tag:blogger.com,1999:blog-55106557033361255012024-03-13T22:25:14.636-04:00Gardasil Side EffectsA Public Forum on Gardasil Side EffectsKristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.comBlogger83125tag:blogger.com,1999:blog-5510655703336125501.post-88919027914384717742011-10-13T07:19:00.000-04:002011-10-13T07:19:28.343-04:00No parents, no VAERS reports on GardasilGovernor Jerry Brown’s failure to veto California’s new anti-STD law—allowing clinics to give Gardasil shots to children without their parents’ knowledge or permission—could have a dangerous side effect.<br />
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Say your kid started having seizures. If you didn’t know he’d been given a vaccine, it wouldn’t even cross your mind to file a VAERS (vaccine adverse event reporting system) report. Nor would you think to contact the vaccine manufacturer. <br />
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VAERS is already notoriously fallible. Although those searching it are wont to say, “Look! It says on VAERS that x number of people have—died, acquired a seizure disorder or an autoimmune disease, whatever— from Gardasil!” that’s rarely the case. Doctors and individuals report anything they believe MIGHT be a side effect or adverse event related to the HPV vaccine, and the scientists of VAERS and the FDA are supposed to follow up and try to determine patterns that bear investigation. Many ‘side effects’ are reported. Some will inevitable turn out to have nothing to do with a vaccine, or not as far as the FDA can determine at this point, anyway.<br />
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Equally, events that could be related to Gardasil frequently go unreported because a doctor refuses, or sees no need, to make a report. Or maybe a parent fails to connect the dots and ask questions. Look at Jenny Tetlock’s case—her parents turned up two rare and virtually identical cases that hadn’t been reported. Like I said, VAERS is fallible.<br />
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And are these busy clinics really going to monitor the health of the kids they are merrily giving the shot to? For months, a year, more? File VAERS reports on anything that seems odd so that the FDA's records are complete? Doesn't seem likely, does it?<br />
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I can't think of any other vaccine that has been gifted with such potentially lax oversight.<br />
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Here I should say that there is as yet no official link between seizures and Gardasil yet, although the anecdotal evidence is mounting and the FDA is apparently beginning to investigate it more thoroughly <a href="http://www.gardasilhpv.com/2010/09/gardasil-and-seizures-is-vaers-now.html">(see here)</a>. <br />
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But how can the FDA even properly begin to make possible connections between Gardasil and seizures, or Gardasil and autoimmune disease, or Gardasil and blood clots, when VAERS reporting is limited even more?<br />
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Oh, wait….<br />
<br />Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com19tag:blogger.com,1999:blog-5510655703336125501.post-867312927086806172011-10-04T11:54:00.000-04:002011-10-04T12:11:30.672-04:00Why Governor Jerry Brown should veto pro-Gardasil AB 499<br />
Presidential hopeful Rick Perry got into an awful lot of trouble for trying to mandate Gardasil, the HPV vaccine. But at least parents would have had the chance to opt out for religious or other reasons. <br />
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AB 499, which has been passed by California’s legislature and is now awaiting a yay or nay from Governor Brown, not only doesn’t offer an opt-out, it also ensures that parents may not even know if their son or daughter has had the vaccine. I’ve got to hand it to Merck; that’s an absolutely brilliant way to ensure that potential side effects and adverse events aren’t reported for study. <br />
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Here’s the thing that shocks the heck out of me. I’ve had tons of people try to badger me into getting Gardasil for my daughters, including pediatricians and gynecologists. And, frankly, it always turns out that I know more about the vaccine and HPV than they do. <br />
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“It’s almost 100 percent successful in preventing HPV infection,” they say. Sure—for the two oncogenic strains it contains, but not for those that currently cause some 34 percent of cervical cancers, nor for any that might fill the biological niche left by the vanquished strains. And the latest results show an overall 17-45 percent reduction in cervical abnormalities, not 100 percent. “Really?” they say. <br />
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Uh, yes.(Shouldn’t you KNOW this?) <br />
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Maybe I’m old-fashioned, but I believe that being fully informed means…being fully informed, both as the giver and as the receiver of the HPV vaccine, or any other healthcare choice. That’s the basis for intelligent decisions.<br />
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Yet if AB 499 becomes law, some spotty little twerp who doesn’t even know that smoking hugely ups the chances of getting a persistent HPV infection—or, for that matter, why the word ‘persistent’ is important—can pull the HPV vaccine trigger on a 12 year old. The kid won’t be considered smart enough to have a beer for another 9 years, mind you, but somehow he’s smart enough to completely understand, and consent to, the risks and rewards of a vaccine. Right now. Oh, and of course he’s confident enough to say ‘no’ to a doctor if he weighs the risks and rewards and decides against it. <br />
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Yeah, sure. <br />
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<strong>So I’m one of those 'crazy anti-vaxxers,' right?</strong><br />
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I fully expected to get Gardasil for my kids when it came out. But I'm a parent. So I researched and thought carefully about our options. What I found was that there is a lot of anecdotal information about autoimmune disease being triggered, a plausible theory backed by a reputable study about why this might be so, pause for thought in Merck’s own studies; and strong evidence that Merck’s marketing machine has emphasized the risks of HPV, completely ignored the role of individual lifestyle choice, and minimized potential risks of the vaccine. <br />
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And as The Lancet puts it, autoimmune diseases “arise in genetically predisposed individuals but require an environmental trigger.”<br />
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My kids have a family history of autoimmune disease, specifically MS. One child has already been diagnosed with Raynaud’s disease, which could be something or nothing. We try to keep the environmental triggers to a minimum. So, as a parent, I made an informed choice to get the kids Menactra to avoid a rare but terrifying disease, but nixed the Gardasil, which seems largely unnecessary for our particular family. (We eat our veggies, don’t smoke, get the whole healthy immune system thing, and understand the importance of regular Pap smears.)<br />
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Our choice, and one that we have every right to make. Other families with different circumstances and habits might well, even SHOULD, make a different choice. This is America, right?<br />
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Governor Brown has already taken steps against a circumcision ban—ironically, circumcision is proven to help reduce the spread of HPV—and vetoed a ski-helmet law on the basis that parents have the right and the ability to make reasonable choices for their children. So let’s hope good things come in threes.<br />
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<strong>And Planned Parenthood should be ashamed of itself, too.</strong><br />
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Me, I’m Planned Parenthood’s dream. I’m socially liberal. We have health insurance, so we don’t use their services, but I’ve always donated so that people who don’t have health insurance have options too. <br />
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I don’t run screaming at the very idea of my kids having sex, although I’ve given them The Lecture about rights and responsibilities, physical, emotional and spiritual. <br />
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I’ll talk to them about anything and frequently do, much to their horror. (Particularly, it must be said, after a large g & t. Yum—Hendricks or Cardinal gin. Eat your heart out, Big Brands!) <br />
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If they want to go to a gynecologist, I’ll drive them there, pay the bill, and stay out of the room while they’re talking. But again, I understand that some kids, maybe even mine, can’t discuss some things with their parents. Although it pains me to think it’s necessary, I do think PP needs to provide services to kids so that they can be marginally more intelligent about the choices teenagers are wont to make.<br />
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But the organization’s arrogant support of AB 499 is going way too far for me. So Planned Parenthood is quite literally off MY Christmas list. <br />
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<strong>No perfect choices.</strong><br />
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It’s quite possible that in 10, 20, 30 years one of my kids will be one of the tiny minority of women who suffer the effects of a persistent HPV infection, and I’ll bitterly regret my choice. It’s also quite possible that if I gave it to them I would be one of the tiny minority of parents who bitterly regret saying yes to Gardasil, like the Tetlocks or the Tarsells.<br />
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There’s no perfect choice. As a parent, I make lots of probably imperfect, but informed and thoughtful, choices. And guess what, Assemblywoman Toni Atkins and the policy makers of Planned Parenthood? <br />
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It’s none of your damn business.<br />
<br />Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com8tag:blogger.com,1999:blog-5510655703336125501.post-15737219562842865382011-09-20T15:42:00.000-04:002011-09-20T15:42:26.665-04:00Think politics and religion are divisive? Try Gardasil!OK, gotta admit I laughed quite hard over the whole Michele Bachmann debacle with Gardasil. I’m no unconditional fan of Gardasil, the controversial HPV vaccine, but Bachmann’s remarks about Gardasil causing mental retardation were simply over the top. It’s possible that she was referring to Alexis Wolf, a teenager whose parents believe that she suffered brain damage as a result of Gardasil-induced seizures, but who knows? Ms. Bachmann is keeping mum.<br />
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Still, the bigger issue is substantially more depressing. It’s that the subject of vaccination in general, and Gardasil in particular, is so divisive.<br />
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I’ve read multiple blogs where scientists do a knee-jerk ridicule number on anyone who questions Gardasil, and then go on to deride anything but mainstream medicine. I’ve read multiple blogs where anti-vaxxers do a knee-jerk ridicule number on anyone who supports Gardasil, and attribute nothing but mercenary motivation to the medical industry in general. <br />
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My God, that’s depressing. And worse, unproductive.<br />
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Vaccinations are a miracle. Ask anyone who has suffered polio. But are they are a perfect miracle? Nope. Not by a long shot (pun intended. Sorry about that).<br />
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My hope is that both scientists and thoughtful consumers will eventually recognize a basic fact: some vaccines are pretty damn great, but that doesn’t mean that scientists and consumers alike should roll over and stop asking serious questions about them. And it doesn’t mean that you’re an anti-science idiot if you just say no sometimes. <br />
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Human physiology is an infinitely complex thing, and we’re a long way from fully understanding it. We know vaccines can do proven damage in a tiny minority of cases. We should be working to understand why, and how we can eliminate that risk too. <br />
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We should be looking for the unintended consequences that come with many well-intentioned interventions and eliminating them. And we should be asking questions about a possible cascade effect—perhaps you don’t drop dead on the spot. But could components of multiple vaccines build up over the years, and/or intensify other environmental triggers in the system? Can we identify those people who could be particularly vulnerable to autoimmune disease triggers, and come up with a strategy for them? <br />
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Can we be honest about the risks of disease, the risks that lead to disease (e.g. smoking and lousy diet contributing to persistent HPV infection) and the small risks of vaccination? For God’s sake, can we all act, and react, like grown-ups?<br />
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The best exchange I ever had with a GYN was with one who at first was very skeptical about the idea that eating your vegetables can reduce the incidence of persistent HPV infection by some 50 percent. I gave her a link to a study. And instead of going very silent, or finding some nit-picky thing to focus on, or rolling her eyes, “Thank you,” she said. “This looks extremely interesting. I’ll read it carefully and see if I should talk to my patients about it. I had no idea.”<br />
