HPV Vaccine – Should It Be Required?

Tue, 03/27/2007 - 2:36pm
By: Letters to the ...

Before making a decision about whether or not Merck’s HPV vaccine Gardasil should be required for 9- to 12-year-old girls and teens, let’s look at some information from Merck, the CDC, and the American Cancer Society (ACS).

Cost: Since “the retail price of the vaccine is $120 per dose ($360 for full series),” not including the doctor’s fee or the cost of giving the injection (CDC and ACS), we might want to question the financial incentive that Merck has to get the vaccine mandated and, therefore, eligible for government (i.e., taxpayer) funding. Merck stands to make billions of dollars from this venture, dollars that will offset its losses from Vioxx.

Long-term effects: No one knows the long-term health results for women since there was only a 3.9-year follow-up to the clinical trial. Gardasil “has not been evaluated for the potential to cause carcinogenicity or genotoxicity (damage to cellular DNA, resulting in mutations or cancer)” (Merck).

One long-term effect is the potential for an autoimmune disorder such as arthritis or lupus (Merck). A few vaccine recipients did develop these diseases within the 4-year time span of the clinical trials.

Merck states that it does not know “whether Gardasil can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity” since the only studies were done on rats (although rats cannot even be infected with HPV).

Forty pregnant women who received the vaccine did have “a serious adverse experience during pregnancy,” and “congenital anomalies” occurred when the vaccine was administered within 30 days of conception. Merck is maintaining a pregnancy registry to monitor adverse effects.

Although the vaccine recipients of the study were given “urine pregnancy testing prior to administration of each dose of Gardasil,” there are no plans for this minimal precaution (and extra expense) by legislators who are working to have Gardasil required.

Merck will not be financially responsible for adverse effects or even deaths (part of the 2002 Homeland Security bill). Once Gardasil is deemed a “compensable” vaccine, all compensation will be paid through the National Vaccine Injury Compensation Program (VICP), a federal program established to protect drug companies and health care personnel from liability.

VICP paid out $70 million or greater for four of the five years between 1996 and 2000; however, VICP awarded only $1.9 million in 2004, and the number of awards has steadily declined from 278 in 1996 to only three in 2004. (There are no figures listed for 2005 and 2006.)

This does not mean that there have been fewer adverse reactions, just fewer compensable injuries awarded compensation. The stresses of dealing with federal bureaucracy should be considered before making Gardasil mandatory.

Remember other “safe” medicines, such as Vioxx, that proved to have disastrous results? Merck withheld culpable information from the FDA, doctors, and patients, and numerous lawsuits have been brought against Merck.

Emails revealed that there were scientists who had “great concern” about Vioxx, yet Merck told physicians that there were very few adverse effects (0.5 percent) in one of its trials when actually 14.6 percent of the recipients had had adverse effects.

A video revealed that Merck’s sales reps were trained to avoid answering physicians’ questions about cardiovascular risks and were told that Vioxx did not increase the risk of heart attacks.

Merck even used intimidation tactics to silence medical researchers who spoke out about the risks. By the time the FDA approved Vioxx as “safe and effective,” Merck had completed approximately 60 studies in thousands of patients.

Gardasil has not been tested as thoroughly, yet Merck has launched a national advertising campaign and extensive lobbying efforts to make its vaccine a household word. The vaccine of Merck’s primary competitor will not be available for another 6 months.

Effectiveness: Will the HPV vaccine promote a false sense of security since many have the common misconception that vaccines are 100 percent effective for all recipients? Merck admits, “Gardasil may not fully protect everyone and does not prevent all types of cervical cancer.”

Because the four clinical studies conducted by Merck evaluated the vaccine’s efficacy in women 16 to 26 years of age, not 11-year-old girls, will the vaccine’s effectiveness be the same with younger girls? Is there a greater possibility for side effects in younger recipients?

The vaccine has no preventative effects if the virus is already present, a likely scenario with many teens since “at least 50 percent of sexually active men and women (other medical sources say at least 70 percent) acquire genital HPV infection at some point in their lives” (CDC), many within four years (ACS) of sexual activity. This vaccine “does not treat existing HPV infections, genital warts, precancers, or cancers” (CDC).

