Tuesday, November 10, 2015

Guard Against Gardasil: The Critical Mom's Research

If you are the mother of a nine-to-twelve year old girl, your pediatrician is sure to recommend the Gardasil or the Cervarix shot for HPV--human papillomavirus, otherwise known as the cause of genital warts, a condition that can (but does not usually) lead to deadly cervical cancers. The only surefire way to avoid HPV, which the vast majority of the population has, or will have, is never to touch another person's genitals. 
But the alternative to these infections--there are many types of HPV, and in most cases they clear up by themselves--is the shot.  Is the shot safe?

When I Googled the virus and the vaccines, the name Diane Medved Harper appeared repeatedly, because Dr. Harper, now at the University of Louisville, was one of the physicians employed by Merck to evaluate the vaccine and to run clinical trials. You can read about her here and here.

But I decided to write to her myself, and she very kindly wrote back, and since she had no objection to my sharing our correspondence of November 5, 2015 with my pediatrician, I am also sharing it with my readers.

The Critical Mom: How wise is it to give a vaccine for a condition that may never develop? (If I am correct in assuming that only 10% of infected people develop cancer, that is).

Dr. Harper: Only 5% of infections develop CIN 3 lesions (precancer).  Of the CIN 3 lesions, only 20% become cancer within 5 years, and only 40% become cancer within 30 years -- so less than 1% of HPV infections become cancer after a very long period of time.   How wise it is is a judgement that only you can make:  it weighs the knowledge that you have a screening system in place to detect the CIN 3 precancer and then treat it. Our treatments are nearly 100% effective (LLETZ, usually).  HPV4 or HPV9 only protect against about 47% of the CIN 3 lesions regardless of HPV type;  HPV2 protects against 93% of CIN 3 lesions regardless of HPV type.  Neither prevents all CIN 3, so screening is still necessary.  HPV2 lasts at least 9.4 years.  HPV4 lasts at least 5 years.  HPV9 lasts at least 3.5 years. ​Screening has few side effects -- the worst side effect is being told you were positive for HPV 16 and going to colposcopy and having a biopsy and having the results of the biopsy be normal. You can see the Gardasil Girls videos on the internet.​

The Critical Mom: Would you give your daughter this vaccine? (Side effects reported by parents on forums do seem worse than those reported for the standard childhood vaccinations).

Dr. Harper:  I would give her the option of choosing whether she wanted it -- but I would suggest that she wait until she was at least 16 years, and maybe even 18 years if she had not yet begun any interest in any sexual activity.​

The Critical Mom:  Isn't a yearly pap test enough after my daughter becomes sexually active? My kids know all about condoms and barrier protection and seem like responsible people. 

Dr. Harper: Yes, screening is enough.  And screening has moved to every 3-5 years depending on whether your doctor uses HPV genotyping as a screen.

The Critical Mom:  Is family history important? (We have no family history of uterine cancer--that is, my mother, my aunt, my grandmother, my husband's mother, never came down with it).

Dr. Harper:  No -- this is an infection that is transmitted by skin to skin contact -- not hereditary​.

The Critical Mom: Is it important, in making a decision, to note that more side effects for Gardasil appear to be reported on the Merck website than are listed for standard vaccines like those for polio and diphtheria?

Dr. Harper: I would think that you would want to consider all possible side effects. I would also think that you should want to know whether one vaccine offered better protection and fewer side effects.  In my opinion I believe that HPV2 is superior.​

The Critical Mom: On a related subject: Ana├»s Nin, the diarist, died of cancer of the vagina. As she detailed in her writings, she had sex four times a day with four different partners for a number of months.  A Gardasil vaccine might have been good for her--but when I read around on the net, and listen to some genuinely alarmist videos, like this and this, I wonder if the vaccine is predicated on the assumption that most girls will pursue sexual activity at the same rate that Nin did.

