Should Boys Be Given the HPV Vaccine? The Science Is Weaker than the Marketing

By Jeanne Lenzer | November 14, 2011 3:20 pm

Merck’s promotion of Gardasil, its vaccine against the human papilloma virus (HPV), has a complicated history. First there was the exuberant claim about its reputedly great effectiveness in preventing cervical cancer. Now comes the recommendation last month from the Centers for Disease Control and Prevention, that all 11- and 12-year-old boys should be given the vaccine.

Of Science and Truthiness

The vaccine for boys is important, say advocates, because reducing HPV in boys will reduce transmission to girls and women—only 32 percent of whom have been getting the shots to date. Giving the shots to boys, they say, promotes gender equity. As a bonus, the vaccine may protect against oral and anal cancers in men who have sex with men.

Since a key part of the rationale for vaccinating boys is to protect girls, it’s worth a moment to examine the claims about reducing cervical cancer deaths. Merck won approval for Gardasil from the Food and Drug Administration in June 2006. On May 10, 2007, Merck published the results of a study in the New England Journal of Medicine that claimed an astounding 98 percent efficacy in preventing changes in the cervix used as a marker for cervical cancer.

But that statistic begs closer examination.

To achieve the 98 percent efficacy claim, Merck excluded from analysis anyone who “violated” the study protocol. In other words, all real-world problems that arose were excluded from analysis. Problems like girls who refused to take a second or third shot after they became sick and (correctly or incorrectly) blamed the vaccine. Or doctors who incorrectly gave the vaccine to someone who shouldn’t have received it.  While it’s worth knowing how effective the vaccine is when it’s used exactly as it should be, for a public-health decision, it’s not as relevant as its real-world effectiveness.

To Merck’s credit, they reported that when all women in the study were analyzed, the vaccine’s efficacy dropped to 44 percent. Still, 44 percent might be considered a smashing success when you’re talking about saving lives. Except for one thing: the numbers get worse. The 44 percent benefit included only those women with the two specific cancer-causing HPV strains found in the vaccine. But when the researchers looked at negative cervical changes from any causes, they found that changes occurred in unvaccinated women at a rate of 1.5 events per 100 person-years, while vaccinated women had 1.3 events—dropping the benefit to 17 percent.

Moreover, most of the cervical changes tracked by the researchers weren’t even indicative of cervical cancer in the first place. Most were innocent cellular abnormalities that either disappear entirely on their own, or never progress to cancer. In fact, when they looked more closely at advanced cervical changes most likely to progress to cancer versus more innocent changes that go away spontaneously, it was the innocent changes that accounted for the decline.

Whether Gardasil will reduce cervical cancer deaths in real-world conditions has simply never been answered. It might—but that would take a long-term study, and one that should be done before it’s widely promoted.

A Cure in Need of a Disease

Now, come the boys. If cervical cancer prevention and gender equity don’t have you jumping out of your seat to grab every preteen boy to get a shot, what about the claim that Gardasil might prevent anal and oral cancers men may get from having sex with other men?

Merck says that in males, the vaccine is 89 percent effective against genital warts and 75 percent effective against anal cancer. On closer inspection, some of the numbers don’t just deflate, they evaporate. First off, let’s define the problem: The annual number of deaths from anal-rectal cancer among all men in the U.S. is 300. And how did Merck get its happy statistics on efficacy? Once again, they reported an idealized benefit by excluding from analysis 1,250 study violators out of 4,055 total test subjects. When the real-world analysis was conducted, the numbers plunged—right down to plum nothing. After evaluating tissue changes in male genitalia that were suggestive of a cancer precursor, Merck reported that vaccine efficacy against such lesions “was not observed.”

Given this, is it worth the risk of exposing millions of youth to the as yet uncertain harms of the vaccine? The CDC states that in rare instances, some vaccines may trigger the potentially fatal and paralyzing condition Guillain-Barré, and Nizar Souayah, MD, of the University of Medicine and Dentistry of New Jersey in Newark, says he and his colleagues found “clear evidence from our database of an increased incidence of Guillain-Barré syndrome in the first six weeks, especially the first two weeks, after [HPV] vaccination.” Guillain-Barré is very rare, even among people who are HPV vaccinated, but the problem is emblematic of the downsides of subjecting millions of people to any medical treatment.

Mo’ Money, Mo’ Money, Mo’ Money

So how did the HPV vaccine become a multi-billion-dollar winner for Merck? Well you might not be surprised to hear that the company happily lavished money on doctors, professional societies, and over 100 legislators. Of course, there is no tie between the recipients of this largesse and their promotion of the vaccine, say beneficiaries like presidential candidate and current Texas governor Rick Perry. In 2007, Perry signed an executive decree mandating that all girls in Texas receive the vaccine. The $28,500 Perry received was minor compared to his other connection to Merck: Perry’s chief of staff, Mike Toomey, became a lobbyist for Merck, championing the HPV vaccine. Once in that position, announced his plans to raise over $50 million for Perry’s presidential campaign.

In any case, the marketing certainly doesn’t seem to have hurt the adoption of Gardasil, which has been administered to millions of girls around the country. Caught up in the joy, some 41 state legislatures have initiated bills to promote or mandate the shots for all girls. With the CDC’s new recommendation for boys, one can imagine that promotion or mandates for them might come next.

Fortunately, some researchers don’t believe the hype. Dr. Diane Harper, one of the lead researchers in the development of the HPV vaccine, recently told the Kansas City Star, the vaccine for boys is “pie in the sky…We’re short of health care dollars. Why should we spend it on that?”

Indeed. There are better ways to spend the billions of dollars currently being spent on HPV vaccines. First, we already have a pretty terrific way to prevent most cervical cancer deaths, and it’s called the Pap smear. Since poor women are less likely to get Pap smears and more likely to die from cervical cancer, we could start by extending medical services to them. Second, many oral cancers are caused by smoking, and men and women who smoke are more likely to die of oral and cervical cancer, so we could invest in smoking cessation efforts.

As Angela Raffle, a specialist in cervical cancer screening, told the New York Times‘ Elisabeth Rosenthal, “Oh, dear. If we give it to boys, then all pretense of scientific worth and cost analysis goes out the window.”

Unfortunately, the hope that we would undertake low-tech, high-yield public health efforts might be the real pie in the sky thinking.


