Posted by Eliza on: 02.08.2007 /
The HPV vaccine has been in the news a lot lately, & it raises a number of interesting moral and ethical issues. Gardasil (made by Merck & Co) was approved in the United States and the European Union in 2006, & is also approved in a number of other countries. Cervarix, a similar vaccine by GlaxoSmithKline, is expected to be approved in 2007. They’re intended for females ages 9-26 (before their first sexual relationship).
The HPV vaccine has the honor of several “firsts” and “mosts”:
Here are some of the issues:
What do you think about the HPV vaccine? these issues? other issues?
Would you choose to have your child vaccinated if you were (or are) a parent?
Who should decide who gets HPV vaccine? Do you think HPV vaccination should be mandated?
Background on HPV and cervical cancer follows, for those who would like more information: There are over 100 known HPV strains; ~37 are sexually transmitted, and 12-19 of those have been linked with increased risk of cervical cancer. Most of the sexually transmitted strains do not cause genital warts or any other visible indication of infection.
Two strains, HPV 16 & 18, are responsible for 70% of cases of cervical cancer. (HPV 16 is responsible for most cases of anal cancer and vaginal cancer, and HPV 16 and 18 are responsible for most cases of penile cancer, but those cancers are much less common than cervical cancer. Cervical cancer and anal cancer occur at higher rates in people with HIV and HPV.) Two other strains, HPV 6 & 11, cause 90% of genital warts. Gardasil contains recombinant viral coat proteins from HPV strains 6, 11, 16, and 18 and induces high levels of protection against new infection from these 4 strains; immunity lasts for at least 4 yrs (but it’s not known how much longer than that it lasts).
HPV infection is quite common; about 75% of women are infected with at least one strain of HPV at some time in adulthood. (Anyone whose sexual partner has ever had a prior partner can acquire HPV. If neither member of a monogamous couple have previously had any sexual relationships, then HPV is not an issue.) HPV infections can be cleared by the body, but sometimes they persist long-term (the HPV DNA becomes integrated into the DNA of the host’s cells).
From Wikipedia’s page on cervical cancer:
Worldwide, cervical cancer is the second most common cancer in women (after breast cancer) and is the third leading killer (behind breast and lung cancer). It affects about 16 per 100,000 women per year and causes death in about 9 per 100,000 per year.In the United States, however, cervical cancer is only the 8th most common cancer of women. About 12,800 women in the United States are diagnosed with cervical cancer and about 4,800 die each year (Canavan & Doshi, 2000). Among gynecological cancers it ranks behind endometrial cancer and ovarian cancer. The incidence and mortality figure for the U.S. are about half that of the rest of the world, a difference which can be attributed in part to the success of screening with the Pap smear.
In Great Britain, the incidence of cervical cancer has reached alarming proportions in that the mortality in England and Wales in women younger than 35 years rose threefold from 1967 to 1987. In a study published in 2004 (Peto J et al) scientists from the London School of Hygiene and Tropical Medicine found that had it not been for effective cervical screening, one in 65 of all British women born since 1950 would have died from cancer of the cervix.
The most recent news about HPV vaccine (in the U.S., at least) is about new laws. On January 30, 2007, Texas governor Rick Perry caused alot of jaws to drop by issuing an executive order making Texas the only state (to date) to mandate the vaccine. Starting in 2008, HPV vaccine will be given to all girls in 6th grade in Texas. This order has the effect of requiring HPV vaccine to be covered by the Texas Vaccines for Children Program, and for young women who are Medicaid-eligible in Texas. With less of a splash, on February 2, 2007, the Virginia Senate passed legislation to mandate the vaccine for girls entering 6th grade; on February 5, the Virginia House followed suit. Both Texas and Virginia have opt-out provisions for parents who strongly object.
Interestingly, Merck & Co. has lobbied & even sponsored legislation in at least 18 U.S. states which have considered making the HPV vaccination mandatory for girls, and the Virginia senator and representative who sponsored the bill have each received campaign contributions from Merck & Co. over the past decade. It’s not clear if any of those activites by the drug company were influential in getting the legislation in Virginia and the executive order in Texas passed. While vaccination requirements for school vary from state to state, vaccines required for school attendance are usually those protecting against diseases transmissible in the school setting — measles/mumps/rubella, for example.
