No parents, no VAERS reports on Gardasil

Governor 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.

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.

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.

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.

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?

I can't think of any other vaccine that has been gifted with such potentially lax oversight.

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 (see here).

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?

Oh, wait….

Why Governor Jerry Brown should veto pro-Gardasil AB 499

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.

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.

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.

“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.

Uh, yes.(Shouldn’t you KNOW this?)

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.

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.

Yeah, sure.

So I’m one of those 'crazy anti-vaxxers,' right?

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.

And as The Lancet puts it, autoimmune diseases “arise in genetically predisposed individuals but require an environmental trigger.”

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.)

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?

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.

And Planned Parenthood should be ashamed of itself, too.

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.

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.

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!)

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.

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.

No perfect choices.

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.

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?

It’s none of your damn business.

Think 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.

Still, the bigger issue is substantially more depressing. It’s that the subject of vaccination in general, and Gardasil in particular, is so divisive.

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.

My God, that’s depressing. And worse, unproductive.

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).

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.

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.

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?

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?

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.”

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.”

Hey, can we talk?

Would 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.

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.

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.

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.

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.

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.

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…”

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.

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?).

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?

Got the Gardasil vaccine—and then Raynaud’s disease?

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.

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.

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.  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.

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.

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.

“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!”

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 (http://nomorepurpletoes.blogspot.com/) or email her at nataliedeuitch@yahoo.com

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!

Seventeen Magazine’s ‘Scary Sex Rumors’ about the Gardasil HPV Vaccine

Ouch. Seventeen Magazine gets both a carrot and a stick for its September 2010 issue’s ‘Scary Sex Rumors’ item about Gardasil.

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.

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.”

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.

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 here), 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.

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.

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 .

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).”

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.
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.

Now that’s a scary sex rumor.

Worrisome Gardasil side effect: cervical cancer screening rates drop significantly

The 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.

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.

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.

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 here .) 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.

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.

© 2010 www.gardasilhpv.com


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.

Gardasil 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 so far.

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.

Nothing.

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.

Had he disproved his own study? Not at all. In fact, a second study had confirmed the first.

“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.

“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.

“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.”

When the first study was published, Shaw was quoted as saying he was “creeped out” by the unexpected results. Is he still creeped out?

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.”

The FDA’s official position on aluminum adjuvants—adjuvants are used to increase the body’s immune response to vaccines—is that:

“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.

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.

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.

“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 suggest that greater scrutiny by the scientific community is warranted.” (My emphasis.)

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.

But I have to include this (references deleted for ease of reading) from the body of the article.

“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.”

Peculiar? That’s an understatement.

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.

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?

I don’t expect the FDA to be interested in my 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.

Now I’m creeped out.

© 2010 www.gardasilhpv.com

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.

Gardasil 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.

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.

The risk/benefit scenario for Gardasil

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.

Despite the fact that India’s status as a fabulous medical tourism destination (see here) 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.

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.

Informed consent

What Karat did get right is the ethical issues of informed consent—and those issues are no less important here.

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.

“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.

“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.”

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.

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.

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?

For more info about pros and cons, see here .

© 2010 http://www.gardasilhpv.com/ . 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 gardasilhpv@gmail.com.

Children 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.

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?

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.

But now your informed decision has been overridden by a complete stranger.

Ridiculous?

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.

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.”

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.

The whys and wherefores

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?

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.

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.

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.

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.

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.

The capacity to consent

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.’

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?

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.

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.

That’s what cigarette companies do. Is Senator Krueger the new face of the Marlboro Man?

Here’s the straight talk for your kids, just in case legislators nationwide are daft enough to jump on the Krueger bandwagon. What you need to know about Gardasil

Teenager Who Died After Cervarix HPV Shot Had Chest Tumor, Pathologist Says

Natalie 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.

“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.”

Cervarix is GlaxoSmithKline’s version of Merck’s Gardasil, a vaccine that protects against two oncogenic strains of HPV (human papillomavirus).

Schoolgirl’s Death After Cervarix HPV Shot Raises Questions about Screening for Underlying Medical Conditions

Britain’s HPV vaccination program was suspended yesterday and a 200,000-shot batch of Cervarix was recalled after 14-year old Natalie Morton turned pale and collapsed after being vaccinated. She died in hospital just hours later.

Because of the implications of her death, an autopsy was performed very quickly at University Hospital in Coventry, England. Initial results indicate that Ms. Morton’s death was a result of an "underlying medical condition," although no explanation was given as to why the shot apparently—although not definitely—precipitated Ms. Morton’s death.

Questions about rare adverse events associated with both Cervarix and Gardasil frequently center on the difference between causality and the trigger effect. Both Cervarix and Gardasil, for instance, have been associated with autoimmune diseases, which arise in genetically predisposed individuals but require an environmental trigger such as chemical exposure or a vaccination.