Full disclosure: I am not anti-vaccine. I’m happy to sport that little scar on my thigh from the smallpox vaccine I received as a kid. Smallpox is a scourge I can live without. Nor do I believe that every claim of calamity occurring after a vaccine is due to the vaccine. What I question is the promotion of vaccines, drugs and medical devices that aren’t backed up by solid clinical evidence and shown to be cost-effective in the real world.


Jeanne Lenzer is a medical investigative journalist and frequent contributor to the British medical journal BMJ. Her work has been published in The Atlantic, The New York Times Magazine, Newsweek Japan, and many other outlets.

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  • Felix

    That’s very disappointing.
    My daughter had her first of 3 shots last week (in the UK).
    Is the evidence really as scarce as you say? Are there any additional studies in progress at the moment?

  • Ian

    The pap smear is a screen and it’s disingenuous to suggest that it’s a good alternative to an effective vaccine (which Gardasil may or may not be). Try telling a young woman who has an oophorectomy and hysterectomy that her yearly pap smear was acceptable prevention.

  • alberta

    Why do you say HPV vaccine may prevent “oral and anal cancers in men who have sex with men”? Men who don’t have sex with men get HPV related throat cancers. HPV vaccine will likely protect women from anal cancers, too.

  • Disgusted

    seriously Discover? This is the crap you’re peddling on your first new blog in awhile? “I’m not anti-vaccine” yada yada yeah right, that’s what NVIC says too. Disingenuous is right.

    Yes, paps prevent many deaths. But do you know what happens with “precancer” conditions, Jeanne? Have you ever had to have an OB go in and biopsy, and then *burn* your cervix? They have a nice little machine that sits by the operating table to suck up the smoke from the burning epithelium. And then you get to bleed for weeks. I’d take a shot in order to prevent that any day of the week. HPV goes way beyond deaths, and way beyond just cervical cancers. I’m also unsure why you’d expect it to protect against non-vaccine strains. We see that with any vaccine where the pathogen has multiple serotypes (S. pneumo, Hib, influenza, meningitis, etc.) You can only expect protection against the ones which are in the vaccine, so the best comparison is indeed how much it lowers morbidity/mortality from the vaccine strains.

    Also regarding looking at pre-cancer changes–is your argument seriously then that we should wait 20-40 years to “really” find the efficacy of this vaccine, when we know NOW that it prevents many pre-cancer conditions? Seriously?

    blah. I expect better from the home of Zimmer and Yong. Very disappointed.

  • Jeanne Lenzer

    Author’s response:

    Felix, I agree, it is disappointing. There are studies in progress, however it will take 10 to 15 years to see the true effects of the vaccine.

    Ian, the pap smear is still necessary – as even the manufacturer acknowledges – because, as I stated in the article, even in the best-case scenario asserted by Merck, most vaccinated women destined to develop cervical cancer will still develop it (1.3/100-person years for those vaccinated vs 1.5/100-person years for those not vaccinated). With regular pap smears very few women have to have their entire uterus and both ovaries removed, instead they often have just their cervix treated.

  • Dan Kegel

    Well… says that if current trends continue,
    HPV-related throat cancer may become more common than cervical cancer by 2020.
    The data’s a little thin there, but the trend is troubling.

    And about the effectiveness in women:
    The article “4-year end-of-study analysis of the randomised, double-blind PATRICIA trial” in the Lancet (
    really makes the vaccine sound great for women.
    5000 or so women with negative pap smears were immunized against HPV-16 and HPV-18.
    Four years later, none of these women had developed CIN3+ (the immediate precursor to invasive cervical cancer). (Judging by Lancet. 2007 Nov 24;370(9601):1764-72., one would have expected 20 women to get CIN3+.) 

    Also, an independent group not funded by the drug companies, found vaccination reduced the total number of CIN2+ lesions in girls; see “Early effect of the HPV vaccination programme on cervical abnormalities in Victoria, Australia: an ecological study”, Lancet, June 2011 (
    ) or “HPV Vaccination Programs Showing Early Results”(
    Before the vaccine was introduced, 0.8% of under-18 girls tested had a high-grade abnormality. Afterward, it was 0.42%.

    So: it seems that HPV-related throat cancer is actually increasing, and HPV vaccination actually does protect girls usefully; the only question left is whether it’s all cost-effective. is a recent study that looks at this question, and says yeah, it costs less than $50,000 per “quality adjusted life year”, the usual
    threshold for cost-effectiveness. talks about this threshold a bit.

    So, while I agree that one should be on guard against marketeering by drug companies,
    and that Gardasil has unquestionably been marketed heavily, that doesn’t necessarily mean
    there’s a rat here.

  • phil

    do you know how Gardasil compares to the bivalent vaccine Cervarix which has been adopted in the UK? I’ve heard that the rate of cervical cancer is predicted to drop by 70% in the cohort of girls that have been vaccinated with Cervarix, and that Cervarix is more efficacious than Gardasil for vaccination against the carcinogenic strains of HPV. is this a similar story of massaged statistics?

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  • Dan Kegel

    About Cervarix vs. Gardasil: compares the two. They both seem good, it’s not completely clear the 4-strain vaccine is better than the 2-strain one.

  • Joshua Nicholson

    The vaccination is very efficacious against cervical intraepithelial neoplasia 2+ (CIN2+), but not cancer. CIN2+ is defined by the National Cancer Institutes as:

    “A condition in which moderately abnormal cells grow on the thin layer of tissue that covers the cervix. These abnormal cells are not malignant (cancer) but may become cancer. Also called cervical squamous intraepithelial neoplasia 2.”1

    The cells “may become cancer.” This definition is indeed very vague inasmuch as any cell out of the 100 trillion that make us humans can become a cancer cell. Well, perhaps these cells are more likely to become the real thing.

    This is however not the case as one comprehensive review on CIN shows. It was found in this review that the likelihood of CIN2+ progressing to invasion is only 5%.2 In other words 95% of the time CIN2+ remains harmless in the woman it is found.

    1 National Cancer Institute, CIN 2, Available at
    2 Andrew G. Ostor, International Journal of Gynecological Pathology 12, 186 (1993).

  • Hermagoras

    As Tara Smith notes in the ScienceBlogs response referenced above, this article is “full of half-truths and omitted facts”. Very disappointing.

