Blog of the Society for Menstrual Cycle Research

When One Less Becomes One More

June 26th, 2012 by Elizabeth Kissling

Abnormal Pap Smears, Cervical Dysplasia and Cervical Cancer Spike Post-HPV Vaccination

Guest Post by Leslie Botha, Women’s Health Freedom Coalition Coordinator, Natural Solutions Foundation,
and Janny Stokvis, VAERS Research Analyst


In 2006, the HPV vaccine Gardasil touted to prevent cervical cancer was introduced to a public generally unaware of the Human Papillomavirus or its threat to adolescent girls and women. However, the public was quickly informed of the dangers of the virus when Merck launched an aggressive advertising campaign designed to capture the attention of girls/women ages 9 to 26 with a catchy jingle and their now famous line: “One Less Girl to Get Cervical Cancer.” Adolescent girls were dancing and singing that they will be ‘one less girl’ in unison with the award-winning TV commercial.

According to Neon Tommy, the online publication for the Annenberg School for Communication and Journalism, USC, the promotion was successful. In 2008 Merck’s marketing techniques even earned Gardasil a “pharmaceutical brand of the year” award from Pharmaceutical Executive for its ‘savvy disease education,’ and for building ‘a market out of thin air’.

Six years later, it appears that ‘one less’ is now turning into ‘one more’ as reports of abnormal pap smears, cervical dysplasia and cervical cancer are appearing in the HPV vaccine targeted market.

Table prepared and provided by authors

As of May 12, 2012 the Vaccine Adverse Event Reporting System (VAERS) showed there have been 26,050 reports of adverse events (including 849 reports from boys/men ages nine to 26) post-HPV vaccination. The National Vaccine Information Center (NVIC) estimates only 1 to 10% of the vaccine-injured are reporting.

Of concern is the significant increase in reporting for cervical abnormalities reported to VAERS each month. Of even more concern is that the American College of Obstetrics and Gynecology has raised pap testing guidelines to age 21 leaving many adolescents without proper cervical screening tools post-vaccination. Yet a significant number of events are being reported by an age group that typically does not develop cervical cancer until age 50 or older. According to Stokvis, some of the reports of cervical abnormalities are occurring four to five years post-vaccination.

Abnormal Pap Smears: 490 (greatest number of incident reports age 14 to 26)
Cervical Dysplasia: 195 (greatest number of incident reports age 14 to 26)
Cervical Cancer: 56 (greatest number of incident reports age 16 to 26)

In January 2012, the American Journal of Obstetrics and Gynecology published the ATHENA HPV study announcing the results of a large cervical cancer screening trial, enrolling 47,208 women 21 years of age or older at 61 clinical sites throughout the United States. The authors reported that in a sub group of 12,852 young women, the HPV vaccine reduced HPV-16 infections only 0.6% in vaccinated women vs. unvaccinated women. Most disturbing are the data that showed other high-risk HPV infections were diagnosed in vaccinated women 2.6% to 6.2% more frequently than unvaccinated women. In fact, the study reported that the increased rate of infections by carcinogenic HPV types in vaccinated women (other than those targeted by Gardasil®) is four to ten times higher than the reduction in HPV 16/18 infections.

Why are these numbers of great concern? According to 2005 -2009 data reported by the National Cancer Institute,

The median age at diagnosis for cancer of the cervix uteri was 48 years of age. Approximately 0.2% were diagnosed under age 20; 14.0% between 20 and 34; 25.9% between 35 and 44; 23.9% between 45 and 54; 16.7% between 55 and 64; 10.7% between 65 and 74; 6.1% between 75 and 84; and 2.6% 85+ years of age.

The problem is that the FDA has not recommended a reliable HPV screening assessment prior to the mass vaccination program. In addition, the CDC estimates 25,000,000 people have been previously exposed to HPV.

In September 2011, Norwegian immunologist, Charlotte Haug, M.D., Ph.D. raised the issue of potential HPV virus replacement in her opinion paper in the New Scientist titled: “We Need to Talk about HPV Vaccination Seriously

There is another serious question that may be answered sooner:  what effect will the vaccine have on the other cancer-causing strains of HPV? Nature never leaves a void, so if HPV-16 and HPV-18 are suppressed by an effective vaccine, other strains of the virus will take their place. The question is, will these strains cause cervical cancer?

Dr. Haug noted that vaccinated women showed an increased number of precancerous lesions caused by strains of HPV other than HPV-16 and HPV-18. She also wrote “…the results are not statistically significant, but if the trend is real – and further clinical trials should tell us in a few years – there is reason for serious concern.”