Remember above where it said that the incidence of cervical cancer in the U.S. was lower due to Pap screening? And yet the U.S. is a major focus of the effort to start vaccination. How about developing countries? From Wikipedia’s page on HPV vaccine:
Pap smear screening is too expensive for routine use in developing countries and HPV-induced cervical cancer remains the second most common cancer in women worldwide. Thus HPV vaccines are most urgently needed in developing countries. With a cost of $360, Gardasil is the most expensive vaccine ever developed. The vaccine will be too expensive for initial use in developing countries unless substantial subsidies are offered. Merck has announced that it intends to support programs to offer Gardasil to disadvantaged women worldwide. The Bill & Melinda Gates Foundation has also expressed interest in helping make preventive HPV vaccines available to women in developing countries. Through the PATH organization, a nonprofit organization whose mission is to improve the health of people worldwide by advancing technologies, the Gates Foundation has donated $27.8 million dollars to implement HPV vaccines. Starting in January 2007, women in India, Peru, Uganda and Vietnam will be receiving the vaccine.
(I’m hoping that vaccination started in those countries last month, as this entry said was planned.)
Comment by: Helen
1Wow, mandating this vaccination for school entry seems a little strange. If it was optional I don’t know if I’d make my daughter have it. I might want to wait and see if it turns out that there are some risks of having it. I might let her choose.
Why is it so expensive? Does it cost a lot to produce or is the drug company making a lot of money from it?
I certainly would like to see countries helped to afford anything safe and relatively easy to administer which could have a significant effect on the health of the people who live there.
Comment by: Jennifer
2I have so many thoughts on this vaccine. I love the idea, and as a 21 year old who is between college graduation and a steady job with insurance, I hope I can get this before I turn 26. If I can get insurance or the government to pay for it, all the better. There is no history of cervical cancer in my family, but there is a history of other types of cancer. I hope my adopted sister (14) can get the vaccine before she is sexually active. As to the specific questions…
Absolutely not, and this constant strain among the mostly scary right wing religious annoys me to know end. I know no one who choses what to do in their sexual life off of the possiblity of cancer maybe one day. Do these people not realize there are still a dozen other negetive consequences to non-thoughtful sexual activity? The mind boogles that people (cough they PRETEND cough) believe that move teens are worried about HPV/cervical cancer than pregnancy, HIV, or a reputation.
I think it should be required, and here’s why. School vaccine requirements are the number one way to ensure people get their shots, and while HPV does not get passed the same way as polio, it does get passed around through sexual experimentation, which happens among classmates. Why not stop the passing on before it starts? I think that insurance should cover the shot, but then I think the insurance should cover more preventive care (including birth control) than my insurance ever has. Of course, many children don’t have insurance, and that is where the government should step up and cover the cost. It is not fair that rich girls should get the shot and not poor girls.
Statistically speaking? Probably not. For instance, if the money for the shot was given to the schools to create healthier school lunches, that would probably create a more immeadiate benefits. Ideally, of course, the government wouldn’t be wasting our tax dollars, and there would be the money waiting to be used for both. They do, and I still think that they should cover the shots because HPV can be spread without a condom,and its important to get rid of that as much as they can. JUstthink how history will judge them if there was a way to cure cancer and we didn’t embrace it.
I don’t see a widescale distribution until this goes generic, and only in countries where there is some sort of centralized government to organize the people, since the shots do have to be administered over time- its not like wandering nurses can hand them a handful of pills and not worry about finding them again in three months.
In addition, I can’t wait for men and boys to be able to get the shots. If we can get rid of an STD we should try!
Comment by: Jamie
3Another intersting side note on this vaccine…
They have found that if women get it, it can prevent about 75% of the those cases of HPV, but if the male gets it, it prevents 90%. Why don’t we hear about that?