  • Joe

    Felix, read this.

    Cervical cancer jab puts girl, 13, in ‘waking coma’ Published: 14 Nov 2011

    “A schoolgirl is trapped in a waking coma and sleeps 23 hours a day after having the cervical cancer jab.

    Lucy Hinks suffered extreme exhaustion immediately after having the Cervarix injection last year.

    She had a top-up dose one month later — and her health has not recovered since.

    Lucy, 13, has not opened her eyes for seven weeks, can no longer walk or talk and spends almost every hour of the day sleeping.

    She collapsed earlier this year and was rushed to hospital.

    Tests revealed she had an enlarged liver and spleen.

    Last night her parents warned mums and dads across the country to be alert to the jab’s dangers.

    The vaccine is given to hundreds of thousands of year eight pupils every year.

    It is designed to protect against the virus that causes almost all cases of cervical cancer.

    Manufacturer GlaxoSmithKline insists the jab is safe.

    But it has been linked to more than 5,000 adverse reactions, including exhaustion to paralysis, since being launched.

    Lucy’s devastated mum Pauline, from Port Carlisle, Cumbria, last night said that doctors were unable to say when her daughter would recover.

    She said: “I would not wish what we’ve been through on anyone.

    “I’ve not seen the whites of Lucy’s eyes for weeks and nobody can tell us when it will turn.

    “I would urge parents to get all the facts, gather as much information as you can. ”

    Ed note: While approved vaccines can have serious side effects, they are quite rare, and incomplete, anecdotal reports like this can be very misleading. The best way to judge the safety of the vaccine is through the already published peer-reviewed articles, and the ones that will presumably be published in the future and look at the vaccine’s long-term safety.

  • Jerome Hoffman

    About an hour ago I wrote a response on the Tara Smith blog critiquing her extremely inappropriate holier-than-thou tone and her extremely non-scientific content; as of right now my comments have not seen the light of day on her web-site.

    There are, as Ms Lenzer points out, many reasons to worry about the push to have this vaccine given widely, in the absence of any evidence that it will beneficially impact actual CANCER in any meaningful way. There is similarly a lack of evidence that over a long period of time, given to many millions of people, it won’t produce substantial harm — particularly if it has to be repeated many times (as may well be the case, if it is to be at all effective). We should always question efforts to encourage widespread use of something which has not yet been shown to be either effective or safe — particularly when those efforts come from an entity that stands to make vast profits if the marketing pays off.

    All of this is aside from some of the other important points noted in Ms Lenzer’s article. These include the diminishing impact of the vaccine (even for microscopic “neoplasia,” rather than actual cancer) under real-world conditions — because so many women have already been exposed to the target HPV serotypes, even as teenagers, because not everyone follows all the study protocols, because cervical neoplasia unassociated with these serotypes occurred prominently even in the manufacturer’s own studies. It MIGHT be true that vaccinating young children could surmount some or many of these problems — but it would be extremely foolish (and anti-scientific) to ASSUME that would happen, without one shred of evidence.

    Furthermore, cervical cancer is not a disease of very young women (the targets of the vaccine), which raises many questions about how often the vaccine would have to be given — especially in light of the near ubiquity of HPV, and the way seropositivity comes and goes even in individuals. In addition, we already have very good public health approaches to cervical cancer. It is true that these often fail in real world circumstances — but this should only reinforce the importance of recognizing that estimates of best-possible-outcomes-under-ideal-conditions can be enormously misleading … and this applies to the vaccine as well.

    There are many vaccines that have engendered truly enormous public health benefits … and there is no reason not to hope that this HPV vaccine could ultimately prove to be beneficial in reducing actual cancer, in a way that outweighs whatever harms it may also prove to produce. But hoping for this should not dissuade us from maintaining appropriate skepticism, unless and until there is real evidence in its favor. Circumstantial evidence about CIN, related to specific serotypes, over a short period, in selected patients, provides a good reason to move forward, and try to establish whether this will actually translate into benefit greater than harm … but it is surely not (as Ms Lenzer wisely warns us) a reason to start subjecting many millions of children to what remains, as of today, an unproven intervention.

  • http://POZLOVING.COM skylover

    The STD counselor on a Herpes support site pozloving, com said herpes doesn’t live outside the body for long..and you can not catch it from inanimate objects in a VERY RARE case if someone with herpes uses a towel after the shower and rubs enough of the “virus” off and someone uses it immediately after there is a VERY slim chance of them getting is since the towel is still damp.. but that would be a very rare occurrence.
    Don’t upset by Herpes. 1 in 4 get STD in USA. Most of people on ==== ” pozloving , com” ===== said it is just a minor virus. And they can deal with it during their se life. I am curious to know the details.

  • Gaythia Weis

    In combating denialism, I believe that it is important that we not back ourselves into an inappropriately absolutist corner.

    HPV vaccine is not a clear cut a choice:–seriously.html
    “Why? First, there are more than 100 different types of HPV, at least 15 of which cause cancer. But the vaccine protects only against the two most important cancer-causing strains, HPV-16 and HPV-18, though it may also offer partial protection against some closely related strains (The Lancet, vol 374, p 301). But the remaining strains still cause cancer. Second, though clinical trials have shown that the vaccine reduces the incidence of precancerous lesions, we cannot say for sure that this will translate into cutting cervical cancer and deaths 20 to 40 years in the future. There are many other gaps in our knowledge. How long does the vaccine provide protection without a booster? Does it affect natural immunity against HPV, and with what consequences? Can we really be sure that the vaccine protects preadolescent girls when proper clinical trials have been carried out only in women aged 16 to 24?”

    Somewhat perversely, even in the face of deaths, sometimes it is local public health agencies that oppose vaccination, and the public which demands it:

    “But even though there have been two deaths from the disease in Fort Collins and two others remain hospitalized, the situation isn’t so dire that everyone should rush out to get vaccinated, said Adrienne LeBailly, director of the Larimer County Department of Public Health and Environment. “Individuals don’t need to do anything immediately for the most part,” she said. “We’ve already treated close contacts (of the affected hockey players) with antibiotics. People need to think at some point whether it’s worth the approximately $125 to be vaccinated versus the extremely low risk that they’ll ever get it.” ”

    I think that we need to strive to approach this topic with a high degree of understanding of the best available data and a measure of humility:

    “Public health officials must acknowledge the reality that they can neither compel vaccination nor pretend that there are no arguments against vaccination.
    We must acknowledge that each parent has the right and the authority to make his or her own choices, and that it is our failing (either in the quality of our vaccines or the persuasiveness of our message), not theirs, if we have failed to convince them that vaccination is the better choice.
    We must acknowledge that we have the best chance of convincing a skeptical public when we put the weaknesses of our arguments and the risks of our interventions front and center and acknowledge the fears that they evoke.

