Musings of a Dinosaur

A Family Doctor in solo private practice; I may be going the way of the dinosaur, but I'm not dead yet.

Monday, August 28, 2006

Gardasil: The Argument Against

For anyone who happens to have been hiding under a psychedelic mushroom for the last year or so, there is a new vaccine recently approved for the "prevention of cervical cancer" called Gardasil. This vaccine is administered as a three-dose series, costs about $120 per dose, and is being marketed for girls and women ages 9-26. So what, if anything, is wrong with this picture?

Just this: The American Cancer Society estimates that in 2006 there will only be 9,710 new cases of cervical cancer, and only 3,700 deaths. I am not disputing that these are horrible deaths, as are many other cancer deaths. But with a total female population of just over 147,000,000, that translates to only about one in 2,500,000 women dying of cervical cancer. At a cost of $360 dollars for the full 3-shot course of vaccine, that comes to about $900,000,000 to prevent one death. One. I'm sorry; no matter how horrible a death, it's not worth 9/10ths of a billion dollars to prevent just one.

Merck (the vaccine's manufacturer) of course uses different numbers, coming up with a much greater benefit by calcualting how many CIN2/3 (abnormal/precancerous paps) were prevented, according to the following statement in their package insert:
CIN 2/3 and AIS are the immediate and necessary precursors of squamous cell carcinoma and adenocarcinoma of the cervix, respectively. Their detection and removal has been shown to prevent cancer; thus, they serve as surrogate markers for prevention of cervical cancer.
Here's the fallacy: yes, every cervical cancer began with a CIN2 or 3, but not every CIN2/3 will go on to an invasive cervical cancer. And of those, only about a third of those patients (in aggregate) will go on to die. But the real catch-22 of the situation is that the women overwhelmingly more likely to die are those who never get a pap test.

Thus we have a huge paradox: those who come for cervical cancer screening, even relatively sporadically, are not going to die of it. The vast majority of cervical cancer deaths are in women who have never had a pap. Not ever. Even one lifetime pap reduces the already very small chance of dying of cervical cancer from tiny to ridiculously miniscule. Those who die are those who do not get screened (for whatever reason, be it financial, cultural, socioeconomic, or other access issues.)

So no; I am not going to recommend Gardasil to my young female patients. (We're completely ignoring the role of males as reservoirs of HPV infection, but then females have historically been on their own dealing with the consequences of sex; but I digress.) We are also not discussing the overall global burden of HPV disease, which is considerable. None of the above analyses apply to women in Africa, where horrible cervical cancer deaths are sickenly common.

What could change my mind?

If Merck were to donate 2 free doses of Gardasil to women in Africa for each dose sold here (which would still net them a ton o'cash) then I would push it like a street-corner crack dealer. But I'm not holding my breath.


At Tue Aug 29, 07:14:00 AM, Blogger Cathy said...

I understand some of your issues with this, but what I don't get is..... Why do want to with hold preventative treatment for American women based on what merck will or will not do? Your last statement takes away from everything else you have said. The fact that if "Merck" were to make this treatment available to African women, "then" you would be pushing it for all of your female patients, implies that you REALLY do see a need for this treatment.

I'm almost appalled that you will not offer this to your patients based solely on the fact that you have these strong beliefs that Merck should donate this medicine to Africa. I'm not saying I don't think it shouldn't be available to them, I'm just saying you aren't being fair to your patients, by not offering it to them based on your personal and NOT professional belief.

There are so many issues to be debated with what you say. You state that women who never had a PAP tests are the only ones who get cervical cancer. You even go so far as to say that if they had even one pap test they wouldn't get cancer. How can you say such a thing? Dysplasia gets missed all the time on pap smears.

Then there is the cost issue you bring up. Why is this cost so outrageous to you? When I compare it to what a GYN visit with a pap test cost, it is not even close to the cost that is accumulated over the years. Even if a women had a pap every (2) years at a GYN visit with a cost of 110.00, over a life of pap tests the savings would be significant.

You should reconsider your views on this, and offer it to your young female patients. After all, it is not their fault that Merck isn't providing drugs to Africa.

At Tue Aug 29, 08:58:00 AM, Blogger Big Lebowski Store said...

Thanks for stirring the pot, man.