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Now THAT’S a person who can hear both sides of the conversation. And so I could hear her, too, when she said, “But you should stand in my shoes for a day to understand why I support Gardasil.” <br />
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Hey, can we talk?Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com16tag:blogger.com,1999:blog-5510655703336125501.post-34763782344561896882011-08-23T14:25:00.000-04:002011-08-23T14:25:25.637-04:00Gardasil’s Adverse Effects: The Institue of Medicine Reports<br />
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On Thursday August 25 at 1:00 PM the Institute of Medicine’s Ellen Wright Clayton (Chair of the committee) plus S. Claiborne Johnston and Douglas Barrett (members of the committee) will host an audio webcast to discuss the committee’s new report, Adverse Effects of Vaccines: Evidence and Causality . The report will be released at 11 AM on August 25 and can then be downloaded at www.iom.edu/vaccineadverseeffects.<br />
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The report is not just about Gardasil—it’s about all vaccines covered by the Vaccine Injury Compensation Program, including the chickenpox, flu, Hepatitis A and B, meningococcal, tetanus, MMR, pertussis, diphtheria, tetanus, etc. It will review the “epidemiological, clinical, and biological evidence regarding adverse health events associated with specific vaccines…the committee will author a consensus report with conclusions on the evidence bearing on causality and the evidence regarding the biological mechanisms that underlie specific theories for how a specific vaccine is related to a specific adverse event.”<br />
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<strong>Want to take part?</strong><br />
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Email your comment to vaccinesafety@nas.edu, but bear in mind that any comment and identifying info you give, including your name, email address, and physical address, will be included in the Public Access File.<br />
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Register to take part in the audio webcast at www.nationalacademies.org; you’ll also find a link to the report there after 11 AM and will be able to email questions to the committee during the webcast via a link.<br />
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Download the report at 11 AM and make a note of any questions you might have. Should be interesting.<br />
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Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com11tag:blogger.com,1999:blog-5510655703336125501.post-61034744832199275672011-07-29T12:10:00.000-04:002011-07-29T12:10:48.644-04:00Gardasil vaccines tainted by debrisLet the PR begin. Merck says it isn’t aware of any ‘adverse events’ stemming from bits of charred shrink wrap found in some vials of Gardasil, Varivax and Pneumovax; of course, the pharma company didn’t think any had stemmed from previous problems with metal particle contamination or cracked vials, either. <br />
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Not that it would have necessarily rushed to tell the FDA about problems anyway. The FDA saw fit to give Merck a rap over the knuckles for delaying adverse event reporting—something that readers of this blog have complained about endlessly after bad experiences. And according to Merck, the worst that recipients of one of years' worth of tainted vaccines can expect is injection site irritation. They know this how, exactly?<br />
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Still, you can rest easy.<br />
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“What we are seeing is that the severity and criticality of observations [by FDA inspectors] are declining,” James Robinson, vice president of vaccines product and technical operations, told the Wall Street Journal. “What we’ve seen in the last few inspections tells us we’re on the right track.” <br />
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Gosh. That makes me feel a whole lot better about the potential for one of my kids having a particle of metal or burned plastic injected into her flesh, and thence her system. Things are better than they were! Who needs perfect?<br />
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Just repeat after me: it’s statistically insignificant, and so is anything you might suffer afterwards.<br />
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Meanwhile, my daughter needs a tetnus booster. Guess I'd better go along to check for cracked vials and to cross my fingers about contamination.Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com9tag:blogger.com,1999:blog-5510655703336125501.post-33194772487716691072011-07-21T09:55:00.000-04:002011-07-21T09:55:24.508-04:00Would you choose Gardasil or circumcision against HPV?I know that guys who haven’t been snipped hate to hear this, but a new study in South Africa might make you want to revisit the subject of circumcision in terms of HIV, HPV, genital warts, etc. (and make women check out prospective partners a little more closely). The study shows that circumcision reduces the risk of contracting HIV by 76 percent. <br />
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76 percent. WOW. And of course, if you don’t get HIV, you’re not going to pass it along to your partner(s), either. <br />
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While it’s hard to say whether those statistics would hold up in the US, where life, health and risks are different, it’s hard to imagine that circumcision could make less than a very worthwhile difference in transmission rates. And it’s not just a matter of cleanliness. The cells in the foreskin are particularly vulnerable to viruses.<br />
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Oh, and then there’s the nasty subject of genital warts. Circumcision cuts (sorry) that chance by 28-34 percent, too, according to another randomized trial in Africa.<br />
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HPV? Not so much. One study found a 27.9% prevalence of high-risk HPV genotypes in uncircumcised males and only an 18.0% prevalence in circumcised males. Their female partners’ risk was 38.7% (uncircumcised partner) and 27.8% (circumcised partner) and it is, of course, impossible to know which way the infection went. But that’s still significant, either as an adjunct to the HPV vaccine series—whether Gardasil or Cervarix—or as part of a well-thought out strategy to lower risk.<br />
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As reported by Michael Smith for MedPage Today: “The procedure offers limited protection against most high-risk types, (researchers) noted, while the HPV vaccine is highly effective, but only against a limited number of genotypes. "The two interventions are likely to have important synergistic effects," they concluded.<br />
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The odd thing is that Medicaid, which serves some of our most vulnerable populations, doesn’t pay for circumcision in 16 states, and yet the US is currently paying for males to get circumcised in Swaziland to the total tune of $30 million. Talk about “things that make you go hmmmmmmm…”<br />
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The current pro-Gardasil campaign has perhaps made many people lose sight of the fact that there’s a heck of a lot worse things out there than HPV. With rates of women getting their annual check-ups already dropping in Australia, where Gardasil has been provided free by the national health system, it’s clear that the vaccine carries a subconscious feeling of… phew, I’m safe from STDs.<br />
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You’re not. Whether you choose Gardasil or not, just remember that a multi-pronged (sorry again) approach to sexual health is crucial. Keep your immune system healthy (get enough sleep and enough veggies and fruits, quit smoking etc.), use condoms (which will help against HPV and HIV but won't eliminate the risk, particularly for HPV), and apply the infamous Seinfeld “sponge-worthy” criteria to potential partners (is he/she really worth it?). <br />
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And guys, it’s up to you. If you’re not circumcised, think about it for your sake and your partner’s sake. Would you do it? If not, why not?Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com10tag:blogger.com,1999:blog-5510655703336125501.post-90428736575397275442011-03-03T12:57:00.000-05:002011-03-03T12:57:25.610-05:00Got the Gardasil vaccine—and then Raynaud’s disease?<!--StartFragment--> <br />
<div class="MsoNormal">I can’t even begin to count the number of readers who’ve commented or emailed about suddenly developing Raynaud’s disease after getting at least one shot of Gardasil.</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">Gardasil has, of course, been associated with myriad problems from seizures to a rapid-onset ALS type disease, as well as Raynaud’s. However, the data has so far only led the FDA to warn about a heightened risk of syncope and blood clots. There’s currently no evidence that Gardasil causes Raynaud’s disease; it’s not uncommon and there is also some evidence that it can be triggered by hormonal birth control, which many girls are beginning to take around the time they get Gardasil.</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">But whether your Raynaud’s eventually turns out to have been caused by Gardasil or the link is definitively disproved, it’s a serious nuisance.<span style="mso-spacerun: yes;"> </span>It causes blood vessels in fingers and toes to clamp down painfully, leading to blisters—even tissue and nerve damage in severe cases. It’s sometimes associated with an underlying disorder such as lupus. It can mean that something as simple as holding a cold Coke or reaching into the freezer can trigger attacks; winter sports are virtually out of the question.</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">Well, maybe. When student Natalie Deuitch was told she had Raynaud’s and warned to either stay warm at all times or start taking blood pressure meds, neither option was acceptable. She loved skiing and outdoor pursuits. Her blood pressure was perfectly fine. And she was sick of the painful blistering on her always-purpling toes.</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">So she researched ways to fix it, and came up with a submersion technique that retrains fingers and toes to react normally to cold. To her astonishment, it helped. A lot.</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">“One night in November my friends and I lay out on the Blue Ridge Parkway, watching a meteor shower. It was 30 degrees and I didn’t get even the slightest Raynaud’s attack,” she marvels. “On the down side, I lost my excuse for not shoveling snow off the driveway!”</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">Natalie hopes to do a lot more research into Raynaud’s and ways to easily fix it—and, she wonders, if you fix Raynaud’s, could you also head off underlying conditions? She’d love to be in contact with other Raynaud’s sufferers for discussion and research. So if you want to ditch the effects of Raynaud’s disease, whatever the cause, and be able to grab a cold one this summer, check out Natalie’s blogspot (<a href="http://nomorepurpletoes.blogspot.com/">http://nomorepurpletoes.blogspot.com/</a>) or email her at <a href="mailto:nataliedeuitch@yahoo.com">nataliedeuitch@yahoo.com</a></div><div class="MsoNormal"><br />
</div><div class="MsoNormal">Oh, and don’t forget—if any condition starts after you get the Gardasil shots, file a VAERS report. Unfortunately, the only way correlation and causation link up is when researchers have sufficient data and can see a significant blip in the norm. Fill out a RateADrug survey too, while you’re at it!</div><!--EndFragment-->Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com10tag:blogger.com,1999:blog-5510655703336125501.post-39881620682305816982010-09-22T17:18:00.000-04:002010-09-22T17:18:13.669-04:00Seventeen Magazine’s ‘Scary Sex Rumors’ about the Gardasil HPV VaccineOuch. Seventeen Magazine gets both a carrot and a stick for its September 2010 issue’s ‘Scary Sex Rumors’ item about Gardasil. <br />
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Addressing the ‘rumors’ and forwarded emails about how “the HPV vaccine has been killing teenage girls!!” the venerable teen magazine came up with both some sensible advice and some scary sex rumors of its own.<br />
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I applaud the writer for noting that “The bottom line is, any vaccine can have some risks, and you need to weigh those risks against the risks of skipping it…talk to your doc, who can help you decide.”<br />
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Although most doctors know very little about Gardasil beyond the standard information, still, I like the advice to discuss the HPV vaccine—not just automatically get it—and the acknowledgement that there’s a balance between risks and rewards for each individual, depending on lifestyle and family history.<br />
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And I can’t exactly argue with the line “while there have been rare reports of scary side effects, like seizures, they haven’t been directly linked to Gardasil.” They haven’t. While there are some mighty coincidental cases of seizures following Gardasil ( and see <a href="http://www.gardasilhpv.com/2010/09/gardasil-and-seizures-is-vaers-now.html">here</a>), we’re simply in the follow-up phase where the FDA continues to monitor reports of adverse events like Graves Disease, lupus, Guillain-Barre, ALS, etc., until they can see statistical differences between vaccinated and unvaccinated populations. So far, there have been no links.<br />