The CDC warns, “The vaccine will NOT protect against all types of HPV that cause cervical cancer, so vaccinated women will still be at risk for some cancers”; and Merck states in its product insert, “About 30 percent of cervical cancers will NOT be prevented by the vaccine.”

Just how effective will Gardasil be when vaccine recipients are older and most likely to develop cancer? Again no one knows the long-term effectiveness of this drug since Merck admits that “the duration of immunity ... has not been established.”

Cost-versus-risk benefit: According to the CDC, “All types of HPV can cause mild Pap test abnormalities which do not have serious consequences. Approximately 10 of the 30 identified genital HPV types can lead, in rare cases, to development of cervical cancer. Research has shown that for most women (90 percent), cervical HPV infection becomes undetectable within two years.”

The CDC encourages personal responsibility: “A Pap test can detect pre-cancerous and cancerous cells on the cervix. Regular Pap testing and careful medical follow-up, with treatment if necessary, can help ensure that pre-cancerous changes in the cervix caused by HPV infection do not develop into life threatening cervical cancer. The Pap test used in U.S. cervical cancer screening programs is responsible for greatly reducing deaths from cervical cancer ... Most women who develop invasive cervical cancer have not had regular cervical cancer screening.”

The ACS gives this encouraging news: “For most women, pre-cancerous cells will remain unchanged and go away without any treatment. But if these precancers are treated, almost all true cancers can be prevented ... Treatment of precancers can stop cervical cancer before it is fully developed.”

The survival rate for the cancer caught in its earliest forms is above 95 percent, and “the death rate from cervical cancer continues to decline by nearly 4 percent a year.”

Since “most HPV types cause no symptoms and go away on their own” (CDC) and cervical cancer does not form suddenly but tends to occur in midlife (35-55), rarely occurring in women younger than 20 (ACS), why is there such a rush to force this vaccine on children? Today most cases of cervical cancer arise in the developing world, not in the U.S. (The Lancet).

Prevention: Since the vaccine is effective for only four of the 40 genital HPV types, “a long-term, mutually monogamous relationship with an uninfected partner is the strategy most likely to prevent future genital HPV infections” (CDC). Delaying having sexual relations as long as possible is healthier since adolescents are biologically more susceptible to infections. Limiting the number of sexual partners and avoiding those who have had multiple partners are two other ways to reduce infection risks. HPV cannot be spread through bodily fluids, nor does it live in blood or any organs (CDC).

“By far, women bear the greatest burden of STDs, suffering more frequent and more serious complications than men” (CDC); therefore, greater emphasis needs to be put on prevention of ALL sexually transmitted diseases and on making teens and parents aware of the growing problem of STDs – a “hidden epidemic” with “severe and sometimes deadly consequences” (CDC). As of 2005, there were an estimated 19 million new cases of STDs in the U.S. each year (up from 15 million in 1999), almost 50% of them among young people ages 15 to 24 (in 1999 only 25 percent of the new cases were in this age group – CDC). The incidence of STDs is rising mainly because people are becoming sexually active at earlier and earlier ages and with multiple partners. “Safe” sex isn’t so safe!

“Just say no” is the mindset toward drugs, smoking, and excessive drinking. Couldn’t abstinence also be emphasized with a media campaign to prevent the emotional and physical impact of unhealthy sexual relationships? Classes covering self-control, decision-making, goal-setting, character development, communication skills, as well as the very real health consequences from the more than 25 STDs, will give teens the tools that they need to realize that they can control their sexual behavior and make wise choices that will have long-term consequences.

Gayla Conley

Peachtree City, Ga.

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Submitted by maryadavis on Tue, 05/27/2008 - 10:45am.

I have a highly addictive nature so if I take pills for any condition I might suffer from I end up needing drug addiction treatment. This is why I prefer the vaccine instead of some other form of treatment.

Basmati's picture
Submitted by Basmati on Tue, 03/27/2007 - 3:08pm.

Ms. Conley covers all the bases spreading Fear Uncertainty and Doubt regarding the cervical cancer vaccine.

My response is best summed up with this cartoon: Click HERE

Get your Klanpoints™ today!

Denise Conner's picture
Submitted by Denise Conner on Sun, 04/01/2007 - 5:40pm.

Basmati, you do like to sit in judgment of others, don't you?

