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Life-saving Vaccine Against HPV! (If You Can Afford It)

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The term "sexually transmitted disease" is charged with emotion. The effects of STDs range from gross, like the draining sores of herpes simplex, to lethal, such as AIDS from HIV. For most STDs there is treatment but no cure or prevention. Recently, a vaccine was found that prevents a potentially lethal STD—human papilloma virus. But the HPV vaccine, which has the potential to save hundreds of thousands of lives, has run into serious political and legal roadblocks.

HPV is an STD nearly endemic in our society, the low estimates being tens of millions of affected Americans. As one medical school professor once described it to our class during a lecture on STDs: "If you have ever had unprotected sex with a partner who has had unprotected sex with anyone else, you have been exposed to HPV." Because a person can be infected but show no symptoms it is easily passed from partner to partner. Also, it can take weeks to months for symptoms to appear. To further complicate the issue, HPV has multiple strains, each of which has a different effect. To date, more than 100 strains have been identified, with more than 30 of the strains being sexually transmitted. Some of them are cleared from the body without any symptoms ever presenting, others cause genital warts, and some cause cancer. By age 50, according to the Centers for Disease Control estimates, at least 80% of women will have acquired genital HPV infection.

While HPV can lead to several types of cancer in men or women, including cancer of the penis, vaginal area or anus, the concern about HPV has always focused on cervical cancer, because it is a silent killer, typically without symptoms until it is at a very late stage and too late to do anything about it. Until the development of a vaccine, prevention of cervical cancer has relied entirely on women getting regular pap smears, which can detect changes in the cervix, leading to early treatment. In 2004, according to the American Cancer Society, over 10,000 women contracted cervical cancer and nearly 4,000 women died of it. Almost all of the deaths occurred in women who had not had regular pap smears.

In 2006 the FDA approved Gardasil, an HPV vaccine targetting four HPV strains that together account for 70% of the cervical cancer and 90% of the genital warts caused by HPV. This was a huge leap forward in the fight against cervical cancer. It is recommended by the FDA for women age 9 to 26 who have never been exposed to HPV, with immunity provided for close to five years. But even before it appeared on the market it met with strong opposition. Among the first to fire preemptive sorties against the vaccine was Concerned Women of America – a right-wing Christian Conservative organization that seeks to “bring Bible principles into all levels of public policy.” Prior to the vaccine’s FDA approval, CWA Executive Vice President Wendy Wright said her organization was against immunizing preteens against HPV. “It would seem to send a message that we’re expecting the girls to be sexually active,” she said. The ferociously conservative Family Research Council, initially vocal in its opposition to the vaccine, has softened its tone, if only a little. FRC Vice President for Policy Peter Sprigg, in a July 15, 2006 opinion piece for WashingtonPost.com, shied away from opposing the vaccine outright, but opposed states making it a mandatory vaccine. In other words, the great defender of states’ rights while the Democrats held the presidency now wants to take power away from the states, so that the vaccine will remain out of the public eye and most girls won’t be immunized.

But even with FDA approval and CDC support, the HPV vaccine has slammed into another wall: cost. Merck, the company that owns Gardasil, charges $120 per dose, with three doses required to provide immunity. But insurers are barely willing to pay for each dose, much less the costs of administering it. CNN.com reports in a Feb. 2, 2007 article that doctors are expected to stock thousands of dollars in inventory, store the vaccine in highly specialized refrigerators, pay for any broken or damaged vials at $120 each, provide syringes, administer the vaccine and pay for disposal of the sharps all for as little as $2 over the cost of each dose administered. Thus, being forced to lose money by providing the vaccine, many pediatricians and family practitioners have stopped providing it. With the public spotlight on the vaccine, some insurers have relented and are raising their reimbursement. But for those without insurance, or insurance that doesn’t provide coverage, or only partial coverage, the vaccine remains out of reach.

There’s an old saying in the pharmaceuticals business: The first pill costs you half a billion dollars, everything after that is profit. Merck says that it will provide the vaccine for free to those who can’t afford it, but the big drug companies say this about all their expensive products, and as any patient who has tried to apply for such fee waivers or any physician who has tried to help their patients apply for the waivers can tell you, cutting through the red tape involved in actually getting a waiver requires a bulldozer. In fact, Merck gave away only about 800 doses in the last three months of 2006. To have an idea of how expensive $120 per vaccine is, consider the following CDC list of vaccine costs, per dose, in 2007: Diptheria/Tetanus/Pertussis: $12.25; Hepatitis B: $26.25; Hepatitis A: $35.57; Mumps/Measles/Rubella: $17.28; Varicella (chickenpox): $56.90.