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I do have to say here that monitoring, of course, involves people taking the initiative to make a report to VAERS even when discouraged by their doctors. It’s thought that potential side effects are both under-reported and over-reported—under-reported because people usually don’t connect the dots unless an adverse event happens immediately; such under-reporting may happen frequently (consider the Jenny Tetlock case, where Ms. Tetlock’s parents discovered two very similar cases of a rapid-onset ALS-type disease that had gone unreported). And side effects may also be over-reported—for instance, at least one of the deaths attributed to Gardasil was due to a car accident, and to the best of my knowledge not because the driver was seizing post-vaccination. <br />
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So if you get a vaccine, and then, say, an autoimmune disease, please report it whether you or your doctor think it’s relevant or not. The FDA will sort it out and they can only assess adverse events properly when they’re fully informed .<br />
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But where I get angry—actually, really angry—is when I see this sentence. “The chances of having a serious problem are really unlikely (less than 2 in 10,000) but the risk of getting HPV in your lifetime is huge (8 in 10).”<br />
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True, 80 percent of women will catch some strain of HPV during their lifetime. What the writer doesn’t mention is that as many as 95 percent of infections are shrugged off by the immune system, leaving behind, it’s thought, a natural immunity. Nor does s/he mention that behaviors such as smoking and poor diet seriously up the risk of an infection becoming persistent and therefore potentially leading to cervical abnormalities, even cervical cancer. Nor does s/he note that because not all oncogenic strains of HPV are included in the vaccine, it’s essential to continue regular gynecological exams. Thus far, trials show overall reductions of anywhere from 17 to 45 percent in colposcopies, cervical abnormalities, etc. <br />
Nope, Seventeen echoes Merck’s marketing campaign, which vastly exaggerates the risks of HPV and minimizes the risks of the vaccine, and doesn’t mention behavioral risks (as in, heavy smokers are 27 TIMES more likely to suffer cervical abnormalities) at all. The implication is that you're highly likely to get cervical cancer if you don't get Gardasil and virtually certain not to get it if you do. <br />
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Now that’s a scary sex rumor.Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com3tag:blogger.com,1999:blog-5510655703336125501.post-43722599028229682452010-09-13T14:29:00.000-04:002010-09-13T14:29:55.281-04:00Gardasil and seizures: is VAERS now taking a connection seriously?Theresa E was floored when she got a phone call from VAERS, the FDA’s vaccine adverse event reporting system. Yes, the caller said, investigators did indeed feel that Theresa’s daughter’s seizures could be a serious reaction to Merck’s anti-HPV vaccine, Gardasil.<br />
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Although Theresa had had a hunch that her daughter’s intermittent seizures could have been triggered by the Gardasil vaccine, doctors completely pooh-poohed the idea. <br />
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But eventually, encouraged by information from Nina Kenney, whose daughter had also begun suffering seizures post-vaccine, she insisted on filing a VAERS report. Her doctor had for months been “too busy” to get around to the paperwork, she said, “and when I took the almost-completed form to him to finish he was a little shocked that I was serious.” <br />
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So when someone from VAERS called shortly afterwards to verify the information she’d provided and made the comment about a serious reaction, Theresa was so stunned that she asked her caller to repeat it. She’s relieved to see that taking the time to report to VAERS was worthwhile; her information will add to what investigators know.<br />
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<strong>Yes, report post-vaccine seizures—even if your doctor discourages you</strong><br />
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"If I can prevent one more person from getting hurt, it’s all worth it. Please encourage people to send as much concrete information to VAERS as possible, because I think that’s why they listened. I didn’t just send the form. There isn’t enough space on the form to give much info, so they got a two-page letter, copies of the school report about where they found my daughter and letters stating that the (Gardasil) vaccines were stored improperly. I felt I was sending too much info, but I am glad I did. Whether it is an active ingredient or an inactive ingredient, they need to find out for sure.”<br />
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None of this is to say that there is now a proven connection between Gardasil and seizures: there isn’t, or at least, not at this point. Teenagers do develop epilepsy and seizure disorders with or without Gardasil. But when seizures follow vaccination in multiple cases, medical investigators need to—well, investigate. That’s what the FDA is supposed to do. And, thank God, they’re now doing it.<br />
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<strong>Do neurologists ask about pre-seizure vaccinations yet?</strong><br />
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In February 2009, Gardasil vaccinations were briefly suspended in Spain after three unrelated incidents in which girls began suffering repeated convulsions hours after being vaccinated with the HPV vaccine. Eventually, authorities determined that the vaccine might have triggered, but not caused, the convulsions—a distinction that still eludes me in practical terms—largely because there were few similar cases on the books. (See <a href="http://www.gardasilhpv.com/2009/04/double-speak-in-spain-over-gardasil.html">here</a>). With the best will in the world, investigators can’t reconcile correlation and causation without enough data. So just make the reports, already. <br />
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After a young girl, Jenny Tetlock, died post-Gardasil vaccination from a highly unusual ALS/autoimmune-type disease mediated by immune response, her neurologist, knowing of at least one similar case, announced to fellow neurologists that she planned to make a study of girls with ALS-type diseases (see <a href="http://www.gardasilhpv.com/2009/10/is-there-gardasil-als-connection.html">here</a>). Finding any such cases requires that neurologists make a habit of asking patients whether they got the vaccine. <br />
<br />
There are so many cases of post-Gardasil seizures that surely it would be smart to call on neurologists seeing new seizure patients to ask them that question, too. Just ask the question—did you get Gardasil? Menactra? Adacel? Together or separately?—and file any appropriates reports with VAERS. Then, if there’s a connection, we’ll know.<br />
<br />
Theresa’s daughter got her first Gardasil shot, along with Menactra, in July 2009. She suffered a commotion-causing ‘sleepwalking’ episode in her dorm in August and a second episode after the second shot. Theresa believes that both episodes were really seizures as her daughter was disoriented and appeared to observers to be on drugs; the second time the teenager recalls feeling twitchy and exhausted (common post-seizure symptoms) afterwards. Then her parents actually witnessed her seizing while they were all on vacation. The experience was devastating, but at least they finally knew was wrong. Now in her second year of college, she’s been diagnosed with a nocturnal seizure disorder and is taking Keppra twice daily.<br />
<br />
<strong>Drugged, drunk—or seizing?</strong><br />
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The drugged appearance is all too familiar to Nina. “I’ve never seen Nora seize, but a few weeks ago I saw her right after a seizure. She was extremely disoriented, and in fact I thought she was drunk. She was very perturbed as well. Flat out mean. She tells me this behavior is a common factor with her seizures. She has yelled at paramedics and anyone who's nearby right afterward. Furthermore, she has no memory of the seizure and often, the entire day leading up to the seizure. Post seizure, she's exhausted and has a terrible headache for a day or two afterward.” <br />
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When Theresa witnessed her daughter’s seizure on vacation, “our daughter did appear to be drunk or really out of it; she could not correctly answer the questions for paramedics after the seizure. After a bit, she did.”<br />
<br />
Which makes one wonder whether some seizures go undiagnosed because the usual reaction to a young adult who appears to be drunk or drugged is an eye-rolling “kids will be kids.”<br />
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“As far as the MRI and EEG,” says Nina, “Nora's MRI and CT scan have been normal. She's only had one EEG and, according to the first neurologist she saw, it showed a 'slight abnormality'. I think he used the term compact partial seizure.” <br />
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The ER doctor’s diagnosis after Nora’s first seizure was syncope/dehydration because he attributed the episode to alcohol consumption the day before—even though the episode included severe tongue-biting, “a classic seizure symptom,” according to the neurologist Nora later saw. When she seized again after her second Gardasil shot, however, the final diagnosis was Epileptic Seizures, and her VAERS report now shows it as a “positive vaccine re-challenge”—which basically means that the same symptoms, or worse symptoms, presented themselves with the second shot, making a connection highly plausible. Nora did not get the third shot.<br />
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<strong>Two girls, two different VAERS responses, two years apart</strong><br />
<br />
Nina had a very different experience with reporting Nora’s seizures to VAERS two years ago.<br />
<br />
When she made the connection between Gardasil and Nora’s seizures, she faxed a letter to Nora’s neurologist, sent another to the pediatrician, filed an online VAERS report, called Merck, filed an online report with Sanofli-Pasteur (because Nora had also received a Menactra shot with her first Gardasil shot), and filed an online report with the NVIC. Only the NVIC and the pediatrician responded.<br />
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A few months later, Emily Tarsell, whose daughter Chris died of still-unknown causes after receiving the Gardasil vaccination, suggested that Nina contact the FDA for the Gardasil lot numbers and reports. When the reports arrived, Nina discovered that Nora’s VAERS report seemed to include Nora among the girls who fainted upon getting the shot, probably because of the ER report after the first episode. She immediately faxed VAERS a letter; they contacted her only to get her neurologist’s contact information and left the report essentially unchanged.<br />
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Only after Nina sent a strongly-worded letter to the Vaccines and Related Biological Products Advisory Committee, prior to their meeting to decide whether to approve Gardasil for boys, did VAERS actually contact her for a timeline of events and further information. Nina’s letter had commented that a year after she’d made all those reports, no-one had bothered to contact her. Two weeks later, she heard from VAERS. After an entire year. <br />
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It bears repeating: Gardasil is not proven to cause seizures in susceptible individuals. If you're considering Gardasil for yourself of your child, you and your doctor need to honestly discuss its pros and cons given your individual circumstances and family health history.<br />
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But, “I subscribe to the Epilepsy Foundation site's parent community,” says Nina, “and there are MANY members whose seizures started after Gardasil. So in spite of what most in the medical community say, I believe there's a connection.” <br />
<br />
And it appears that if there is one, the FDA's finally started seriously looking for it. So do your part. If your child's seizures began only after an adolescent vaccination of any kind, file the report. With or without the help and/or encouragement of your doctor.<br />
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<em>© 2010 www.gardasilhpv.com</em><br />
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<em>Permission is freely given to accurately reproduce the first five paragraphs of this article, along with a link back to this site and the entirety of the article. </em>Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com17tag:blogger.com,1999:blog-5510655703336125501.post-18462015972591932562010-08-25T17:08:00.001-04:002010-08-25T21:36:22.446-04:00Worrisome Gardasil side effect: cervical cancer screening rates drop significantlyThe number of young women getting regular Pap tests has dropped quite significantly in Australia, where Merck’s Gardasil vaccine has been administered to almost all girls aged 12-13 via a school-based program. Women up to the age of 26 have also been able to receive the three-shot HPV vaccine free of charge through a now-ended catch-up program.<br />
<br />
Health authorities are concerned about the ten percent drop in screenings among 25-29 year olds. The problem, they believe, may be that young women have been “lulled into a false sense of security” by Gardasil, which is advertised as a vaccine against cervical cancer. <br />