If I win, do I get to meet DEMOCRAT Robert Byrd, the King of Pork?

Was he the Grand Wizard or the Grand Cyclops?

Exalted Cyclops? Kleagle (a recruiter)? Seems that he had both titles.

Of course, DEMOCRAT Al Gore's father voted against major civil rights legislation, including the Civil Rights Act of 1964.

And Lincoln was a REPUBLICAN!

Doubt you give President Bush any credit for the appointments of Condi Rice, Colin Powell, Rod Paige, and others.

Just trying to be "fair and balanced"!

Denise Conner's picture
Submitted by Denise Conner on Sat, 03/31/2007 - 6:22pm.

Basmati, you can only respond to others' reasoned arguments with emotion.

Don't let the facts get in the way of your ramblings.

Why should taxpayers have to pay for this vaccine, and why should it be FORCED on school girls?

If someone wants the vaccine, that person can pay for it.

ALL of the facts should be considered BEFORE getting the vaccine, though.

Click here for an even better cartoon:


Read the article, "Merck's Murky Dealings: HPV Vaccine Lobby Backfires" here:


Basmati's picture
Submitted by Basmati on Sat, 03/31/2007 - 7:53pm.

Denise, I gotta tell you that when I first saw that cartoon I posted, when I saw that shiny-eyed Christianist zealot in the last panel screaming about people who contracted the HPV virus "deserved" their fate....I immediately thought of you. Watching you squeal in outrage above makes me that this cartoon was a little too close for comfort for you too! Smiling

With regard to the cartoon you posted, I urge you to revisit your
favorite conservative Christianist websites for fresh talking points very soon. Another company, GlaxoSmithKline,filed an application with the government this past week to seek final approval of their own HPV vaccine! This is just awful for you, I realize, in that it deprives you of your favorite "Gardisil=Merck=VIOXX!VIOXX!VIOXX!" scare tactic.

Didja hear that the Glaxo field test was an enormous success with a trial population of 30,000 women? You'd better get cracking to see if you can find instances of post-vaccination symptoms like headaches, appendicitis, car accidents and such that you usually bring up to cast aspersions on the efficacy of the vaccine!

Additionally, I notice that while you continually harp about the cost of the HPV vaccine, you've never mentioned that since last October, Merck has offered the vaccine to doctors who treat uninsured patients (families up to $40K income) at greatly reduced prices. Since you are fair 'n balanced, albeit in a Fox News sorta way, I am sure this was a simple oversight on your part.

I continue to remain saddened that you continue to value making political points at the expense of the health of your daughter(s). But truthfully, I'm not surprised.
Get your Klanpoints™ today!

Denise Conner's picture
Submitted by Denise Conner on Sun, 04/01/2007 - 4:50am.

You've yet to tell me what is a "Christianist zealot."

Is it the opposite of an atheist zealot?

If anyone "squeal[s] in outrage," it's you. I just present facts.

I didn't realize that medical journals, the Am. Cancer Society, the CDC, CorpWatch, etc. are "conservative Christianist websites." In fact, CorpWatch is a very liberal source; that's why George Soros donates to its parent company, the Tides Center.

I don't need "fresh talking points" from anyone; I can do my own research.

Don't recall reading that "Merck has offered the vaccine to doctors who treat uninsured patients (families up to $40K income) at greatly reduced prices." What's your source?

There's probably a government reimbursement program involved somewhere because Merck is a corporation, not a charity. If not, then Merck's other customers must bear the expense of the discount to some. That's basic accounting.

Merck was not reducing the cost to the government to provide the vaccines, a cost that taxpayers will bear.

Getting the vaccine should be a personal, private CHOICE, not a governmental mandate.

Submitted by fishoutofwater on Wed, 03/28/2007 - 7:35am.

Basmati, I agree with and enjoy most of your posts, and while the cartoon you posted is funny, I have to take issue here.

Even a researcher who has worked to develop this vaccine says that it should not be mandated for young girls.