Pap smears have already been documented to save lives.

What we need to prevent is a future loss-of-faith in preventive care visits to the OB or FP.

That said, Gardasil's not a bad idea, it's just not a reason for celebration.



At Tue Aug 29, 07:24:00 PM, Blogger Cathy said...

Flea, I know all to well that pap test save's lives! I also know, all to well, that dysplasia can get missed on pap tests. Pap tests are probably the best cancer prevention tests ever invented. But sometimes those cells just get missed.

At Tue Aug 29, 07:47:00 PM, Blogger #1 Dinosaur said...

Cathy: I'm not advocating "withholding preventative treatment for American women". I'm just pointing out that this is an expensive intervention to prevent an extremely unlikely occurence (development of invasive cervical cancer) in my specific patient population (upper middle-class girls and women who are extremely unlikely to go the rest of their lives without GYN care.)

In terms of costs, you seem to imply that a full vaccination course cancels out the need for biannual GYN visits. It doesn't. (And even though my charge is $90, I only get $78 for such a visit; not $110.) So we're talking about adding $360 worth of vaccination against a disease fewer than 10,000 women in this country will get in 2006, that isn't going to appreciably reduce their preventive care costs down the road anyway.

The biology of HPV, cervical dysplasia and invasive cervical cancer is such that even though dysplasia may be "missed on paps all the time", the overall progression is indolent enough that relatively infrequent surveillance is more than adequate to intervene in plenty of time to prevent invasive cancer.

Regarding the whole Merck thing (I would say, "Don't get me started", but I suppose it's too late): I do not buy lottery tickets. However if a kid comes around my neighborhood selling raffle tickets to support their team, I will buy them. Not because I think I might win whatever the prize is, but to support the cause. Similarly with Merck: if I knew that immunizing women at ridiculously low risk was helping to subsidize the vaccination of women who really needed it, I would be that much more inclined to do so.

By the way, for the record: I am extremely straightforward with my patients and explain my reasoning to them. If they feel strongly that they want the vaccine, I would find a way to get it to them (though I may ask them to pay for it up front, since I'm not yet sure I can get paid for it by the insurance companies.)

At Wed Aug 30, 04:22:00 AM, Blogger Cathy said...

This comment has been removed by the author.

At Tue Sep 12, 09:44:00 PM, Blogger ema said...

At a cost of $360 dollars for the full 3-shot course of vaccine, that comes to about $900,000,000 to prevent one death. One. I'm sorry; no matter how horrible a death, it's not worth 9/10ths of a billion dollars to prevent just one.

Except the vaccine prevents HPV infection. So, in order to have an accurate analysis, you need to factor in the costs associated with HPV infection.

From a quick search, here are some numbers:

A cervical examination with a normal routine papanicolaou smear incurred costs of 57 dollars (95% CI, 57-57). Costs that were associated with abnormal routine screening diagnoses ranged from 299 dollars for atypical squamous cells (95% CI, 245-352) to 2349 dollars for high-grade squamous intraepithelial lesion (95% CI, 1,047-3,650). The costs of histologically confirmed cervical intraepithelial neoplasia ranged from 1026 dollars for cervical intraepithelial neoplasia 1 (95% CI, 862-1191) to 3235 dollars for cervical intraepithelial neoplasia 3 (95% CI, 2051-4419); a cost of 376 dollars (95% CI, 315-436) was associated with false-positive test results.

...those who come for cervical cancer screening, even relatively sporadically, are not going to die of it....So no; I am not going to recommend Gardasil to my young female patients.

*Maybe* they won't die of cervical cancer, but unless they're offered an opportunity to prevent HPV infection via vaccination, they are going to undergo increased surveillance for dysplasia, and, possibly, invasive interventions.

We're completely ignoring the role of males as reservoirs of HPV infection...

I don't have the refrence handy, but if I recall correctly, there are ongoing trials with males in Virginia.

At Thu Sep 14, 06:57:00 AM, Blogger #1 Dinosaur said...

Ema, you are absolutely right, and I must confess that your comments reveal that my objections to the aggressive marketing of the vaccine in this country are mainly political.

