1 In 4 Teenage Girls Have Received Gardasil
34 CommentsBy Ed Silverman // October 10th, 2008 // 6:05 am
Whether this means Merck’s HPV vaccine is making great inroads is unclear, but Gardasil does appear to be on its way to becoming accepted, according to the first federal government study of vaccination rates for the controversial shot.
The vaccine protects against strains of the human papillomavirus that cause about 70 percent of cervical cancers. Federal health officials recommend girls get the shots when they are 11 or 12, if possible, before becoming sexually active (here is the info from the CDC’s Morbidity & Mortality Weekly Report).
Vaccine proponents had been hoping for higher vaccination rates, contending Gardasil can reduce the nearly 4,000 cervical cancer deaths that occur each year in the US, but many families are cautious about the safety of new vaccines, Patti Gravitt, a Johns Hopkins University associate professor of epidemiology, tells the Associated Press [Our note: Gravitt consults for Merck, she received research grants from Merck and is a member of Merck's speaker bureau. You can look here].
Some parents have other issues with Gardasil. For one, the vaccine is expensive, retailing for about $375, although many health insurers now cover it. And there are questions about whether it confers lifetime immunity or if a booster shot will be needed. Still others worry vaccination will send teenagers the wrong message about premarital sex.
“Some parents may be adopting the attitude with their daughters that, ‘Well, you’re still young. I can wait a couple more years before you’re sexually active,’” Gravitt, who was not involved in the research, tells the AP. “My personal opinion is that this seems quite reasonable after the first year.”
The Centers for Disease Control and Prevention based the study on household telephone surveys done in late 2007. The survey results cover the time frame from when the vaccine came on the market in mid-2006 to when the survey questions were answered.
The results are based on nearly 3,000 teens ages 13 to 17 for whom the researchers could verify vaccination information through medical records. Of the girls in the survey, 25 percent had received at least one Gardasil shot. That’s about 2.5 million of the 10 million girls in that age group.
Anne
It’s not really 1 in 4 - it’s 1 in 4 of the subset of people that take their 13-17 year olds to doctors to vaccinate.
Tim
It will be a frigid time in hell before I would let my 12 year old roll up her sleeve for Merck’s Gardasil or any other scientifically inept vaccine. Scare tactics and poor science rules this part of Big Phrama.
Do some good research and consider if this segment of the so called health care system actually does what it purports to do. And please don’t accept any advice from the FDA on safety. Remember their impotance in the Vioxx case 5 years ago!
harpy
Thanks for saying “HPV vaccine.” I’m getting really annoyed at the papers/articles calling it a cancer vaccine. Not that it’s untrue necessarily - but it is misleading and inaccurate.
Nina Kenney
This article angers me. My healthy 18 year old daughter had the first two shots in the series and suffered adverse reactions….syncope and seizure. According to VAERS there have been nearly 10,000 reports of adverse reactions similar to my daughter’s and some much, much worse.
This vaccine, while groundbreaking, is unnecessary. Cervical Cancer statistics have declined in the United States due to women practicing healthy gynecological habits…annual exams that pap tests. Furthermore, how many booster shots these young women will need in their lifetime is, at this time, unknown.
Please don’t be fooled by the slick advertising campaign and how this vaccine has been lauded in the press. Be one less uninformed parent. Get the facts before you consider this vaccine. I wish I had.
Doug Bremner MD
Cervical cancer kills 0.002% of the population per year, and probably all of those are women who don’t get pap smears. Even if you get the shot they are still going to recommend pap smears. And if you get pap smears you can avoid cervical cancer related mortality. And they at one time made this vaccine mandatory for girls in Texas? Thanks, George.
http://www.beforeyoutakethatpill.com/2007/10/Gardasil.html
nipsey russell
“Still others worry vaccination will send teenagers the wrong message about premarital sex.”
really? i just dont get this. ok, lets pretend i meet these people half way and assume there is something wrong with pre-marital sex…..if i take my 11 year old to the doctor to get a vaccine, do i really ned to have an in depth discussion with them about the disease and its “moral” implications? At what point did/do these same people explain to their daugheters what the measles vaccine they got as toddlers was for? polio? if you are worried about promoting sluttiness but still feel your child should be protected from ANY preventable disease, just take them to the doctor and tell them its just one more in the lengthy series of disease preventing shots thye should get. would most 11 year olds press the point???
Justice in MI
Doug - is that the U.S. population? I assume so.
We discussed Gardasil in a class of mine two years ago just after the various promo strategies were more fully outed and many states were considering mandating. One of my students, herself the daughter of an ob-gyn nurse, talked about what treatment for cervical cancer actually entails. Yes, most women survive it. But it is a horrid thing to go through.
