A Breakthrough Drug, But Only For Women
The human papillomavirus (HPV) vaccine is a breakthrough drug because it dramatically reduces the odds of women getting deadly cervical cancer.
Some 20 states are considering or have adopted mandatory programs for middle school-aged girls to be vaccinated against HPV, although most are allowing opt-out provisions for parents who do not want their daughters inoculated.
Texas Governor Rick Perry’s recent decision to require 11- and 12-year-old girls to be vaccinated has ignited a firestorm of controversy among conservative religious and sexual abstinence advocacy groups who claim the vaccine — marketed as Gardasil by Merck & Co. — will encourage young girls to have sex.
Civil liberties and anti-vaccine groups also have spoken out because of concerns that Gardasil is being forced on girls and is being introduced too quickly with little real-world experience beyond clinical trials.
Additionally, there are concerns about the expense of the vaccine – About $360 for a three-shot course — and whether girls from poor families will be able to avail themselves of the drug.
But lost in the debate is a huge question:
If Gardasil is so good at pushing back against the epidemic of sexually transmitted infections and diseases, why not give it to males as well?
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23 Responses to “A Breakthrough Drug, But Only For Women”
Mandatory Vaccinations…
Yesterday Texas Governor Rick Perry issued an executive order that mandates a new 3-step vaccination for pre-teen girls. One would assume that there is a medical crisis either in play or in the making for Perry to do an end-run around public debate in…
I am sure this has nothing to do with the fact that a former top aide to Perry is Merck’s chief lobbyist at the state government level for Gardasil.
If you want to eliminate a virus from the populace, you need to vaccinate the entire infectable populace, not just those that are at risk for severe illness. Restricting it to females only makes sense if the potential risks from the vaccine are serious enough, and frequent enough, to only warrant vaccinating at-risk patients.
Personally, I doubt this vaccine will stay “female-only” for long. Maybe it will at first, but once enough women have been vaccinated to make clear that risks are minimal, boys and men will be vaccinated too. I don’t think this will happen because government officials will be so concerned about female health that they make it mandatory but that it will become mandatory because there is no WAY Merck and GSK are missing out on potentially 50% of the market, and their lobbyists will make this known in the halls of power. Sad that things work that way, but no less true.
Lynx:
I have to agree with you. This was a tough post to put together because Gardasil does seem to be extremely effective and I didn’t want that to get lost. My overriding concern is that once again Big Pharma is the tail that wags the dog. It is just plain wrong that public-health policy is being driven by Merck’s lobbying and advertising prowess.
I’m not sure about Gardisil’s effectiveness in the male population, not being an expert in immunology.
However, another factor overlooked is the prevalence of cervical cancer and the number of resulting deaths.
If I remember correctly, there are about 10,000 cases of cervical cancer every year and about 3700 deaths. In comparison:
There are about 150,000 deaths from lung cancer every year, and about 15% (about 22,000) will be non-smokers.
Colon cancer kills between 50,000-60,000 every year.
Heart disease, which is the #1 killer of men and the #2 killer of women, kills 500,000 every year. Strokes claim 150,000 lives.
So, in comparison to other diseases, cervical cancer isn’t all that common.
And then I had this thought:
I don’t agree with conservatives who think Gardasil will automatically increase promiscuity–if the threat of disease stopped people from having sex, then HIV should have resulted in mass celibacy.
However, if you abstain from sex or only have a single sexual partner and use barrier protection methods, your chance for getting HPV and cervical cancer is extremely small. On the other hand, if you don’t use barrier protection methods and have multiple sexual partners, your chances increase considerably.
So, if you automatically vaccinate all girls, aren’t you kind of implying that they’re going to be in the latter category rather than the former–especially given the pressure kids are under to have sex these days?
Alan G:
In my view, sexuality has no place in discussing Gardasil. It’s a red herring because teens are going to have sex and get raped and sexually assaulted regardless of the vaccine.
I think that the likelihood of getting HPV and cervical cancer via rape is pretty small. If I’m not mistaken AIDS is overwhelmingly results from consensual sex, and it’s far more deadly than HPV. The risk of dying from cervical cancer resulting from HPV transmission via rape, I would suspect, is vanishingly small.
And I’m not sure about this being a “red herring”. Society sends people all kinds of subtle messages regarding sex and gender roles. Conservatives may overstate it, but I wonder if there isn’t some sort of subtle but significant message sent by requiring pre-teens to get an STD vaccine, a message that might not always be helpful
Alan – many of the people diagnosed with AIDS in the last couple of decades have been heterosexual women whose husbands fooled around and brought it home. So not being promiscuous does not necessarily protect you.
