tag:blogger.com,1999:blog-82877261224605151882024-02-20T01:57:00.512-08:00HPV Vaccine for Men?Informally exploring off-label use of HPV vaccines such as Merck's Gardasil in men.
I am not a doctor. This blog does not include, nor intend to include, medical advice.Joehttp://www.blogger.com/profile/06507129113803243988noreply@blogger.comBlogger17125tag:blogger.com,1999:blog-8287726122460515188.post-13228948278780854292012-02-06T08:17:00.000-08:002012-02-06T08:19:37.583-08:00HPV vaccine shows efficacy in preventing anal cancer<a href='http://www.aidsmap.com/page/2234343/'>A study in <i>Clinical Infectious Diseases</i> shows evidence that Gardasil has efficacy in the prevention of anal cancer</a> in a population of HIV-negative gay men.
To repeat a theme I've put forward many times in this blog, strains of HPV have been linked by varying degrees of evidence to nearly one dozen types of cancer, and for those we've been able to get a handle on, when we look closely, we see HPV vaccines demonstrating efficacy at reducing those forms of cancers. It is not difficult to imagine that this trend might continue as we carefully examine the rest of those types of cancer.Joehttp://www.blogger.com/profile/06507129113803243988noreply@blogger.com1tag:blogger.com,1999:blog-8287726122460515188.post-73084115680616156782011-10-25T09:47:00.000-07:002011-10-25T09:55:55.658-07:00CDC recommends vaccinating boys<a href="http://gma.yahoo.com/cdc-panel-votes-extend-hpv-vaccine-young-boys-133827046.html">The CDC today recommended vaccinating boys starting at the age of 11.</a><br /><br />I'm glad that I'm able to say "I told you so.", not just because I love being right (I do), but because this is a reflection of the fact that we have a fucking vaccine that prevents a fair number of types of cancers in both men and women, and that preventing cancer is, I believe, a good thing. <br /><br />I'm also delighted that the article indicates some of the types of cancer we have clearer evidence for. You probably saw the recent study on throat cancer and its putative links to HPV, oral sex and kissing, but there's some suggestive data beyond even the several types of cancer ABC lists, e.g, the study I linked a few months back on lung cancer, probably too early to push that link as certain (it is far from certain), but my intuition is that we'll see that link more cleanly evidenced in coming years as well.Joehttp://www.blogger.com/profile/06507129113803243988noreply@blogger.com0tag:blogger.com,1999:blog-8287726122460515188.post-69401896063270546432011-02-03T09:39:00.001-08:002011-02-03T09:56:36.061-08:00The Los Angeles Times notes another study showing that <a href="http://www.latimes.com/health/boostershots/la-heb-gardasil-men-02022011,0,2161615.story">Gardasil works in men, too.</a><br /><br />Unfortunately, they conclude:<br /><blockquote>By blocking penile and anal warts, the vaccine can reduce the incidence of the related cancers. But the incidence of both of those cancers is low, so critics of the vaccine argue that the public health benefits are not sufficient to justify the high cost of widespread vaccination for any male group other than, perhaps, homosexuals. Proponents, however, argue that women contract HPV from men and that vaccinating men bolsters herd immunity, thereby protecting women.</blockquote><br />Which is fine as far as it goes, with the information provided there, there is a fair question. What's omitted, however, is the evidence that HPV, and perhaps some of the same strains of HPV that are protected against in this vaccine, are involved in even <span style="font-weight:bold;">*more*</span> forms of cancer. For example, <a href="http://lungcancer.about.com/od/causesoflungcance1/f/hpvlungcancer.htm">HPV has been implicated as the second-largest cause of lung cancer in a study that discovered correlations between lung cancer and the incidence of HPV 16 and HPV 18.</a> So we have this virus, and it causes cancer in some bits of tissue in women, and we know that, and we see a certain correlation, and yeah, we see that same correlation in men and women with lung cancer. It may be scientifically accurate to say that we don't know that there's causation there for lung cancer, but you'd have to be a complete moron to think that causation was improbable. HPV 16 is also, according the the WHO, the cause of a variety cancers of the <a href="http://www.springerlink.com/content/q676132t254373n5/">mouth and throat.