Even in 2009, a voice of concern by medical researchers about virus replacement was raised:

However, the biological mechanisms of different HPV types are not yet fully understood, and the significance of cross-protection is limited by a small number of lesions, short study period, and lack of data on ICC. It is worth noting that following HPV vaccine implementation, other high-risk HPV types than HPV 16 and 18 could replace the biological niche of HPV 16 and 18, thereby causing a relatively greater proportion of cervical cancer and cervical cancer precursors cases [9,10]. If this occurs, there is a potential to offset the benefits of vaccination. HPV vaccination evaluation programs should consider this possibility and evaluate changes in HPV type distribution in high-grade lesions and ICC over time relative to HPV types found in the general population with documentation of HPV vaccination history. Long-term follow-up during further vaccine evaluation is expected to address those two issues.

O Canada! Gardasil® Vaccine May be a Medical Experiment on Older Women

June 5th, 2012 by Elizabeth Kissling

Guest Post by Leslie Botha, Broadcast Journalist

It appears that women ages 27 to 45 in Canada are being subjected to the same type of Gardasil® advertising campaign adolescents and their families are in the United States. The full page advertisements are running continuously in magazine supplements in Sunday newspapers north and south of the border.

‘Now women ages 27 to 45 can benefit from Gardasil®’. Say what? Benefit from what? ‘Talk to your health care professional today.’ Now, I am not sure of what is going on in Canada – but in the U.S., healthcare professionals have nearly become pharmaceutical sales representatives, and women cannot go in for a doctor’s exam without being pressured to go on the birth control pill or get vaccinated. In fact, a stamp is now placed on a patient’s chart to remind doctor’s if the adolescent is in the process of getting the three-shot Gardasil® series or has been ‘counseled and refused’ vaccination.1

According to the U.S. FDA, there is no health benefit to getting Gardasil® for women ages 27 to 45. Then why is the vaccine being offered to older women in Canada?

Only the Facts Ma’am

In April 2011, after a long awaited decision the U.S. FDA ruled against Merck’s supplemental biologics license application (sBLA) for an indication to use GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in women ages 27-45. This was Merck’s 4th request to expand Gardasil® use to an older population of women.

In a brief statement Merck stated that: “An indication for adult women was not granted; instead, the Limitations of Use and Effectiveness for GARDASIL® was updated to state that GARDASIL® has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age.”1

Within the same month Merck issued a press release announcing Health Canada had approved use of Gardasil® for women ages 27 – 45 for preventing cervical cancer, vulvar and vaginal cancers, precancerous lesions and genital warts caused by HPV strains 6, 11, 16, 18. Health Canada was surprisingly silent on the HPV vaccine issue and did not release a statement of their own.2

This should have been the first red flag for Canadian women. According to Pharmalot, “Although Canada is a smaller market than the U.S., the approval is a notable step for Merck, which has been counting on a larger demographic target to boost sorely needed vaccine revenue.”3

The needed revenue is due to the decreasing uptake and non-completion of the three-shot series in the U.S. Health insurance records have shown that among 19 to 26-year-old women who received their first Gardasil shot, the number of 19 to 26-year-old women completing the 3-shot series dropped from 44 percent in 2006 to 23 percent in 2009. A similar decline was seen in the pre-teen demographic where 57 percent of girls in 2006 completed the vaccine series, compared to 21 percent in 2009.4

Perhaps another notable step for Merck will be to go back to the FDA with data from Canada to prove that Gardasil® can be demonstrated to prevent cervical cancer in this older demographic. This is a highly likely scenario, since the CDC has stated: “While there are well-established cancer registries in the United States, it will take decades before the impact of the vaccine on cervical cancer is observed.”5

What is potentially wrong with Gardasil® use in older women?

The CDC estimates approximately 20 million Americans are currently infected with HPV. Another six million people become newly infected each year. HPV is so common that at least 50% of sexually active men and women get it at some point in their lives. 6

Gardasil® was not designed to treat pre-existing HPV infections – and therefore it was tested on women who were not exposed to HPV. This type of pre-screening prior to vaccination is not available to medical consumers in the U.S. or in Canada and was actually discouraged by the FDA.

This alone gives rise to a major concern because women are mostly unaware they have been exposed to HPV. In addition, women who are not aware they have the virus but get the vaccine could suffer outbreaks of genital warts or abnormal precancerous lesions. Both conditions require extensive treatment. 7

Why is this happening? A chart in the May 2006 FDA Vaccines and Related Biological Products Advisory Committee’s report clearly shows that women who have been previously exposed to HPV and who are vaccinated with Gardasil® have a vaccine efficacy rate of -44.6%, and -32.5% post Cervarix, placing those vaccinated at an increased risk of developing cervical cancer, as well as suffering from other adverse reactions. 8

According to American Cancer Society estimates, deaths from cervical cancer fell by 74% between 1955 and 1992, mostly due to Pap smear screening. The rate continues to fall 4% annually without Gardasil®. Hopefully, there will not be an increase in cervical rates due to the HPV vaccines. That unfortunately will remain to be seen, although reports of cervical dysplasia and cervical cancer are being reported by young women post vaccination.