Take fifteen year old Jenny Tetlock, who apparently had a predisposition to autoimmune disease as seen in an early childhood skin condition. She died within two years of onset of a very rapidly progressing ALS-like paralysis that began shortly after vaccination with Gardasil; the autopsy showed that she had damage to her spine that was caused by “neurological disease that was mediated by immune responses.”

Although no definitive link with Gardasil has been made, the question still looms large in the minds of concerned scientists, doctors and parents—even if Gardasil didn’t definitively “cause” Ms. Tetlock’s death, did it trigger it? And if so, how do we stop that from happening again? Can we, and should we, insist on a better screening process to find individuals likely to be adversely affected by immunization?

The VAERS passive surveillance system reports eleven cases of cardiac arrest after vaccination with Gardasil. The Advisory Committee on Immunization Practices recommended back in 2003 that military personnel with known underlying heart disease or cardiac risk factors, such as diabetes or a smoking habit, should NOT be given the smallpox vaccine after it was associated with increased cardiac “events.”

And the FDA has found a slightly increased risk of blood clots to be associated with Gardasil, which should raise questions for girls who are on the Pill; and when two girls in Spain suffered repeated convulsions for months after being given the vaccine, an investigation found that the convulsions weren’t caused by Gardasil but could have been triggered by it.

Meanwhile, Dr Caron Grainger, joint director for public health for the National Health Service Coventry and Coventry city council, simply said in a statement: “The preliminary postmortem results have revealed a serious underlying medical condition which was likely to have caused death. We are awaiting further test results which will take some time. However indications are that it was most unlikely that the HPV vaccination was the cause of death.”

NHS officials urged parents not to be alarmed and to allow their children to be vaccinated when the Cervarix program resumes next week. Girls aged 12 and 13 in British schools are given the HPV jab in school unless their parents specifically object. The batch of Cervarix that was used for Natalie Morton’s vaccination has been returned to GlaxoSmithKline for further testing, and schools are awaiting fresh supplies.

Cervarix and Gardasil are both new vaccines against the human papillomavirus, which is usually shrugged off by the immune system but can, in a very tiny percentage of cases, cause cervical cancer and (even more rarely) penile, esophageal, anal or testicular cancer. The vaccines use genetically engineered VLPs (virus-like particles); Cervarix protects against two oncogenic strains of HPV and uses a novel adjuvant, AS04; while Gardasil uses an aluminum adjuvant and protects against two oncogenic strains and two genital wart-causing strains.

Vaccination programs usually work on the “greater good” principle, with the idea that a few patients might experience adverse side effects, even death, but lives will be saved overall. Merck has been widely criticized for its heavy-handed over-selling of Gardasil, notably in last month’s JAMA.

What do you think? Could we do a better job of screening individuals prior to vaccination rather than adopting a “one size fits all” policy?

Gardasil — Exempt from Truth in Advertising Standards?

People who ask questions about Gardasil are invariably told that they’re scientific ignoramuses, endangering their children with their crazy paranoia. Last week, however, JAMA, the Journal of the American Medical Association, issued stinging critiques of the over-selling of the HPV vaccine and the potential skewing of any risk/benefits analysis. It was rare criticism from the medical profession.

The truth is, we have more legal protection from an under-powered blender than we do from a vaccine.

Gardasil could well be the best thing since the invention of SmartPhones. But it could also alter our life for the worse, permanently, or it could simply be a waste of time and money. Merck and the FDA are making highly educated guesses, but you’d never know that from the hype. As consumers, isn’t it time we started demanding a little respect and honesty? Don’t we deserve sufficient information to come to a reasonable decision?

Under the Federal Trade Commission Act, advertising must be truthful and fair, and it must not deceive. Advertisers must have evidence to back up their claims. An ad is considered deceptive if it either contains a statement or omits information that might well mislead consumers who are acting reasonably under the circumstances. It also must not omit information that is important to a consumer’s decision to use or buy the product.

With Gardasil’s unprecedented marketing, said Drs. Sheila and David Rothman in JAMA, “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.”

Science can be defined as ‘what we know so far.’ Or as Dr. Charlotte Haug put it in her JAMA editorial about Gardasil, “medical knowledge is typically incomplete and ambiguous.” Often, what we think we know turns out to be wrong, or just the tip of the iceberg. It would be totally irrational to reject all medical science on the basis that we might find out something to the contrary later, but it is equally irrational to try to make a decision about a new treatment without being in possession of all the known facts, particularly when huge financial benefits to the vendor weigh in.

“GARDASIL is the only cervical cancer vaccine that helps protect against 4 types of human papillomavirus (HPV): 2 types that cause 70% of cervical cancer cases, and 2 more types that cause 90% of genital warts cases,” says Merck. “Be one less,” say the ads. The implication: if you don’t get Gardasil, you do get cervical cancer.

Here’s my Truth in Advertising version.