This is not taking a position on Gardasil - personally I am strongly against mandating and Merck has given us more than enough reasons for disstrust. Still, when we talk about mortablity, and what “treatable” means (for any serious condition), I think we need to think in very specific terms. At least for us non-MDs, it’s easy for us not to see the realities behind the words.
Christopher
Doug,
Fair point but that’s still over 5,000 deaths in the US per annum which could be avoided, pap smears notwithstanding. And not to quibble but your stats are incorrect as I’m assuming no male deaths occur from this so your population base is too large. Anyway…
Doug Bremner
Nipsey: Maybe they could tell their kids that it is a shot that will help them believe in talking snakes and loaves of bread that fall out of the sky.
JiM: This is for the US, based on 4,000 cervical cancer related deaths per year. This cancer is more uncommon than most, e.g. breast. I do not advocate for or against– I think it is a personal decision. But I am against mandating it. And it makes me sick when I see these promos like girls wearing gardasil bracelets advertising that they got their shots. Talk about promoting sluttiness.
Nathan
Doug — I think you need to learn some math. There are 4.5 million deaths per year in the US. There are about 4500 deaths per year due to cervical cancer. That comes to 1 of every 1000 deaths, or approximately 0.1%.
Moreover, the LIFETIME risk of cervical cancer is approximately 1 out of every 100 women.
Nathan
Woops — my bad. There are only 2.5 million deaths per year in the US. That makes the risk of death from cervical cancer to be 0.2%. You are off by a factor of 100.
Christopher
Nathan,
Where are your numbers from? Cancer Mondial (2002) shows about 5,000 deaths p.a. in US and NCI (2008) about 4,000.
Nathan
First, Doug, now I understand our differences. You meant that 0.002% of the POPULATION would die from cancer. I’m talking about the people already dead. I’m sorry I accused you of not knowing your math.
Second, Christopher:
I’ve forgotten where I got the numbers from. But you are correct. The NCI estimates there will be 3800 deaths from cervical cancer this year.
http://www.cancer.gov/cancer_information/cancer_type/cervical/
The CDC states that 2,448,017 people died in the US in 2005. 3800 / 2448017 = 0.0016 = 0.16%. Now, remember that you have to DOUBLE that because only half of the population is capable of getting cervical cancer (women). Therefore, in 2008, approximately 0.3% of female deaths will be from cervical cancer. Small, yes. Insignificant, no.
Christopher
Thanks Nathan,
That was my earlier point to Doug that the gender difference wasn’t accounted for. But the more important point - significant as you say - is that 3,800 women die from this each year in the US. Statistics aside, they are real people and I think the bigger point is that there are a number of ways one might reduce the risk, HPV vaccines included.
harpy
I’m no statistician, but if you’re going to get all numbery do you take into account that the HPV being vaccinated against only account for ~70% of cervical cancers? And can you compare it to the people who’ve suffered reactions to the medication? Any long term risks associated? Seems like an awfully big risk for an uncertain return.
Nathan
harpy,
You are right on both counts. At *BEST* the current vaccine will prevent 70% of those deaths. But it should ALSO prevent ~70% of the suffering caused by non-terminal cancer. (~12000 women per year are diagnosed with cervical cancer)
As far as risk, I am assuming that this vaccine is no more risky than other vaccines. Kids are vaccinated against chickenpox and mumps — hardly considered deadly diseases — yet there is no public outcry.
By the way, I’m not in favor of manditory vaccination. (yet) Not enough is known about long term effectiveness and it’s only been on the market for a couple of years. However, I am going to get my two daughters vaccinated when they reach the right age.
Justice in MI
Some of you vaccine folks will know, but I recall the theory that suppressing the HPV viruses that Gardasil covers, the ones it doesn’t could become more prevalent.
Anything to this?
Informed in NJ
It is really hard to know who to trust anymore - everyone has an agenda!
Dr. Brenner seems to be part of the same psychiatry department at Emory whose Chairman (Nemeroff) just stepped down in shame - Dr. Brenner, do you have any conflicts to report?
The FDA and the drug industry have had enough problems to cause a parent to second guess our decision to vaccinate our daughters against a horrific disease (thanks Justice in MI for reminding everyone) - in addition to the premature deaths of women, think about how many children are not born b/c many women are left with an incompetent cervix, as a result of surgical procedures to remove HPV infected cells from their cervix.
The bottom line for me is that every drug/vaccine we take comes with it a risk/benefit assessment and the average American seems to want all the benefit without any possible risk - this is just not reality! My hope is that everyone does their own assessment of the risk/benefit ratio and makes an informed decision. I did, and I decided to have my daughters vaccinated and thankfully they are both fine.
As for mandates, I agree that we should hold off, however, the Texas story is an interesting one. What has been commonly reported is how Merck worked to influence this decision, what is less commonly reported is the impact this dying woman had on Governor Perry.
http://www.youtube.com/watch?v=OIsWB348z-Q
Justice in MI
“The bottom line for me is that every drug/vaccine we take comes with it a risk/benefit assessment and the average American seems to want all the benefit without any possible risk - this is just not reality!”