Have You Had HPV? Tweet It Today!

September 16th, 2011 by Elizabeth Kissling

The Village Voice has declared today, Friday, September 16, ‘Tweet That You Have Had HPV Day’.

U.S. readers probably know that on Monday, Congresswoman Michele Bachmann upbraided Texas governor Rick Perry for requiring girls in his state to have the vaccine during a Tea Party sponsored debate among Republican candidates for the presidential nomination, and then claimed the HPV vaccine causes ‘mental retardation’.

One dramatic response came on Twitter from writer Ayelet Waldman, who wrote that she got HPV from her husband in a monogamous marriage, and had to have cervical lesions removed. She was promptly told to keep that to herself, it was TMI, and that it was probably her fault for being slutty. (For an excellent critical summary of the whole kerfuffle, read Jill’s post at Feministe.)

HPV is easy to spread and hard to detect. From the CDC:

HPV is passed on through genital contact, most often during vaginal and anal sex. HPV may also be passed on during oral sex and genital-to-genital contact. HPV can be passed on between straight and same-sex partners–even when the infected partner has no signs or symptoms.

A person can have HPV even if years have passed since he or she had sexual contact with an infected person. Most infected persons do not realize they are infected or that they are passing the virus on to a sex partner. It is also possible to get more than one type of HPV.

HPV is easily spread, but can be prevented and treated. As the Village Voice article asserts, “Perhaps the greatest danger in the battle against HPV is one of PR. People are ashamed (after all, it’s an STD), and women in particular are shamed. No one wants to admit it, no one talks about it, and when people do, it’s in whispers and there’s a lot of misinformation.”

So talk about it, tweet about it, and don’t be ashamed. Fight sex negativity.

Cervical Cancer Vaccine NOT Recommended for Older Women

March 2nd, 2010 by Elizabeth Kissling
HPV virus magnified.

HPV virus magnified.

Although it pains me to see how low the threshold is for defining “older women” in this research, I am glad to see that the findings of this longitudinal study confirm that the HPV vaccine is of little to no benefit to older women. The study was published in Journal of the National Cancer Institute last month.

In a 7-year population-based cohort study in Costa Rica, the researchers looked at more than 9000 women in four age groups: ages 18–25, 26–33, 34–41, and ≥42 years to assess whether women’s age and the duration of carcinogenic HPV infections influenced subsequent persistence of infection and risk of cervical cancer. They found that regardless of the woman’s age, newly detected infections were associated with very low absolute risks of persistent infection or cancer.

Although cervical cancer is more common in older women, it usually develops many years – even decades – after exposure to a carcinogenic virus. The research team found that the rate of newly detected infections dropped with age — to 13.5 percent in women 42 and older, from 35 percent in women 18 to 25. In younger and older women alike, new infections generally cleared up without treatment.

The researchers concluded that the potential benefitof prophylactic vaccination or frequent HPV screening to prevent or detect new carcinogenic HPV infections is low in women aged 34 years and older.

Will HPV Screening Replace Pap Tests?

January 26th, 2010 by Elizabeth Kissling

Photo of two women in medical consult.Researchers in Italy have recently completed a study comparing the effectiveness of DNA testing for HPV (human papillomavirus) to the commonly used Pap smear for detecting cervical cancer. Their findings suggest that more cases of cervical cancer can be prevented with HPV testing than with the conventional Pap smear, especially for women over 35.

There are, however, some disadvantages to using DNA tests to detect HPV. For example, the test is less specific, which means that there are more false positives in the results. This means more women have to return for further testing. In practice, HPV screening has a callback rate of about 25-30%, compared to a callback rate of about 5-7% for Pap smears, according to Dr. Mark Einstein, a gynecologic oncologist and director of clinical research at Montefiore Medical Center in New York City.

Health News Review points out that although the HPV test is more effective in the sense that it prevents invasive cervical cancer by detecting persistent high-grade lesions earlier and providing a longer low-risk period for older women, replacing Pap smears with it is not necessarily more cost-effective for patients, given the costs of the additional colposcopies that result from the higher callback rate from HPV testing.

What are you doing this month for your cervix?

January 7th, 2010 by Elizabeth Kissling

hpv_cardSome ecards, creators of absolutely genius electronic postcards, have introduced a special series of HPV WTF cards to commemorate National Cervical Health Month. (I’ll bet you didn’t even know it was National Cervical Health Month!)

Send them to people you care about who have a cervix.

[via Feminist Campus]

Readers should note that statements published in re: Cycling are those of individual authors and do not necessarily reflect the positions of the Society as a whole.