Another HPV vaccine on the way

GlaxoSmithKline has filed for FDA approval of its HPV vaccine, Cervarix. It would compete with Merck’s Gardasil, which has been on the market since June.

GlaxoSmithKline counters that Cervarix is more powerful and may prevent up to 80 percent of cancers, thanks to the company’s proprietary adjuvant, AS04, a key booster ingredient. It also is funding an unusual head-to-head comparison to try to prove Cervarix is more potent than Gardasil.

GSK has not announced how expensive Cervarix will be, but Gardasil costs $360 for the three-shot regimen. I had high hopes that the competition would bring the price down, but sadly it doesn’t look like that’s going to happen:

Jean Stéphenne, president of GSK Biologicals, the company’s Belgium-based vaccine division, said in an interview last month that GlaxoSmithKline aims to win over physicians and others by proving Cervarix is better, not by selling it for less.
“If you start a price war, you give the impression that your product is of lower quality,” Stéphenne said during a trip to Philadelphia.

…and Big Pharma doesn’t get as rich.
FDA approval is expected sometime between October and January.

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13 Comments

  1. TinyRobot
    Posted March 30, 2007 at 3:56 pm | Permalink

    “Cervarix”? What a name! It sounds like an official title or something. Perhaps I’ll put that on my resume?

  2. BabyPop
    Posted March 30, 2007 at 4:46 pm | Permalink

    No joke. I don’t know why they didn’t go with my suggestion: Cooter Armor!

  3. Justin
    Posted March 30, 2007 at 7:36 pm | Permalink

    I’m sorry if maybe I’ve missed a post about this, but the Canadian federal government recently announced money for vaccination for girls across Canada, and some womens groups have raised concerns, saying that we’re treating girls like guinea pigs (or something to that affect). Not that I expect any of the wonderful feministing women to have thorough understandings of Canadian public policy, are there any thoughts?

  4. Justin
    Posted March 30, 2007 at 7:38 pm | Permalink

    that should be “but are there any thoughts?” My apologies.

  5. annajcook
    Posted March 30, 2007 at 11:44 pm | Permalink

    I am still undecided about how I feel in regards to initiatives to actually mandate vaccines against HPV. I know there are usually opt-out options for parents who have the where-with-all to go through the bureaucracy for an exemption, but it is still troubling to have something still relatively new mandated. I can’t help thinking about the situation with hormone replacement therapy in recent years.
    In reference to the U.S. debate about mandating the vaccine, there was an interesting piece in The Nation a few weeks ago (you can find it at: http://www.thenation.com/doc/20070326/houppert). It helped me consider some of the positive reasons for mandating the vaccine, which may also apply in Canada’s case.

  6. annajcook
    Posted March 30, 2007 at 11:48 pm | Permalink

    I’m sorry . . . the link doesn’t seem to work. If you go to The Nation website (http://www.thenation.com), you can search for “Who’s Afraid of Gardasil?” by Karen Houppert, which appeared in the March 26, 2007 issue.

  7. Raging Moderate
    Posted March 31, 2007 at 11:19 am | Permalink

    As Justin says, the Conservative government of Canada has budgeted $258 million to help provinces pay for the vaccine. There are no plans as of yet to make the vaccine mandatory, but there are concerns that it will be the next step. Interestingly, opposition for mandatory vaccination has come from some women’s groups and medical professionals. The main cause of concern are statements made by Dr. Diane M. Harper (desribed by Canadian media as “a leading researcher who spent 20 years developing the vaccine for humanpapilloma virus”).
    I don’t know how to post a link, so I’ll quote some of her comments:
    “Giving it to 11-year-olds is a great big public health experiment,” said Diane M. Harper, who is a scientist, physician, professor and the director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center at Dartmouth Medical School in New Hampshire.
    “It is silly to mandate vaccination of 11- to 12-year-old girls. There also is not enough evidence gathered on side effects to know that safety is not an issue.”
    “This vaccine should not be mandated for 11-year-old girls,” she reiterated. “It’s not been tested in little girls for efficacy. At 11, these girls don’t get cervical cancer – they won’t know for 25 years if they will get cervical cancer.
    “Also, the public needs to know that with vaccinated women and women who still get Pap smears (which test for abnormal cells that can lead to cancer), some of them will still get cervical cancer.”
    The reason, she said, is because the vaccine does not protect against all HPV viruses that cause cancer – it’s only effective against two that cause about 70 percent of cervical cancers.
    For months, Harper said, she’s been trying to convince major television and print media to listen to her and tell the facts about the usefulness and effectiveness of this vaccine.
    “But no one will print it,” she said.
    “To mandate now is simply to Merck’s benefit, and only to Merck’s benefit,” she said.
    Any thoughts on Dr. Harper’s comments?