It is expected that the overall cost will decline over time, but given the prevalence of HPV, the high cost of the vaccine, the reluctance of the insurance industry to pay that cost, vocal opposition from politically connected right wing organizations who think money is better spent telling youngsters to wait until marriage, and tepid support from a presidential administration that sees eye to eye with the Conservative Christians, it is likely that cervical cancer will continue to be a killer for a long time. For parents who would like their daughters immunized and young women who would like to be immunized against HPV, and thus drastically reduce their chances of contracting cervical cancer, the struggle continues.

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About Dr. Tim

  • Bob

    Hmmm. Why does Merck need a waiver on future lawsuits if this hasn’t been fast tracked by the FDA???

    January 3, 2007 10 Things You Might Not Know About Gardasil

    You might have noticed recently that the makers of the new HPV vaccine Gardasil really really really want you to try their product. I think the TV commercials are running about every 7.5 seconds. I admit that I tend to be pretty skeptical of the whole women’s health “industry”, so after seeing the ads about five million times, I decided to do some research.

    10 Things You Might Not Know About Gardasil

    1. The vaccine only decreases your chances of getting cervical cancer, it doesn’t eliminate the risk. Straight from gardasil.com: “HPV Types 16 and 18 cause 70% of cervical cancer cases.

    GARDASIL may not fully protect everyone and does not prevent all types of cervical cancer, so it is important to continue regular cervical cancer screenings.”[1]

    Merck is upfront with this information; they don’t try to hide it or spin it. But with all of the media coverage and information floating around about the “100% effective cancer vaccine”, it’s helpful to remember that Gardasil is only 100% effective at doing what it is supposed to do, which is preventing certain specific types of HPV, not preventing all cervical cancer.

    2. Even without the vaccine, the number of cervical cancer cases is trending downward and has been for years. (This is only true in the U.S.; worldwide it is one of the top cancer killers of women because women in many other countries have limited access to Pap tests and other health services.)

    The Gardasil commercials refer to “thousands of women” being diagnosed with cervical cancer in the U.S. each year, which is true, but they don’t put that number into context.

    “Cervical cancer has gone from being one of the top killers of American women to not even being on the top 10 list. This year cervical cancer will represent just 1 percent of the 679,510 new cancer cases and 1 percent of the 273,560 anticipated cancer deaths among American women. By contrast, some 40,970 women will die of breast cancer and 72,130 will die of lung cancer.

    According to the American Cancer Society, “‘Between 1955 and 1992, the number of cervical cancer deaths in the United States dropped by 74 percent.’ Think about it: 74 percent.”[2]

    So Merck wants parents to have their pre-teen and teenage daughters vaccinated. But if current trends continue, by the time these girls are old enough to be at risk, how big will the risk really be? Check out the government’s statistics on cervical cancer for yourself at the National Cancer Institute website.

    3. Gardasil is one of the most expensive vaccines ever, at about $360 for the series of three shots, plus the cost of doctor visits. Call me cynical, but I can’t help but think about how much money Merck stands to make from this if they can manage to convince all young women and all parents of young girls that this vaccine is a necessity. And while we’re at it, call me a conspiracy theorist too for wondering if maybe Merck just might be exaggerating the cervical cancer risk by a lot in order to scare young women and mothers into buying their product.

    “‘We’re seeing a fairly remarkable uptake of Gardasil,’ said Rick Haupt of Merck & Co., which reported sales of the vaccine had reached $70 million, exceeding analysts’ projections.”[3]

    Gardasil is a cash cow. The revenue stream is big now, with the potential to get much bigger. This is especially important for Merck, which is still dealing with the scandal surrounding their pain medication Vioxx, which they had to withdraw from the market in 2004 after it was found to increase the long-term risk of heart attack and stroke in patients who took it regularly. Thousands of lawsuits have been filed by former Vioxx patients. Vaccines like Gardasil are needed to provide the constant stream of cash that will help Merck to recover from Vioxx.