Besides, if you think that the gyn's are going to give up their annual paps (even though it seems clear that q 3-5 years is fine with Thin Prep) you've got another think coming. Actually, it's the patients that are resisting the change. At that rate, any savings from working up fewer abnormals goes down the drain.

Given the overall global burden of HPV disease, I think getting this vaccine to women in Africa would be enormous. Gates Foundation work?

At Mon Sep 25, 06:23:00 AM, Anonymous Anonymous said...

Your math is shocking.

How did you get to $900,000,000?

Buy a calculator and try again.

At Mon Sep 25, 03:34:00 PM, Anonymous Anonymous said...

Your maths is being doubted and checked over at

If you stand by it, come and defend it?

At Mon Sep 25, 07:32:00 PM, Blogger #1 Dinosaur said...

Hello, BadScience. Love your stuff, but I can't figure out how to post there without joining (and I'm already part of way too many boards.)

I apologize for the roughness of my numbers, but I still feel very strongly that this vaccine is not worth it. Even at $71,000 per life.

My main point is that ordinary GYN care (regular paps) is perfectly adequate to catch HPV disease before it advances to the point of invasive cervical cancer and death. So I don't believe the vaccine itself will actually save anyone's life, since the women who will get aren't the women who are going to go a lifetime without GYN care.

Here's another analogy: if there were a very expensive hat that would lessen your children's chance of being hit by lightning, would you buy it for them? Most would say, no; the baseline risk is ridiculously small, and is reduced even further by common sense, such as not standing outside in thunderstorms.

At Tue Sep 26, 06:24:00 PM, Anonymous Anonymous said...

Hello Dinosaur.

The cost of $360 for a *vaccine* seems very expensive. I always thought that they cost at most tens of dollars. If they were rolled out via a public health initiative, for tens of millions of Westerners, I'd hope the price would drop dramatically.

In the blog, you said:
I apologize for the roughness of my numbers, but I still feel very strongly that this vaccine is not worth it. Even at $71,000 per life.

At $71,000 per life, assuming the cancer victims would otherwise have twenty years of productive work ahead of them, wouldn't this actually work out cheaper on an acturial basis than the payouts required to deal with the loss of earnings and medical treatment?

Jim (jimbob on badscience)

At Sat Dec 09, 11:40:00 PM, Anonymous Anonymous said...

I would pay $900,000,000 to prevent the death of one person I know.

At Tue Feb 06, 09:41:00 AM, Anonymous Anonymous said...

Hiya...just a quick question.

From the vaccinations emerging for cervical cancer,

I would just like to know a list of groups of individuals who you feel should recieve this vaccination and a list of groups of individuals who you feel should definetely not take the vaccination.

In answering this, i would like a justification if possible on to the presence of each group of individuals taking into account their risk, the benefits of the vaccination, ethical issues and the financial cost of the vaccine.

Thank you for your time and am eargerly anticipating your response.


At Tue Feb 06, 09:43:00 AM, Anonymous Anonymous said...

This is really important for me to understand so so if you would like to explain to me in person, my email address is


At Thu Feb 15, 01:52:00 AM, Blogger Chris Nandor said...

I am really ticked at this Gardasil nonsense. It's become nothing more than a money-maker for Merck.

Let's look at the facts. Most girls do not become sexually active until they reach high school, and then, of course, they usaully continue through high school. Merck and Texas are requiring it for sixth graders. Yet, the vaccine may not work past three years from when it is given. So unless they plan on giving it again in ninth grade and then in 12th, this is actually causing harm by giving girls a false sense of security.

If they really cared most about saving lives, they would try to maximize its effectiveness, which means giving it to the girls later, not earlier. Merck even lies on their web site, falsely claiming that if girls get vaccinated early, they will be protected later when they need it. The science does not back up that claim.

Texas Gov. Perry compared it to polio vaccines. Except people don't get HPV because someone forgot to wash their hands. It is not spread through casual contact. It is spread through a conscious choice. Merck says HPV is easily transmitted, but it is even more easily prevented through conscious choices. I am not saying "choose abstinence," I am saying let's not pretend that we are all mere animals who lack the ability to control our impulses. Sex doesn't just happen. You can control yourself. Many of us do, in fact, control ourselves. And there's no sense in requiring it for everyone just because some people both lack the will to control themselves, and the will to take precautions (such as voluntarily taking the vaccine).