Gardasil targets the two strains of the HPV virus that currently cause 70 percent of cases of cervical cancer and two strains that cause genital warts. Your chance of dying from cervical cancer is extremely small if you have regular check-ups. HPV may also cause (even more rarely) cases of oral cancer, anal cancer, and penile cancer. We do not yet know whether Gardasil will be effective against these cancers and will not know for several decades, but the hypothesis seems likely to some degree.

You can reduce your small chance of developing HPV-related cancers dramatically by eating healthy foods, by not smoking, by limiting your sexual partners, and by undergoing regular screenings. 95 percent of cases of HPV are currently shrugged off by the body. You should consider your lifestyle honestly when making a risk/benefit analysis.

Gardasil may offer some further protection. After 3.6 years, the results from two randomized, placebo-controlled trials following 17,622 women who were vaccinated with Gardasil after showing no previous exposure to 14 HPV types and had normal Pap smears to begin with were:

· 17 to 22 percent reduction in ASC-US: atypical squamous cells of undetermined significanceassociated with a high-risk type of HPV

· 17 percent reduction in LSIL: low-grade squamous intraepithelial lesion

· 36 percent reduction in ASC-H: atypical squamous cells/cannot exclude high-grade squamous intraepithelial lesion

· 45 percent reduction in HSIL: high-grade squamous intraepithelial lesion

Colposcopies were reduced by 20 percent, cervical biopsies by 22 percent and surgery and other invasive treatments by 42 percent.

Protection against genital warts appears to be extremely good.

We do not know whether replacement diseases will occur should non-vaccine strains of the virus (there are more than 100, and at least 15 are known to be oncogenic) fill the biological niche left by vaccine strains. We do not believe that this is likely but the vaccine Prevnar has shown that it can happen.

We do not know how Gardasil will affect natural immunity to the more than 100 strains of HPV.

We do not know how long immunity will last and whether single, or perhaps multiple, booster shots will be necessary. We do not know whether, should immunity to HPV-16 and HPV-18 wear off, older adults will be able to fight off the virus as well as younger adults.

Data from the passive VAERS system that is used to monitor vaccine adverse events, along with data from clinical trials, appears to indicate that Gardasil is well-tolerated by the vast majority of individuals. The FDA has determined a slightly greater risk of fainting and associated injury and of blood clots.

Anecdotal evidence and VAERS reports associate Gardasil with an increased risk of auto-immune disease and neurological problems, including rapid-onset ALS, arthritis, Graves Disease, paralysis, seizures, chronic headache, etc., predominantly in very active girls, but no causal link has been found at this time and incidence does not occur at a very significantly greater rate than in the general population. Incidence of auto-immune disease, which may be triggered in genetically pre-disposed individuals and more often in women by environmental factors, is generally rising. We do not know why. We do not know if a rapidly increasing lifetime burden of vaccine adjuvants plays some part, although high levels of aluminum have reportedly been found in spinal taps from some affected girls.

There was concern that initial studies of Gardasil showed a 44.6 percent increase in CIN 2/3 (the highest grade of pre-cancerous lesion) in a sub-group of individuals who had existing vaccine-type infections at time of vaccination. Further analysis showed that an unbalanced proportion of these subjects may have had enhanced risk factors such as a current smoking habit or a history of cervicovaginal infection or STD. Background evidence provided to the committee approving Gardasil concluded that, after balancing risk factors and sub-dividing sub-groups, vaccination could be said to reduce CIN2/3 by a modest 5.5 percent. Overall, a combined figure for subgroup studies showed an enhanced risk of disease of 11.7 percent in subjects who tested positive for vaccine-relevant HPV at the beginning of the study.

You may wish to get an HPV test and/or a pregnancy test prior to vaccination. You may wish discuss the advisability of vaccination with your doctor if you or your family has a history of autoimmune disorders.

You should not get Gardasil if you’re allergic to yeast or if you’re pregnant or planning to become pregnant soon.

You should report any and all potential adverse reactions to VAERS, being sure to include valid contact information, and not just all immediately post-vaccination allergic reactions, as the CDC’s handout implies.

Actually, the Feds DIDN’T Say Gardasil Causes 400 Percent more Deaths

When you question a vaccine, whether as a parent, researcher, doctor or writer, you automatically get put in the “crazy” camp. And it doesn’t help when there are people out there misreporting facts and misattributing information.

I’m quite sure I don’t get everything right, but if I don’t, it’s not for want of fact-checking to the very best of my ability. So it made me nuts watching an error-ridden article mushroom across the web last week. The story was about how the feds have concluded that Gardasil causes 400 percent more deaths than the meningococcal vaccine Menactra, and it immediately rang alarm bells for anyone who tries to keep up properly with the unfolding Gardasil side-effects story.