  8. Posted March 31, 2007 at 12:59 pm | Permalink

    Well, it (Harper’s statement) seems kind of silly. When else would you vaccinate someone other than BEFORE they’ve been exposed to whatever the hell you’re vaccinating for?
    Also, Cerverix reminds me of Cerberus, the many headed dog that stood at the gates of Hell. I can’t decide if this is a good or a bad thing.

  9. Raging Moderate
    Posted March 31, 2007 at 1:27 pm | Permalink

    “When else would you vaccinate someone other than BEFORE they’ve been exposed to whatever the hell you’re vaccinating for?”
    That’s another of the issues. We don’t know whether or not they already have the virus.
    Dr. Harper: “HPV is a skin-to-skin infection. Although the only way to get cervical dysplasia is through an HPV infection, and HPV is most often associated with sexual activity, HPV is not just spread through sex. We have multiple papers where that’s documented. We know that 3-year-olds, 5-year-olds, 10-year-olds, and women who have never had sex have been found to be positive for the cancer-causing HPV types.”
    The question for me then becomes, why don’t we test girls for the virus before giving them the vaccine?
    Dr. Harper: “The only way to test for the presence of HPV is through a vaginal swab – which is inappropriate for young girls.”
    Do we really want mandatory vaginal swabs of young girls, too?
    But I think the most important question is, why should we make the vaccine mandatory for young girls when one of the scientists who was instrumental in creating the vaccine says she has no idea if it is safe or not for young girls?
    Do we really trust the pharaceutical companies more than Dr. Harper?

  10. BabyPop
    Posted March 31, 2007 at 1:42 pm | Permalink

    As someone affected by cervical cancer (radical hyst about 1 year before the publicity of the disease due to the vaccine), I have mixed feelings about it. I think the consensus is that there is no consensus. Many of the same groups that defend vaccination (and mandatory vaccination) have members (and lots of numbers to back) who oppose it. Feminists are on both sides of the issue, as are those in the health care field, the education field, the policy field, etc, etc, etc.
    And as far as your “do we really trust x more than y” then to that I say: Who the hell is Dr. Harper? Is she the only scientist instrumental in creating this vaccine that opposes it being mandatory? I would have to read more about her background, credentials, and reasons behind her opposition to determine that.

  11. roymacIII
    Posted March 31, 2007 at 2:15 pm | Permalink

    That’s another of the issues. We don’t know whether or not they already have the virus.
    Why is that an issue? Sure, there are going to be a few girls that young that have already contracted the dangerous strains, but the highest estimate I’ve seen is that about 25% of women in their teens have contracted any strain of HPV, let alone the more dangerous strains, and that’s late teens, when they’re much more likely to be sexually active than, say, 11. The only question that really matters in this regard is whether or not there is a danger in receiving the vaccine once you’ve already contracted HPV. I’ve seen no study that indicated that there was a danger in vaccinating someone who’s already contracted HPV.
    The question for me then becomes, why don’t we test girls for the virus before giving them the vaccine?
    Dr. Harper: “The only way to test for the presence of HPV is through a vaginal swab – which is inappropriate for young girls.”

    I’m not a woman, so I can’t really say for sure, but why should it be inappropriate for a medical professional to do a medical test like that? Is it inappropriate for a medical doctor to see a young boy’s penis if it’s part of a medical procedure? And, again, if the vaccine doesn’t hurt a girl who’s already got HPV, why is this test even necessary?
    why should we make the vaccine mandatory for young girls when one of the scientists who was instrumental in creating the vaccine says she has no idea if it is safe or not for young girls?
    This is actually the only question that I think is really important here. Is the vaccine safe? The fact that she says it may or may not be isn’t the end-all be-all, though. It’s not like she’s the only one working on it, or like no other doctor is capable of running tests or having a valid perspective.
    There are myriad reasons why, if it’s safe, it should be made manditory. The safety issue is the only one that really concerns me, though. It looks like it’s safe right now, but I can understand being concerned about that. Generally, everything I’ve seen suggests that this is a good thing, though.
    Do we really trust the pharaceutical companies more than Dr. Harper?

  12. Alex
    Posted March 31, 2007 at 3:29 pm | Permalink

    I think it’s an overstatement to say that this qualifies as ‘using little girls as guinea pigs’. In both Canada and the United States, you are not allowed to just put a drug on the market unless you have already spent a considerable ammount of time using guinea pigs as guinea pigs, as well as running valid double-blind tests on human subjects (that part comes after the guinea pigs). If you’re allowed to sell a drug, that means that there’s no reason to assume that it’s particularly unsafe when used for its intended purpose. That’s not to say that there is not possibility that it’s dangerous, but it’s not as though we’re just sticking random chemicals in a syringe and seeing what happens.

  13. Justin
    Posted March 31, 2007 at 7:24 pm | Permalink

    I work in a Canadian provincial health department, and I have to say that from what I’ve seen, medical professionals are overwhelmingly in favour of universal vaccinations for girls.

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