Comment by: benjamin ady
4Wow you ask provocative questions. I love the “Is it a good use of resources?” This is so relative, isn’t it? I mean … sachs says we need to have something like US$165 billion in international aid by 2015, if we want to end extremem poverty. George and friends want to spend *another* US$300 billion on the war on iraq in the next coupla (yes, I said “coupla”. I’m trying to sound like George. can you say “nucular”?) (sorry, that was uncalled for) years. so what does “good” mean in this context? Interesting. who’s getting rich from the HPV vaccine? Is it good for them to get rich? Maybe I should buy one share of stock in the drug companies, to help me consider the question from both an insider and an outsider perspective. Unfortunately, I can’t *really* get an insider perspective on extreme poverty (well, I could, but when it comes right down to it, do I want to?)
are drug companies evil? Or are they kind of like us, a strange conglomeration of enormous evil and astounding good? hmmmmm…
Comment by: Helen
5Benjamin wrote:
lol :)
Comment by: ncxian
6Is this true? Then why would girls be the target population?
What does HPV do to guys–any cancers?
Comment by: Doreen
7I am so against mandating this vaccine that I cannot see straight. Talk about “big brother” government. If I had a young daughter, I would absolutely not force her to have this vaccine.
It was rushed through the process - no other vaccine was mandated this soon after approval. There are questions about its safety for its target demo - young girls - only 5 percent of the patients tested were in this category.
There is no evidence this vaccine prevents cervical cancer in humans because the trial period did not last long enough to evaluate this.
Women who cannot afford a pap smear to detect cervical cancer surely cannot afford this vaccine. Seems like another example of how the drug companies are in bed with the politicians.
Anyone remember (or suffer from) the voluntary swine flu vaccine in the late 70’s?
Comment by: Eliza
8I think the 75%/90% figures Jamie gives above are from this data: HPV strains 16 & 18 (the carcinogenic strains in the current vaccine) are found in ~70% of cases of cervical cancers (various other strains, not in the vaccine, are found in the other 30%), but in ~90% of cases of penile and anal cancer. (HIV-infected gay man are at highest risk for HPV-associated anal cancer, but HIV negative men and women can develop anal cancer too). So the current HPV vaccine could, at best, prevent 70% of cervical cancer but 90% of penile and anal cancers. In the studies on the vaccine, it eliminated cases of pre-cancerous changes associated with HPV 16 & 18, but there were still women who had pre-cancerous changes & had other HPV strains. On concern is that the strains that aren’t covered by the current vaccine might increase in prevalence & basically move into the “void” left by the successful prevention of HPV 16 & 18. (If they are now “competing” at a viral level for hosts to infect, & HPV 16 & 18 “win” when they’re present, and suppress the other strains.) So, an inadvertent outcome of mass vaccination could be a temporary reduction in cervical cancer, then an increase again as the other HPV strains take over, so to speak.
However, far more people develop cervical cancer than develop penile and anal cancer, so women do bear the brunt of cancers associated with HPV.
Comment by: benjamin ady
9Once again I am being forced to reevaluate. I was guessing that the religious right would be against this vaccine, arguing that it gave “permission” or “approval” for sexual activity.
So I checked out Dobson’s FOTF (family.org), and their position statement seemed eminently sensible–they support widespread availability, but oppose mandated use in public schools.
And now these two states that are arguably bastions of the religious right have mandated the vaccine. I mean clearly George and co are from Texas, and Jerry Falwell is from Virginia.
So call me enormously cynical. But it really makes me want to follow the money. Does the religious right (I know, labelling so broadly is probably both unuseful and confrontational. Sorry) have some sort of strongish underlying connection with these drug companies? I just have this enormous underlying sense that … yes, the vaccine may be enormously helpful and effective … for the drug companies, it really is all about the money, and there is a *TON* of money in pharmaceuticals, legal and illegal. And when there is a *ton* of money involved, somehow the worst in people comes out. or something like that. It just feels really really suspicious and even a little wrong to me.
BICBW
Comment by: Doreen
10I like the way you think Benjamin - you have very good instincts!
——————————
On July 8, 2003, an editorial by the Reverend Jerry Falwell was published in the Washington Times. The purpose of this editorial was to discourage lawmakers from passing a bill that would enable Americans to purchase lower cost medications from countries that have safety standards comparable to those of the United States.
———————————-
The pharmaceutical industry contributed more than $20 million in political contributions in the past election (2002). The Center for Responsive Politics estimates that $8 out of every $10 went to Republicans.
———————————
Sept. 2003 - The Rev. Louis P. Sheldon of the Traditional Values Coalition is under fire for working as a front for pharmaceutical lobbyists to oppose a bill that would permit the importation of prescription drugs from foreign countries.