Forensic tracking (not that hard; it was quoted as the entire source for the article) took me back to a New Zealand pro-life blog’s mistake. Back in March, familylifenz posted, “A new report, issued in February, by the centralized federal Vaccine Adverse Events Reporting System in the United States, has compared the anti-HPV vaccine Garasil, with the Menactra (meningococcal) vaccine, and it has found that Gardasil is associated with a far high rate of serious adverse effects than Menactra is.”

One staffer for a natural health site somewhat belatedly picked up on this and apparently followed the provided link back to the report itself for the 400 percent statistic but didn’t notice that it was, in fact, issued by the National Vaccine Information Center, not VAERS. The NVIC isn’t a federal agency, it’s an organization founded by parents whose children have been damaged by vaccines.

The NVIC’s very useful report analyzed data about Menactra and Gardasil from the VAERS system and made some recommendations to the CDC, the FDA, and Congress. It did indeed note that Gardasil was associated with four times as many deaths (and with even greater increases in other adverse events) as Menactra. To say, however, that “a federal report” came to that conclusion, and that researchers for VAERS had commented on the unusually high death rate, is—well, flat-out wrong.

No beef with the NVIC. I thought the report was interesting and blogged about it back when they issued it.

“I am all about the Gardasil vs. Menactra stat as it lives in my house,” wrote one reader to me just yesterday. “I have three kids who all had doctor appointments last June 16, 2008. All three got Menactra; only Nora got Gardasil too, and she was the only one to end up in the ER 5 days later. And again 20 days after her second shot.” Her daughter has been on anti-seizure medication ever since; and she's far from the only girl who has suffered seizure problems after getting the vaccine.

There are obvious pitfalls to the report on the passive VAERS system, of course, as vaccine side-effects are both under-reported and over-reported, and any scientist will quickly point out that correlation doesn’t equal causality. And the CDC isn’t one whit alarmed by the numbers of Gardasil-related adverse events because—even at four or more times the rate of those related to Menactra—in the context of multiple millions of doses given, they’re statistically insignificant (unless you’re a victim or the parent of one, naturally) and it’s statistics that ring alarm bells.

I don’t much like Gardasil. To me it seems rather ineffective, likely to cause replacement disease and highly suspect as a trigger for a variety of auto-immune diseases in susceptible individuals; and Merck’s marketing tactics, what with fake medical journals and doctor-discrediting “hit lists,” are frankly shocking for even the most cynical among us. Unless something happens to change my mind, I’m not getting Gardasil for either of my own daughters.

But when I see an erroneous story being picked up and regurgitated without question on multiple sites and blogs, it is just infuriating. Pretty soon it will have gained the same “everyone knows” status as that canard about how the CDC “knows” that HPV doesn’t cause cervical cancer.

It’s quite possible, even probable, that there’s real harm being done with HPV vaccines. And yet there are careless people out there are making damaged girls and their parents look like credulous crazies. Please, check facts.

So Why ARE Gardasil Girls Suffering Fainting and Syncope?

You knew it would happen just as soon as the FDA asked for an upgraded warning on Gardasil package inserts, drily explaining that an awful lot of girls seem to be fainting after their HPV vaccinations, and wouldn’t it be rather a good idea to monitor them and make them sit down. What with the possibility of suffering grievous injuries and all.

Well, duh.

But right on cue, here come the usually male-generated media and blog comments about how teenage girls faint all over the place anyway. Couldn’t possibly because of this particular vaccine. Here’s a typical comment:

“Now ask yourself: If you line up a bunch of giddy 13-year-old girls for an injection that has something to do with sex, cancer and genital warts, would you expect more or fewer than 2 in 10,000 to faint during the process?” The writer goes on to jokingly (one assumes) wonder whether Gardasil isn’t actually preventing mass fainting.

I don’t think I’ve heard a man wonder out loud whether the mention of sex—faugh, Sir!—wouldn’t make a woman faint since I read a cartload of 19th century novels in college a few decades ago.

Can there really be people out there who are unaware that the average 13-year old (and indeed the average 11 or 12 year old) is not only quite au fait with the oh-so-shivery idea of sex but, sadly, might even be quite practiced in the art of doing various unspeakable things? And that these kids have obligingly held out their arms to get stuck many, many times since infancy, usually without even asking what the damn needle is for?

Trust me, that’s not why they’re fainting. Even Merck is prepared to admit that the genetically-engineered ‘virus-like particles’ (VLPs) in this novel type of vaccine might have something to do with both the fainting and with the more severe and longer-lasting pain associated with Gardasil.

My own 16-year old has an almost pathological fear of needles. My ultimate threat when she breaks curfew is an acupuncture appointment (I know, but it’ll give her lots to talk about when she’s in therapy later). As a six year-old she actually bit the doctor who tried to give her an MMR booster, and last year literally back backed away like a startled horse over a truly fearsome shot being given her in preparation for a trip to India.

But she has never, not once, come even remotely close to fainting.