Dr. Harper: Yes, the adolescent pediatricians promoting the vaccine see only the segment of the adolescent population who indeed are having sex at Nin's frequency.  The vaccine may not have helped her as HPV infections causing vaginal cancer are not necessarily covered by HPV4 or HPV9.​
I am very glad to have Dr. Harper's opinions and for the time being have decided not have my daughter vaccinated. Folks with a history of cervical cancer in their families may well feel differently.  I have watched a number of videos of young women who claim that their health has been damaged by the vaccine--Gardasil girl videos referred to by Dr. Harper above; I've also read and seen video accounts that discredit the girls, or that claim no distinct pattern has emerged explaining the girls' idiosyncratic reactions: the implication is that the girls who got sick were already sick, or that their reactions are too rare and unusual to worry about.

So far, I don't agree.  I've decided to continue questioning experts--I've sent an email to Dr. Marcia Angell, the professor of medicine at Harvard who was the first woman editor of the New England Journal of Medicine. Haven't heard from her yet, but hey--how many experts are going to get around to writing some obscure mom?

That is why I appreciate Dr. Harper's response--and, should you read this, Dr. Harper, know that I did forward your remarks to my pediatrician, who thanked me, then insisted that the vaccine offered significant protections, that his thirteen-year-old daughter had already had the first shot, that his wife is a gynecologist who approved it. When I asked him why a pap smear wasn't enough, he rolled his eyes. When I asked if he'd seen any of the Gardasil girls videos, he smiled and said, "Not yet."  He told me his daughter had been vaccinated. But that's not what I need to know. I need to know what percent of women are afflicted by cervical cancer, what kinds of screenings exist, and how to assess the side effects when the mothers and the medical authorities appear to differ. So, Moms, do your own research.  Since the manufacturer of the vaccine, Merck, lists significant side effects on its website, I will wait.  Compare that Merck page to the ones for polio and other standard childhood vaccines.
Personally, I'd wait on a vaccine about which so many side effects including death, continue to be reported.


  1. Thank you for this questionaire.Our oldest daughter will turn 9 next year and I already talked to a few collegues of mine about the vaccine and if my daughter should have it. None of them had their daughters vaccinated. There are cases of cervical cancer in my husbands family and in mine, so my sister in law told me that was her reason to get her daughter the shot. Reading your blog just showed me, how misinformed she was. So thank you again!!
    by the way...are you heading south for/at/around christmas?

  2. Hi, Three-Brats-Mom! We probably aren't, alas, because--see previous post--the eleven-year-old has to perform in the Nutcracker on Christmas Day! But we hope maybe after that day . . . will be in touch! About the vaccine: I just think all mothers should do their own thinking, their own research--talk to any expert whom you respect.

  3. You might want to talk to someone who treats gynaecological cancers, if you're interviewing experts. Early stage treatment isn't without risk - a woman in my home town recently suffered severe internal burns when they uses the wrong strength acid for her colposcopy. It seems logical to me to put the fence at the top of the cliff than talk about how great the ambulance is at the bottom.

  4. I'm thinking of numbers. If the fence at the top of the cliff causes irreversible damage in a few girls, I don't want my daughter to be one of those girls--especially if gynecological cancer is relatively rare. But I take your point, and I will try to find someone who treats gynaecological cancers.

  5. Thank you for this fair and informative post about the HPV vaccines.

  6. You're welcome. I'm hoping to hear from doctors. Actually, I just wrote to the man who developed the vaccine, Dr. Ian Frazer, who can be seen discussing why the vaccine is particularly good for developing countries, where no screening for gynecological cancers is available.
    I wish to be able to assess how great the risk is for girls in developed countries, where plenty of screening is available.

