By Dr. Mercola
Women over age 21 are now being dissuaded from annual PAP smears.
PAP smears screen for cervical cancer typically associated with human papillomavirus (HPV), which health officials say is responsible for most cases of cervical cancer.
The USPSTF (US Preventative Services Task Force) and the American Cancer Society are now recommending women undergo PAP screening only once every three years, beginning at age 21 and ending around age 65.
The problem with this stance is that PAP smears prevent cervical cancer deaths far more effectively than the HPV vaccine ever will.
And it's hard to compare the potential side effects of the HPV vaccine with the potential side effects of PAP tests.
I've never heard of anyone dying or becoming paralyzed from a PAP smear.
Now, I don't necessarily disagree with the recommendation to reduce the frequency of PAP testing.
As Philip Castle of the American Society for Clinical Pathology states:
"If you test every year you find a lot of benign infections that would go away on their own... You end up overscreening, overmanaging and overtreating women who are not actually at risk of getting cervical cancer."
Side effects of overtesting may include vaginal bleeding, pain, infections, risks of pre-term delivery, and psychological impacts of facing a possible cancer diagnosis.
Why Opt for the More Hazardous Option?
What I DO question is, why are cancer groups recommending getting rid of a safe and effective screening method, which we know saves lives, while vigorously advocating the clearly risky HPV vaccine?
Since the release of Gardasil into the market in 2006, many thousands of serious adverse events have been reported to the government's Vaccine Adverse Events Reporting System (VAERS), including 26 deaths in the past 12 months alone. Furthermore, cervical cancer is not even in the top 10 cancers that kill American women every year. The death rate from cervical cancer in the United States is about 3 per 100,000 and most cervical cancer deaths occur in older women who have had chronic, undiagnosed and untreated HPV infection for many years.
Annual Screening Doesn't Find More Cancer than Three-Year Screening
Despite the new PAP screen guidelines, most physicians continue to recommend annual PAP screening to their patients, mostly because they (and their patients) are in the habit of doing so. Some physicians also fear their patients will not come in for annual exams and other screening if the PAP is not required every year. But doing unnecessary testing is not the best way to convince women to get regular checkups.
Evidence shows that screening women for cervical cancer more frequently than every three years does not detect more cancer. Women, who have not been exposed to HPV, are not at risk for cervical cancer. Besides, it's important to know that the immune response of the majority of women is strong enough to clear up HPV infection within two years without any intervention—in fact, this is what happens 90 percent of the time. Even the CDC admits to this fact on their website. Only certain varieties of HPV are high-risk. Two types (types 16 and 18) cause 70 percent of all cervical cancers. But these cervical cancers are very slow growing, which is why less frequent PAP screens are still effective.
But there is more to this story than meets the eye. The driving force behind this "new and improved" PAP schedule may have more to do with vaccine marketing than kind-heartedly saving you from stepping into the cold metal stirrups every year...
Are Women Just Pawns in the Gardasil Game?
There is a good deal of evidence that the revised PAP guidelines are part of a plan to rescue Gardasil vaccine sales, which are embarrassingly low. It's estimated that only about one in four eligible women and girls have chosen to get all three HPV injections.
The vaccine is expensive, costing between $400 and $875 for the three-shot series. Studies show that cost-effectiveness of the vaccine is questionable, especially for women over age 20. Researchers at Harvard School of Public Health conducted a study, funded by the CDC, of the cost-effectiveness of HPV vaccination. They found that the older a woman is, the less cost-effective the vaccine will be. The findings were published in the New England Journal of Medicine in August 2008.
The study assumes that Gardasil provides lifelong immunity against HPV. Cost effectiveness will be worse if the vaccine were actually found NOT to be as effective after 10 years, which may very well be the case... In fact, it's a bit surprising that they would assume the vaccine would provide lifelong immunity. According to the National Cancer Institute, the vaccine has only been shown to provide protection against persistent cervical HPV 16/18 infections for up to 8 years.
The other issue is that mass use of Gardasil could put pressure on the HPV strains associated with cervical cancer that are not contained in the vaccine to become more dominant and cause cancer. One way to make the vaccine more cost-effective is to cut costs in other areas. So, the next question is, where can costs be cut?