--If girls are vaccinated as preteens, immunity may have worn off by the time they are most likely to need it. The vaccine has been shown to be effective for five years, but there is no data beyond that time frame.
--The vaccination, which does not protect against all strains of HPV associated with cancer, may lull girls and women into a false sense of security, and they will fail to get checkups and paps. A decline in pap screening actually could result in an increase in cervical cancer.
--The effectiveness of the vaccine has not been proven in girls younger than 16, and its safety has not been tested in conjunction with other vaccines a girl may have at the same time. So far, at least 40 cases of Guillian-Barre syndrome have been reported in girls who received the HPV vaccine in combination with the meningitis vaccine. No one knows which vaccine is the culprit, or if it is the combination of vaccines.

The researcher also says that giving the HPV vaccine to young girls is a "great big public health experiment," and that to mandate the vaccine now "is simply to Merck's benefit, and only to Merck's benefit."

The full text of the article can be found here:


Submitted by jen157 on Thu, 08/06/2009 - 4:37am.

Any type of mandating vaccines like this is a bad idea for so many reasons. HPV is a dangerous disease but come on people everything is so drastic all the time.

Basmati's picture
Submitted by Basmati on Wed, 03/28/2007 - 8:05am.

Thanks for the article. I actually agree with one of Dr. Harper's assertations, specifically innoculating pre-teen girls. I think age 16 should be the minimum age.

I personally think the charge of "doesn't protect against ALL strains" is a bit of a red herring. The vaccine appears to prevent 70-90 percent of ALL cervical cancers, depending upon age of innoculation (lower=better).

Finally, the researcher you identified in your article, Dr. Diane Harper, was testing a competing HPV vaccine product from GlaxoKlineWelcome so I'm not sure that her bias isn't totally monetarily related.

Here's a link to her saying many positive things about the vaccine
Get your Klanpoints™ today!

Denise Conner's picture
Submitted by Denise Conner on Sat, 03/31/2007 - 7:07pm.

Disclosures: Dr. Diane Harper “serves on the study planning committee for Merck and GSK [GlaxoSmithKline] and is a clinical site PI [principal investigator who is responsible for collaborating with the overall PI to ensure appropriate clinical conduct, including reporting of serious adverse events (SAEs) as well as events that are unexpected during clinical trials – duties are outlined in FDA form 1572] for GSK.” She is a professor at Dartmouth Medical School and Director, Gynecologic Cancer Prevention Research Group, Norris Cotton Cancer Center, Hanover, NH.

American Cancer Society Guideline for Human Papillomavirus (HPV) Vaccine Use to Prevent Cervical Cancer and Its Precursors” (CA: A Cancer Journal for Clinicians, Vol. 57, pp 7-28)

"Amid the public and government enthusiasm, the limitations of the vaccine are being largely ignored, said Diane M. Harper, MD, a researcher at Dartmouth Medical School involved in the vaccine's clinical trials. She doesn't believe that HPV vaccination needs to be mandatory and worries that women will become overconfident in the abilities of the vaccine, and not understand the continuing risk of cervical cancer and need for Pap tests.

"'The worst thing that could happen is that a whole bunch of 11- and 12-year-olds get vaccinated and then they decide they never want to go in for a gynecological exam and you're going to have increases in the number of cervical cancers,' said Dr. Harper."

"'Vaccinated women will still develop cervical cancer, and vaccinated women will still develop cervical cancer precursors caused from the other oncogenic HPV types not covered by the vaccine,'" she said.


"The American College of Physicians (ACP) is the nation's largest medical specialty society. Its mission is to enhance the quality and effectiveness of health care by fostering excellence and professionalism in the practice of medicine."

Submitted by fishoutofwater on Wed, 03/28/2007 - 8:40am.

The article states that Harper's research has been funded by both Merck and Glaxo. Do you know if she still receives funding from Merck? Will state legislation mandating HPV vaccination be brand-specific? If Harper doesn't oppose the use of ANY manufacturer's HPV caccine on preteens, then I would question her objectivity.

Submitted by fishoutofwater on Wed, 03/28/2007 - 9:52pm.

Another issue is the fact that HPV is almost always sexually transmitted. What justification does the state have in mandating this vaccine for school attendance when HPV is hardly ever (the CDC web site says only 2% of cases) spread through casual contact? (The same argument could be made about mandating vaccination for Hepatitis B.)

Additional reading on this topic can be found here:


I think it's also worth noting that The American Academy of Family Physicians opposes state legislation mandating HPV vaccination.


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