    It may seem counterintuitive, but embracing humility may be the best thing we can do. Humility will build trust in those who believe (sometimes accurately) that we are not telling the whole story. Humility might resonate with those parents who genuinely want to do right by their children but have not been convinced by “the facts.””

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  • cia parker

    Among girls, the HPV vaccine has proven to be quite dangerous. The VAERS in the U.S. has received over 10,000 reports on adverse events caused by it, over 900 deaths, over 800 cases of paralysis, and thousands of trips to the emergency room. Girls like Zeda Pingel within weeks of the vaccine became unable to walk or talk, and she is fed through a feeding tube and breathes through a tracheotomy. She had been a teen-aged cheerleader and honor roll student. The vaccine was pulled in Spain and India when it killed girls there. Many previously healthy girls have died of a heart attack shortly after getting the vaccine.

    It is unconscionable to drag boys into this tragedy in order to promote gender equality. It would, of course, greatly increase revenue for the pharmaceutical companies.

    Ed: Again, while alarming, isolated horror stories are not the best way to judge overall safety of vaccines. We need to look at peer-reviewed studies; VAERS is self-reported and not as reliable.

  • Dan Kegel

    Yeah, humility is good, nobody likes to be preached to from on high.

    I feel bad about my earlier reply – it was full of facts and references, but it missed the simple story:

    If you read the study closely, the vaccine works great as long as you give it to women who are not infected by HPV yet, and who don’t have cancer yet.
    So there’s nothing new here – as long as we vaccinate girls as planned, it should be effective.


  • Jen Farrah

    Thankyou for the honesty re. the in- efficacy of this shot for boys. I wish Discover would advocate as well for the safety of this vaccine for any child. It does seem to have more serious adverse events associated with it than other shots given to similar aged children. I am very glad to have not given it to my 17 year old girl. I had severe dysplasia and paps do their job.

  • Gaythia

    I think we need to figure out how to give the public better mechanisms to sensibly analyze these things.

    VAERS is a necessary tool that allows medical professionals to compile reports of things that might be relevant if they turn out to have statistical significance when they occur after a vaccination. See: Thus, it is important that parents and doctors report anything and everything that they can think of. Which makes the process hard not to be worrisome. In some ways VAERS itself is the result of us having only a partial medical communication strategy. Because, if we had a statistical data base that included all medical treatments at a given age, and not just self initiated reports after vaccinations, it would be much easier to separate vaccination data from random effects.

    But I do think that the way to appeal to the sensibilities of average members of the public is to deal with them as if their questions and concerns are worthy of discussion. Certainly Pediatricians are sick of hearing about autism, for example. But to new parents, the question is new, fresh and deserving of answers. Our rushed medical care system needs better communication strategies.

    In my opinion, it has been highly counterproductive to draw hard lines in which anyone who raises question about existing vaccination priorities or effects is lumped in with antivaxx extremists. If someone feels that they are not being given straightforward answers and individual attention, they are much less likely to comply with medical protocols.

  • Jeff C

    The article is informed, states facts, and stays on topic. There are legitimate question regarding the Gardasil’s effectiveness and safety. There are also legitimate conflict of interest questions. The NIH developed the virus-like particle technology used in the vaccine and profits from the vaccine’s success, yet the NIH-linked CDC added the vaccine to the pediatric schedule. Merck has lobbied furiously to enact Gardasil state mandates for school admission despite the total inability to spread HPV through casual contact. Top it off with Merck’s indemnification from vaccine adverse reaction liability due the National Vaccine Injury Compensation Act of 1986.

    Yet mentioning any of the points sets off howls of indignation. Even broaching the subject is labeled as irresponsible, dangerous, and “disappointing”. Some things just aren’t allowed to discuss in polite society, vaccine safety and the need for 48 vaccines doses before kindergarten (per the 2011 CDC schedule) are at the top of the list. By the way, if you were born in 1983, that number was only 22 doses. If you were born in the sixties, it was only twelve before kindergarten. Ask yourself, with all these additional vaccines, are kids healthier today?

    To those pushing the explosive growth of the vaccine schedule: They are our kids, not yours. We will decide what is injected into their bodies, not you. We are not “anti-vaccine nuts” but we are anti-schedule. Vaccination is an invasive medical procedure with both risks and benefits, thus requiring informed consent. The decision is our, not yours.

  • NonyMous

    Jeanne Lenzer, you are an angel for writing this article. Thank you so much for doing some actual investigative work rather than regurgitating the junk science, bought and paid for by the vaccine industry, spouted as medical dogma by everyone else in the media. The serious side effects of this particular vaccine are being denied by an industry that wishes to force these vaccines on every possible boy and girl in this nation. Some vaccinees are suffering seizures and juvenile ALS-like symptoms. This is not right.

  • dyson

    @Dan Kegel.

    You’ve hit the nail on the head.
    That is the crucial element that is missing from this flawed analysis by Lenzer.

  • dyson

    @Cia Parker#18.
    VAERS reports are not reliable indicators.

    There have been analyses of the VAERS data, and of 34 confirmed deaths that were reported following 40 million doses of Gardasil, “there was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine and some reports indicated a cause of death unrelated to vaccination.”

    Most deaths are coincidental. Young people die, all the time, and it is tempting to link deaths to some prior event, but usually this will be entirely coincidental.

  • dyson

    @ Gaythia Weis #15

    I get your drift. Because the vaccine won’t prevent 100% of cancers, it’s better to do nothing.

  • toni

    there have been more than 34 deaths post vaccine in this country alone. and young girls dont typically just drop dead.
    we have seen cases of SIDS with specific vaccinations. look up WYETH SIDS DPT. and you’ll find SIDS related to dpt and internal memos at Wyeth to the vaccine division to spread the different lots around the country to avoid the obvious connection.
    the vaccine infers such short term immunity that to risk a vaccine in children years before they are sexually active is inane.