PAP screens would be an obvious choice, and they do appear to be the sacrificial lamb in this case. In my review of the literature, I did in fact find many "versions" of the recommendation to cut back on the frequency of PAP screening in the name of making HPV vaccination more "cost-effective."
Are Regulators Reducing PAP Smears to Rescue a Vaccine Flop?
It seems the HPV vaccine, once anticipated as the flagship vaccine of the 21st Century, has fallen flat on its face. The industry hyped it as highly effective AND cost-effective—and, in both cases, it appears to be neither. So now they're clamoring for a rescue plan, as evidenced by the following several documents. The first document is a 2006 white paper discussing implementation strategies for the HPV vaccine, in which the following recommendation is made (p.44):
"In the longer term, the introduction of an effective vaccine will undoubtedly change the balance of costs and benefits for routine screening. Policymakers should seriously consider changing the nature of screening regimens for vaccinated women (Trimble 2005, Lowndes and Gill 2005). For example, they might reduce the frequency of screening—even to as little as once per lifetime—or shift from Pap smears to HPV DNA testing (Harper 2005a, Lehtinen and Paavonen 2003, Shaw 2005)."
The white paper also suggests that giving HPV vaccine at age 12 (and the vaccine is licensed for children as young as nine years old!) is a way to reduce cancer rates and lower overall health care costs (p.39). Further evidence for financial motivation behind the revised PAP screen schedule can be found in this 2007 report, which discusses the costs of establishing this vaccine worldwide. On page 13, it says:
"Cost-effectiveness analyses can help decision makers determine how to optimally combine cervical cancer screening with HPV vaccination. For example, in the United States, a cost-effective approach would be to combine HPV vaccination with screening starting at age 25, conducted every three years (Goldie et al. 2004)."
The third document is a CDC report from 2010 that details costs associated with HPV vaccine implementation. It shows the cost-effectiveness of vaccinating 12-year-old girls and the declining cost-effectiveness as girls (and women) age.
An analysis by researchers at Stanford University went so far as to use mathematical models to predict how various PAP screening schedules (annually, or every 2, 3, 4, or 5 years) would affect your life expectancy, assuming you were HPV vaccinated (refer to Figure 5 in Stanford report). They concluded that PAP testing every 4 years will increase your life expectancy and reduce healthcare costs, provided you are vaccinated. Just how much more life will this buy you?
Drum roll please…
You may live an extra 2.8 days.
Yes, by getting the HPV vaccine and having PAPs every 4 years, you can perhaps add one "long weekend" to your life, compared to the current recommended schedule, according to Stanford's mathematical model. You'll not add 2 years to your life, mind you, but 2.8 days. Hopefully you won't spend that long weekend getting treated for seizures, paralysis, blindness, blood clots, stroke or cardiac arrest—which are just some of the adverse effects reported from receivers of this vaccine. Adding a few days to your life won't necessarily add more life to your days.
The Stanford researchers also noted that the more often you get PAPS, the longer your life expectancy will be, but more frequent PAPS increases costs substantially. So what they've done is made the argument that cutting back on PAP tests will cut down on costs.
I think you can see that this "new and improved" PAP screen schedule may have arisen more out of concern for the financial bottom line—the bottom line for Big Pharma and their shareholders, that is—rather than from genuine concern for women's health.
All of these mathematical models assume that the HPV vaccine confers long-term immunity. However, there is some evidence this is not the case. According to the National Cancer Institute, the vaccine has only been shown to provide protection against persistent cervical HPV 16/18 infections for up to eight years, but some evidence suggests the induced immunity may wane in as little as five years.
If this is true, then it's possible that the cost-effectiveness picture may be even LESS rosy than the bean counters have predicted. But what about the possibility that the vaccine could actually increase your risk for cervical cancer?
Evidence that Gardasil May Actually INCREASE Your Cervical Cancer Risk
A study in the Lancet poses this as a real possibility:
"Vaccinations alone will not prevent cervical cancer unless their efficacy is longer than 15 years; if the duration of efficacy is shorter and efficient boostering is not organized, the onset of the cancer in women is merely postponed… if even more young vaccinated adolescents mature into women who willfully refuse cervical cancer screening, the population rates of cervical cancer will increase."