<br />
Merck’s human papillomavirus vaccine actually only protects against the two HPV strains that cause 65-70 percent of cervical cancer, so it’s essential that women continue to get regular screenings. It’s particularly important because replacement disease, whereby other strains of the virus fill the biological niche left by the two vaccine-relevant strains, may well become an issue. And so far, although the vaccine has proved very effective against the vaccine-relevant strains, overall cervical abnormality rates have dropped by only 17-45 percent.<br />
<br />
Regular Pap smears alone can eliminate at least 90 percent of cervical cancers. When a woman gets an HPV test along with the smear, there’s very little chance that cervical cancer will sneak up on her. (See <a href="http://www.gardasilhpv.com/2009/01/hpv-test-plus-pap-versus-gardasil.html">here</a> .) Women are advised to go for screenings every 1-3 years; screenings are also important because doctors will usually check for breast cancer and other health issues at the same time.<br />
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All in all, it’s hardly surprising that Australian health officials are "concerned." And if you or your daughter have had the Gardasil shots and have shelved regular exams, well, don't, is all I can say.<br />
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© 2010 www.gardasilhpv.com<br />
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Permission is freely given to accurately reproduce the first five paragraphs of this article, along with a link back to this site and the entirety of the article.Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com4tag:blogger.com,1999:blog-5510655703336125501.post-31529038187089675742010-05-25T17:03:00.003-04:002010-05-25T22:22:59.101-04:00So who’s reporting Gardasil to the FDA’s Bad Ad program?I’m sure this makes me a Bad Person, but I’m still absolutely howling at the discomfiture of Pharma faced with the FDA’s ‘Bad Ad Program.’<br />
<br />
As reported in Advertising Age by Rich Thomaselli: “’You've got more than a handful of doctors and medical professionals who maintain little to no use for DTC advertising. Christ, just look at any survey," said a brand-marketing director at one of the top five drug-makers, referring to surveys and studies that show some physicians feel pressured by patients to prescribe drugs they saw in an ad. "Tell me some of them aren't going to use this watchdog program to their advantage.’”<br />
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One can only hope.<br />
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The FDA’s new program asks doctors to report any ads that omit or downplay the risk, overstate the effectiveness, or promote off-label use, of any drug. They can do so anonymously, which of course opens things up to everyone—the average pissed-off consumer who’s fed up with his kids watching sleazy primetime Viagra and Cialis commercials; angry parents who have watched a child suffering from what they believe to be side-effects from the heavily-promoted Gardasil vaccine; or any number of people who were convinced by sophisticated ads that they were suffering from ‘social anxiety disorder’ or ‘overactive bladder disorder’ and then found themselves hooked on crappy meds.<br />
<br />
Truthfully, all pharmaceutical ads are bad ads. They market never previously heard-of conditions or hype others to the point that you’re certain you must have whatever it is. They recite side-effects, as required by law, only while playing happy, hopeful music and showing scenes of relief, joy, hope, love and Hallmark-style family life—with never a mention of the estimated 270 Americans who, according to journalist Melody Petersen, die every day from prescription medicines used as prescribed.<br />
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It’s curious that we ban ads for cigarettes but allow ads for medications. ‘DTC’—direct to consumer—refers only to pharma advertising, because for no other business do advertisers need to score an end run around a gatekeeper. After all, shouldn’t it be your doctor saying, “oh, you’re occasionally incontinent? Hey, do some Kegels and knock it off on the coffee—and if things get really bad, there’s a drug I can prescribe,” rather than the patient saying, “Doctor, I suffer from a Overactive Bladder Disorder and I can cure it with this excellent drug I heard about during MacGyver—give it to me, now!”? <br />
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Heck, no. There’s no money in that. <br />
<br />
And it’s not just the annual $5 billion in DTC advertising that’s a concern, although there are now terrifying rumblings about ‘product placement’ ads (how do you think they’ll get in those mandated risk disclosures? Don’t worry; they’ll think of something). Pharma markets deceptively to doctors, too.<br />
<br />
There was the scandal about a very convincing fake medical journal designed to fool doctors into prescribing Vioxx (read about it <a href="http://www.gardasilhpv.com/2009/05/gardasil-and-fake-medical-journal.html">here</a>).<br />
<br />
Then there was that study that found that much of the drug trial information that’s written up in medical journals is skewed and often ghost-written by Pharma (read about it <a href="http://www.gardasilhpv.com/2008/12/did-your-doctor-get-unbiased.html">here</a>).<br />
<br />
There was even a UM study that found that “where a potential conflict (of interest, due to pharma funding or financial interest) existed, randomized trials were more likely to link patient survival to a particular treatment.” Read about that <a href="http://www.gardasilhpv.com/2009/05/gardasil-and-conflicts-of-interest-in.html">here</a>.<br />
<br />
And I’ve recently been dipping into Melody Petersen’s fascinating book, <em>Our Daily Meds</em>. Read it and weep. (No, really. I wept from sheer frustration with the perversion of pharma's power to heal, and you will, too.)<br />
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So should we call the FDA about the Gardasil campaign? Eminently watchable girl-power ads with smart girls and slightly emo skateboarders, all taking charge of their health and vowing to be one less? Is that bad advertising?<br />
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Well, I’m not necessarily going to take issue with calling it a cancer vaccine, despite the inevitable inference that it will put an end to cervical cancer—which it certainly won’t—and despite the risk of replacement disease, alteration of natural immunity, etc. that could lead to new causes of cervical cancer. Accepting surrogate endpoints isn’t unreasonable, although so far Gardasil isn’t exactly setting the world on fire results-wise.<br />
<br />
But I can certainly take issue with Merck’s overstatement of the case for Gardasil. Heck, even the Journal of the American Medical Association did that. Drs. Sheila and David Rothman wrote in JAMA that “by making the vaccine’s target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to adolescents was maximized, and the sub-populations most at risk practically ignored…the material [put out by Merck-funded PMAs] did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on the risks and benefits.”<br />
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<a href="http://www.gardasilhpv.com/2009/08/gardasil-exempt-from-truth-in.html">Here's</a> my Truth in Advertising version of Gardasil ads from last year. <br />
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Anyway, if you’re, ahem, a doctor, and want to report a Bad Ad, here’s where to do it: email badad@fda.gov or call 877-RX-DDMAC. Be prepared to state your case; you’ll need to provide very specific and concise information about how the ad violates the law if you want to be taken seriously.<br />
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Now whether any Pharma ads at all should be legal—well, that’s another matter. You need to have a chat with your legislative representatives about that.<br />
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<em>© 2010 <a href="http://www.gardasilhpv.com/">http://www.gardasilhpv.com/</a> Permission is freely given to accurately reproduce the first five paragraphs of this article, along with a link back to this site and the entirety of the article. </em>Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com4tag:blogger.com,1999:blog-5510655703336125501.post-30091822746901228872010-04-29T13:42:00.002-04:002010-04-29T18:56:07.661-04:00Gardasil convulsions discounted, yet Australia halts flu vaccines on convulsion newsA two-year old girl died within 12 hours of receiving a new trivalent flu vaccine by CSL in Australia, 67 others suffered febrile convulsions, and at least 410 children in suffered from side effects like fever and vomiting. <br />
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So Australian health authorities have halted use of the vaccine for children under five while the issue is investigated. One possibility is that the children were more vulnerable to side effects from the vaccine, which includes swine flu as well as two strains of seasonal flu, because of having received the two-shot swine flu vaccine last year. <br />
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Although the relatively swift action seems commendable, some Australian parents are complaining that their kids had suffered reactions to last year's swine flu vaccine and their concerns were dismissed without follow-up.<br />
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That probably sounds familiar to parents of kids who have, they believe, suffered side effects from Gardasil, Merck's three-shot HPV vaccine series. True, there’s a difference between febrile convulsions, more common in young children, and the convulsions and seizures that are suffered by adolescents post-vaccination (see <a href="http://www.gardasilhpv.com/2010/04/gardasil-seizures-and-mitochondrial.html">here</a> and <a href="http://www.gardasilhpv.com/2009/02/bad-batch-of-gardasil-or-just-side.html">here</a>), but post-Gardasil convulsions and seizures are habitually written off.<br />
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As always, it’s important for parents to assess the risks and benefits of vaccines versus the risks of disease for their own families. There’s never a perfect, one-size-fits-all scenario—but it’s crucial that health authorities follow up reports of adverse reactions instead of dismissing them out of hand as either unconnected, statistically insignificant, or just meritless "anti-vaxxer" raving. And they need to follow up more than once when warranted, and investigate the cummulative effects of vaccines, too.<br />
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If you suffer an adverse reaction to any vaccine, report it immediately to <a href="http://vaers.hhs.gov/esub/index#Online">VAERS</a> and <a href="http://www.rateadrug.com/">RateADrug</a>.Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com0tag:blogger.com,1999:blog-5510655703336125501.post-47972480042322378682010-04-21T08:00:00.001-04:002010-04-21T19:08:50.999-04:00Gardasil and aluminum vaccine adjuvants: Researchers find neurological damage from aluminum adjuvants in two separate studies.Science is a laborious process; two steps forward and one step back. Quicksilver minds formulate a hypothesis and painstakingly set out to prove it, and then other researchers argue, test, counter, and prove or disprove the results. Science is only ever what we know <em>so far</em>.<br />
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So when I read a study showing that an aluminum adjuvant, used in various vaccines including Gardasil, DTaP, Tdap, hepatitis A and B, and anthrax, had caused serious neurological problems in lab mice, I relaxed. I confidently assumed that I’d find studies and comments utterly refuting the work. Probably the FDA or CDC would have something reassuring to say about it.<br />
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Nothing.<br />
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OK, then. I contacted one of the study’s authors, Dr Chris Shaw, a research scientist at the University of British Columbia in Vancouver. He and his colleagues had, after all, set out to look at Gulf War Syndrome and the more than doubled rate of ALS in serving military personnel, not debunk vaccines.<br />
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Had he disproved his own study? Not at all. In fact, a second study had confirmed the first.<br />
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“We did do a second study with more animals that largely confirmed the first, including findings of altered memory functions,” he wrote back. “Additional histology from the first study also clearly showed the presence of aluminum in motor neurons in the spinal cord along with the expression of a protein associated with Alzheimer's disease. <br />
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“There is little doubt in the scientific literature that aluminum is toxic to cells, including human cells of all types (check the recent Keele conference on aluminum for more details). What the industry and most doctors argue is that the amount/shot is small. This is true, but what is not accounted for is the total body burden that kids today receive over their formative years. I'm close to your age and had maybe 10 shots before I was 20. The recommended number now is something over 40 before age 16. <br />
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“The second argument that aluminum is harmless is that as a common element we all eat milligrams of it daily. This is also true, but you should check out the papers of Dr. J. Walton of Australia who has clearly demonstrated Alzheimer's-like cognitive decline in older rats given aluminum in their water. In addition, vaccines present the aluminum in a very different way from the digestive system in that the injected aluminum goes into both the circulatory and lymphatic systems.”<br />