Wow, I am tired of this one. I haven’t met an ‘average American’ yet who was unaware that ‘all drugs have dangers,’ yadayada. All the DTC ads play a sampling, even though in a way that tries to camoflage their import (that has to do with the average DTC ad; not the average American).
As things are now going, my sense is that it might be harder for the “average American” to believe that “all [approved] drugs have _benefits_.” And, obviously, there is a sense those citizens would be right about some number of them.
Informed in NJ
All the more reason to be informed.
Nathan
Justice writes: “Wow, I am tired of this one. I haven’t met an ‘average American’ yet who was unaware that ‘all drugs have dangers,”
Maybe you don’t get out too much Justice. I’ve met plenty of people who, while they wouldn’t SAY this, certainly act like it. Many of them in my family. Everyone one is aware that drugs have risk. They just think that the risk is to someone else - not to them.
Nathan
Justice writes: “As things are now going, my sense is that it might be harder for the “average American” to believe that “all [approved] drugs have _benefits_.” And, obviously, there is a sense those citizens would be right about some number of them.”
1) What drugs are you talking about? (specifics, please)
2) Is it my imagination, or do you seem to have been drifting more towards the “anti-pharma” crowd lately? You don’t seem to be as impartial as you did 6 months ago…
Lisa Van S
Informed in NJ,
You have a real name?….
Doug Bremner MD
Informed in NJ, my disclosures are on my web sites.
Nathan
Justice asks: “Some of you vaccine folks will know, but I recall the theory that suppressing the HPV viruses that Gardasil covers, the ones it doesn’t could become more prevalent.”
I haven’t been able to dig up any info on HPV. However, a close analogy is Prevnar. It is a pneumococcal vaccine for infants. It is similar to Gardasil in that it only protects against the most virulent strains of pneumococcas. (9 strains) One strain (19A) has become more prevelent since the introduction of Prevnar in 2000. However, it is FAR from being ineffective. The rate of meningitis in the US has fallen from ~25 cases per 100000 population to ~13 cases per 100000 population. The CDC estimates that the vaccine (now manditory I believe) has saved approximately 10,000 deaths and an additional 160,000 cases of infection. In responce to the increase in the 19A strain, two companies (Wyeth and Merck) have developed follow-up vaccines to additionally target the resurgent strain.
This is very similar to antibiotic resistance. The battle will never actually be “won”. We’ll always have to keep developing new antibiotics and new vaccines to deal with the ever-changing bacterial and viral threats.
Here’s the article about Prevnar that I got the above info from: http://online.wsj.com/article/SB122341849865912983.html?mod=googlenews_wsj
Justice in MI
Just catching this thread again now.
Nathan - I am not anti-pharma. I’m a stockholder in three companies. I use rx drugs. I depend on rx drugs.
It may be that I am more “edgy” as preemption approaches - as I’ve often said, because of the disaster I believe it will bring to the industry as well as all of us. It’s also hard not to react to the seemingly endless stories of sleaze, but you may have noticed - in the Nemeroff story - my focus was on corruption in academia, my own bailiwick, not pharma. Takes (at least) two to tango.
Re: the comment about benefits, I was referring to the various polls we’ve seen and what I hear back from doc friends about increasing numbers of pts who don’t want to be on anything. These docs, at least, feel something has changed. And they certainly aren’t describing pts who are not aware of risks - almost too aware, from their perspective.
Justice in MI
Forgot to answer with specifics re: hyperiflated benefits. Well, we’d debate about claritin, the coxibs, some ssris, etc., but here is one from my own experience.
When Alphagan (for ocular hypertension) went off patent, Allergan stopped selling it in the U.S. and substituted Alphagan P to keep market share. Alph P had 25% reduced active ingredient (brimonidine tartrate) and a different preservative which claimed to be less irritating to cornea (essentially no evidence for this claim). Major promo claim was that relative risk of ocular allergy was 33% less with P. In real numbers, that was 90 people of 100 not having allergy compared with 85.
In the meantime, relative risk of lack of efficacy (criteria defined by FDA and Allergan) with P compared with original formulation, no longer available in U.S., was 400%. That bit didn’t get into the promos.
Benfit? Progress? Honesty? Please also be specific.
Nathan
Justice,
“Benefit? Progress? Honesty?”