    “Merck, struggling since the 2004 recall of its blockbuster pain pill Vioxx, has staked its turnaround in part on vaccines. They accounted for $1.1 billion of its $22 billion in revenue last year, or 5 percent, the highest share since at least 1995.” [4]

    4. While we’re on the subject of liability, lawsuits, and profits, there’s another angle to consider. If Merck can get state governments to put Gardasil on their lists of vaccines that are required for schoolchildren, it can become a part of a federal vaccine liability program. Meaning that Merck will not be liable if Gardasil turns out to be harmful some time in the future. [5] [6] [7]

    If I felt like being cynical again, I might think that this is one of the reasons why a vaccine for a sexually transmitted disease is being marketed not just to young women who are having sex or are going to become sexually active soon, but also to girls as young as nine. There’s a hell of a lot more stability and profitability in a required childhood vaccine than there would be in an optional vaccine meant only for young women.

    It’s important to remember that no matter how many feel-good, we’re all in this fight together and we’re just doing this out of the goodness of our hearts ad campaigns they run, drug companies are not non-profit organizations. They are in this to make money and a lot of it, and while that doesn’t mean that all prescription drugs are harmful and horrible or that all doctors are evil, it does mean that when it comes to our health, we probably shouldn’t take anything at face value.

    5. There have been no long-term studies done on the effect of the vaccine after 5-10 or more years, and testing on young girls has been extremely limited.

    “Merck has tested the cervical cancer vaccine in clinical trials of more than 20,000 women (about half of them got the shot). The health of the subjects was followed for about three and a half years on average. But fewer than 1,200 girls under 16 got the shots, among them only about 100 9-year-olds, Merck officials said, and the younger girls have been followed for only 18 months.” [8]

    If parents are expected to take their daughters to get a series of expensive immunizations, wouldn’t it be nice if they had any idea at all about what effects these girls might have to deal with 5 or 10 years down the line?

    If you’re wondering what the rush was, part of the answer could be patents. When a company’s patent on a particular drug expires, that’s when generic versions of the drug can be developed and released into the market, which obviously drives the price and the profits of the original drug way down. Merck’s patent on the extremely profitable cholesterol drug Zocor expired in June of this year, and Gardasil is one of the new drugs being counted on to bridge Merck’s financial gap. According to the FDA, Merck filed an application for a patent extension for Gardasil on December 6th.

    This CNN Money article has more info on Merck’s financial past, present, and future.

    6. It is unknown how long the immunity provided by Gardasil actually lasts.

    “Public health officials want to vaccinate girls early, before they become sexually active, even though it is not known how long the immunity will last.” [9]

    “Tests show that the vaccine lasts at least four years. Long-term results aren’t known yet.” [10]

    And straight from the FDA: “The duration of immunity following a complete schedule of immunization with GARDASIL has not been established.”[11]

    So if I do decide that it’s worth the risks to my hypothetical nine year old and that I should go ahead and give her the vaccine, in the end I don’t even know if it will do her any good at all by the time she actually becomes sexually active.

    I completely disagree with the people who are against this vaccine for “moral reasons” and claim that the vaccine will encourage young women to be promiscuous because their STD risk will be reduced. But I do have a problem with the fact Merck isn’t telling women that their immunity may only last for a few years. The women and girls who get the vaccine may base some of their future sexual choices on the assumption that they are protected, but by the time many of them become sexually active this may not be true anymore.

    7. The studies done on Gardasil were not set up to investigate whether the vaccine itself has the potential to cause cancer.

    “GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity.”[12]

    car·cin·o·gen n. Any substance or agent that tends to produce a cancer.

    ge·no·tox·in n. A chemical or other agent that damages cellular DNA, resulting in mutations or cancer.

    8. Gardasil is one of many vaccines containing aluminum, and there is increasing evidence suggesting that aluminum-based vaccines can have harmful effects. Aluminum is a neurotoxin and the aluminum in vaccines can potentially reach the brain. Since the list of required childhood vaccines is only getting longer over time, children are being exposed to doses of aluminum that may exceed what their bodies are capable of managing. Aluminum in vaccines has been linked to a variety of neurological disorders, including Alzheimer’s, although a lot more research is needed. [13] [14]

    It’s also interesting to note that according to the FDA, Merck tested Gardasil along with the Hepatitis B vaccine (currently on the required list), to make sure that there were no negative effects to administering both vaccines during the same doctor’s visit. The tests showed no apparent problems. [15] However, the hepatitis vaccine was the only one that was tested, so it is unknown whether any of the other required childhood vaccines could be potentially harmful when combined with Gardasil. There was also no information in any of the studies about what adding Gardasil to the required list would do to the cumulative aluminum levels in children’s bodies.