There was an interesting discussion of Gardasil and the public schools over on The 5th Estate livejournal community a month or so ago. It’s too long to describe well here, but it’s worth a quick read.
Why? They spent a ton of money developing an effective, safe drug that has the potential to save a lot of lives. What exactly do you want them to do? Wait until people notice all on their own?
You cannot expect altruistic behavior from companies that are for profit, and the profit motive is what drives the development of these drugs in the first place.
How is this any different from environmental groups using their money and clout to get legislation passed to meet their desires? Profit? Then are no for-profit companies to be allowed to lobby?
There are no indications that this is a dangerous drug, or that it wasn’t fully vetted by the FDA. So now they have a product that can both serve the public good, and return a profit for the R&D money spent.
Big Pharma certainly plays rough and tumble, but they have also made everyone’s lives incredibly better. As a diabetes suffer, and someone who is bi-polar, I can truly say that I could not function in life without modern medications.
Not everything they do is evil, nor is the pursuit of profit evil in and of itself. And never forget that as people complain about the ‘obscene’ profits drug companies make off of any given drug ‘X’, those profits have to pay for the 20 some-odd other drugs that failed somewhere in the process, and never make it to market.
Or, like Vioxx, they develop a new, truly wonder-class of drugs, that due to admittedly severe health problems for some when taken in high doses for extended periods of time, the entire drug class gets sued off the market.
It has been said by others, and it unfortunately is true. Tylenol (liver damage), aspirin (ulcers, Reye’s Syndrome), penicillin (epileptic seizures, allergic reactions), polio vaccine (vaccine-induced polio), and so many other drugs that have helped humanity significantly could not possibly be deployed today as new drugs.
Angliss:
Thank you for the discussion link. I will add it to the list of links that I put up at my blog.
Good point Holly. Monogamy is no protection.
However, what I was trying to say was that the risk of getting cervical cancer from HPV depends on multiple factors:
1. Sexual activity
2. Use/non-use of barrier contraception
3. Effectiveness of vaccine (about 77% I belive)
4. Chance of contacting HPV sexuall
5. Chance of HPV causing cervical cancer
6. Death rate from cervical cancer
My concern is that some women will be at such a low risk of cervical cancer that it might actually be more risky to take a new vaccine than to skip it. Given the sheer number of vaccines (mandatory and optional) now available, people are beginning to wonder if it’s such a good idea to take so many.
AustinRoth:
How quaint that you are willing to cede life-and-death decisions to for-profit companies whose paramount interests are keeping up their stock prices and market shares.
The public-health system in the U.S. is on life support to begin with. This just makes it all the more vulnerable to predators like Merck.
Once again, the issue isn’t whether Gardasil is safe and effective or whether teens will screw their brains out after being vaccinated.
The issue is that Merck, as have other Big Pharma players, has assumed as quasi-governmental roll and that is very, very bad because they could give a rat’s rectum about the public good.
…there’s only two chicks I would do in that pic…the black/mixed chick in the black tank and miniskirt and the chick on the waaaaaaay right
One thing that y’all have failed to mention is that this vaccine will only cover a *very* few of the over 100 different strains of HPV. IIRC, this vaccine will only cover 2 strains that lead to cervical cancer and 2 that causes genital warts. IIRC, there are around 10 strains that lead to cervical cancer. So, this is in no way a cure for anything. Maybe they’ll improve on the vaccine in the future. Who knows. It is entirely possible that people can be infected more than once by any of the strains that they’ve not encountered before.
I agree that males should also be vaccinated, since they’re basically the carriers. I see this as a way for the company to generate hugh amounts of money for more R&D, not something that is a ‘cure’ for anything. It was, IMNSHO, wow, we can take care of a few strains, let’s go and make money, then we’ll work on the rest of the strains. Probably a management decision and not a scientific one. Yes, I agree that the advertisements are very misleading and that the big pharm shouldn’t have a say about public health policy.
AustinRoth,
I share your view that BigPharma is often vilified unfairly and that there’s nothing inherently evil about a corporation behaving as a corporation will: to maximize profits. But I also think that while Merck should be free to lobby for govt to promote its product and should be free to advertise, its also vitally important for us to view those attempts with a healthy dose of skepticism. We should play devil’s advocate to their assertions in order to come to the best public policy and individual decisions about our health care.