There's so much wrong with this, it's just depressing.

At Thu Feb 15, 04:04:00 AM, Blogger Chris Nandor said...

One more thing ... this vaccine only prevents 70% of cervical cancers. So if you've not already done so, reduce the number of cases by 30%. That is, 6797 new cases in 2006, not 9710, or whatever. Not sure about death figures.

At Fri Feb 16, 07:11:00 AM, Anonymous Anonymous said...

I'm in agreement with you and several of the other commenters here. The alleged benefits are bought at enormous cost. Primary care groups like mine in Minnesota are so locked into third party contracts that we will lose money giving the vaccination. So we have decided to soften the blow by only giving the vaccine after a counselling session, which may keep us from taking a financial bath. And for all you purists and universal health care fans, yes, medicine is a a business and we need to stay in the black to pay our employees as well as ourselves. Your point about donating vaccine to third world countries is excellent. The chances of many women in those countries of having a single Pap smear in their lifetime is small, so a vaccine like Gardasil would make a huge difference. You know, if it weren't for the nauseating marketing campaign Merck has started, I wouldn't feel so opposed to what is happening. Is anyone else completely disgusted with DTC advertising? Now, for crying out loud, Medtronic is using DTC ads to sell ICDs? Is that an item where consumer choice plays a major role? Tylenol vs Advil, I can see that. But a defibrillator? Give us a break please. Whoops, I've gone completely into a different topic!

At Fri Feb 16, 12:24:00 PM, Blogger Red Rabbit said...

If I had kids, I would give them the vaccine. I'm encouraging my sis to get it for hers.

I love the idea of getting Merck to pledge to get it to Africa. They are doing 5-yearly visual inspection of the cervix with acetic acid (VIA) for any woman they can reach, but it's just starting, and so once or twice a week you get a woman with invasive and probably inoperable cervical cancer, and you get to realise what it must have been like prior to the Pap in the developed world. The amount of good this vaccine (or a compulsory license thereof) could do in Africa is BEYOND BELIEF.

People who say kids aren't sexually active until a certain age are terribly unrealistic and blinkered. My husband teaches twelve-year olds in a nice little town in England and is continually shocked by their behaviour. And those are the kids who get to choose. Heaven knows, there are plenty who don't.

Never mind the kids we see in clinics with condyloma acuminata. *sigh*

At Tue Jun 26, 08:34:00 AM, Anonymous Anonymous said...

should i still get the shot if i am sexually active an only 17?

At Sun Aug 19, 01:08:00 PM, Anonymous Anonymous said...

I realize this post is very old and I'm commenting many months later...

I have HPV and because of that have had two LEEP procedures as well as many biopsies. I also had to visit the OB weekly until my daughter was 20 something weeks old so he could view my chopped up cervix to make sure it was holding my kid in (not dilating prematurely).

Now, I believe that in comparing medical costs, the vaccine is much cheaper than all the time and procedures I required.

My daughter has been vaccinated. The military families are covered. I'm slightly pissed they aren't offering it to my son so he could prevent giving this pain in the bottom to his future partners.

I enjoy your blog and appreciate your disdain for Merck's focus and lack of philanthrophy. I share that view. Along with great wealth and power comes great reponsibilites. I don't know how to get pharmaceutical companies to answer to this. I bet other countries handle them differently.

At Tue Oct 09, 05:09:00 PM, Blogger Mocksoup said...

Not just the price of the vaccine, are we even asking about the deaths of perfectly healthy teenage girls that "might" have been saved by the vaccine, but instead had sudden cardiac death when the virus attacked their hearts?

I have a heart condition, my daughter might have the same and the doctor didn't even THINK about that when the question was posed yesterday.

I am glad that I took the time to research this on my own. My daughter will be taught to use condoms, and to get gyn exams yearly. I would rather have the talk about safe sex, than giving a eulogy at her funeral.

At Wed Mar 12, 08:49:00 AM, Anonymous Anonymous said...