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When the first study was published, Shaw was quoted as saying he was “creeped out” by the unexpected results. Is he still creeped out?<br />
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Yes—“mostly by the lack of interest in most of the medical community….As for the various regulatory agencies: none commented on the results of our study. DOD declined to comment when asked.”<br />
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The FDA’s official position on aluminum adjuvants—adjuvants are used to increase the body’s immune response to vaccines—is that:<br />
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“Aluminum adjuvant containing vaccines have a demonstrated safety profile of over six decades of use and have only uncommonly been associated with severe local reactions. Of note, the most common source of exposure to aluminum is from eating food or drinking water.”—FDA website.<br />
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Depends on your definition of a demonstrated safety profile. Aluminum used as an adjuvant is certainly known, albeit rarely, to cause macrophagic myofasciitis in genetically susceptible individuals. The symptoms of macrophagic myofasciitis, a muscle disease first identified in 1993, include joint and muscle pain, fever, weakness, fatigue, and muscle tenderness. Although these symptoms are commonly found in girls and women who may be suffering from an adverse reaction to Merck’s HPV vaccine Gardasil, it’s unknown how many have undergone a muscle biopsy to test for macrophagic myofasciitis.<br />
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What Dr Shaw and Dr Michael Petrik’s second study found was that mice injected with one equivalent-to-human dose of aluminum adjuvant, and then a second dose two weeks later, “showed significantly increased apoptosis of motor neurons and increases in reactive astrocytes and microglia proliferation within the spinal cord and cortex. <br />
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“Morin stain detected the presence of aluminum in the cytoplasm of motor neurons with some neurons also testing positive for the presence of hyper-phosphorylated tau protein, a pathological hallmark of various neurological diseases, including Alzheimer’s disease and frontotemporal dementia. A second series of experiments was conducted on mice injected with six doses of aluminum hydroxide. Behavioural analyses in these mice revealed significant impairments in a number of motor functions as well as diminished spatial memory capacity. The demonstrated neurotoxicity of aluminum hydroxide and its relative ubiquity as an adjuvant <strong>suggest that greater scrutiny by the scientific community is warranted</strong>.” (My emphasis.)<br />
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In the interests of brevity, that’s from the abstract. I’d recommend reading the entire paper as published in the Nov. 2009 Journal of Inorganic Biochemistry.<br />
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But I have to include this (references deleted for ease of reading) from the body of the article.<br />
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“In spite of the long history of widespread use, the physicochemical interactions between aluminum compounds and antigens are relatively poorly understood and their underlying mechanisms remain relatively unstudied. It also seems that there have been no rigorous animal studies of potential aluminum adjuvant toxicity. The absence of such studies is peculiar given the well known observation that aluminum in general can be neurotoxic under a number of conditions and adjuvants in particular have previously been implicated in neurological disease.”<br />
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Peculiar? That’s an understatement. <br />
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I forwarded the article to a number of scientist buddies for comment and possible dismemberment. I hung onto this post for months, innocently awaiting responses, and got literally none. Like Dr Shaw, I was surprised and disconcerted by the lack of apparent interest. I’ve seen polio; I’m not anti-vaccine—but I’m all for ensuring that vaccines are as safe as they possibly can be. These are our children.<br />
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Since when has science been about accepting decades-old dogma without question? And why is it scientifically OK to use an aluminum adjuvant in the placebo group of a vaccine trial, as Merck did, thus potentially masking adjuvant-related adverse reactions?<br />
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I don’t expect the FDA to be interested in <em>my</em> ideas. But I do expect it—and pay its employees—to be interested in the safety of my children. So when a reputable, qualified team of scientists in a reputable research facility raises a legitimate safety question, I’d anticipate that the FDA would respond with unbiased concern and curiosity rather than silence.<br />
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Now I’m creeped out.<br />
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© 2010 www.gardasilhpv.com<br />
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Permission is freely given to accurately reproduce the first five paragraphs of this article, along with a link back to this site and the entirety of the article.Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com96tag:blogger.com,1999:blog-5510655703336125501.post-22938303420416085252010-04-16T14:54:00.001-04:002010-04-16T14:56:05.155-04:00Gardasil and seizures to be considered by Vaccine CourtLast year the FDA mandated a revised label for Gardasil, warning health care providers about the continuing reports of syncope in those who’ve received the HPV vaccine, including “jerking movements, loss of bladder control, and other signs that resemble epileptic seizures, but is not epilepsy.”<br />
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However, stories about post- Gardasil epilepsy, continuing seizures and convulsions that are certainly not merely “syncope” continue to pour in—and on Wednesday the Ronan Law Firm filed a petition “in the United States Court of Federal Claims seeking damages for injuries suffered by 16 year old Alexis Wolf after she received the human papillomavirus vaccine, Gardasil. The case seeks recovery under the terms of the National Vaccine Injury Compensation Program.”<br />
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Wolf, who is diabetic, received all three Gardasil shots although she had already begun exhibiting some perplexing behavioral issues by the time she got the third shot. Eventually a psychiatrist realized that she was in fact suffering seizures that apparently cannot be controlled by medication. According to information posted by her parents, the former honor roll student now tests at a fourth grade level and is in constant pain.<br />
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Yesterday I posed a question about Merck's HPV vaccine Gardasil, seizures and mitochondrial disease <a href="http://www.gardasilhpv.com/2010/04/gardasil-seizures-and-mitochondrial.html">here</a> .<br />
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It will be interesting to see how the federal vaccine court, which in 2008 awarded damages to a child whose undiagnosed mitochondrial disease was aggravated by multiple vaccines, rules on this new case.<br />
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Meanwhile, best wishes to Ms. Wolf and her family.<br />
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© 2010 <a href="http://www.gardasilhpv.com/">http://www.gardasilhpv.com/</a>.Permission is freely given to reproduce the first two paragraphs of this article, along with a link back to this site and the entirety of the article. For other uses, please contact Kristin at <a href="mailto:gardasilhpv@gmail.com">gardasilhpv@gmail.com</a>.Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com0tag:blogger.com,1999:blog-5510655703336125501.post-77526066183256381942010-04-15T08:00:00.003-04:002010-04-18T08:28:14.589-04:00Gardasil, seizures, and mitochondrial disease newsVery much in the realm of, hey, that’s interesting…I wonder…what if?…is the possible connection between vaccines, underlying mitochondrial disease, and the seizures, convulsions and epilepsy that are a common factor for many of the women who report adverse events they suspect are connected to Gardasil.<br />
<br />
Even as the news broke this week that researchers have created a ground-breaking technique for preventing damaged mitochondrial DNA from being passed from mother to child, more mothers were wondering what had triggered seizures in their kids after vaccination with Gardasil. <br />
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Although most scientists routinely dismiss the vaccine-autism link, the federal Vaccine Court found in 2008 that giving nine vaccines in one day (good grief!) to a young girl with undiagnosed mitochondrial disease had very probably triggered her autism. The court’s conclusion was, specifically, that the vaccines had “significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in energy metabolism” and caused brain damage.<br />
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There’s no real proof that vaccines can trigger anything nasty in people with underlying mitochondrial disease. But neither is there any proof that they can’t, and given that very, very little money is spent on mitochondrial disease research, we’re not likely to see any clear evidence either way in the near future. So we have to at least start asking questions.<br />
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Mitochondria are like little energy-producing batteries in cells. They contain their own DNA, and up to one in 200 children are born with mutations in their mitochondrial DNA, apparently to little ill effect. In about one in 6,500 children, however, mitochondrial disease develops and can cause serious, even fatal, conditions. Mitochondrial dysfunction can also be caused by environmental triggers such as drugs or infections. When disease does present itself, it can cause a wide variety of seemingly unrelated problems<br />
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In the US, roughly one in 4,000 children develops mitochondrial disease by the age of 10. And up to 50 percent of people suffering from mitochondrial disease also suffer seizures.<br />
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Gardasil’s connection with seizures, of course, hit the headlines in a big way last year. Spain temporarily halted its Gardasil vaccination program when two unrelated girls started suffering recurring convulsions after being vaccinated from the same batch of Gardasil. Investigators eventually concluded that Gardasil might have triggered the convulsions, but not caused them.<br />
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Since I wrote about it <a href="http://www.gardasilhpv.com/2009/02/bad-batch-of-gardasil-or-just-side.html">here</a> and <a href="http://www.gardasilhpv.com/2009/03/further-post-gardasil-convulsions-send_06.html">here</a> , numerous readers have written to say that they, or their child, have suffered single or multiple seizures after receiving the vaccine. To date, VAERS (vaccine adverse event reporting system) reports include 857 cases of convulsions and 77 cases of epilepsy post-Gardasil vaccination.<br />
<br />
So could Gardasil be aggravating underlying mitochondrial disease in certain individuals? <br />
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Like I said, it’s an interesting theory. Very possibly a stretch. But science starts with asking questions and making connections. So let’s ask that question, and maybe consider assessing the kids who’ve suffered serious and currently inexplicable adverse reactions.<br />
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<em>If you or your child have suffered seizures or any other adverse event after receiving an HPV vaccination, be sure to fill out a report at </em><a href="http://www.rateadrug.com/"><em>here</em></a><em> and </em><a href="http://vaers.hhs.gov/esub/index"><em>here</em></a><em>.</em><br />
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© 2010 <a href="http://www.gardasilhpv.com/">http://www.gardasilhpv.com/</a> . Permission is freely given to reproduce the first three paragraphs of this article, along with a link back to this site and the entirety of the article. For other uses, please contact Kristin at <a href="mailto:gardasilhpv@gmail.com">gardasilhpv@gmail.com</a>.Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com4tag:blogger.com,1999:blog-5510655703336125501.post-10868844849523035822010-04-13T11:22:00.002-04:002010-04-16T13:33:41.715-04:00Gardasil in India: the real issue. Why don’t we women insist on informed consent?Last week’s flap over the suspension of the Gardasil vaccination program in India left many people shaking their heads. While four girls did indeed die post-vaccination (although not immediately post-vaccination) and some side effects, including epilepsy, were reported, the Indian Council of Medical Research (ICMR) has concluded that none of the deaths were due to the vaccine. Two deaths were due to poisoning, or suicide, they said; a third was due to drowning, and the fourth to pyrexia (fever) of unknown origin.<br />
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Naturally the average mind is going to throw up a few warring questions about the motivations and actions of both those promoting the program and those—families and activists—who are calling for a halt to it. But it’s India. We may never know what truly happened.<br />
<br />