  • Gaythia Weis

    @Dyson, No! I actually am a vaccination supporter, however, I think that our policy analysis and communication techniques are flawed, and that the focus on jousting with antivaxx extremists has sometimes caused a misdirection of resources.

    In the case of whooping cough, states like California and Texas are now having great success with a strategy that attempts to create a “cocoon of safety” around newborn infants. Because, as it turns out, parents and other adult caregivers who were either never vaccinated, or who are now in need of a booster, are the main threats to too young to vaccinate infants, not some anti-vaxxers kid down the street. Although, childhood vaccination programs are also necessary, I think we wasted precious time getting to the place where we could actually analyze real issues in real places like California’s Central Valley.

    A large amount of our problems are not due to standard middle class situations. Hepatitis B is another case in point. Focusing on programs that attempt to reach adult populations can have the greatest public health effect. See for example: “While not yet approved by the U.S. Food and Drug Administration, these studies show increasing acceptance and use of antivirals to break the cycle of mother-to-child infection, which causes the majority of chronic HBV infections worldwide.”

    I think that others interested in vaccination programs could learn from our experience here in Larimer County, Colorado, that I mentioned above, where now have ongoing, privately held fundraisers to support meningitis vaccination programs. This started with a ‘reverse psychology’ push from a local public health department that initially argued that vaccination (in the face of local deaths) was not a cost effective approach.

    I believe that this demonstrates that while members of the general public may question individual instances of vaccination policy implementation, there is a rather large reservoir of support for the science of vaccination.

    That is why, in the case of HPV vaccine, I think that we need to have real conversations about the issues raised. Adult females of my age have some sort of internal balancing act going on in which either some forms of HPV have helped us establish a natural immunity, or else those forms or other forms may be in the process of leading to cervical cancer. Hence the need for annual pap smears.

    What happens to overall herd immunity towards forms that cause cancer if the HPV vaccination changes the population distribution of various HPV forms? Are we really targeting HPV forms that will, over time, decrease carcinogenesis and enhance immunity? The reference I cited above and others such as this JAMA article indicate that there is still room for a more complete cost/benefit analysis. Such discussion might actually lead to an expansion of vaccination targets. Would a change in exposure potentials indicate that immunization might be useful to consider at older ages? If we can’t target HPV overall, do we need to look at developing booster vaccines that help cope with shifts in the HPV population distribution?

    As public health policy, are we over-emphasizing (and funding) vaccination at the expense of access to Pap smears? How long does immunity last? What happens when immunized young adults start losing their immunity? Our current vaccination policy, targeted at reaching children before pretty much any of them become sexually active, could lead to a large group of young adults whose vaccination induced immunity is wearing off right about the time they do become sexually active. At the same time there is increasing pressure to push back the first age at which Pap smears are preformed, and also increasing the time intervals between pap smears.

    Then what happens? Less cervical cancer cases or more?

  • cia parker

    To Gaythia:

    Pediatricians are sick of hearing parents ask questions about autism? It’s respectful to answer their questions as though they were good ones? The parents are asking because it’s obvious to everyone with no financial stakes in the matter, only children that they love, that the vaccines stand an excellent chance of damaging their child for life, with autism, ADHD, asthma, bowel disease, diabetes, or food allergies, all signs of an immune system reacting to strange antigens showing up in its territory by way of vaccines, and skewed to an auto-immune reaction thereby.

    Pediatricians are sick of fielding queries about the devastating, lifelong damage they are themselves inflicting?

    Parents must read about the HPV vaccine very carefully before deciding to get it for their child. If their child is the one paralyzed or killed by it, then in retrospect the Pap test and ways of avoiding disease by safe sex or moderation in sex, and avoiding habits like smoking, will seem like sensible measures far preferable to a vaccine that is very reactive and dangerous. The dozens of other serotypes of HPV are already expanding to fill the gap left by the two cancer-causing serotypes that are in the vaccines, which may well mean that the danger of accepting the vaccine was incurred fruitlessly.

    My daughter is autistic thanks to the hepatitis-B vaccine. I do not ever bore doctors by talking to them about their having ruined my daughter’s life, because I know they have nothing at all of any value to tell me, and I’d rather not waste my time by dealing with them at all, ever.

  • raz

    @ dyson

    What % of cancers will the vaccine prevent?

  • dyson

    The vaccine should prevent infection with subtypes 16 and 18 HPV, which cause around 70% of cervical cancers.

    However, they also generate cross protective immunity against subtypes 31, 33, 45, and 51, so the vaccine might provide a broader range of protection than first thought.

  • raz

    @ dyson

    I wasn’t asking what % of cancers the vaccine SHOULD or MIGHT prevent according to
    GlaxoSmithKline Biologicals..

  • Perry

    Every person, male or female should be vaccinate against HPV. Apparently, I picked HPV from the birth canal when I was born. I have had about 30 procedures to remove the infestation sites from my eye lids and my penis, after I had managed to pass it on to my wife who had a much worse time of having it removed. Please all get of your high horses and realize there is much more danger from NOT a vaccine than having it.
    Remember polio, smallpox, rubella, mumps, and numerous other disease that have made our forebears life miserable. HPV is a growth disease, and needs to nipped in the bud, preferably before the virus gets tougher and more mean, as it will…
    Vaccinate now. My three children (both sexes have lined up and had it).

  • Gaythia

    It is my understanding that the forms of HPV which are likely to cause warts are generally considered to be “low risk” when it comes to cervical cancer, and thus are not the focus of the vaccine.

  • sam

    First, I don’t understand how you cut 98% down to 44%. If half of the people participating in the study don’t take the drug properly then they shouldn’t be included in the study. You certainly don’t keep them in the denominator of the effectiveness quotient. Did you intend to say that of the remaining participants the drug was 44% effective?? The relevant comparison is with some kind of control sample in any case.

    Second, when you say that the vaccine only affects 2 cancerous strains you drop that number to 17%; so more than half of cancerous HPV strains are not defended against (modulo prevalence)? And when you continue saying that “most” abnormalities precented are not pre-cancerous are you double-counting the drop from 44% to 17%?

