Friday, November 13, 2015

Gardasil Concerns, Part Two: A Conversation with Dr. Ian Hector Frazer, Developer of the HPV Vaccine

Dear Readers, I believe in going to the very top with the tough questions, so I wrote with no hope of an answer to the physician who developed the HPV vaccine, Dr. Ian Hector Frazer, Professor of Medicine, of the University of Queensland, Australia, and Chairman of the Board of the Translational Research Institute. He wrote back right away, answering my questions thoroughly. Here is our e-conversation of November 12, 2015:

The Critical Mom:  I write as a lay person trying to assess the risks of HPV vaccine for my
eleven year old daughter. I've already read the CDC page and the Merck pages, and of course discussed the vaccine with our pediatrician, who tells me his daughter has been vaccinated, but I can't ignore the reports of adverse reactions from a number of young women, even though the CDC seems to think there's no pattern to them and that they therefore remain insignificant. I also wonder why, when only 1% of women in the developed world are affected, I'd want to assume that my daughter is at risk.

I pasted in my blog post of November 10, 2015 with the remarks of Dr. Diane Harper. 
Dr. Frazer: Most of what Dr Harper writes in response to your questions is true.  However,  unfortunately,  12,000 women continue to die of cervical cancer in the USA each year where PAP smear screening is supposedly routine. 

While only 1% of women infected with HPV will develop cervical cancer, more than half of all sexually active woman (even those in a monogamous relationship with only one partner ever) will become infected with a cancer causing HPV virus.  PAP screening is not a perfect test, (50% of precancers are missed  on any one PAP sampling) and it therefore only works to reduce the risk of cervical cancer  if a pap is done regular every 2-3 years - even then, some women have disease that progresses from undetectable to invasive cancer within 2 years.

In Australia where about 80% of girls have been vaccinated over the last 10 years there  has been a dramatic reduction in abnormal pap smears (yes we still do them,  because Gardasil 4 only prevents about 70% of cervical cancers - those due to HPV16 and HPV18 - this will be less of an issue with Gardasil 9 which covers over 90%).  
However from next year we’re  going to test for the viruses that cause cervical cancer, rather than looking for cancer cells, and testing will be done less   frequently because the virus test catches cancer causing infections earlier than the pap smear test.   

The HPV vaccines have proven safe - the US and European regulatory authorities have stated that there are no long term problems attributable to the vaccine - just sore arms for a day or two in a small number of girls and boys, and a 1 in a million chance of an allergic reaction (that's the same odds as for all the other vaccines your daughter would be likely to have had as a baby).  
See for example this recent report from Europe that two diseases that have been said to be associated with the vaccine are not.

Another incentive to vaccinate is prevention of genital warts, not lethal, but common, difficult to treat, and can be passed from mother to baby to cause a rare but distressing and sometimes lethal disease in the child. 

In Australia genital warts and abnormal pap smears in young women  are now occurring at less than 10% of the rate that was observed prior to the introduction of routine vaccination of girls in 2007 – modelling predicts that with universal vaccination the infection will eventually be eradicated from the community altogether (maybe in 50 years).
In the meantime, personal protection through vaccination is effective at reducing the risk of cancer, and safe.   

It's also worth pointing out that  the studies in Australia have shown the greatest benefit has been in girls vaccinated at age 12 – those vaccinated at age 14 or older have had significantly less reduction in disease.  The most likely reason for this is that by age 14 a significant number of girls have had contact with the papillomavirus (contact does not need to be penetrative sexual intercourse – other forms of genital contact are sufficient to spread the virus).   The median (average) age of first sexual contact for girls  in most countries in the developed world is between 14 and  15. 

The Critical Mom:  I have a pap smear every year--actually my doctor recommends every year. Why isn't a yearly pap test enough? You mentioned "every 2-3 years."

Dr. Frazer: The recommendation in Australia is that unless you have had an abnormal pap in the past you should have the test every two years.  In Australia this strategy works as Gabrielle Medley did a chase back on all women over a period of years who had developed cervical cancer in Australia, and found that each of  the women who had had cervical cancer had not had smears according to the schedule, or had had the smear but had had no treatment for an abnormal one. . I.e the women who followed the pap smear schedule and had treatment for an abnormal smear when it was found did not get cancer.  Unfortunately like the US we still have deaths from cervical cancer because only 50% of women follow the PAP smear protocol. 

The Critical Mom: If so very few women develop dangerous cancers when so many are infected, and when so many infections seem to clear by themselves, how wise can it be it to vaccinate when the person might never be in danger to begin with?