<strong>The risk/benefit scenario for Gardasil</strong><br />
<br />
But here’s the thing. In the US, if a woman follows an intelligent, conscious lifestyle, the risks of the HPV vaccine probably outweigh the over-hyped benefits. In India, the risk/benefit scenario is entirely different. Cervical cancer is the number one cause of death for Indian women; the disease burden is huge. Although a cheap, low-tech test involving vinegar could save more than 100,000 lives annually if funded, the stark reality is that it isn’t. The likelihood that all those women will get this test every year or two over decades is remote; it’s even more unlikely that the government will get truly serious about cervical cancer by promoting regular Pap smears and HPV tests for all women.<br />
<br />
Despite the fact that India’s status as a fabulous medical tourism destination (<a href="http://www.rateadrug.com/Slide-medical-tourism--17-top-medical-tourism-destinations.aspx">see here</a>) has spawned excellent hospitals that legally must, and do, also give health care to indigent Indian citizens; despite the fact that India’s government is using boom money to try to alleviate the truly dreadful living conditions of many of its citizens—well, many women just don’t have regular access to health care. <br />
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Even though HPV vaccines do not appear to be nearly as effective as they’re made out to be, vaccination would almost certainly be worthwhile for those women. Shame on activists like Brinda Karat for not considering the facts.<br />
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<strong>Informed consent</strong><br />
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What Karat did get right is the ethical issues of informed consent—and those issues are no less important here.<br />
<br />
According to Karat, Gardasil was dramatically oversold to the impoverished “tribal” girls and their parents. Some of the participants in the trial didn’t even understand the language used in the pamphlets and by the administrators. <br />
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“The process of licensing the vaccine in India raises many serious questions,” she further contended at a press conference, “as time and again scientific logic and the ethical guidelines have been violated at each step. <br />
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“Our law clearly states that no trials of drugs can be conducted among children before trials are conducted on adults, and the vulnerable sections of society cannot be used for human trials.”<br />
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It’s a little tenuous to suggest that Merck was experimenting on particularly vulnerable sections of society this time around, given that Gardasil has been approved for use in many developed countries since 2006. But that informed consent thing? Spot on. And it’s true in the US, too.<br />
<br />
I’m tired of women being treated, and allowing themselves to be treated, like complete idiots. A good doctor should lay out the facts—this is what HPV is, this is how the immune system deals with it, this is how your lifestyle affects your immune system, this is what happens when the immune system DOESN’T get rid of HPV. This is what the vaccine can and can’t do. This is how effective it’s been so far (17-45 percent in preventing cervical abnormalities from all strains of HPV). These are the known side effects, these are the ones that are reported but not proven. <br />
<br />
Just tell us the damn truth. Many of us will decide that the potential benefits outweigh the possible risks. Some will decide the opposite. Some will choose to do whatever the doctor recommends. But whatever we decide, we’ll be making an honest, informed, choice. Don’t we deserve that? And shouldn’t we demand it?<br />
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<em>For more info about pros and cons</em>, <a href="http://www.gardasilhpv.com/2010/02/gardasil-pros-and-cons.html">see here</a> .<br />
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© 2010 <a href="http://www.gardasilhpv.com/">http://www.gardasilhpv.com/</a> . Permission is freely given to reproduce the first paragraph of this article, along with a link back to this site and the entirety of the article. For other uses, please contact Kristin at <a href="mailto:gardasilhpv@gmail.com">gardasilhpv@gmail.com</a>.Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com2tag:blogger.com,1999:blog-5510655703336125501.post-14840176180171362432010-03-29T12:36:00.002-04:002010-04-16T13:35:17.013-04:00Pre- Gardasil Essential for Sexually Active Women—the HPV TestQuestion: would you get a possibly risky vaccine if you thought it was going to be of little, if any, benefit? <br />
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Answer: yes, if you follow current medical advice and fail to do your own risk/benefit analysis.<br />
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Gardasil, the anti-HPV vaccine that is marketed for the prevention of cervical cancer, is currently approved for use in girls and boys from age 9 to 26 in the US. It’s also approved for women up to age 45 in Australia and may soon be approved for women up to age 45 in the US, too.<br />
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However, Gardasil doesn’t cure existing infections. There’s even some evidence that it might cause existing infections to become persistent—Merck’s trial originally showed that women with existing infections were more than 46 percent more likely to suffer a lesion, although they then determined that the study was “unbalanced.” After subtracting women who had extra risk factors, such as a smoking habit, Merck found that the vaccine conferred a very slight benefit. Overall, the combined studies showed an extra risk of a little more than 11 percent from vaccination with Gardasil for infected women. Even in clinical trials that include only uninfected women, so far the results come in at just a 17-45 percent reduction in cervical abnormalities caused by all types of HPV.<br />
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Since up to 80 percent of women will be infected with HPV at some point in their life, particularly in the earlier, usually more sexually active years, it’s recommended that the vaccine be administered—at a cost of roughly $500, including the $360 cost of shots and administration—before a child becomes sexually active. <br />
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That makes sense as long as you’re OK with the potential side effects. (The FDA says those are limited to fainting and blood clots, although it’s looking into some mighty peculiar cases of rapid-onset ALS “mediated by immune response.” Anecdotal evidence shows a possible risk of post- Gardasil autoimmune disease and neurological issues, including intermittent and ongoing paralysis, seizures, arthritis, Guillaine-Barré, Graves Disease, etc.; however, the FDA and CDC consider the links to be statistically insignificant.)<br />
<br />
But I’m completely at a loss to understand why the CDC advises that getting an HPV test ahead of vaccination is unnecessary.<br />
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Sure, that’s almost certainly true for a kid who has yet to have sex. Although HPV has been found in non-abused children, even newborns, because the virus is spread skin-to-skin, the vast majority of cases are spread sexually. (Of course, the obvious issue here is that, if you can find an older teenager willing to say in front of their parents that they’re having sex—wow.)<br />
<br />
And there are limits to the effectiveness of the HPV test. Although the current test is sensitive to 14 high-risk strains, it can’t yet tell you which strain you’ve been infected with, though a follow-up test IS available that can check for extra-high risk 16 and 18 if the first test is positive. It can’t tell if you have a “hidden” infection, nor can it tell you if you have had HPV in the past and are now almost certainly immune to that strain. <br />
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We also have to get over the idea that we have sweat sleeplessly or go in brandishing swords if an HPV test is positive. It’s positive? So what? Your immune system is just busy working on flushing it out and creating an immunity. What YOU have to do is work on supporting your immune system by eating your fruits and veggies, giving up the ciggies and getting enough zzzzs. You also have to protect any partner(s) with some very safe sex. Then get another test in a year or so. <br />
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Right now, the HPV test is recommended only for women older than age 30 in combination with Pap smears. (And it’s worth noting that when you get a combination Pap/HPV test, you can relax with a 99.84 percent certainty that you won’t develop cervical cancer within the next three years if the results are negative. Seems like a no-brainer to me.)<br />
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However, if it were me contemplating getting three expensive and not-without-risk shots of Gardasil or Cervarix, I’d sure want to find out, as best I could, whether there was any point at all.<br />
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<strong>© 2010 </strong><a href="http://www.gardasilhpv.com/"><strong>www.gardasilhpv.com</strong></a><strong> . Permission is freely given to reproduce the first paragraph of this article, along with a link back to this site and the entirety of the article. For other uses, please contact Kristin at </strong><a href="mailto:gardasilhpv@gmail.com"><strong>gardasilhpv@gmail.com</strong></a><strong>.</strong>Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com0tag:blogger.com,1999:blog-5510655703336125501.post-62000177273529611022010-02-25T13:14:00.001-05:002010-02-25T13:14:45.437-05:00Merck funding and the push to give Gardasil without parents’ knowledge or consentWell, color me naïve. Last week I wrote <a href="http://www.gardasilhpv.com/2010/02/children-to-be-given-gardasil-or.html">here</a> about two ill-advised bills currently attempting to make it legal for clinics and school nurses to give children HPV shots (Merck’s Gardasil is the brand most commonly used in the US)—regardless of age, and without their parents knowing a thing about it.<br />
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"Although some bloggers have speculated about the motives of these zealous legislators, particularly with regards to campaign contributions by Merck,” I wrote, “I don’t doubt that they think they’re doing the right thing—even if they’re in fact being preposterously over-reaching.”<br />
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Now a regular reader has written to let me know that Senator Liz Krueger is in fact a member of Women in Government, a group that was heavily criticized for attempting to make vaccination with Gardasil mandatory for public school attendance after receiving substantial funding from Merck.<br />
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OK, sometimes I’m a real innocent.Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com2tag:blogger.com,1999:blog-5510655703336125501.post-69332653664756103052010-02-18T14:17:00.001-05:002010-02-25T13:21:03.572-05:00Children to be given Gardasil or Cervarix without parents’ knowledge or consent?Imagine. You brush up against your daughter and she winces; you pull up her sleeve and see the telltale needle mark. She’s what, perhaps 12 years old.<br />
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It was Gardasil, not heroin, duh, she says. The nurse said it was safe and now I will never get cervical cancer. Don’t you want me to stay healthy, Mom?<br />
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Well, yes. And so, because you know that she has a strong family history of autoimmune disease on both sides, you’ve deliberately chosen to protect her health by avoiding getting her extra shots. Particularly Gardasil, because it’s a novel type of genetically engineered vaccine, as yet unproven, and of questionable value. You’re cautious because it has anecdotally been associated with autoimmune diseases—which are triggered in susceptible individuals by environmental factors—and your doctor has advised you, dammit, to be cautious with shots. <br />
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But now your informed decision has been overridden by a complete stranger.<br />
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<strong>Ridiculous?</strong><br />
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If the scenario of a minor child—as young as nine—being given a shot without a parent’s knowledge or consent seems absurd, think again. New York Senate bill S4779, sponsored by Senator Liz Krueger and co-sponsored by Senators Adams and Parker, provided for exactly that. And although S4779 has been held in the Senate Codes Committee for improvement and clarification of the bill's language, Ms. Krueger is reportedly determined to get it through at some point. Meanwhile, Assemblywoman Amy Paulin has sponsored New York Assembly bill A06702, which is almost identical apart from an attempt to make vaccination with Gardasil mandatory for school attendance.<br />
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The bills seek to ensure “that a health care practitioner may provide medical care related to the prevention of a sexually transmissible disease, including administering vaccines, to a person under age eighteen without the consent or knowledge of his or her parents or guardians, provided such person has capacity to consent to the care, without regard to the person's age, and the person consents. The section provides further that any release of patient information regarding vaccines provided under this section shall be consistent with sections 17 and 18 of the public health law.”<br />