    9. Gardasil is only for women.

    “Boys would not have to be vaccinated, although they can get HPV. There are no HPV tests for men. The vaccine has not yet been tried on men.” [16]

    Men can get HPV. Men can give HPV to their partners. Men can get genital warts from HPV. Men can get cancer from HPV. (80% of HPV-related cancers affect women, but the other 20% include penile and anal cancers affecting men). [17]

    So why wasn’t Gardasil tested on men, and why isn’t Merck funding PR campaigns to educate men about their HPV risk? Is it because they feel that there’s more of a stigma surrounding men’s sexual health, and that it would be more difficult to convince men and parents of boys of the risks? And as a result they wouldn’t be able to make nearly as much money off of men as they will off of women. (Sorry, there’s that cynical thing again.)

    I think both men and women can take issue with this. Men, because their sexual health is really not being addressed here. They don’t even have a test that can tell them whether they have HPV or not, so even if they want to be responsible about it there is only so much they can do. And women, because they are being asked to take full responsibility for HPV prevention. Women and girls are expected to take on all of the costs and the risks of this vaccine, and even if they do get vaccinated they could still be infected with HPV by a male partner who has been told that HPV isn’t something that he needs to worry about.

    From the Centers for Disease Control and Prevention website: “There is no clear health benefit to knowing you have this virus–since HPV is unlikely to affect your health and cannot be treated. For most men, there would be no need to treat HPV, even if treatment were available– since it usually goes away on its own.” [18]

    Isn’t it a little irresponsible (and sexist) to say there is no benefit to a male HPV test? Regardless of the possible health issues such as penile or anal cancer, isn’t not infecting your unsuspecting partner also considered a benefit? Men are reassured that tests and treatment are unnecessary because their HPV infections will likely go away on their own, while the fact is that most women’s HPV infections will go away on their own as well. [19]

    Apparently, when Gardasil went before an FDA panel for approval, Merck asked the panel to approve the vaccine for boys also, even though they have not done the same amount of testing on boys as they have on girls.

    “Merck asked the committee to endorse vaccination of boys age 9 to 15, too. Urging them not to wait for ongoing studies to end, it said evidence shows Gardasil can prevent some male cancers and may slow the spread of sexually transmitted HPV. ‘By delaying three-plus years, we could have an additional 100,000 [cancer] cases that could have otherwise been avoided,’ Barr told the committee. But panel members didn’t vote on the request, calling the idea compelling but unproven.”[20]

    It seems to me that we need to spend more time researching HPV in men and boys, not less time. And it would be nice to feel like Merck was taking this issue seriously and not just tacking it on as a “me too” measure in order to get approval more quickly. On the flip side, it’s a positive step that more research on HPV in men is now being done. Maybe they’ll even change their minds and decide that it is worthwhile to develop a male HPV test after all. They could probably share a lab with the researchers who are hard at work on that male birth control pill we’ve been hearing about for years.

    10. The bottom line: Don’t get this vaccine just because your doctor/mom/sister/friend/a perky TV commercial told you to. But don’t not get it just because some chicks with a blog say that they aren’t going to. It’s your health, your decision. Do your own research and accept no guilt trips. My own mom wanted me to consider getting the vaccine (it is also being recommended for sexually active young women, even though it will probably do us–well, do evil slutty me anyway–no good), but she encouraged me to research it first, so I did. When I told her what I had found out, she agreed with my decision not to get it.

    The Gardasil ad campaign is screaming at us to be “One Less”, meaning one less woman affected by cervical cancer. I’m all for that. I’m just going to try to reach that goal in my own way… as one less woman making an uninformed decision.

  • Thank you for providing such an informative overview of this vaccine. #8 is especially concerning. Currently in Texas, some of us are working to rename our governor to Gov. Perck, or perhaps Dictator Perck. Seems Rick Perry is attempting to mandate into law all girls in Texas be required to have this vaccine.

    Glad I didn’t vote for him.

  • HPV is epidemic in no small part because condoms don’t adequately protect you.

    The cause of mandating the HPV vaccine is funded by none other than Merck, the billion dollar corporate welfare handout would go to them.

    There can be promotion of the vaccine without mandating disclosure. The state, quite simply, doesn’t need to know who is vaccinated and who is not. Keep your laws off my daughters body.

  • Bob, thanks for posting the Gardasil piece from evilslutopia, they often have well presented material. As a practicing surgeon I don’t think that it’s a terrible thing that industry (Big Pharm, Big Medical Device, etc.) spend a lot of money on research. We work with them often to develop many new products that have saved millions of lives. The problem is there needs to be the other half of the equation, which is government investment (as in NIH funding, for example), which has been slashed under W’s reign, just like all science and engineering funding has been slashed, even though that’s where we get the most “bang for our buck” in tax dollars. (And no, I don’t get any kickbacks from industry.) The point is, I don’t have a few hundred million dollars lying around to develop new products and drugs and the government has dropped the ball, so that leaves industry as the only source of new research.