Comment by: Eliza
11Helen wrote:
Drug companies have this problem that they have to put alot of money into research & development, & only infrequently do they find a drug that can make it to market, so they really want (need) the drugs they do market to bring in lots of money (to pay not only for the R&D of that drug, but also for all the others that didn’t end up working out). The new drugs & vaccines are expensive to develop, no doubt about it. The HPV vaccine involves making (essentially “growing”) recombinant copies of portions of the HPV virus of certain strains, & packaging them in “virus like particles” as a delivery method, all of which has to be done under sterile conditions, etc. New drugs and vaccines have to be tested, & data showing they are safe and effective (over at least a few years) have to be presented to the FDA. Then there’s that advertising campaign to develop, that’s expensive too. ;)
Thus the price is high, and also the drug (& now this vaccine) are marketed heavily in any way they think might increase market share. (How do they decide what price to put on a new drug? I’ve heard it’s what the market will bear, but that’s just hearsay.) Once a drug is doing well, there’s every incentive to keep the price high & keep trying to expand the market; those funds do go back into R&D, but (in ironic tone:) the profit is also nice for the company & its stockholders.
I don’t know of vaccines coming out as generics (other ‘me-too’ companies putting out cheaper versions of the same thing, once the patent has worn off). There are a few vaccines for which there are 2 brands on the market, like Hepatitis B vaccine and meningococcal vaccine, but each is a brand name. It’s not clear to me that having 2 brands of a vaccine necessarily lowers the price; Hep B vaccine costs
From the Wikipedia page on HPV vaccine there’s this interesting tidbit, suggesting that Merck’s R&D costs might not have been as high as if they’d developed this vaccine from scratch:
Comment by: Eliza
12Doreen, I missed your comment #7 earlier. You said:
True, but this part doesn’t bother me, because in the case of cervical cancer the changes progress over several years from mildly atypical to early precancerous and so on, & the studies showed a dramatic (essentially complete) reduction in the precancerous changes from HPV 16 & 18 in women who got the vaccine, but no reduction in precancerous changes in unvaccinated women (or in the few vaccinated women who picked up other strains of HPV). It would take 10 yrs (or more) to prove that the cancer rate actually dropped.
Interestingly, Pap smears were never proven reduce the risk of cervical cancer in prospective studies, yet it has been quite clear after the fact that Pap smears are quite effective at reducing that risk.
Great point, that the women who stand most to benefit from this vaccine are not the group that will get it, for economic reasons. Even at my least cynical, it seems like another example of how goods and services are marketed to those who can pay (or, who have an insurance company that can pay) even if (as is often the case) those aren’t the people in greatest need.
Vaguely. Remember back when everyone used to be vaccinated against smallpox in childhood, & there was no need for boosters? Then remember just a few years back when potential “first responders” (including health care workers) were advised to be vaccinated, even if they’d been vaccinated in childhood? The response was underwhelming, and it’s probably a good thing because (from here)::
(Smallpox vaccine is a live but weakened virus, so it actually causes a mild form of the disease to trigger an immune response. The HPV vaccine is not a live virus, it’s just pieces of the virus’s shell, same idea as Hepatitis B vaccine, so it should have no potential to cause the infection it’s aimed at protecting.)
Comment by: Doreen
13Eliza - thanks for the clarification on cervical cancer.
The swine flu vaccine, from wikipedia. So vivid to me because I was a college freshman and there was a big debate about whether to get vaccinated or not.
The U.S. swine flu scare of 1976
On February 5, 1976, an army recruit at Fort Dix said he felt tired and weak. He died the next day and four of his fellow soldiers were later hospitalized. Two weeks after his death, health officials announced that swine flu was the cause of death. Alarmed public-health officials decided that action must be taken to head off a major pandemic, and they urged that every person in the U.S. be vaccinated for the disease. President Gerald Ford was confronted with a potential swine flu pandemic. The vaccination program was plagued by delays and public relations problems, but about 24% of the population was vaccinated by the time the program was cancelled.
An immunopathological reaction to the vaccine in some people is believed to have caused about 500 cases of Guillain-Barré syndrome resulting in death from severe pulmonary complications for 25 people. More people died from the vaccine than died from the swine flu itself.