A couple of points:
1) As far as I can tell, the generic is still available - people don’t HAVE to buy the more expensive one if they don’t want to.
see: http://www.ophmanagement.com/article.aspx?article=85797
2) Is 5% fewer allergic responses really a benefit? It depends on whether you are one of those 5% or not! If you’ve already been established on the drug with no allergy, then certainly there is no benefit. For new patients, however, it isn’t clear who will and who won’t be allergic. So a doctor will see ~33% fewer “adverse event” follow-up visits. Is that a benefit to the health-care system? It depends on how much the extra doctor’s office visits cost vrs. how much the added expense of the non-generic drug is. I don’t know the answer.
3) I couldn’t find any info on the lack of efficacy of the newer product. (but I couldn’t get access to the full text journal article either) This is what I was able to find: “The baseline intraocular pressure (IOP) was 24.4 ± 2.45 mmHg for brimonidine 0.2% and 24.39 ± 2.56 mmHg for brimonidine Purite 0.15% (P = 0.985). The IOP was at trough drug effect after 4 weeks of brimonidine 0.2% and brimonidine Purite 0.15% therapy were 20.10 ± 2.01 mmHg and 21.00 ± 1.67 mmHg (P = 0.001), respectively. The IOP at peak drug effect after 4 weeks of brimonidine 0.2% and brimonidine Purite 0.15% treatment were 18.10 ± 1.73 mmHg and 18.20 ± 1.71 mmHg (P = 0.518), respectively. Brimonidine 0.2% was found to cause more allergic conjunctivitis than brimonidine Purite 0.15% (P < 0.001).”
4) This is a strategy that is used all the time. Looks at Wyeth’s “new” antidepressant (Prestiq). Is it really an advancement? I say let the market decide. Same with this one.
Nathan
Justice — let’srelate this back to our original question. You stated “My sense is that it might be harder for the average American to believe that all approved drugs have _benefits_.”
I’m not trying to be smug here, but if Allphagen the best you could come up with then I don’t think the industry has much to worry about in reguards to “all approved drugs having benefits”. This drug clearly has benifits (over placebo) — it just doesn’t have clear benefits over a generic.
Justice in MI
Nathan - Your comment obviously is smug, but so it goes. I didn’t claim it to be the “best I could come up with,” just one I happen to be familiar with. BTW, in Allergan’s last effort to fight off a generic, they tried to claim that P was actually safer than original formulation, even though they continued to sell original in thirty other countries (just not the U.S.). I can smugly say that’s scuzzy. So did the relevant judge.
My main point, though, was about the way Americans have come to view drugs in general over the past few years. While I do not have a good study to demonstrate it, I believe it likely that there is as much heightend doubt out there about benefits as there is heightened anxiety about risks.
It’s that perception that was the point of my post. Again, not something a shareholder wants to know. Nor one who believes - as I do - that, for most approved drugs and for most pts, benefits do outweigh risks.
Justice in MI
Didn’t see Nathan’s first post. Allergan was able to fight off the appearance of a generic for eighteen monhts _after_ patent expiration. That’s better than many cases for pts who rely on a medication - three years is not untypical.
BTW, all of this the result of the tricks and tactics of those lawyers your always worrying about, but this time they’re working for the company, not pts.
I didn’t say less ocular allergy was not a benefit - obviously it is for those pts. But the ten times greater likelihood of failed efficacy would, in my book, outweigh that if one were looking at the whole picture a the product.
Nathan
Justice, that patent dispute is actually quite interesting. It turns out that the generic companies were trying to get a generic approved for an indication that Allergen never marketed (or patented) Alphagen for. Allergen alleged that the generic companies were making an “end run” around the Allergen “method-of-use” patent that was still in-force. The courts actually AGREED with Allergen but felt compelled based on previous court precedent to rule against them. Here’s a brief history of it:
http://www.wlf.org/upload/4-3-03ALLERGAN.pdf
Justice in MI
This is all lawyerly smoke, but I don’t have time to explain why.
In the meantime, there is the big issue of Hatch-Waxman abuse. And there is also the issue you raised initially, about what it means to be “fair” in judging the industry right now (whether it’s me judging or someone else).
I find that the most interesting, and challenging, question of all. I look forward to returning to it on another thread.
Nik
Everyone has an agenda, the drug companies, health insurance companies, even the Doctors we are entrusting with our childrens’ care. As parents we also have an agenda: to look out for the best interest of our children.
The amazing thing here that should not be overlooked, is that there is a group of researchers at Merck who actually discovered that a percentage of women in the world could possibly not have to suffer from a certain cancer if protected from HPV with this vaccine.
Researchers were led in that direction through the work of Nobel Prize winner, Harald zur Hausen…”Thanks to this research, we now have vaccines that prevent infection by these carcinogenic strains of HPV, which are responsible for around 70 percent of all cervical cancers and kill an estimated 175,000 women a year. (www.arstechnica.com)
There is a risk in all that we do; I feel that if I could protect my child from having HPV and pre-cancerous cells, as I do, then I will vaccinate my child and will be grateful to the folks who have spent their lives working on this amazing research.