  7. "If the fence at the top of the cliff causes irreversible damage in a few girls"

    Where are you getting your information about that from? It's a popular theory in antivax circles, but the overwhelming scientific consensus is that there are no serious side effects beyond what you'd expect for any vaccine in that age group:



  8. Dear Trouble,
    Look, I'm going to check every one of these links. But a layman has to ask: why do physicians who were involved in the clinical trials of these vaccines, and why do other prominent medical researchers, have serious reservations? Have you seen the One More GIrl gardasil documentary film? These researchers who know medicine have gone to the trouble to speak at length about their reservations. They must feel strongly enough to potentially damage their careers when they do so. Are they all nuts? Are they all alarmist? How can I, a layman, possibly know? They do not appear to me to be crazy people. While I know nothing of medicine, I do know something about the history of medicine--I know, for example, how Semmelweiss's views on hand washing were rejected, even though mortality of mothers in childbirth was reduced to 1%. Even though medicine has advanced considerably since Semmelweiss, people are still the same--and someone like me is left weighing the wish to trust her pediatrician with the knowledge that he seems a conservative type, not likely to do other than trust any professional journal he reads. The fact remains that a number of young women who got the vaccine seem to have had adverse reactions. The New York Times article of a few days ago says there's no pattern to these reactions--but maybe the pattern has not yet been discerned. Do you know anything about a study of autoimmune responses to the vaccine?

  9. Dear Trouble,
    Let me trouble you again: The nih link you sent includes this statement:
    "In particular, no increased risk of autoimmune disease has been shown among HPV-vaccinated subjects in long-term observation studies."
    What are these studies? Who did them?
    My children have all the usual vaccines--I'm not some antivax nutcase nor do I cotton to Sarah Palin's views. But I do pay attention when I see many videos of young women saying they feel very sick after they got this shot. I'm sure all this could be mass hysteria but at the moment I do not have the impression that it is. Now, back to your links.

  10. More trouble: I am pasting in this link so that all readers may see a medical overview about the vaccine's supposed safety: http://www.who.int/vaccine_safety/committee/topics/hpv/GACVS_Statement_HPV_12_Mar_2014.pdf

    And here are more of my nagging questions: why do we need a vaccine for an infection that typically clears up spontaneously? Is it not better for the body to clear its own infections? If a very tiny percentage of girls and women, 1% or less, cannot clear these infections and develop cancer, should the entire population be vaccinated?

  11. My daughter got this vaccination at age 18 and had no side effects. It worries me to see so many people fearful of getting vaccinations that will *protect them* not infect them. We are losing herd immunity because the herd thinks any vaccination is suspicious, as if all doctors were participating in the Tuscaloosa syphilis scandal rather than doing their best to help their patients. I disagree with you here, C.M.

    1. Dear Agatha,
      And others--I'd like to hear more, both from those who feel "if your child is vaccinated, then you are the herd," and those who feel differently.
      My hunch is still that there is something different about the HPV vaccines:
      (1) some versions of the vaccines appear to be safer than others.
      (2) What the medical authorities--the CDC and the European Medical Society--say differs from what some mothers say. Extremely. This is not true of most other vaccines.
      When I read the CDC and Merck websites about the polio vaccine, and all the other childhood vaccines my children had, I don't see a number of warnings about side effects. Relatively few reactions are reported about these typical childhood vaccinations, which I believe all children should have as protection.
      The story continues to be different about the HPV vaccines. I'd like to know more. Pediatricians, researchers, mothers, please do weigh in!

  12. My daughter got this vaccination at age 18 and had no side effects. It worries me to see so many people fearful of getting vaccinations that will *protect them* not infect them. We are losing herd immunity because the herd thinks any vaccination is suspicious, as if all doctors were participating in the Tuscaloosa syphilis scandal rather than doing their best to help their patients. I disagree with you here, C.M.