OK, you people are all missing the point....the REAL issue is that this vaccine is not proven safe. At least 2 of the components are known to cause infertility!!! HELLO?? Not to mention it contains aluminum...
In studies of older women who got it, almost 1/2 had miscarriages or malformed babies if they conceived shortly after or were already pregnant when getting the vaccine.
Blood clots, paralysis....these are other "rare" side effects.
When drug companies say "rare" you need to go running with your hands over your head, screaming! That means "deadly". Like Lipitor...the "rare" muscle side effect is killing and maiming 1000's a day (I predict lawsuit soon, but I digress..) but it is still FDA MUST be safe.
If anyone thinks FDA approved carries any weight when it comes to safety, do some research and think again.
This vaccine is a big experiment with the lives of our daughters and their future children!
WHY are we targeting only females? This is carried and transferred by both sexes! HELLO...yet another attempt by BIG PHARMA to cash in on women...after all..they lost the HRT war now that those chemical (not real hormones) have been proven to be unsafe.
The get all sorts of kickbacks and freebies from the drug companies to "push" their drugs.
It is sickening and shameless.
Sorry dino, but I have lost 99.9% of my respect for Drs. and the FDA.
It's all about profit margains, not saving lives.
MERCK has to get ready for the big FOSAMAX lawsuits...already set aside 48 this is to be their next big cash cow.
Not to mention that there is no proof that HPV causes cancers. It "may" the inserts.
We are big guniea pigs.
My 14 year old daughter will not be getting this deadly vaccine...and she has read all the articles and research so she knows why mom is not having her roll up her sleeve.
Oh, and women who got the vaccine who may have had HPV already are showing signs of more aggressive pre-cancerous lesions....hmmmm

At Fri Mar 28, 02:27:00 AM, Anonymous Anonymous said...

Where to start...Everything has risks...Everything. So to reject something due to the risk is ridiculous, we wouldn't even have antibiotics if someone didn't take a risk. I have a feeling that most of the people against this treatment haven't actually been diagnosed with HPV or undergone a LEEP procedure, which is surprising considering the prevalence of the virus. I find it unethical to deny patients a treatment due to personal opinion. Not only that, but if you have some amazing ability to predict which of your patients will go on to develop cervical cancer, I applaud you. You can't pick out who's immune system will suppress the virus and who's won't. Not only that but consider the women in the minority, like myself. I am 21, had very few partners and developed severe dysplasia in a year. I recently underwent a LEEP procedure and will tell you not only was it the most painful thing I have experienced but the emotional effects of having pieces of your cervix removed are indescribable. If 3 shots could have prevented this, I would have gladly taken them. Now I look forward to PAPs every three months and possibly more procedures, Do you have no heart? Give these young girls hope. This vaccine is not an answer, but it's a start. And to the person who says sex is a choice...yes it is. And if you can see the high risk strains of HPV by all means, sell your talent as a service. There are no symptoms of HPV in men and NO TEST for men. So unless you have a miraculous gift, having sex with someone with HPV is not a choice, Do you think if I had known I would have made the same decision? You are the kind of person that makes people feel ashamed of it, even though almost 50% of the population will have HPV at one point in their lives. Until you live through this, and have seen it's worst, kindly keep quiet. And no offense but I am positive that the one person that cost us all that money...was worth it. Wouldn't your daughter or sister or mother be worth it? If you don't think so why don't you tell them that. There are multiple sides to everything, and I see where you get your ideas and that's fine...But we all should definitely be in charge of our medical care and our lives.

At Fri Mar 28, 02:33:00 AM, Anonymous Anonymous said...

HPV is found in skin and mucous membranes...Condoms do not offer complete protection. AND...If drug companies are cashing in on women whatever...Lets complain to nature or the Creator or whatever. It is women who get cancer, not men.

At Fri Apr 25, 04:21:00 PM, Anonymous Anonymous said...

I had a pap smear when i turned 18 after my first partner. I was fine. It wasn't until 6 months later when i was raped that I was given HPV by my rapist. It's been almost 10 years and i still have HPV, and i still get the pap and i still get the colposcopy every 6 months. The emotional scars of having to have the colposcopy done is like being raped all over again. I didn't have a choice when it came to being raped. I get regular check ups. I was in a horrible situation. I think if we're going to talk about HPV we need to talk about who's has it. it's not just low income women anymore. It's everyone. It's men, it's women, it's young girls, it's young boys. I don't think if you talk to your daughter intelligently about the dangers of HPV you'll have a problem with her thinking she's safe even after she gets the vaccine. Because if you're speaking honestly you're talking about all the pitfalls of the vaccine as well as it's strengths. you're talking about what it does and doesn't protect. you're talking about what she can do to stay safe on top of the vaccine. There is a responsibility that a woman has for her own body, and if we teach it to our girls when they're young, we'll see a decrease in HPV, abortions and STD's in general.