</a><br /><br />While many of these cancers are, too, rarer than cervical cancer, they add up. While everyone should cautiously consider the risks, costs and potential benefits of this as well as any other sort of medical procedure, the weak defense of the potential value of this vaccine in the Los Angeles Times is, I fear, misleading and potentially harmfully so. <br /><br />When I was growing up, "Still no cure for cancer." was a catch-phrase for the inability of science to provide anything we might want. Here we have not a cure but (in some ways, better) a preventative for cancer, for perhaps a dozen variety of cancers, but we're giving it less respect than Rodney Dangerfield. I'm baffled.Joehttp://www.blogger.com/profile/06507129113803243988noreply@blogger.com0tag:blogger.com,1999:blog-8287726122460515188.post-91449202185107954382010-12-17T14:06:00.000-08:002010-12-17T14:08:06.418-08:00While Gardasil was approved for use in preventing genital warts in men in 2009, I note that last month the FDA <a href="http://www.rttnews.com/Content/HealthNews.aspx?Id=1488535&SM=1">extended it's approval of Gardasil to include the use of it in men to prevent anal cancer</a>. Well done.Joehttp://www.blogger.com/profile/06507129113803243988noreply@blogger.com2tag:blogger.com,1999:blog-8287726122460515188.post-64090243333917067512010-02-18T13:25:00.000-08:002010-02-18T13:39:35.258-08:00Gardasil effective at preventing anal cancer in men who have sex with men.Yesterday at EUROGIN, Merck <a href="http://www.drugs.com/clinical_trials/phase-iii-data-merck-s-gardasil-efficacious-against-anal-caused-hpv-6-11-16-18-8878.html">annouced results</a> of a Phase III clinical trial of men who have sex with men. The study provided data which suggests that Gardasil is effective 78% effective at reducing the rate of anal intraepithelial neoplasia, a precursor to anal cancer. There's a pretty large confidence interval on the effectiveness percentage (roughly 40-90%), but the effect is signficant in any case.<br /><br />In addition to anal cancer, HPV strains have also been linked to cervical, neck, mouth, throat, esophogus, penile, vaginal and lung cancers, as well as a variety of kinds of warts.Joehttp://www.blogger.com/profile/06507129113803243988noreply@blogger.com1tag:blogger.com,1999:blog-8287726122460515188.post-66489399084214607732009-09-11T12:21:00.000-07:002009-09-11T12:30:01.752-07:00HPV second biggest cause of lung cancer?Y'know how I've been mentioning that HPV isn't just an issue of cervical cancer, but also neck, mouth, throat, esophogus and penis cancers? Now perhaps we can add lung cancer to that list. <br /><br />A study out of the Institute of Pathology, published in the journal "Lung Cancer" (v.65, issue 1) <a href="http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T9C-4TY8W1M-2&_user=10&_coverDate=11%2F18%2F2008&_alid=837721555&_rdoc=1&_fmt=high&_orig=search&_cdi=5111&_sort=d&_docanchor=&view=c&_ct=14&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=43d6c5ac48b0e48e312177e4ab6fa8a6">finds a strong linkage between HPV and lung cancer. </a><br /><br />The authors conclude:<br /><span style="font-style:italic;">The data suggest that HPV is the second most important cause of lung cancer after cigarette smoking and strongly argues for additional research on this issue.</span><br /><br />While nobody is saying that HPV vaccines are a cure, nor are they a single solution to cancer numbers of types of cancer some strains of HPV are involved in is very telling. I suspect that developing widespread herd immunity to carcinogenic HPV strains will have a statistically significant effect on cancer in the United States and the World. What's not to like?Joehttp://www.blogger.com/profile/06507129113803243988noreply@blogger.com4tag:blogger.com,1999:blog-8287726122460515188.post-61330314009092636302009-09-10T11:29:00.000-07:002009-09-10T13:00:21.861-07:00FDA Panel Recommends Approval for Men 9-26<a href='http://www.cnn.com/2009/HEALTH/09/09/fda.gardasil.males/index.html'>Today, an FDA panel recommended that the cancer vaccine Gardasil be approved for use in men and boys aged 9-26.