  13. I'm hardly the herd--my children have all the usual vaccines. This one is different, because the reported side effects have not been dismissed by several chief researchers who worked on its development, like Dr. Diane Harper. Dr. Ian Frazer, who originated the vaccine, has just returned my email and agrees with most of what Dr. Harper said, above. My questions continue to be: Does this vaccine protect, even if the girl has no side effects? Under normal conditions, 80-90% of the population acquires the virus occasionally capable of developing into cancer. What Merck doesn't advertise is that all but around 5% of these infections go away without any treatment. Only 1% of these infected people get the deadly cancers. Pap tests once a year are better than pap tests every two or three years if you want to avoid vaccinations or cancer. Since the HPV virus is--unlike polio, diphtheria, measles, mumps, rubella--something that the body can fight, is it really wise to remove the body's ability to fight it? Dr. Harper does not dismiss the reported adverse effects as mass hysteria. Let's wait and see what happens in the next few years.

    1. If your child is vaccinated, then you ARE the herd. Herd immunity.

    2. If your child is vaccinated, then you ARE the herd. Herd immunity.

  14. The pages I linked to have a reference section at the bottom that lists the studies they refer to.

    My understanding of Diane Harper's public comments about Gardasil is that she's more wary of what it adds to people's protection within the current screening framework, than of its side effects. The researchers getting media attention for making claims about side effects aren't a representative sample of people working in the field, and what they don't have is large scale data to support their claims.

    Most people can fight measles, mumps and rubella - even polio is asymptomatic a lot of the time. Plenty of people live their lives without being aware they have hepatitis B. We vaccinate all the time against diseases that are a nuisance for many and serious for a few, because we don't know who those few will be, and none is always better than a few. Vaccinating doesn't remove your body's ability to fight it - it teaches your body to fight it without exposing you to the risk of getting the disease. Genital warts are a lot more common than cervical cancer - they're not deadly, but I wouldn't want them.

    I agree it will be interesting to see what happens in the next few years. There's debate on whether for younger teens two doses is as good as three, which would be great for everyone except the drug companies. Evidence of long term effectiveness is getting longer and longer. But the downside of waiting is that the people you care about will be moving towards the age at which they will be exposed to HPV, and it's no use at all to vaccinate after you've caught it.

  15. I'm afraid there's very little evidence for Dr. Harper's statement that "adolescent pediatricians promoting the vaccine see only the segment of the adolescent population who indeed are having sex at Nin's frequency (four times a day for months)"; quite the opposite!
    The question of whether vaccinated girls have sex more often than unvaccinated girls has been studied, and the answer seems to be that vaccinated and unvaccinated girls don't really differ in their sexual behavior.
    See e.g. http://www.ncbi.nlm.nih.gov/pubmed/23071201, http://archinte.jamanetwork.com/article.aspx?articleid=2109856,
    http://jsn.sagepub.com/content/early/2014/01/10/1059840513520042.abstract, or
    So, no, pediatricians who recommend the vaccine aren't treating sluts!

    The sad fact is that the lifetime risk of cervical cancer is about one in 154; see
    It's not a theoretical risk.

    Since 99% of cervical cancer is indeed caused by HPV, the vaccine is highly effective at preventing high risk HPV infections, with at most one booster shot can protect girls until age 31 - after they're safely married off and no longer likely to pick up HPV.

    None of the above would matter much if the vaccine weren't safe, but as far as I can tell, studies show it's far safer than not getting vaccinated. (See e.g. http://www.ncbi.nlm.nih.gov/pubmed/23027469 and http://www.bmj.com/content/347/bmj.f5906 for two of the larger safety studies.)

    I didn't hesitate with my son; even though he's far from ready to date, we had him vaccinated at his 7th grade checkup.

    No offense to Dr. Harper, but perhaps she should check her facts again.

  16. I think I was missing an 'and' somewhere, sorry for the slight garble :-)

  17. No offense taken. I continue to be eager to hear all opinions--whether you're for or against the vaccine. Thank you all for reading the posts and responding.