I had one partner before I was raped. I used a condom and respected myself, my body and my choices.

I will get my daughter vaccinated. I will also teach all of my children how to use condoms, how to respect themselves, how to wait until they're sure it's real love and not peer pressure.

I wouldn't wish what has happened to me on anyone. I wouldn't wish regular colposcopies on my worst enemy.

No one should have to go through this.

At Mon May 12, 09:06:00 PM, Anonymous Anonymous said...

i'm having to do a persuasive speech on this topic and am very surprised at my findings. i once had hpv, had to get the leep procedures and multiple biopsies. and sad to say, i would rather go through all those horrible procedures again than to pump my body full of experimental drugs being pushed by big pharmacuetical companies. i've learned to have safer sex and get yearly pap smears. my hpv was caught early enough, and i refuse to live in fear of getting it again. we rely too much on the government and the fda to protect us. there was a time when we weren't so dependent on drugs to keep us alive. it isn't at all as neccessary as they are trying to convince us that it is. please do your research. it's only been on the market oor a couple of years. lord knows what side affects will coming creeping out 10 years from now when men aren't able to create testosterone and women aren't able to conceive. we have no idea what we're getting ourselves into

At Wed May 14, 01:48:00 AM, Anonymous Anonymous said...

The use of (for now) expensive HPV vaccines may decrease the pool of infected individuals. HPV is now thought to be responsible for a very significant portion of head and neck cancers, and there is anal cancer to consider as well. The morbidity associated with these infections is not insignificant. While the vaccine is not proven to prevent the above-mentioned cancers, you cannot deny that this vaccine represents a breakthrough in prevention of contagious illness, and offers some hope for prevention of deadly and disfiguring cancers. Of course it is quite expensive for now, but eventually the cost will decrease. I find it appalling that you want to punish Americans because Merck is profiting from their innovation. Shall we punish you for profiting from your medical practice? Shall we tell you that you're not allowed to make money unless you donate 25% of your visits to the indigent? Of course not. Preventing contagious illness is beneficial to more than the person being treated.

At Wed May 14, 01:45:00 PM, Anonymous Anonymous said...

Gardasil is approved for males in at least Australia that I know of (and many countries in Europe, if I'm not mistaken). Men and boys are being vaccinated here in the US, as an out-of-pocket expense to the patient. Oh, the thought of a lymphedema being prevented, by preventing the need for a cancer treatment--that sounds real nice. You might like this:"Meanwhile, the non-profit international health group PATH, supported by the charitable foundation of Microsoft founder Bill Gates, will begin exploring the possibilities for distributing Gardasil to women in the developing world. PATH will launch a five-year effort to investigate how such distribution can be undertaken, starting in India, Uganda, Peru and Vietnam.

The effort will be backed by a $27.8 million grant from the Bill and Melinda Gates Foundation, with the support of Merck and GlaxoSmithKline. Glaxo announced in 2004 that it too had developed an HPV vaccine (see Vaccine may protect against cervical cancer) and is seeking a green light from the FDA to begin distribution."

And this:

all found with a Google search.

At Tue Jul 08, 01:25:00 AM, Anonymous Anonymous said...

Maybe its too late to stir this particular pot but in Australia the vaccine is free for all women under the age of 26(or thereabout, I'm not 100%). further to this in Australia all school aged children are vaccinated at school with it, for no charge, this includes high school students (up-to approx 18/19)We get vaccinated for HPV and many many other diseases including hep B during our school years for free.

maybe instead of saying oh yeah it might only prevent one death and it'll cost 1 billion don't get it. As a doctor this is one of the last things you should be saying!! yo should campaign for it, any reduction in life (even one in the lower socio economical groups) is a good thing! There's a reason Australia has a lower death rate from preventable diseases. government initiative and education.


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