I’ll grant you that adolescent girls are more likely to be on faint-worthy crash diets than toddlers, so let’s look at the numbers reported to VAERS, the notoriously fallible vaccine adverse event reporting system. We’ll compare them to the numbers for Menactra, since it’s given to roughly the same crash-dieting teenage crowd.

2,172 girls have suffered syncope after being given the Gardasil vaccine. Out of 463 teens who’ve suffered syncope after the Menactra vaccine, 389 were girls and 6 sex unknown.

So roughly five and a half times as many girls have fainted after receiving the Gardasil vaccine as after Menactra, and Menactra has been on offer for about a year and a half longer than Gardasil, which went on sale in 2006, and is routinely given to both boys and girls. (Compare that to the chicken pox vaccine, part of vaccination programs for both sexes since 1995, with a total of 312 cases of post-vaccination syncope.)

Now you can merge those figures statistically into the population until they’re not there anymore. Even 2,172 cases are a blip among the millions of doses administered.

Or you can join the airheads who say, “FGS, would you rather your kid had cervical cancer than risk fainting? Mine will get the shot even if they’re laid out on the floor!” Totally ignoring, of course, the fact that it’s not an either/or choice and that a) the risk of cervical cancer is tiny b) Gardasil is only 17-45 percent effective in preventing pre-cancerous cells c) fainting isn’t the only potential side-effect and could be the sign of something else going on.

But I’d have a lot more respect for Merck, the CDC, the FDA, and yes, those bloggers, if they said, hang on. It’s probably nothing, but if over five times as many kids are fainting, shouldn’t we check it out? Is this the canary in the coal mine? Could VLPs, never before used, be having an effect we really know nothing about?

Gardasil, Oprah, and Crazy Talk

Me, I don’t watch Oprah. Nothing personal—I just don’t watch a whole lot of TV. But I do occasionally read the Oprah magazine, and find it to be exceptionally well written and usually informative. Would I take everything as gospel? Nope. But would I dismiss it out of hand? That’s also a nope.

Newsweek is apparently far better at the dismissing business.

Ambushed by an intriguing cover, featuring a totally deranged-looking Oprah and a story title that read, CRAZY TALK – OPRAH, WACKY CURES AND YOU, who could resist? So I didn’t.

I don’t know a thing about Suzanne Somers. Couldn’t tell you what The Secret is if it bit me. And no doubt Newsweek writers Weston Kosova and Pat Wingert made some excellent points about both (60 supplements a day? Seriously? Does Ms. Somers rattle like a rainstick?)

But I’ve been researching HPV and Gardasil a lot, so my attention was caught by mention of one of Oprah’s ‘regular experts,’ Dr. Christiane Northrup. Again, I don’t know a lot about her, but what I have heard always seemed pretty sensible, so it was rather a shock to find Newsweek putting her in the crazy category when she talked about Gardasil.

“Where I’d put my money,” she’s quoted as saying, “is getting everybody on a dietary program that would enhance their immunity, and then they would be able to resist that sort of thing. All right?”

You can practically hear the guffaws as the writers note that “…Oprah (did not) question Northrup’s assertion that women can stop the spread of a cancer-causing sexually transmitted disease by eating healthy foods. There is, Wood (Susan Wood, former head of the FDA’s Office of Women’s health) says dryly, ‘no evidence that money spent on general health promotion’ will do that.”

Now, I really hope that their general level of research is a lot better than that, because clearly they don’t know what the devil they’re snickering at. And nor does Ms. Wood, unless they truncated her comments.

True, Gardasil aims to protect women against four strains of HPV, the human papillomavirus, which is a virus that is spread through sexual and sometimes not-so-sexual skin-to-skin contact. And persistent infections, caused by any of about 40 strains of HPV out of more than a hundred, can indeed cause cervical cancer.

What these authors don’t seem to have properly researched is that roughly 80 percent of the population will be infected with HPV at some point in their lives, and as many as 95 percent of those infections will be cleared by the body. It’s only when an infection becomes persistent that it causes trouble. And why does an infection fail to clear itself?

Because of a crappy immune system. And why would an immune system be crappy? Often—not always, of course, but often—because of a crappy diet, sorely lacking in fruits and veggies.

A University of Arizona study that was reported in the journal Cancer Epidemiology, Biomarkers & Prevention found that women who ate a lot of veggies were more than 50 percent less likely to have persistent HPV infections. Fruits and juices appeared to be somewhat less protective than vegetables, but still proved to be a valuable addition to creating a strong immune system.

Smoking, incidentally, also damages a body’s natural immunity, increasing the risk of developing pre-cancerous lesions by up to a whopping 27 times, presumably because both smoking and HPV affect the molecules (called cytokines) that control tumor growth. For more info on that, check out the study authored by Anthony Gunnell from the Karolinska Institutet in Stockholm, Sweden.

Strengthening the host is usually far more effective than trying to stop a virus, which has a nasty habit of sending in different strains as a replacement disease (think the common cold). Given that the latest studies show Gardasil to be only 17-45 percent effective against pre-cancerous cells, I’d certainly keep chowing down on the broccoli and kohlrabi, myself.