    I appreciate your work, but these differences amount to a factor of 4 change in how I interpret your results, so it would be really nice to get a response. Thanks!

  • dyson

    You didn’t ask how many cancers has it prevented, but what percentage of cancers WILL the HPV vaccine prevent. That is a future tense question.

    So that’s a bit like asking how many 4 foot tall kids will not reach expected adult height if you don’t feed them any protein in their diet. You need a bit of time to reach the definitive end point, but if you can show that after 5 years you stopped 90% of them growing from 4 foot to 4 foot 6 inches, you have pretty good evidence to demonstrate a lack of protein impairs growth.

    With HPV vaccine all we can presently do is see how many of the advanced pre-cancerous/carcinoma in situ lesions it will prevent. Give it another 5-10 years and the invasive advanced cancer stats will be in.

    This study below shows that in HPV-naive 15-25yr olds, the vaccine efficacy was 100% against the highest grade (adenocarcinoma in situ) at 4 years.

    Of course, you may wish to wait 15 years before you get sufficient evidence to convince yourself it is a good idea, but by then it will be too late for several generations of our children.

    You may also wish to rubbish this study because it was funded by pharma. In fact I know you will. But pharma are crucial partners in medical research, and if we didn’t use drugs that were developed with pharma trial funding we wouldn’t have life savers like ACE inhibitors, recombinant biologicals, clopidogrel, human insulin etc. I also hope you appreciate that this HPV study was carried out in many major academic centers of medical excellence, and that if you think the many hundreds of researchers of these analyses (which are independently scrutinized by data safety monitoring bodies who have nothing to do with pharma) are all in GSK’s pocket and are willing to lie about the results then you have another think coming.

  • dyson

    I don’t really understand Lenzer’s point either. Her figure of 44% efficacy comes from this section of the paper when it analyzed all recipients of the vaccine, whether infected with HPV or not at baseline:

    “Vaccine efficacy was 44%, with high-grade cervical disease related to HPV-16 or HPV-18 developing in 83 subjects in the vaccine group and 148 in the placebo group. Most of the cases (defined as consensus diagnoses) that were added to the first intention-to-treat analysis (98%), as compared with those in the unrestricted susceptible population, were high-grade cervical disease caused by HPV-16 or HPV-18 infection that was present before the first injection.”

    So the vaccine isn’t that good at preventing lesions in women who already have infection with HPV – Well knock me down with a feather.
    Next she’ll be saying smallpox vaccine isn’t any good because it doesn’t stop people who already have smallpox from dying.

    The results for women who were naive for the vaccine strains of HPV were quite astounding. Yes, so far it’s only the early stages of carcinoma, before it becomes invasive, but we owe it to a generation of our kids to offer that protection now, and not in 10 years time when it’s too late and they have already been infected.

  • SHP


    “It may seem counterintuitive, but embracing humility may be the best thing we can do. Humility will build trust in those who believe (sometimes accurately) that we are not telling the whole story. Humility might resonate with those parents who genuinely want to do right by their children but have not been convinced by “the facts.”

    But I do think that the way to appeal to the sensibilities of average members of the public is to deal with them as if their questions and concerns are worthy of discussion.”

    Gaythia, I want to say kudos on the calls for humility, but the notion that treating questions “as if” they are worthy of discussion makes me wonder – how can you be both humble and condescending at the same time? Is this my interpretation only? I hope so.

    I’m not a subject matter expert, but I’ve been knee deep in this discussion for over 15 years. The questions always have been, and will continue to be, worthy of discussion. And I have observed, as Jeff C said, that in many cases, even broaching the subject is regarded as irresponsible, dangerous, “disappointing”. Understanding the significance of this apparent failure of a large segment of the medical profession (the religious zeal when it comes to inoculations and the greater good, to the extent that basic human rights and informed consent simply get kicked to the curb) would be the most important step towards also understanding real humility.

    This thread and many others include interesting statistical details and discussion, and risk vs benefit – wonderful – yet at the end of the day, they all seem to get rolled up into a big club, used to hit those crazy antivax extremists over the head. Sometimes subtly. But he message is there. I’m not sure you need a more effective communications strategy, and I don’t need you to humor me. I think what you need is to genuinely respect me and my questions and my right to informed consent, to the same extent that you expect me to respect you and your expertise / advice. You get what you give. I am free to take it or leave it. You give me compliance orders, I give you the appropriate response (insert graphic here – use your imagination). Please – no lectures on the risk to the herd – this is hypocrisy at best. We all do a thousand things every day that put others at risk, often when simple, non-invasive, zero risk alternatives are easily, readily available. Children in impoverished countries will die in the time it takes to write this post here. Any of us could change that for the price of a Starbucks. Most of us won’t. This is the herd in action. Got milk?

    Please – put the needles back in the same black bag with the other meds and interventions and carry on. Lose the “communication strategies”, fire the lobbyists, send the Merck reps home, and listen (more) to your patients.

  • raz


    First. The answer to my question is much more complex then you’re trying to suggest.

    Second. Tell us more about the notion of “conflict of interest”.

  • Amos Zeeberg (Discover Web Editor)

    Jeanne is currently working on a response that should answer many of the questions here about her post. Stay tuned.

  • Concerned Mom of Teens

    Thank you so much for publishing this article. I personally know of at least three girls who have suffered chronic neurological effects from receiving this vaccine, and whose doctors acknowledged that the vaccine was the cause. Please understand that I am not an anti-vaccine vigilante; far from it. This is quite a different sort of vaccine than those which prevent communicable and deadly childhood illnesses. In fact, I spent almost 14 years of my legal practice as a health care lawyer, and most of them at HHS. Many of my family members are physicians. What has concerned me most about this vaccine, is that parents are not being given adequate information about the potential downsides of it. Not because of a conspiracy among doctors of course, but because the primary care docs simply haven’t received much information about the negatives – all while their associations, the CDC and State governments are giving it a major push into widespread public use, even to the extent of requiring it for rising middle schoolers in some districts. There are at least a half dozen well respected, main stream physicians I know who have decided NOT to let their own young teen children have this vaccine, and who have even declined to offer it to their own patients. One of the concerns noted by three of them, is in regard to the epidemiological studies. The only criticism I would make, is of the editors casual dismissal of self-reported websites or responses, as being unreliable, compared to peer reviewed studies. While that’s generally true, one has to also realize that many of these families do so because they have no other avenue of reporting. When the numbers of negative responses are this high, and yet disregarded by the legislators, regulators and associations – something is indeed amiss. In other words, this is far from being “crap” as one of your uninformed early commenters said. Perhaps “Disgusted” and his/her ilk should spend less time engaging in juvenile verbiage, and more time researching the issue. Again, thank you for your excellent work, and reporting.