</a><br /><br /><blockquote><span style="font-style:italic;">According to Anna Giuliano, an independent scientist at Moffit Cancer Center in Tampa, Florida, and the trials' principal investigator, "The data clearly demonstrates that there was a benefit to men in receiving Gardasil. Overall, we saw a 90 percent reduction in disease -- genital warts and pre-cancerous lesions -- caused by HPV in men and an 89 percent reduction in genital warts incidence.</span></blockquote><br /><br />Get that, a <span style="font-weight:bold;">90% reduction</span> in pre-cancerous lesions for the types of cancers under study.<br /><br />The FDA will likely follow the panel's recommendation. This is great news, let's be clear. This is a <span style="font-weight:bold;">vaccine for some types of cancer</span>, it's appears to be quite safe and appears to be effective in men. (As was true with women, the focus of early research has been on younger age cohorts, the lack of a recommendation for men above 26 does not mean that there's evidence against its use at ages above 26, it means that there's simply not significant data there yet.)<br /><br />This is also good news epidemiologically. If you want to wipe out a virus that causes at least a half-dozen types of cancer (cancer-causing HPV strains have been linked to cancer of the cervix, throat, mouth, anus, penis and neck), and the disease is sexually-transmitted, you're going to have a lot easier time if you don't exclude half the population you're trying to protect. To be clear, I'm not criticizing caution and this phased approach to using the vaccine, but in the long run, the more the vaccine is used across wider parts of a population the more that everyone (at least anyone that ever comes into contact with anyone else) will benefit.Joehttp://www.blogger.com/profile/06507129113803243988noreply@blogger.com1tag:blogger.com,1999:blog-8287726122460515188.post-3469416638780874782009-02-24T22:35:00.000-08:002009-02-24T22:37:00.099-08:00Merck Applies for FDA Approval of Gardasil for Men<a href='http://www.cbsnews.com/stories/2009/01/06/health/main4703200.shtml'>Story at CBS News,</a> from January.Joehttp://www.blogger.com/profile/06507129113803243988noreply@blogger.com0tag:blogger.com,1999:blog-8287726122460515188.post-30715398862883841242009-02-06T13:08:00.000-08:002009-02-06T13:59:42.897-08:00HPV Vaccine Found Effective in Men<a href="http://www.bloomberg.com/apps/news?pid=20601202&sid=aajzweDaXZh0&refer=healthcare">A Merck study of the use of Gardasil in men showed efficacy, with the vaccine demonstrating a sharp reduction in "genital warts and pre-cancerous lesions."</a><br /><br />Additional studies are ongoing, and Merck has not yet received permission to market Gardasil to men, but this is the first study that verifies, and I think pretty clearly verifies efficacy for the vaccine. <br /><br /><a href='http://www.eurogin.com/2008/EUROGIN2008_LastMinuteAbstracts.pdf'>Abstract of the talk announcing these results at EUROGIN 2008.</a> (PDF, First and fourth of the several abstracts in that document.)Joehttp://www.blogger.com/profile/06507129113803243988noreply@blogger.com0tag:blogger.com,1999:blog-8287726122460515188.post-32257098887722086222008-10-05T23:03:00.000-07:002008-10-05T23:12:05.378-07:00Three Shots and You're VaccinatedI had my final injection last Friday, I noticed only the slightest tenderness at the injection site (not having noticed any the first two times.) This completes my vaccination process.<br /><br />At this point, Merck's ongoing Phase III study of Gardasil in men continues, I'll report when and if results are published, or as other related news comes out.Joehttp://www.blogger.com/profile/06507129113803243988noreply@blogger.com0tag:blogger.com,1999:blog-8287726122460515188.post-24198400895324877252008-05-14T15:28:00.000-07:002008-05-14T15:30:25.620-07:00HPV and oral cancers in men<a href='http://www.cbc.ca/health/story/2008/05/14/hpv-cancers.html'>HPV linked to more than half of throat/tonsil cancers in men.</a> When will the Gardasil men's studies reach their endpoints? How much longer do we have to wait?Joehttp://www.blogger.com/profile/06507129113803243988noreply@blogger.com0tag:blogger.com,1999:blog-8287726122460515188.post-66325929671436545162008-04-21T15:50:00.000-07:002008-04-21T16:01:32.668-07:00Second ShotHad my second injection today. It got delayed a couple days after a minor dental thing, the next injection is four months from now.