    With specific regard to Gardasil, the touchiest part of this debate is whether to make it mandatory for school attendance. For progressives, this is basically a lose-lose debate; either you agree that it should be mandatory, and thus give more money to Big Pharm, or you think it should not be mandatory, in which case you’re supporting the Christian Right, which is fighting this the same way they are fighting abortion, chipping away, one step at a time up until they can overturn Roe v. Wade.

    As for some specific points in the piece: 3800 deaths in 2004 from cervical cancer is not an insignificant number, especially considering that they are highly preventable deaths. And although there has been a decline in deaths, with a reawakening of the sexual revolution and condom use practically spurious, it is likely we will see a resurgence. Plus, this is not a disease that kills women in their 80s or 90s, but can kill very young women. And trust me, as someone who has taken care of patients dying of this, this is not how you want to go.

    Length of protection unknown: True, but also true for all vaccines. For example, in order to maintain hospital privileges I am required to have titers drawn every few years for vaccinations I have received. Trouble is, no one knows what level of titer offers protection against, for example, Hep B. So the state or county or hospital sets its own standards based on zero data. It’s a complete guess. So slamming Gardasil for this is hardly fair, it’s a condemnation of all vaccinations, but unless you’ve ever tried to actually do any of this research (I have), you have no idea how hard it is to actually get that kind of data.

    Aluminum and cancer causing potential: Again, something that is true of most vaccines, but it’s all about balancing risks. Saying you’d rather take a very large and known risk versus a small unknown risk makes little sense. Imagine the following scenario: You’re trapped in a room and there are keys in each of two boxes, each of which has a blade that occasionally drops down and chops your hand off. The one on the left drops down about one in ten times, the one on the right drops down about one in ten million times. Which would you choose? My advice, anytime you have to calculate odds, go with the least possible chance of a bad outcome.

    Tested only with Hep B: Again, this is true of most vaccines. Before slamming research as inadequate, actually try and do some of this research. Any research is painstaking, but anything that involves children (such as vaccines) is a nightmare to conduct.

    Cost: It is very expensive. So is Varicella. But wait, chickenpox isn’t lethal, why do we care? Because the virus doesn’t go away and eventually causes shingles. Sure it’s not likely to happen until you’re in your 50s or older, but if you plan on living that long, let me assure you that it is beyond miserable, and can lead to blindness, facial deformity, even death. Personally, if I could go back in time and get the Varicella vaccine, I’d take it. The HPV vaccine offers a similar option for cervical cancer.

    Men and HPV: I agree that more research is needed on men, but because the research hasn’t been done yet doesn’t mean it’s not a good idea for women.

    In summary, I agree with the original article’s point that a well-informed decision is the best way to go. But my advice is, if you can afford it, and it’s available, it’s unwise to let opportunities to improve future health slip away, because odds are you will live to regret that decision.

  • Nancy

    As a breast cancer patient, I would tell anyone to be the first person in line if a vaccine is offered to reduce your chance of getting ANY kind of cancer.

    There is a vaccine for shingles and I paid out of pocket to receive it. My mother has suffered from unresolved shingles—-expremely painful.

    People spend hundreds of dollars on IPods, prom dresses, spring break vacations, weddings, cars and other non essentials for their daughters. I really don’t understand parent’s value system when it comes to health for their children—-why does a vaccine need to be free before they get on board. My guess is that they haven’t experienced cancer in their family. But darkness will most likely visit some day—why not minimize the odds for all of our daughters.

  • Nancy

    Chris Rose: We seem to have two ‘Nancys’ here again. I didn’t post this.

  • Yes, you’re right, Nancy, she’s another one.

  • Hank Sloan

    If Merk cut advertising cost and just appealed to the doctors, the vaccine would just cost $10. Remember people, there not there to save people, only money!!

  • Tabitha

    My name is Tabitha and I have HPV… I’ve just recently found out and wanted to find out research about it. I am only 16 years-old and to hear that 4000 women die from it is kinda…scary! I am being regularly treated with

    Much Love,

  • THE cervical cancer vaccine Gardasil may protect against a broader range of cervical cancers than first thought, its manufacturer CSL said today.

    Gardasil is the world’s first vaccine that prevents infection by human papillomavirus (HPV), which is linked to cervical cancer.