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  19. Hello there and thank you for this blog. Mother of 5 here still sitting on the fence about HPV vaccination (my kids have received all other vaccinations so I'm not anti-vax). Like you, I am nervous about this particular vaccine and even more nervous about the new Gardasil 9 given it has twice the aluminum as Gardasil 4. Adverse events continue to be reported across the world (nearly 25% of all vaccine adverse effects reported through VAERS are from this vaccine alone) yet the vaccine is still in wide circulation and still heavily promoted. To this day, I don't understand why the placebo test in clinical trials for Gardasil 4 was an aluminum adjuvant and why for Gardasil 9 it was Gardasil 4. I'm not a scientist or a doctor but why wouldn't they use a completely inert saline placebo in both trials? The only conclusion I can draw is that they wanted to minimize the incidence of adverse reactions. And why was this vaccine rushed to market in the first place - cervical cancer is hardly an epidemic. So many unsettling questions about this vaccine. Every doctor I have spoken to continues to recommend HPV vaccination but when I question about adverse reactions they seem largely unaware of what has happened in other countries (Ireland, Japan, India, Spain, Denmark etc) and of course any reaction is always dismissed as purely coincidental and not caused by the vaccine. Curious if you've come across any new information regarding (1) duration of protection (Gardasil 4 has been out for nearly 12 years now so we should know if it is effective beyond 5 years); (2) adverse reactions including increase in autoimmune conditions, premature ovarian failure, paralysis, POTS, CFS etc; (3) Any insight/research on the gene-replacement theory that more virulent strains of non-vaccine HPV may (or has already started to) surface as a result of vaccination. I recently read that HPV may not even be the cause of cervical cancer in which case, if true (and I'm skeptical about this one), this vaccine will prove to be completely useless in cancer prevention and have only served to damage innocent girls and now boys. Have you had a change of heart about vaccinating your children since you first wrote about this? If so, what made you change your mind and which specific vaccine did you innoculate with (Gardasil 4, 9 or Cervarix). Diane Harper seems to prever Cervarix because I think it confers longer and stronger immunity to HPV 16 and 18. Any information you have would be greatly appreciated. I cannot sit on the fence forever and need to make a decision one way or the other and am frantically trying to sort this out. If you could also share what Ian Frazer said to you that would be greatly appreciated as well. Did you ask him if he would vaccinate his own children? Just curious.

    1. Dear Anonymous--I hope you saw my more recent post, just a few weeks ago! I did arrange for my daughter to have the Gardasil shot--because the gynecologist I trust said she'd seen no adverse events for the ten years she'd been giving the shot and also that this HPV epidemic is in young people--not people my age, people my daughter's age. I've included all that Ian Frazer said in the above interview--but go ahead and contact him yourself--just Google him and you should find him. My daughter has not experienced any side effects that I can see.

    2. Thank you for your quick reply! No I did not see your updated post so I apologize for asking a question you'd already answered. Do I assume correctly that you vaccinated with Gardasil 4 and not 9 since 9 is too new for your gynecologist to have 10 years experience with. I am leaning towards vaccinating but now not sure which of the vaccines to get. Ceravix, Gardasil 4 or 9. I am very happy to hear your daughter did not experience any ill side effects. Thank your again for sharing your thoughts. The weight of this decision keeps me up at night.

  20. We're in Germany, so the vaccine may be slightly different but I believe it was Ceravix. But everything I've read lately says this vaccine is safe, and that it particularly protects girls. I'm close to my daughter and believe she feels too young for any erotic involvement--and I've also told her it's far better to wait-- but at least now she is protected.

    1. Thank you. I believe Ceravix is the one Diane Harper prefers due to longer and stronger protection against HPV 16 and 18 specifically. We're in Canada and the new Gardasil9 is replacing Gardasil4. It offers protection against 9 HPV strains including 16 and 18 which both Ceravix and Gardasil4 also protect against. It is supposed to cover 90% of all HPV-related cancers (compared to 70% with the other 2 vaccines).
      Thank you again for responding to my comments. All the best to you and your daughter!

    2. Thanks! In the end, I guess it comes down to whom to trust. Always a tough call, but I think I made the right choice.