<br /><br />I didn't follow up after the first injection, I should say that I didn't notice any side-effects at all, I suspect the second one will go the same way.<br /><br />I had a lovely discussion with the nurse who did the injections, she's involved with writing protocols for the clinic, and said I was to give her a ring if I got any trouble about the injection. I said that I expected some confusion but that everyone had been cool and reasonable about it.<br /><br />I guess I should say more about this. Off-label use of any sort of procedure or medication is going to raise eyebrows, particularly if a medication someone has only ever seen given to (say) women is being given to men. Given the serious danger of error in any sort of medical prescription, <span style="font-style:italic;">it's only right</span> that unusual applications of medications, particularly off-labels ones, should raise enough attention for people to at least double-check that the prescription was, say, written correctly. This isn't bias or discrimination, it's just good "systems engineering" to make sure that the chances of medical error are reduced. I don't sweat it, if you find yourself in my position, you shouldn't either.Joehttp://www.blogger.com/profile/06507129113803243988noreply@blogger.com0tag:blogger.com,1999:blog-8287726122460515188.post-19958777814587875422008-02-18T09:18:00.000-08:002008-02-18T09:22:06.850-08:00First shotLast Friday I dropped by the medical foundation for the first of my three Gardasil shots. <br /><br />I noticed no side-effects, it's possible that there was slight swelling that was hard to see from my point-of-view of the injection site on my left shoulder. <br /><br />The nurse injecting me, as well as the paperwork, made a point of referring to the shot as "the HPV vaccine" rather than by its product name. I wondered about this for a while, but surmise that a generic name like that is more likely to trigger a "wait a minute" response in case of error, so I can see at least one possible point.<br /><br />Next injection is two months from now, the one after is four months later.Joehttp://www.blogger.com/profile/06507129113803243988noreply@blogger.com0tag:blogger.com,1999:blog-8287726122460515188.post-44279133373210345142008-02-13T10:48:00.000-08:002008-02-13T10:50:58.279-08:00ApppointmentFirst injection at 10:15 Friday. Making the appointment was a little strange, I ended up having to call to make the appt. with the injection clinic, and I could, early in the call, hear what I imagine was confusion on the part of the person I was talking to, eventually she said this might be the first injection of a guy done at their facility. Interesting!Joehttp://www.blogger.com/profile/06507129113803243988noreply@blogger.com0tag:blogger.com,1999:blog-8287726122460515188.post-29009647819994993712008-02-09T07:08:00.000-08:002008-02-09T07:15:38.488-08:00HPV and oral cancer<a href='http://biz.yahoo.com/ap/080201/hpv_oral_cancer.html?.v=1'>This article</a> discusses HPV being the cause of an increasing proportion of cases of oral cancer in men, likely both because of an increase in oral sex, as well as a decline in smoking, reducing the number of smoking-related oral cancer cases.<br /><p><br />That same article notes that Merck intends to ask for FDA approval to use Gardasil on men sometime in 2008, other reports I've seen say the studies they have might still not apply to my age group.Joehttp://www.blogger.com/profile/06507129113803243988noreply@blogger.com0tag:blogger.com,1999:blog-8287726122460515188.post-44451716207024479902008-02-08T13:08:00.000-08:002008-02-08T13:12:48.559-08:00Going for It!My doctor has agreed to give me an off-label Gardasil vaccination, and I have just indicated to her that I'd like to proceed with it.<br /><br />Okay, now, some important disclaimers:<br /><br />I am <span style="font-style:italic;">absolutely not</span> recommending that you follow my lead, or do not follow my lead in this. I am by necessity working with limited information. I will share with you my thinking, but only for completeness sake. I am not a doctor. My doctor did not recommend that I have this vaccination. The FDA has not approved it for use in patients like myself.