So Northrup is certainly not out in left field when she talks about enhancing the immune system so that one can resist ‘that sort of thing.’ On the contrary, science is on her side.

And when I read an article that is so obviously slanted towards the premise that Oprah is nuts and spreads 'crazy talk', it makes me wonder how accurate Newsweek's previous offering, showing President Mahmoud Ahmadinejad of Iran looking as if he has failed to eat his prunes for far too long (where do they GET these pictures?) is going to be when I get to it.

Farrah Fawcett's Cancer, HPV and Gardasil

Farrah Fawcett, like Jade Goody, has focused our attention squarely on the tiny, but very real, dangers of HPV. Last night a documentary dealing with the iconic actress’ struggle with anal cancer aired to an audience of an estimated 8.9 million viewers.

In March all eyes were on reality TV star Jade Goody, who died at the appallingly young age of 27 from cervical cancer. Now Fawcett, known for her portrayal of an abused woman in The Burning Bed and for her longtime role in Charlie’s Angels, has highlighted the perils of anal cancer. In 2006 she was diagnosed with the highly curable cancer and initially was thought have beaten it; the disease, however, returned and spread to her liver.

Furious about on ongoing series of detailed leaks about her condition to the National Enquirer, and knowing that they could only come from staff at the UCLA Medical Center, 62 year-old Fawcett set a trap worthy of the French Resistance and spurred new legislation in California to safeguard patient privacy—and she’s continued to tackle her disease with equal energy, even sharing with the public what was originally supposed to be private video footage of her ordeal as a way to spread awareness.

At least those 8.9 million viewers, then, are now to some extent familiar with the disease. Anal cancer is even rarer than cervical cancer. The American Cancer Society estimates that in 2009 there will be 5, 290 new cases diagnosed in the US, mostly in people in their 60s, and about 3,190 of those will be found in women. Because anal cancer can be treated very effectively if found in time, only about 710 of those cases will die.

It’s thought that the human papillomavirus, HPV, is the cause of anal cancer. As with cervical cancer, many—even most—people will be infected with the virus at some point but it clears itself in roughly 95 percent of cases; only when an infection becomes persistent does it cause real trouble. Smoking, sleeping around, and weakening the immune system through poor diet all increase the chances of an infection becoming persistent (smoking alone can increase the chances by up to 26 times), and in the case of anal cancer, having anal sex is certainly a risk factor. Some patients, however, have no risk factors.

Symptoms can include bleeding or itching around the anus, pain in the anal area, a change in bowel habits, a lump in the anal area, swollen lymph nodes in the anal or groin area, and abnormal discharge from the anus.

Problems can usually be detected with a digital exam during a Pap test, colonoscopy, or prostate cancer screening. Anal cytology testing, a relatively new test that’s rather like an anal Pap smear, can also be performed if a patient is high risk for one reason or another. Fawcett’s battle highlights for us yet again the importance of regular screening.

The new Gardasil vaccine (in use since 2006) aims to protect against two of the most commonly cancer-causing strains of HPV, 16 and 18, as well as two that cause genital warts, although a recent study shows that 16 has for some years been losing ground to non-vaccine types. Because there are more than 100 different strains of HPV, and of those more than 40 can cause cancer, replacement diseases may well be an issue if non-vaccine types decide to fill the biological vacancy left by 16 and 18.

Two recent placebo-controlled studies showed that Gardasil decreased the risk of different types of pre-cancerous cells by 17 to 45 percent. It’s not known how long the vaccine will remain effective but a recent study showed strong protection against HPV type 16 alone for 8.5 years.

The vaccine has been associated with a number of side-effects, including Guillain-Barré Syndrome, an unusually rapid form of ALS, paralysis, and convulsions and epilepsy. No causal link has been definitively proved as yet; critics point to a high number of VAERS reports, particularly compared to Menactra, a vaccine that is aimed at a similar population. When three young girls in Spain lost consciousness and convulsed—the two we know most about have been in and out of intensive care ever since—health authorities determined that the vaccine had not caused the convulsions, but could have triggered them.

Germany and Scotland are both considering changing or ending their HPV vaccination programs because of concerns about the efficacy of the program. Many people are looking to other preventatives currently in the development pipeline, such as an ointment made with GML that would also protect against HIV.

Because of the potential side effects and less than complete protection provided by both Cervarix and Gardasil, consumers should research the pros and cons of the vaccines for themselves Regardless of your opinion about Gardasil as an HPV preventative, however, HPV is indeed an issue that we should all be aware of, and one can only be thankful to public figures like Farrah Fawcett who are willing to go very, very public to that end.

Meanwhile, my very heartfelt prayers are with her, and with her family and friends too.