My wife and I discussed this a few weeks ago when Perry first mandated it. She is in the medical field, I’m not. I think our biggest issue was that Perry mandated it, w/ no discussion at all.
What would stop him from mandating any other drug he pleased?
As Austin said above VIOXX was sued off the market, but not for what I think he listed. I believe it was found out after the fact that merck knew about the issues, and decided not to notify anyone. They knew the side effects and allowed profit to get in the way of that. For those two reasons I think this is a bad idea.
Andrea I thought there were 36 possible strains that can cause cervical cancer and genital warts. I thought I read that when this first came out, but I could be wrong there.
But as you stated this isn’t the end all be all solution, additionally Women still need to get checkups. My concern is many will see this as a silver bullet, and not continue to get regular checkups assuming they are safe from getting cervical cancer. The fact is, cervical caner can still happen even if you take this.
I think males will be able to get the vaccination in the near future, clinical tests are still being conducted on that part.
I’m glad Shaun posted this, I’ve seen this discussion elsewhere and it has been much less civil.
CStanley:
You make an important point: No one in an official position is playing devil’s advocate.
Jim B et al:
I received an anonymous comment at my home blog from someone who said:
That is welcome news insofar as my sex discrimination concern goes, but it does not obviate the big issue — that Merck is the tail wagging the public-health dog on this one.
x
CS – I wasn’t advocating or agreeing with Perry’s ‘mandate’, although I am having my daughter get the shot. I was objecting to the concept that because Merck was involved, it must somehow be the wrong thing to do.
Everyone also conveniently ignores the fact that Perry explicitly allowed for anyone who wants to opt out, for whatever reason, do so.
That makes it somewhat less than a mandate. Had he presented more as ‘everyone who wants the shot will be able to get it through their schools, everyone who does not will not be required’, it would have been accepted much better.
However, despite his political skills in some areas, public communication has never been one or his strong points.
BTW – is is just me, or does it seem like there are a lot of Texans that visit TMV?
AustinRoth:
The opt-out provision was not “conveniently ignored.” It was noted in the second paragraph.
Perry, as you note, may not be a good public communicator, but he’s no dummy and surely understands that a mandatory program of this nature would not pass legal muster.
The second second paragraph says, ‘although most (states) are allowing opt-out provisions’.
Then the third paragraph says, ‘Texas Governor Rick Perry’s recent decision to require 11- and 12-year-old girls to be vaccinated’.
Kind of leaves the impression that maybe Texas isn’t one of the programs with an opt out, unless you already know the whole story.
AND, from Yahoo News’s Tom Bevan, ‘Gardasil was put on the 2007 “recommended immunization schedule” issued by the American Academy of Pediatrics, American Academy of Family Physicians, and the Advisory Committee on Immunization Practices of the Center for Disease Control.’ Those are not ‘Big Pharma’ shills.
Even the NYT (not a publication I find myself agreeing with too often) says it is the right thing to do.
This smacks to me of it cannot be acceptable (to some) because of a combination of it coming from a Republican, and there being ties to Merck from an ex-Perry aide.
If he was a Democrat with no connection to Merck, and did the exact same thing, he would be hailed for putting the welfare of children ahead of the objections of religious fundamentalists, IMHO.
Shaun,
I thought they were doing it for guys, just wasn’t sure of the timeframe. Do you know if it keeps them from being an incubator though? They get it and can still pass it along, so it protects them from genital warts, but they can still give it to someone else?
I still would have thought, no matter who the leader was (gov, pres, den mother etc) that they went over the line with this. You know if a dem did this R’s would scream about personal privacy as well, and they should imho. It really doesn’t matter who does it, I don’t think you mandate something that has a rather small, on the grand scale of diseases that is, effect on the population as a whole. This can’t be passed via the air or general contact like other diseases we’ve been immunized for. Additionally, the cost is pretty high, and does smack of a nice fat guaranteed check for Merck. As well as a bill for middle income families. Though they can opt out if they so choose.
Cervical cancer has been declining, and this will certainly help, of course we likely won’t see the results for about 10 years or so.
But, that said, I think my real concern was that a person in power essentially unilaterally decided what was good for the population as a whole.
Then again, I also am not a fan of Perry. I think on the whole he has been pretty useless. This on top of his dirty coal power plants just makes me think he cares more about his future after politics with big business than anything else.
Me personally, if I had a daughter, I’d probably wait 2-3 years to see what the long term effects are, and if more of the strains could be included.
Yeah, weird how Texans show up here. Me, I lived in TX for 23 yrs prior to moving in August to Kansas.