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?

Gardasil’s Adverse Effects: The Institue of Medicine Reports

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.

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.”

Want to take part?

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.

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.

Download the report at 11 AM and make a note of any questions you might have. Should be interesting.

Gardasil vaccines tainted by debris

Let 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.

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?

Still, you can rest easy.

“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.”

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?

Just repeat after me: it’s statistically insignificant, and so is anything you might suffer afterwards.

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.

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!