Health Authorities May Ditch Gardasil and Cervarix

Gardasil and its rival Cervarix cost governmental health programs, insurance companies and individuals billions. Most governments have approved vaccination programs on the assumption that if an HPV jab guards against the two viruses that cause 70 percent of cases of cervical cancer, then the vaccine will eliminate roughly 70 percent of new cancer cases.

Oops. Real-life study results don’t bear out that assumption at all, and now that Gardasil has been found in two placebo-controlled studies to reduce pre-cancerous cells by just a meager 17 to 45 percent, both Scotland and Germany are reconsidering their hugely expensive HPV vaccination programs.

13 leading scientists in Germany have said that the vaccine is leaving women vulnerable to other strains of the virus and that information about its effectiveness is misleading. The Robert Koch institute, which makes recommendations about publicly-funded vaccination programs in Germany, is reassessing Gardasil and expects to issue a report within about two weeks. As one expert said, "The results of the studies clearly contradict many overly optimistic pronouncements. Women are entitled to be adequately informed."

Women in the US are apparently not as entitled to be informed, as recent news reports about Gardasil have focused primarily on information that the vaccine has proved to be extremely effective against HPV strain 16 for up to 8.5 years—a statistic that now appears to be rather beside the point.

Senior public health experts in Scotland also warned that HPV vaccines might not be as effective as expected after reviewing the two large-scale studies of Gardasil. Although the competing vaccine Cervarix is administered by the National Health program in Scotland, Cervarix uses the same VLP-type vaccine along with a novel adjuvant to target the same cancer-causing viruses. Specific data about Cervarix’s efficacy is not currently available.

The randomized, placebo-controlled trials of Gardasil followed 17,622 women who underwent Pap testing at the start of the trials and then every 6 to 12 months. All the women showed no exposure to 14 common HPV types and had normal Pap smears to begin with. After 3.6 years abnormal cells were reduced by between 17 and 45 percent, depending on the type.

Colposcopies were reduced by 20 percent, cervical biopsies by 22 percent and surgery and other invasive treatments by 42 percent.

Results Unsurprising

A study published earlier this year in the Journal of the National Cancer Institute (JNCI) looked at both early and invasive cervical cancers from 1980 to 1999 in a New Mexico population. The study found that HPV types 16 and 18 had caused 66.3 percent (not 70 percent) of cervical cancers and, more worryingly, that type 16 was already being replaced by types other than 16 or 18 (the two strains covered by both Gardasil and Cervarix).

Although this replacement was taking place pre-Gardasil, experts have long theorized that one or more of the many other strains of HPV could fill the biological niche left by elimination of 16 and 18. This kind of ‘replacement disease’ has already been seen with the pneumococcal vaccine Prevnar. It’s unclear at this point whether replacement diseases have been the cause of Gardasil’s disappointing results as Merck did not release an analysis of the types of HPV found to have caused the abnormalities in the study subjects.

Merck is having better luck with Gardasil’s efficacy against genital warts. Gardasil, unlike Cervarix, also guards against two wart-causing strains and reports from Australia show that new diagnoses of genital wart infections have dropped by 48 percent.

Meanwhile, women who are weighing the pros and cons of the Gardasil vaccine, now have more complete information, even if—distressingly—the results of the two studies have received little publicity. Reports have associated convulsions, paralysis, epilepsy, numbness etc. with the vaccine, although as yet no causal link has been established.

Gardasil and the Fake Medical Journal Scandal

By Kristin Johns @ http://www.gardasilhpv.com/

Maybe this doesn’t really belong in a blog focusing solely on Gardasil and HPV, but my jaw hit the ground so hard when I read about this little shocker that I just can’t help myself. And it sure sheds a horrifying light on the lengths that Merck, the manufacturer of Gardasil, will go to for the sake of sales.

Turns out that Merck made up an entire fake medical journal for marketing its osteoporosis drug Fosamax.

Talk about a bone-headed (sorry) scam. The Australasian Journal of Bone and Joint Medicine was published by Elsevier, famed for heavyweight scientific journals such as The Lancet, and contained favorable data for Merck products like Vioxx and Fosamax. According to TheScientist.com, the journal so closely mimicked a traditional, peer-reviewed journal that one George Jelinek, an Australian physician and member of the World Association of Medical Editors, testified in court that "Only close inspection of the journals, along with knowledge of medical journals and publishing conventions, enabled me to determine that the Journal was not, in fact, a peer reviewed medical journal, but instead a marketing publication for MSD[A]" (a Merck subsidiary).

The Scientist’s information came from a look at testimony in a lawsuit filed against Merck by a man who believes his heart attack was caused by Vioxx. “The Federal Court has heard that Merck & Co "prepared and gathered" doctors and academics to write the company's own research on Vioxx, which was then published in prestigious medical journals as independent studies…The drug company also allegedly produced an entire journal—called The Australasian Journal of Bone and Joint Medicine—and passed it off as an independent peer review publication,” reported The Australian on April 9.