Comment by: Karen
14Isn’t that one of the arguments for making it mandatory, however? If it is mandated for school attendance, surely government health care programs would be required to cover its cost for their indigent clients, right?
Or am I missing something?
In terms of my feeling on this, I’ve read good arguments on both sides (not the ones that say the vaccine will encourage promiscuity - that viewpoint displays a profound misconception about how people evaluate sexual opportunities, particularly kids!).
My general feeling is that society’s default position should be to do everything possible to protect the health of its citizens. If there are preventive measures developed, they should be accessible to all - including children whose parents might not know about, afford, or take advantage of them if they are not mandatory. (Routine vaccinations against other diseases only started greatly reducing their incidence after laws mandating them were put into effect.)
As long as there is an opt-out clause in place, which Texas has established, I think I lean towards making the vaccinations required. If I had a daughter I would certainly get the vaccine for her, either way.
Comment by: Eliza
15The group who’d miss out on any benefit in the US are women who aren’t poor enough (or young enough) for government programs (Medicaid, state government vaccine programs) but who can’t afford either Gardisil or Pap smears. Cervical cancer is most common in the U.S. among women who have not had a Pap smear in the past 10 years, and immigrant women (maybe for the same no-Pap reason).
Gardasil isn’t expected to remove the recommendation for Pap screening, since it doesn’t protect against every carcinogenic strain of HPV (and also because we don’t yet know how long it may be protective). So then there will be costs in the system for both Gardasil and for Paps (though there should be fewer downstream costs to work up and treat abnormal Pap smears).
Comment by: Eliza
16For any vaccine or screening test, it’s most cost-effective to target it to the people at highest risk.
I did some back-of-the-envelope calculations today about cost-per-life-saved with Gardasil.
Let’s say Gardasil costs US$500 for the 3-shot series (including charges for giving the shot). The info I’d linked to in the main post gives this data for worldwide rates of cervical cancer: 16/100K women get the disease, 9/100K women die of the disease. If Gardasil prevents 70% of cases (those associated w/ the 2 strains it protects against), then vaccination of 100K women should prevent 11.2 cases, and 6.3 deaths, among those 100K women (assuming vaccination provides complete & long-lasting protection).
Vaccinating 100K women at $500 each would cost 50 million dollars, which works out to $4.5 million per case of cervical cancer prevented, and $7.9 million per death from cervical cancer prevented.
I cruised around on the web & in medical literature and found comments that for screening and preventions, measures which cost up to $50,000 per year of life saved are generally considered cost-effective, and those costing over $100,000 per year of life saved are considered too costly. (Obviously, a whole bunch of assumptions & value judgments go into that.) I’ll use CPYOLS to stand for “cost per year of life saved” for the rest of this post. This page shows estimated CPYOLS saved for other interventions (the only vaccine on this chart is influenza vaccine, a good deal at $500 CPYOLS).
Cervical cancer affects women at earlier ages than breast or uterine cancer, so a death from it means more years of life lost than for alot of other causes of death in women, but at $7.9 million per death prevented, it would have to prolong life for 79 years to meet the $100,000/yr of life saved “cut off”. (There must be info on CPYOLS for other vaccines, but in a quick search all I found was one paper which calculated it for a pneumococcal vaccine & used $1/dose as the cost of the vaccine; maybe bulk purchasing and/or discounts for 3rd world countries can find some great deals like that!)
I’m thinking that $7.9 million could be used in other ways, to save many more lives.
My enthusiasm level for Gardasil is rapidly waning. I think I’ll wait for it to go on sale (”90% off!”).
Comment by: Laura M.
17On a personal note, several relatives in my family have dealt with this medical issue. My mother is at 20+ years survival and counting, and my sister is currently hospitalized recovering from surgery. From my perspective, I can’t think of this issue in terms of ‘cost-effectiveness’.
I live in Dallas, Texas, and until I read this entry I hadn’t been aware of Perry’s executive order. I applaud his decision, and believe me if you knew me you’d be falling out of your seat right now to hear that. I have strong Libertarian political views-meaning I am always opposed to government regulations which limit individual rights except when undeniably necessary for the protection of the life, health and safety of society. I believe the potential preventive rate of 70% means this is one of those situations which qualifies.