<br /><br />Those disclaimers aside, do I think this is a good idea for <span style="font-style:italic;">me</span>?<br /><br />Let's break it down. I think there are two basic concerns. Safety and efficacy. On top of that, there's are just costs (time and money, it won't be covered by insurance), and meta-concerns.<br /><br />First, safety. Published tests only cover Gardasil safety in women. Two things give me additional comfort here, but they should not necessarily be something *you* take for granted. First, Merck has been running for several years a test on men. These tests have not been released to the public, but Merck has announced it intends to ask for approval for men this year in any case. While I have no illusions that Merck would not push for approval of a borderline safety case, the completion of the study, combined with the rarity of gender-specific safety issues in similar vaccines, make my comfort in the general safety of this choice strong.<br /><br />Second, efficacy. I am far from convinced that this will be effective. The number I keep <i>pulling out of my ass</i> is about 30%, reflecting that the vaccine is effective in younger unexposed women, but lacking additional data on older people and men, and without any actual evidence that I have or have not taken on various HPV strains. I'd almost be surprised if I'd never taken on HPV in some strain or another at this point in my life. Moreover, Herpevac, IIRC, a HSV vaccine, was shown to be effective in women and not men, there's some precedent for gender-specific activity, although that may or may not reflect the differences in the anatomy. Very little is known (or at least published) about effectiveness with respect to anal, penile, throat and mouth cancers. So, I pull "30%" out of my ass. That's enough that it might make a difference to me, or a partner, or a partner's partner someday, but far from anything certain. If I'd come up with 10%, I wouldn't be doing this. If I'd come up with 70%, I would have pushed for this sooner. <br /><br />Price: I'm paying for this out of pocket. *shrug*. The three injections are going to run me about $360, as I understand it. But that's why I have money, to make my life better. I'm not particularly cost-sensitive, of course that's an issue for most folks.<br /><br />Other terms: One concern my doctor expressed, not so much as an accusation as a "I would be concerned if X, but I don't imagine that's your way.", was that I'd presume efficacy and change my behavior based on the thought that the vaccine was effective when it might not be. This both has implications for my own health and my partners, and this leaves me, I feel, with an ethical duty to not only explain to potential partners why they should not feel particularly "safer" because I've done this. And I think that's probably right.<br /><br />Anyway, I weighed it all, and there, the decision is made, the die is cast. Wish me luck. Wish us all luck, a successful vaccine that prevented oral, throat, penile anal and cervical cancer in large swaths of the population would be a very great thing indeed.Joehttp://www.blogger.com/profile/06507129113803243988noreply@blogger.com0tag:blogger.com,1999:blog-8287726122460515188.post-76519510409209210412008-02-08T13:02:00.000-08:002008-02-08T13:08:16.724-08:00Welcome!Gardasil, Merck's HPV vaccine, currently has approval for use in the US "on-label" for younger women. This vaccine has the potential to make a difference not only in the landscape of cervical cancer, but also, possibly, other cancers that both men and women might be at risk for--oral, throat, penile and anal cancers all seem to have some correlation with HPV infection.<br /><br />For this reason, I explored being vaccinated with Gardasil "off-label" with my doctor. This blog will talk about the vaccination process and some of the issues surrounding Gardasil as well as off-label uses of Gardasil, particularly in men.<br /><br />Now, the issues here are complex, and I'm using this blog to explore them and share them, but you should take everything here with a great deal of skepticism, for reasons that I will be elaborating on in future posts.<br /><br />Until then, welcome.Joehttp://www.blogger.com/profile/06507129113803243988noreply@blogger.com0