The journal apparently had no acknowledgement anywhere in its pages that it was funded solely by Merck, and the editorials were basically summaries of the articles with scant references. In happy phrase, Honorary Editorial Board member and rheumatologist Peter Brooks admitted that he had in the past put his name on a few “advertorials.” Advertorials?

Oh, God. What have medicine, science, and indeed publishing, come to?

I want to believe in medicine and science, I really do. I want to be able to go to my doctor and believe what he says and take his advice. I want to believe that when our pediatrician advises me to get my girls that 3-shot series of Gardasil vaccinations, she’s read up fully on it in objective, well-written and peer-reviewed journals that cover properly-conducted trials. I want to believe that Merck genuinely tries to cure diseases, not just to make money hand-over-fist like some cheap Main Street emporium marketing fashion to gullible teenagers.

But good grief, they’re making it increasingly hard.

Luckily I know enough responsible, ethical scientists and doctors to know that the once-honorable traits of all-encompassing curiosity and genuine caring still exist. I’m pretty sure that my doctor wouldn’t dream of adding spurious medical credibility to “advertorials.”

But on my shelf, I have a little green bottle that I dug out of an ancient dump. Once upon a time, according to its raised lettering, it contained “Doctor Kilmer’s Swamp Root Kidney Cure." I’m starting to wonder whether a few of my medicines shouldn’t go up on that shelf right alongside it.

Why Potential Gardasil Side Effects Aren't Reported to VAERS

The whole issue of the vast inadequacies of the VAERS (Vaccine Adverse Event Reporting System) has become a bit of a brain worm for me. After all, in general I’m a believer in vaccines, but it’s essential that we know everything about them that we can—and thoroughly investigate every single possible connection with an adverse event or side effect.

Because (to badly paraphrase John Donne) any child’s death or disability diminishes us, and particularly so if we could have prevented it.

The VAERS issue came up because the parents of Jenny Tetlock asked officials to look into the possibility that the extraordinarily rapid-onset paralysis that was killing their daughter could be connected with the Gardasil vaccination she’d recently received. The huge VAERS database turned up no comparables. And yet when the Tetlocks started a personal blog appealing for help they found two very strong comparables, girls who had also just received the vaccine when they develped a similar form of paralysis. Those other two cases, it turns out, had simply never been reported.

Which has led me to wonder how much VAERS actually encourages reporting. (VAERS reports can be filed by anyone, including parents or patients as well as doctors, nurses and pharmacists). So I duly trotted off to our pediatrician’s office and picked up a flyer—you know, the information sheet you’re handed before you get a vaccination, explaining what, why, and who.

Troll down to section 5, which covers risks. It says that the HPV shot does not appear to cause any serious side-effects (fair enough; there have been no definitive connections that I know of) and that although it COULD cause a serious problem such as a severe allergic reaction, the risk of any vaccine causing serious harm or death is very small (again, fair enough, if you’re talking about direct causation. We don’t know a whole lot about the other kind one way or another).

It explains that mild reactions include pain at the site (duh!!), redness or swelling at the site, mild fever, itching, and moderate fever. Fine.

Then I start to get crabby.

“Life-threatening allergic reactions from vaccines are very rare. If they do occur, it would be within a few minutes to a few hours after the vaccination.”

Now, that’s reasonable, followed as it is in section 6 by an explanation of the symptoms of severe allergic reaction—high fever, behavior changes, difficulty breathing, wheezing, hoarseness, hives, paleness, weakness, a fast heart beat or dizziness. After advice about what to do, it requests you to ask your doctor to contact VAERS, or do so yourself, if you or your child experience a severe allergic reaction and explains how. Again, fine.

So why am I crabby?

Because the very, very clear implication is that an immediate allergic reaction is the only serious side effect or adverse event that could possibly be connected to Gardasil—or any other vaccine, for that matter. There's not even a mention of Guillain-Barré syndrome, although a recent study found that there appears to be an increased risk of its appearance in the two to six weeks following vaccination with Gardasil.

No wonder the parents of those other paralyzed girls didn’t think to report the paralysis to VAERS. There may be a connection, there may not be. There may be a connection between other adverse events and Gardasil, or there may not be. It may be reasonable to say that if a vaccine can, even rarely, immediately cause your body to react badly, it could also cause a slower adverse reaction in some people. Or it may not be. But the government body that advises parents to get these vaccines for their kids has a duty to investigate fully and to encourage the reporting of ALL potential reactions, not just immediate and severe allergic reaction; and so do the companies that sell the vaccines.

There’s a petition for reform of the VAERS system over at http://www.thepetitionsite.com/1/oneclickonelife, or you can access it via the site http://oneclickonelife.org/.

I don’t care whether you think Gardasil is the devil in disguise or the best thing since Starbucks ice cream: please zip over there and sign it. Regardless of your views on vaccines or experience with them, our kids deserve the best immunizations and the best monitoring systems we can give them.