  • sigh

    sigh, this article is not well reasoned, do more research try again please.

  • dyson

    First. If you seek even more complex answers perhaps this is not the forum in which to seek them.
    Second. I take it that even with a transparent declaration of potential conflicts, and an independent assessment that such potential conflicts have been irrelevant to the research outcome, you will find this as sufficient reason to dismiss any research findings that are unacceptable to you?
    Third. For a relevant exposition of what comprises a genuine and relevant conflict of interest, look up the words “Andrew Wakefield”.

  • dyson

    Jeanne, if you are planning a further response, perhaps you could concentrate on exploring the efficacy of these vaccines in those who do not already have the infection. That is after all the target vaccination population.

  • rdiac

    As has been commented elsewhere about this article – Holy Cats! *grabs popcorn*
    I don’t see Jeanne getting out of this corner w/o much ontology or a ruckus!

  • raz

    Perhaps this is not the forum in which to disseminate simplistic answers.
    And, we’re not dealing with “potential” conflicts here, they’re quite real. Too many people on all levels have a financial reason to dismiss any research findings that are unacceptable to their sponsors.

  • dyson

    I take it you are accusing the scientists who conducted these studies of having financial reasons to dismiss research findings unacceptable to the funders of their research.

    That’s quite a claim. Let’s break it down. By the phrase “dismissing research findings unacceptable to their sponsors” you imply that they will not only dismiss their “true” findings, but of course they will have to substitute alternative “favorable” data, in other words deliberately falsify what their own research has found. That is transparent fraud. For that to occur, you need to have so many hundreds of people in on the conspiracy, and you must envisage that these researchers are willing to risk their entire future careers, just hoping against hope that none of their despicably unethical fellow conspirators entertain a change of heart and blows the whistle.

    You must also envisage that these research groups will have falsified their findings, but that this runs the risks of followup research uncovering their fraud. You see science wins out in the end, always. So even if the multilayered multiple conspiracy holds true, others could expose it at any time, through independent work or analysis.

    I don’t think you comprehend who is doing this research either – their careers are not dependent upon one pharma sponsor. Look at the dozens of institutions mentioned in the Appendix, would you, and the clinical and research centers they come from and positions they hold. Many hold high office in National Cancer Registries, or Epidemiology and Public Health. There are Professors from Johns Hopkins, Emory, Duke. Some authors are oncologists who presumably stand to make more money when there are MORE cases of cancer, rather than less.

    All quite implausible, I think any rational person would agree. I am sorry your arguments here seem to have degenerated to the level of whining: “Pharma shill!”. I’d far rather discuss the science. But then most antivaccine campaigners prefer the easy option.

  • dyson

    Jeanne, I also hope you read Tara Smith’s blog before you pen a new blog response here.

    I also Tara published Jerome Hoffman’s comments (see post 215 above) within the hour, and that she responded comprehensively to it.

  • Eleanor

    Argh, when did Discover Blogs start “teaching the controversy” on vaccinations?

  • raz

    Your problem is that you don’t (want to?) see the big picture. Try reading this:

  • Garbosmed

    What’s little discussed but should be are two very salient points.

    First, the adverse event rate for this vaccine is being calculated against number of doses shipped, rather than number of doses administered. What that means is that if the manufacturer ships two million doses, but only two are administered and both of those patients have adverse reactions, the true adverse event rate is 100% but it is being “officially” calculated as 1 in 1 million. If health officials think the vaccine has such a good safety profile, why the statistical charade?

    Second, in the original clinical trials for Gardasil it was found that the vaccine had a NEGATIVE efficacy of over 44% in women who had already been exposed to the strains of HPV found in the vaccine. That means they had 44% higher risk of developing cervical abnormalities. (See the FDA meeting document here: ). Public health officials “solved” this problem by mandating the vaccine for younger children before they become sexually active, despite the vaccine not being adequately studied in that population and ignoring evidence that HPV can be transmitted maternally and those children may already have been exposed despite never having sex. Currently there is NO HPV testing mandated before vaccination. This is a ridiculous risk that should be mitigated but it won’t be due to cost and the confusion is might create over the relative benefits (or lack thereof) of this vaccine. It’s no wonder the public has lost trust over this issue.

  • dyson

    Neat dodge.

    Now you are confusing your uncorroborated attempts to smear the authors of this HPV vaccine study under discussion with accusations of fraud with the “bigger picture” of vaccination policy, funding, marketing, politics and ethics.

    There is a lot to say about these, much of it contentious and some of it bad, but nothing which detracts from the efficacy of the vaccine. If you wish to broaden the debate into these multiple areas, feel free, but I’d rather stick to the subject under discussion than see people introducing straw men into the debate.

  • raz


    As a matter of fact, “there is, as yet, no direct scientific proof of the effect of the vaccine on morbidity and mortality, and it will take significant time and resources to obtain such evidence.”

    All the rest is vaccination policy, funding, marketing, politics and ethics.

  • Hemlock

    “This is however not the case as one comprehensive review on CIN shows. It was found in this review that the likelihood of CIN2+ progressing to invasion is only 5%.2 In other words 95% of the time CIN2+ remains harmless in the woman it is found.”

    2 Andrew G. Ostor, International Journal of Gynecological Pathology 12, 186 (1993).

    Sounds rather authoritative, but is an cherry picked quote that misrepresents what the study said by substituting in higher grade lesions in for the figures found by the author for CIN1. As Ostor noted himself, testing can become treatment as biopsies can alter the course of events either by obliterating a very small lesion or causing an inflammatory response and also that it’s impossible to predict whether a lesion will progress or regress just from looking at it. It’s very likely these figures are an underestimate, as other studies in the 1950-60’s into Carcinoma in Situ and it’s progression to cancer found this happened at least 30% of the time (studies ranged in length from 1-23 years). At least a third of women having the condition become invasive cancer is significant, and it’s simply wrong to suggest that progression is so rare that you can ignore the whole thing. Ostor’s study stopped at CIN3 as it’s unethical to sit there and watch study participants develop cancer just so you know how often it happens, particularly when the condition is very treatable at an earlier stage. Actually, that’s the same for the vaccine and for – using the endpoint of high grade lesion is sufficient, given you know a significant number will go on to develop cancer. Early prevention/treatment whether with a vaccine or a smear to detect the lesion earlier saves a lot of morbidity and mortality down the track.