We are one of those families which relies on government funded programs in order to vacccinate our children, and these mandatory laws are the only thing which will make it possible for low-income families to provide this vaccine for their daughters. I can’t believe I’m saying this (shudder, shudder) but thanks to Gov. Rick Perry’s action, my little Sara will now have access to this life saving vaccine in just a few short years. Keeping in mind my family’s succeptability to this virus, that means everything to me.
As for the wider issue, mandatory vaccines just plain make sense in Texas, with our large immigrant population and low-income population. What makes sense for Texas doesn’t necessarily make sense everywhere else though.
Comment by: Julie Clawson
18A few thoughts…
as per the Texas/Perry mandate - the word from my relatives (all who live in Texas) is that Perry does stand to gain from the vaccine and is under investigation for this. Is this true? I don’t know.
If this is mandated for school attendance all schoolgirls will have to get it and can be covered by government vaccine programs. As “poor” pastors our child’s vaccines are covered as long as they are required by the schools. And the cost of this is nothing compared to the RSV shot ($1000 a shot given once a month!)
Would I give this shot to my child. Yes. Anything I can do to protect her I will. And even if I live under the delusion that religious guilt will scare her from sex - i know that 1 in 4 women experience some form of sexual assault in their life. Why not help protect her from whatever evil I can?
Comment by: Laura M.
19I recently saw on an evening news magazine program (wish I could remember which one) that recent studies show that 93% of people admit to having sex before marriage. I’ve read other studies that show approx. 70% of married people (when you average men and women together) admit to having sexual affairs during the marriage. That last one is really hard to swallow, but it’s backed up by lots of different studies.
What’s worse, the sexual assault statistic Julie mentioned above is considered to be a gross underestimation, based on numbers of reported cases.
Comment by: Jakki Opollo
20Indeed the idea of a vaccine is great especially since HPV kills almost 5000 people annually. I applaud the Gates foundation for attempting to make this vaccine available to developing nations however the truth of the matter is that this vaccine is just as unaffordable to many more in the United States. Yes we must think globally but first act locally. Did governor Perry consider the implications of this mandate on the Public health system? First of all the vaccine is too expensive infact it has been described as the most expensive vaccine, how are minorities (who most of the time are uninsured and underinsuredand) indigent populations expected to pay for this? What are the consequences if parents of school age children cannot afford to pay for this? Are tax payers expected to bear the burden? The implementation of such a mandate calls for a collaborative approach, Governor Perry mandated this without the input of key stakeholders such as the American Medical Association, his whole approach to this effort is implausible and warrants revision.
Comment by: Eliza
21Hi Jakki Opollo - it sounds like Texas has a program that covers childhood vaccines for people without insurance coverage, as do other states (some? all? I don’t know). I haven’t looked up the details, like who qualifies, but the idea is to extend vaccine coverage to every child, because many childhood vaccines protect not just the person being vaccinated, but the general population - against airborne diseases like measles/mumps/rubella and chickpox, for example. HPV is a bit different since there’s no direct threat to life from the infection itself (it’s an indirect threat, via cervical cancer). I assume it’s funded from the state budget (from tax revenues).
So, yes, one consideration is what services the legislature would have to cut, from other programs, to stretch the state budget since more $$ would have to go into the vaccine program to pay for this mandated vaccination. Or, the legislature might end up raising taxes to cover the budget gap. (In either case, it’s not likely to come back to the taxpayers as: you’re paying more, or getting fewer services, because of this vaccine mandate.)
Benjamin (and others) had mentioned earlier that some of the decision-makers might stand to gain financially from promoting universal HPV vaccination. I tried searching for any indication of this last week, when the topic came up, but didn’t find any smoking gun, but certainly any of those links could be difficult to find, & prove.
One other comment - Hepatitis B vaccination is now recommended for all kids in the US (though I don’t know whether it’s a requirement for school entry anywhere). That’s actually the first vaccine to prevent a sexually transmitted disease, since hepatitis B can be transmitted sexually (usually through anal intercourse between gay men, rather than through other kinds of sexual activity). It also prevents hepatitis B transmission through sharing of needles in injection drug use, oh and also transmission through blood contact (as in dental and other health care workers). Most people who are being vaccinated aren’t going to be going into health care fields, so it’s mostly protection in case kids try IV drugs or gay sex when they’re older. Only, that’s not how it’s described. I find that quite interesting.