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Wonderful. Not only could a nurse shoot up my kid with Gardasil or Cervarix even if I’ve specifically decided against it, I couldn’t find out for sure what those needle marks are. I’d have no clue as to why my child might have started convulsing, as did two girls in Spain right after getting their shots.<br />
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<strong>The whys and wherefores</strong><br />
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Although some bloggers have speculated about the motives of these zealous legislators, particularly with regards to campaign contributions by Merck, I don’t doubt that they think they’re doing the right thing—even if they’re in fact being preposterously over-reaching. Merck has done a fantastic job of persuading the public, including (apparently) some legislators, that if our kids don’t get the three Gardasil shots at a total cost of around $400 per child, they’re gonna get cervical cancer. Why bother to research the real facts?<br />
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Merck, of course, has notoriously been highly unscrupulous about its sales jobs—from concocting an entire fake medical journal and deliberately discrediting doctors and researchers who questioned Vioxx to paying off professional medical associations (PMAs) to promote Gardasil to other health professionals, without any appropriate transparency and discussion of risks and benefits. Not to mention its participation in the skewing of reporting drug trials endemic in professional journals.<br />
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The company is not going to spend a whole lot of effort on educating anyone about the full pros and cons of Gardasil and the truth about HPV. Particularly when its Gardasil sales have just plummeted by almost 80 percent in Australia, where a massive HPV vaccination campaign has ended.<br />
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Nor can we rely on doctors to educate themselves and us. In the context of Gardasil, Newsweek even quoted Susan Wood, former head of the FDA’s Office of Women’s Health, as believing that there was no relationship between a healthy diet and a strong immune system that could fight off HPV on its own and leave a natural immunity in its wake—totally contrary to solid scientific evidence.<br />
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And so we have legislators falling for the quick fix. Kids are having sex, their theory goes, and indulging in risky behavior. They already come to us to get birth control and treat STDs, so let’s PREVENT the STDs with a very expensive shot that must be safe because the government says so (Vioxx, anyone? BPA? Tambocor? Thalidomide?). It must be effective because Merck says so. Parents, of course, are just naïve, uncaring, and/or prudish and should have no say in the matter. <br />
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Never mind that kids who are already having sex have a heightened risk of developing a high-grade cervical abnormality if they are infected with vaccine-type HPV when they get Gardasil—particularly if they smoke.<br />
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<strong>The capacity to consent</strong><br />
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But wait. The target kids have to have the “capacity to consent,” right? They can make decisions for themselves, especially if they’re already having sex, a supposedly adult activity. Gardasil is recommended for kids as young as nine, and kids as young as nine have been known to have sex ‘willingly.’ <br />
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The capacity to consent implies the ability to understand and weigh all the pros and cons of Gardasil. Frankly, I’ve been giving my DOCTOR info that she, as an overworked professional, didn’t have previously. And yet Ms. Krueger and friends think that a nine year old—hell, a sixteen year old—can sit there and figure it all out before making an informed decision? <br />
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I’d think a lot better of Ms. Krueger if she initiated healthier foods in schools. Or campaigns that educated kids about the behaviors that cause persistent HPV infections and, potentially, cancers. I’d be good with efforts to teach parents about Gardasil, honestly cataloging the risks and benefits. I’m not necessarily against Gardasil for the right, most at-risk population as long as their family history is taken into consideration. <br />
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But I am totally against usurping parents’ rights, making uninformed decisions, and encouraging kids to make uninformed decisions. Especially when there’s a financial motive on the part of clinics and drug companies. <br />
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That’s what cigarette companies do. Is Senator Krueger the new face of the Marlboro Man?<br />
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<em>Here’s the straight talk for your kids, just in case legislators nationwide are daft enough to jump on the Krueger bandwagon. <a href="http://www.gardasilhpv.com/2010/02/gardasil-pros-and-cons.html">What you need to know about Gardasil</a></em>Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com4tag:blogger.com,1999:blog-5510655703336125501.post-61768168657993930752010-02-18T13:55:00.004-05:002010-02-25T13:30:17.060-05:00Gardasil pros and consGardasil has been hailed as the first vaccine against cancer, protecting women against some of the strains of human papillomavirus. HPV can, in a tiny percentage of cases, cause cervical cancer. Gardasil also been reviled as oversold and potentially dangerous. Here’s what you need to know:<br />
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• Up to 80 percent of people will get HPV, a virus akin to the common cold, in their lifetime. There are more than 100 strains of HPV, multiple strains of which COULD cause cancer in limited circumstances.<br />
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• 95 percent of those infections are self-limiting—they’ll be beaten off by your immune system, leaving you immune to further infection with the same strain.<br />
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• Only if an infection becomes persistent could it cause pre-cancerous lesions.<br />
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• <strong>Your behavior dramatically affects the chances of an infection becoming persistent</strong>.<br />
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• <strong>If you smoke</strong>, you have up to a 2,700 percent greater chance of getting a persistent HPV infection. (Anthony Gunnell, M.A.Sc., Karolinska Institutet, Stockholm; November 2006, Cancer Epidemiology, Biomarkers & Prevention)<br />
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• <strong>If you don’t eat vegetables and fruit regularly</strong>, you are 50 percent more likely to get a persistent HPV infection. (Rebecca L. Sedjo, MSPH, et al: University of Arizona, US; Cancer Epidemiology, Biomarkers & Prevention)<br />
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• If you have <strong>multiple sexual partners</strong>, you will exponentially increase your chances of getting a persistent HPV infection.<br />
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• <strong>Oral birth control</strong> and having sex at a <strong>young</strong> age may increase HPV risks.<br />
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• Being <strong>uncircumcised</strong> or having an uncircumcised partner increases HPV risks.<br />
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• <strong>Insufficient sleep</strong> on a regular basis, <strong>drug use</strong>—anything, in fact, that depresses your immune system—will increase your chances of getting a persistent HPV infection.<br />
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• With all that, if you get regular Pap smears, the chances of an infection progressing to pre-cancerous lesions and then cervical cancer are very small, and if it does, it is extremely curable when caught early. About 4000 women, some 60 percent of whom have not had smear tests, will die of cervical cancer in the US this year. It is twice as likely to affect Hispanic women and 50 percent more likely to affect African American women, probably because of economic factors. The number of cases drops by about 4 percent annually.<br />
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<strong><span style="font-size: large;">Gardasil</span></strong><br />
• Gardasil protects against the two strains of HPV, 16 and 18, that currently cause close to 70 percent of cervical cancer, plus two wart-causing strains. There are more than 100 strains of HPV. Merck’s research shows a small degree of cross-protection against strains not covered by the vaccine.<br />
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• Gardasil is a novel type of genetically engineered vaccine.<br />
<br />
• Although ads imply that you will not get cervical cancer if you get Gardasil, Gardasil does not protect against many oncogenic strains of HPV. So far, Merck’s research has shown a rather meager <strong>17-45 percent</strong> <strong>reduction</strong> <strong>in all cervical abnormalities</strong> in vaccinated girls. Recent figures of 89 percent reduction refer only to abnormalities and persistent infections caused by the four vaccine-type strains and do not include abnormalities caused by other strains.<br />
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• Although HPV16 and 18 caused the majority of invasive cervical cancer in a sample of women in New Mexico, the overall proportion attributable to HPV16 has dropped over 20 years, giving way to non-18 types. (C.M.Wheeler, PhD, University of New Mexico; Journal of the National Cancer Institute 2009). <br />
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• There is some concern that non-vaccine HPV types will fill the biological niche, an effect known as replacement disease. Merck does not think this likely, although it has happened with the vaccine Prevnar.<br />
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• The effect on natural immunity and duration of protection is currently unknown. Nor is the effect of new HPV infection in older adults when immunity has worn off.<br />
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• Merck’s research showed initially that Gardasil caused a 44.6 percent increase in the highest grade of pre-cancerous lesions in women who were already infected with vaccine-type HPV. Merck determined that the study was unbalanced and that those women also had high risk factors such as smoking. After ‘balancing’ the study, the combined figure for subgroup studies showed an enhanced risk of disease of 11.7 percent for females who had vaccine-type HPV at the start of the study.<br />
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• If you are already sexually active, get an HPV test prior to vaccination, particularly if you smoke or are otherwise high-risk.<br />
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• A neurologist has expressed concern about unusual immune response-mediated inflammation in the spine of a girl who died from an unusually rapid onset ALS-type disease and believes it may be associated with Gardasil. <br />
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• The FDA associates Gardasil with heightened risks of syncope and blood clots.<br />
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• Gardasil has also been associated anecdotally with Graves Disease, paralysis, Guillaine-Barré syndrome, seizures, chronic headache, and various autoimmune diseases although not at statistically extraordinary levels. Merck’s studies showed a slightly elevated risk of various types of arthritis. Incidence of autoimmune disease, which is triggered in susceptible people by environmental factors, is rising rapidly and an ever-increasing lifetime burden of vaccines and accompanying adjuvants may be a factor. This has not been proven, however. In trials of Gardasil, placebo vaccinations used an aluminum-containing adjuvant, something that could mask sideeffects.<br />
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• You should still get regular Pap tests, even if you have been inoculated with Gardasil.<br />
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It’s important to honestly assess your family medical history and lifestyle prior to getting the course of vaccinations. Read up on the facts. Gardasil may well be right for you, but it is not 100 percent effective or safe. Know its limitations—and yours.Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com6tag:blogger.com,1999:blog-5510655703336125501.post-32212182459561631082010-01-15T13:08:00.001-05:002010-01-15T13:14:37.997-05:00Merck looks to expand $400 Gardasil use while scientists say a $2 test could prevent 100,000 deaths from cervical cancerMaybe it’s just me. But I found it extraordinarily offensive that on the same day that scientists in Britain reported that 100,000 deaths from cervical cancer could be prevented annually by the use of a $2 test overseas, reports surfaced that Merck is once again trying to get approval for Gardasil (cost: $360 per person, plus whatever health care providers charge for administering it) to be used for women aged 27-45.<br />
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The difference is, of course, that expensive Gardasil will be used in the US, where it is least needed. Although at least 80 percent of women here will be infected by the HPV virus, 95 percent of those infections will be shrugged off by healthy immune systems, leaving in their wake a natural immunity to further infection. Of the small percentage of cases that become persistent, many could be avoided by eating a healthy diet with fruits and vegetables, quitting smoking, getting enough sleep, limiting sexual partners, etc. And most (granted, not all) persistent HPV infections that do turn to cancer can be caught early by regular screening. <br />