    Here’s what the author says: “The literature dealing with the natural history of cervical intraepithelial neoplasia (CIN) since 1950 is reviewed, in particular from the viewpoint of regression, persistence, and progression. When stratified into the various grades of severity, the composite data indicate the approximate likelihood of regression of CIN 1 is 60%, persistence 30%, progression to CIN 3 10%, and progression to invasion 1%. The corresponding approximations for CIN 2 are 40%, 40%, 20%, and 5%, respectively. The likelihood of CIN 3 regressing is 33% and progressing to invasion greater than 12%. It is obvious from the above figures that the probability of an atypical epithelium becoming invasive increases with the severity of the atypia, but does not occur in every case. Even the higher degrees of atypia may regress in a significant proportion of cases. As morphology by itself does not predict which lesion will progress or regress, future efforts should seek factors other than morphological to determine the prognosis in individual patients.”

  • Halliday

    Let’s put this into context – I assume most of you responding are healthy or fairly healthy and one or two may have a similar experience in respect of what I am going to relate to you now.

    Now imagine yourself as a trusting 13 year old. You look at your mumm and she advises you that the HPV is safe. The medical professionals, the government and the manufacturers say so in their very sparse literature but clever marketed strategy. It’s going to save your life. You are not going to get Cervical Cancer if you take this vaccine. (SCARE TACTICS).

    So you are 13, you like sports, you play sports: football, cycling, tennis, basketball, bowling, dancing, jogging, mucking around, play fighting, walking, normal teenage stuff. You also don’t want to die of Cervical Cancer. No one does.

    Then you get the shot. You are sick, dizzy, have a headache, sore arm. A month later (a relatively short space of time to notice a reaction), you get the second shot. Again you are sick, dizzy, have more headaches, your arm aches. The symptoms don’t go away. In fact they get worse. Your 13 you don’t feel like yourself, you don’t what’s wrong with your body, your not able to communicate to your parents that you feel different. You start feeling stiff, and get stiffer.

    Then you parents notice the expected side-effects have not gone away. You are acting oddly but you can’t tell them what is wrong beause you don’t know yourself.

    Then you find your body racked in pain, every muscle and joint aches. Your sick, you can’t eat, your tired. Your 13 lying in a sick bed. You can’t walk, you have no energy. You don’t go to school. You have string upon string of unexplained illnesses that the doctors can’t fix. The very people the leaflet says to go to if you suffer a side-effect – they can’t fix you.

    You are 13 and you are scared. What’s happening mummy?

  • Shawn Siegel

    The editor has several times recommended caution in considering anecdotes and VAERS reports of adverse HPV vaccine reactions. Parental anecdotes are also eye-witness accounts, and certainly should not be routinely discounted; the simple fact is, if the vaccine left terrible consequences in its wake for even one girl, it certainly can damage others, and medical science has no way of predicting who will react adversely. The editor also states that VAERS reports (in the U.S.) are not as reliable as peer-reviewed studies, but this article addresses Merck’s own clinical studies, going beyond peer-reviewed studies. If the author’s statements regarding Merck’s own findings are correct – a rote matter of fact, not opinion – than Gardasil has, in essence, zero effectiveness. The editor says, as well, that VAERS is self-reported – it is not. While VAERS reports can come from parents, most of them come from doctors. Moreover, even the Journal of the American Medical Association (JAMA) has cited studies concluding that only 1% of serious reactions ever get reported. VAERS currently reflects 71 deaths associated with HPV vaccines, and almost 10,000 serious reactions. We have no way of knowing what are the real figures. In the vaccine world, safety is determined by weighing the ostensible benefits against the risks, but if the record of adverse reactions – that is, the actual indication of risk – is egregiously incomplete, risk is literally an unknown quantity.

  • Lana

    Why are we spending so much time and effort on something that “may” prevent a disease that in the US accounts for .001 of the annual deaths? To me, vaccines are important for prevention of fatal conditions…but many of them that are given here are not actually preventing death, rather preventing missed work days among parents, and potentially creating other, more serious, conditions. Where are our priorities?

  • raz


    I just came across the words “Andrew Wakefield” in this Editorial:

  • STAR

    Lana, you make a very good point. It is certain that with the money to administer all those vaccines they could teach kids to eat vegetables in school and give them more exercise initiatives saving many many lives…

  • justamom

    @Gaythia Weis
    What happens when immunized young adults start losing their immunity? Our current vaccination policy, targeted at reaching children before pretty much any of them become sexually active, could lead to a large group of young adults whose vaccination induced immunity is wearing off right about the time they do become sexually active. At the same time there is increasing pressure to push back the first age at which Pap smears are preformed, and also increasing the time intervals between pap smears.
    Then what happens? Less cervical cancer cases or more?

    Can anyone who supports the Gardasil vaccine speak to this issue? I have been looking in vain for answers while trying to decide whether to have my 13 year old vaccinated. Her pediatrician has been recommending it for 3 years already and I have held off primarily because my daughter is terrified of shots and I felt confident that I wasn’t anywhere close to her being sexually active. I am as concerned about the possible need for booster shots when she reaches the age of 21 when she is more likely to be sexually active than throughout the next 7 years as well as currently needing 3 rounds of shots now. I am also concerned about more aggressive and immune resistant forms of the virus as well as substitution of other forms of HPV as the agents of cervical cancer. Do we have real world data about the effectiveness of the vaccine since it was introduced? Shouldn’t the initial vaccinated populations be in their early to mid-20’s by now?

  • giddypony

    Pap smears do not prevent cancer. Nor cancer deaths – early detection might but wouldn’t be better to not get it at all?

    I recently lost a male friend to oral cancer caused by HPV – you didn’t address that at all


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