing of HPV vaccines.
Thank you very much for your prompt attention to this issue and I look forward to hearing from you.
 CDC Vaccine Information Sheet: HPV Vaccine- Gardasil. May 3, 2011.
Copy of letter suitable for printing as reference.
[Note from SaneVax: The SaneVax Team would like to express their sincere appreciation to all of the people involved in the creation and editing of these letters. We sincerely hope everyone reading them takes the opportunity to use them to make your voices heard and your concerns understood.]
Letter to Dr. Shiffman at NCI
Mark Schiffman, M.D., M.P.H. Senior Investigator Executive Plaza South, Room 5026 6120 Executive Boulevard Bethesda, Maryland 20892-7335 301-435-3983 301-402-0916 firstname.lastname@example.org
Dear Dr. Schiffman:
Since you are the first scientific officer to promote mass HPV vaccination of women as a means to prevent cervical cancer , and have been working with the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) as the Medical Monitor of the human papillomavirus (HPV) vaccine trial , you must know that the HPV vaccines currently being marketed were approved by the FDA under the Fast Track Drug Development Programs. You must also be aware of the fact that approval of the HPV vaccine was based on using “CIN 2/3, AIS, or worse by histology – with virology to determine the associated HPV type” as the surrogate endpoint in the evaluation of the efficacy of the vaccine to prevent cervical cancer.
According to the Guidance for Industry, Fast Track Drug Development Programs-Designation, Development, and Application Review, “Where an accelerated approval is based upon a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity, postmarketing studies are ordinarily required “to verify and describe the drug’s clinical benefit and to resolve remaining uncertainty as to the relation of the surrogate endpoint upon which approval was based to clinical benefit, or the observed clinical benefit to ultimate outcome” (57 FR 58942, December 11, 1992).”
Since the clinical endpoint used in the clinical trial for Gardasil and Cervarix approval was not an “irreversible morbidity”, post-licensure studies are required to verify and describe the vaccine’s clinical benefit and to resolve remaining uncertainty as to the relation of the surrogate endpoint upon which approval was based to clinical benefit, or the observed clinical benefit to ultimate outcome, according to the FDA drug law.
This letter is to request you, the official medical monitor of the HPV vaccine trial leading to its final FDA approval under the Fast Track Drug Development Programs, to publish the HPV genotypes which are causing precancerous and cancerous cytologic changes in the women who have been immunized by the HPV vaccines, under the brand names of Gardasil and Cervarix. Based on the VAERS Reports, a significant number of post-vaccinated women are now developing cervical precancer and cancer lesions. It is extremely important for the public to be informed if these cervical precancer or cancer lesions are being caused by vaccine-relevant HPV genotypes or by HPV genotypes not targeted by the HPV vaccines. Since both the FDA  and the NCI  have acknowledged that the only reliable HPV genotyping is by DNA sequencing, the consumers who have paid a great price to this controversial vaccine want to have the data based on HPV genotype determination by DNA sequencing.
As the official Medical Monitor of the HPV vaccine clinical trial, you are held accountable for supplying the post-licensure monitoring survey results as requested. If no reliable data are forthcoming, you should recommend rescinding its approval until a reliable post-licensure monitoring system is instituted.
I am looking forward to receiving your reply.
Norma Erickson, President
Cc:Director FDA, Margaret Hamburg Director HHS, Kathleen Sebelius Director CDC, Thomas Frieden
 Schiffman M, Wentzensen N. From human papillomavirus to cervical cancer. In Reply. Obstet Gynecol 2010; 116:1221-1222.
 FDA Industry Guidance Documentation
Letter suitable for printing and distribution.
[Note from SaneVax: To date, 12 June 2011, neither the letter to Dr. Schiffman, or the letter to Dr. Markowitz have received any official response. Please feel free to print them out and send them again with your own cover letter. These people need to know that the SaneVax Team is not the only group watching their actions.]