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Still, an incredibly effective marketing scheme that fails utterly to accurately inform women about the pros and cons of the vaccine has convinced women that unless they pony up big bucks they’re going to get cervical cancer.<br />
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Now Merck, dismayed by flagging sales and by clear evidence that Gardasil isn’t cost-effective for the potentially lucrative male market and its recommendation only as a wart-preventer and not as a cancer preventative for boys, is once again going after the older women market. It will be interesting to see whether they have found a way around earlier evidence that Gardasil may actually cause existing HPV infections to become cancerous.<br />
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Meanwhile, in developing countries, where women often aren’t able to get regular life-saving Pap smears and equally often have depleted immune systems due to inadequate diet—countries where Gardasil would actually make sense—a simple, dirt-cheap test could really, truly save lives. It can be used in rural areas without sophisticated equipment and labs; a nurse, midwife, or OB/GYN simply swipes the patient's cervix with acetic acid (vinegar) and then looks at the tissue. If lesions are present, the tissue turns white.<br />
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The only obstacles? Raising awareness, and getting enough money and qualified people to do the $2 tests and follow-up. Without, of course, a fraction of the budget that Merck has used to sell the largely unnecessary Gardasil vaccine.<br />
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So once again, I’m telling Blue Cross/Blue Shield: thanks for offering my girls the vaccine, but please send the $800 to an appropriate charity that offers VIA screenings to women in developing countries instead. Hey, that’s 400 potentially life-saving tests. Doesn’t that sound more cost-effective than inoculating two very low-risk girls?Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com3tag:blogger.com,1999:blog-5510655703336125501.post-370208808693099642009-10-21T15:57:00.000-04:002009-10-21T15:57:25.128-04:00Gardasil Optional, Not Recommended, for Boys--Will You Pay for It?It’s up to you now. The Advisory Committee on Immunization Practices voted almost unanimously to tell doctors that they’re free to give boys the Gardasil vaccine as a way of avoiding future bouts with genital warts—which affect about one percent of the population—but they’re not going to recommend it as a routine vaccination.<br />
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Nor do they plan to recommend it as an “anti-cancer” vaccine, which is the way it’s been sold to many millions of girls. Although the HPV virus can cause esophageal, anal, testicular, penile and perineal cancer in boys, such cancers are very rare, and even then a large percentage aren’t associated with the human papillomavirus. The only real advantage would be to protect future partners.<br />
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Merck, with billions on the line, had determined that the vaccine would be very cost-effective for boys by assuming that the vaccine would be 100 percent effective in preventing cancer and that the vaccine would cost $400 per child—at $360 for the cost of the shots alone, that doesn’t leave much to pay the cost of three visits to the doctor. <br />
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A Harvard study, however, went on the assumption that the vaccine would be 75 percent effective and cost $500 per child, and found that the cost of vaccinating boys would be spectacularly cost-ineffective.<br />
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The Advisory Committee apparently agreed with Harvard.<br />
There is certainly no reason to assume that Gardasil will be 100 percent effective. Merck’s own study of more than 4,000 boys didn’t even find that, and Gardasil trials have shown the HPV vaccine to be just 17-45 percent effective in preventing cervical abnormalities in girls thus far. Gardasil has also been associated anecdotally with a number of rare, but serious, side effects, including autoimmune diseases and a form of ALS. <br />
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Meanwhile, it’s doubtful that many insurance companies will now pay for Gardasil for boys, although government programs may do so for those on Medicaid. Parents might prefer to be sure that their children understand the importance of getting annual exams as adults and of eating fruits and vegetables, avoiding smoking, being circumcised, getting sufficient sleep, and limiting the number of sexual partners—all factors that are known to substantially cut the risk of getting a persistent HPV infection.<br />
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So are you willing to fork over the cash yourself? Do you think Gardasil’s worth it?Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com5tag:blogger.com,1999:blog-5510655703336125501.post-16416185534941814412009-10-18T18:39:00.001-04:002009-10-18T18:41:55.477-04:00Is There a Gardasil / ALS Connection?All it would take is for neurologists to ask young female patients—and soon, young men too—a simple question. <br />
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“You have symptoms of ALS. Did you have the Gardasil vaccination?” <br />
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That’s the only way that we’re going to eventually find out whether the unusually rapid-onset ALS-like paralysis that killed Jenny Tetlock and Whitney Baird was indeed related to their recent vaccinations with Gardasil. <br />
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Up until now, no-one’s been asking. Most parents take routine vaccinations for granted and don’t think to bring it up. Merck and the FDA insist there’s no link. But at the 134th meeting of the American Neurological Association, Catherine Lomen-Hoerth, MD, director of the ALS Center at University of California San Francisco Medical Center, was asking. <br />
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Jenny Tetlock died from a neurological disease, mediated by immune responses, which led to extensive damage in her spinal cord. Lomen-Hoerth noted the unusual inflammation in Jenny’s spine and announced that she and her team are planning to study girls with ALS, both those who got the vaccination and those who didn’t, to compare symptoms and pathological features. <br />
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Hopefully, neurologists will now start asking about Gardasil—so simple!—and perhaps even comb through the records of any current and deceased patients with juvenile ALS, and then send the information on to Lomen-Hoerth. It won't just be Jenny's parents who are saying, look, maybe there's no connection, but we want to know for sure.<br />
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And it’s not at all irrational to ask that question. Right now, there’s no causal link established between Gardasil and ALS, and two cases among millions of girls safely inoculated with the HPV vaccine means zip. However, given the unusual spinal inflammation (not a hallmark of ALS) and Jenny and Whitney’s shared history of a childhood autoimmune skin disorder that might have made them more vulnerable; given that periods of paralysis have marked mystery post-Gardasil medical conditions in a number of girls—given all that, there’s good reason to ask the question seriously.Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com5tag:blogger.com,1999:blog-5510655703336125501.post-28151969190746126372009-10-10T16:12:00.000-04:002009-10-11T21:16:51.944-04:00Dr. Diane Harper Badly Misquoted on Gardasil and CervarixI’m not a regular reader of the Guardian’s “woo-medicine”-debunking columnist Ben Goldacre, and when I do read him I often disagree with him.<br />
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But he hit a home run with his latest Bad Science column.<br />
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He took apart a front page Sunday Express article that has already been widely disseminated around scare sites on the Internet. Of course, you can’t read it on the Sunday Express site anymore because it's been removed. Probably because Dr Diane Harper, who was quoted as saying that HPV vaccines are more dangerous than cervical cancer, is about to sue the pin-striped pants off the always-lurid Express. Or so I hope.<br />
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I’ve often felt sorry for Dr Harper. She seems like a forthright, intelligent scientist who removes herself from Merck’s marketing hysteria to make sensible cautionary comments about the Gardasil vaccine, which she has worked on and in general supports. But her comments are frequently taken out of context and paraded around the web as if she were an anti-vaccine crusader.<br />
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As someone who is wary of Gardasil to the point of thus far turning it down for my daughters, who have a family history of autoimmune disease; as someone who would like to see an awful lot of very serious questions about Gardasil taken very seriously and answered very seriously, it makes me LIVID. We need more people in the pharmaceutical industry to encourage scientists, physicians and the public to ask intelligent questions and not simply swallow the party line wholesale. So-called reporters like the notorious Express’s Lucy Johnston badly undermine the likelihood of that happening.<br />
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If I’ve understood Dr. Harper correctly—forgive me if I haven’t, Dr. Harper, and feel free to correct me—she thinks that HPV vaccines are in general a good thing but that Gardasil should have been introduced more slowly and cautiously; and that perhaps people with family histories of auto-immune disorders should be particularly cautious. She thinks—again, if I understand correctly—that Merck’s unprecedented intensive marketing campaign has oversold Gardasil; that the 3-shot series and its marketing might make women cavalier about still-essential annual exams; that we don’t know how long protection will last.<br />
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According to Goldacre, what she doesn’t think is what she was reported as saying in the Express’s article. That the cervical cancer vaccine 'may be riskier and more deadly than the cancer it is designed to prevent.' That the jab 'would do nothing to reduce the rates of cervical cancer in the UK.' Etc., etc., etc.<br />
Goldacre simply contacted Harper directly when he read the article.<br />
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“I will explain Harper's position in her own words,” he writes. “They are unambiguous: ‘I did not say that Cervarix was as deadly as cervical cancer. I did not say that Cervarix could be riskier or more deadly than cervical cancer. I did not say that Cervarix was controversial, I stated that Cervarix is not a 'controversial drug'. I did not 'hit out' – I was contacted by the press for facts. And this was not an exclusive interview.”<br />
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Harper did not "develop Cervarix" but she did work on some important trials of Gardasil and also Cervarix. "Gardasil is not a 'sister vaccine' as the Express said, it is a different compound. I do not know of the side effects of Cervarix as it is not available in the US.’<br />
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“She did not say that Cervarix was being overmarketed. ‘I did say that Merck was egregiously overmarketing Gardasil in the US – but Gardasil and Cervarix are not the same vaccines’…She also suspects from modelling data that for the specific and restricted group of women who are punctilious about attending every single one of their cervical cancer screening appointments, vaccination may have little impact on their risk of death from cancer; but even they will benefit from the reduction in reproductive problems caused by treating pre-cancerous changes in cervical cells.<br />
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‘I fully support the HPV vaccines," she says. "I believe that in general they are safe in most women. I told the Express all of this.’”<br />
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That was a lot of Goldacre’s column to reproduce. But I think it bears repeating as long as the Sunday Express article inevitably circulates and spawns more mis-information.Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com9tag:blogger.com,1999:blog-5510655703336125501.post-21258151125868077932009-10-01T10:05:00.000-04:002009-10-01T10:05:19.121-04:00Teenager Who Died After Cervarix HPV Shot Had Chest Tumor, Pathologist SaysNatalie Morton, the 14 year old schoolgirl who collapsed right after being given the Cervarix immunization and died just hours later, was suffering from a malignant tumor in her chest.<br />
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“The pathologist has confirmed today at the opening of the inquest into the death of Natalie Morton that she died from a large malignant tumor of unknown origin in the heart and lungs,” said Dr Caron Grainger, joint director of public health for NHS Coventry and Coventry city council. “There is no indication that the HPV vaccine, which she had received shortly before her death, was a contributing factor to the death, which could have arisen at any point.”<br />
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Cervarix is GlaxoSmithKline’s version of Merck’s Gardasil, a vaccine that protects against two oncogenic strains of HPV (human papillomavirus).Kristin Johnshttp://www.blogger.com/profile/08344523053859405902noreply@blogger.com3