Dr. Frazer: No one has died as a result of the vaccine (with 80 million women immunised world wide), whereas 12,000 women die of cervical cancer each year in the US and 250,000 worldwide, and 70% of those deaths would be avoided by prior vaccination.   So I’d suggest that the risk without vaccination is much greater that any perceived risk with vaccination. 

The Critical Mom: The vaccination is said to be painful. Is that not in itself possibly a bad sign?

Dr. Frazer: Its a sign that your immune system is reacting to the vaccine – your immune system needs a kick start to make a new immune response, and the sore arm is the physical manifestation of the kick start that the vaccine gives. This occurs with all vaccines. However, we don’t remember the pain of a vaccine that was given when we were 2 years old (fortunately)!

If you doubt the virtues of vaccination, you might want to  look at a graveyard that was in use in the 19th century and count the number of children under 10 who died of infectious diseases that we now vaccinate against like measles, chickenpox, diphtheria, tetanus, whooping cough. 

This gives me plenty to think about. Point by point:

Girls, get your pap test! Every year! Here in Northwestern Germany, my gynecologist recommends a yearly exam and pap smear.

No one has died as a result of the vaccine (with 80 million women immunised world wide)
 • According to a group known as the National Vaccine Information Center--whose beliefs are generally rejected by the medical profession--deaths have occurred as a reaction to the vaccine. Wikipedia identifies the group as a "public charity" and an "anti-vaccination advocacy group."
Be aware, readers, that by quoting their opinions I'm giving equal time  to the highly respected Dr. Frazer and to a group that is considered by many physicians to be the lunatic fringe. This group disputes not just the HPV vaccine but many vaccines; some doctors associated with them are against all vaccines. Some believe in a different vaccine schedule.

I don't buy the idea that all vaccines are bad and I would not need a visit to a 19th-century graveyard to convince me that many children died of diseases now prevented by the standard childhood vaccines. 

 The website publishes the claim that the following girls and women died or were disabled after receiving an HPV vaccine: 

Even if I remain uncertain about the reality behind these stories, I'm still bothered by two things: 
(1) The rate of reported  adverse reactions to HPV vaccines seems higher than the rate of reported adverse reactions to any other vaccine.

(2) Why should there be "a pattern" to reactions in order to consider them legitimately reactions to the vaccine?  You can go on the discussion of the vaccine and find an explanation, the gist of which is: a man gets a vaccine, happens to hit his vaccinated arm with a hammer the same day, and complains of an adverse reaction in that arm.

If only it were that simple. Are all these reactions really something that science can measure? To say yes means to assume that there must be a pattern to a reaction. 

Doctors and concerned citizens, continue to weigh in. I'm a tough customer. Before I consider this vaccine for my daughter, I'm going to be damn sure I think she'll be helped, not hindered, by it. 


  1. Boy, I sure wish the vaccine had been around in my day. I contracted HPV in college and had to have many, MANY years of awful treatments (freezing, topical chemotherapy, biopsies) for HPV, cervical lesions and, ultimately, a hysterectomy before I had borne children. Not to mention the disruption to my sex life.

  2. I am very sorry to hear that you had to endure the illness and the painful treatments. Would you might letting me know if you went every single year for a pap test?

  3. Yes, I did, since Freshman year, that's how they found out. It didn't make a difference that I had a pap every single year - that's not prevention, that's only detection after infection. Other than the vaccine, only barrier method sex is prevention, and in many cases like mine, that fails.

    When you contract the virus, your OB sees the cervical lesions and/or the vaginal warts, and treats them however - freezing, acid, what have you - and then that doesn't always work, so you have a "cone biopsy" where they cut out the center of your os, then they do another, wider cut, and so forth. Finally, they say the womb has to come out because of the invasiveness or potential for invasiveness. And that's a barrel of monkeys. And now, I STILL go and get tested, twice a year, a pap and a colposcopy. Terrible time waste but necessary.

    A friend of mine had cone biopsies and, when pregnant, she had to have her cervix banded shut and go on bed rest so as not to deliver prematurely.

    1. Thank you very much for sending these details--it's a gruesome disease, and I'm still weighing the value of a vaccine to prevent over the tragedies of women whose lives are destroyed by the vaccine that works so well for many.

  4. I cannot emphasize enough the sheer number of times I have had the speculum shoved in for freezing or biopsies or cone biopsies and then for follow up inspections and then for repeat treatment and then more and more. Ugh. I once ran into my gynecologist rushing into Van Cleef and Arpels (as I was walking past). Going twice a year now is a comparative breeze, though still high anxiety.

  5. Thanks for the comment, and the details: the choice comes down to the relative safety of the vaccine. I'm saddened by these horror stories, but also by those of women who say their health collapsed after the vaccine.