And according to Merck (Gardasil's manufacturer), if you have already been exposed to HPV prior to receiving the vaccine, Gardasil has been found to increase your risk for precancerous (or worse) lesions by 44.6 percent.
Gardasil: From Flagship to Flop
There is absolutely no proof and no clinical trials that demonstrate Gardasil vaccines confers long term protection against development of cervical cancer. The studies were not done prior to licensure.
Pre-licensure clinical trials did not follow young girls or women for decades to establish how long they were protected. In fact, in clinical trials Gardasil's protection against cell dysplasia leveled off at four years, and clinical trial participants were given a fourth dose to boost the number of antibodies measured in the blood of those vaccinated. So the efficacy being reported by Merck is based on clinical trials using four doses of the vaccine, even though patients are being given only three.
In a slide presentation in October of 2009 at an NVIC conference, Harper made the point that early vaccination may only postpone, not prevent, future cervical cancers, and that we cannot eradicate HPV.
I believe one of the reasons many women and girls are opting out of HPV vaccines, in addition to the high price tag, is they are becoming educated about the potential risks versus the benefits. And given the high rates of adverse reactions, it's reasonable to assume a fair number of women are having bad reactions after their first or second shot, causing them to not return for the third.
Can Gardasil Lead to New Kinds of Cervical Cancer?
Gardasil confers immunity to only two of the 15 HPV strains that are associated with cervical cancer. This prompts a troubling question. Could the mass use of Gardasil (and the other HPV vaccine, Cervarix) put pressure on other HPV strains to become more dominant and perhaps more virulent in causing cervical cancer
This is a very real possibility and federal health officials and Merck already know that other HPV strains not contained in Gardasil vaccine could become more dominant and continue to cause disease. In fact, this "replacement effect" was discussed in the Journal of the American Medical Association in 2007 following the vaccine's licensure and recommended universal use in 11-12 year old girls in 2006.
There is historical precedent that gives plenty of evidence that mass vaccination policies put pressure on infectious microorganisms to evolve and create new strains or substitute non-vaccine strains with other strains. The "replacement" effect has happened with other infectious organisms that have developed resistance to vaccines used on a mass basis, such as pertussis (whooping cough) and pneumococcal vaccines.
In effect, the mass use of HPV vaccines in the absence of adequate scientific evidence that the vaccine is safe, effective and will not lead to vaccine-resistant HPV strains, brings up this big question: Is this an uncontrolled medical experiment on young girls and women?
It seems to me that getting this vaccine is like playing "Russian Roulette" with your health. CNN Money had it right: the vaccine is a dud. And the new recommended reduced PAP screening schedule may just be the industry's attempt to rescue it – but at what cost to the health of young girls and women in America?
Please don't fall for the notion that an HPV vaccine of questionable safety and effectiveness can replace getting regular PAP screens. According to one of the world's top experts on HPV, the HPV vaccine is associated with enough serious side effects that it could prove riskier than the cancer it is supposed to prevent in women, as cervical cancer is usually entirely curable when detected early through normal PAP screenings.
For More Information on HPV & Gardasil Vaccine
The National Vaccine Information Center has more information on HPV and Gardasil vaccine, including descriptions of Gardasil vaccine reactions and links to the Gardasil vaccine product manufacturer insert.
To search the federal VAERS database of Gardasil vaccine reaction reports to the federal government, see this link.
I also urge you to sign NVIC's "Investigate Gardasil Risks Now!" petition.
- Reuters October 19, 2011
- New England Journal of Medicine August 21, 2008 - NEJM 2008; 359:821-832 J. Kim, et al "Health and Economic Implications of HPV Vaccination in the United States"
- Current and Future HPV Vaccines: Promises and Challenges (White Paper) 2006
- HPV Vaccine Adoption in Developing Countries: Cost and Financing Issues December 2007
- CDC Report February 24, 2010
- Emerg Infect Dis. January 2003 - Emerg Infect Dis 2003 January; 9(1): 37-48 G. Sanders et al, "Cost Effectiveness of a Potential Vaccine for Human papillomavirus"
- Lancet September 2010 - Lancet Infectious Diseases, September 2010, Volume 10, Issue 9, pages 594-595 D. Harper et al, "Cervical cancer incidence can increase despite HPV vaccination"
- Medical News Today June 28, 2007
- Huffington Post December 8, 2009