So who’s reporting Gardasil to the FDA’s Bad Ad program?

I’m sure this makes me a Bad Person, but I’m still absolutely howling at the discomfiture of Pharma faced with the FDA’s ‘Bad Ad Program.’

As reported in Advertising Age by Rich Thomaselli: “’You've got more than a handful of doctors and medical professionals who maintain little to no use for DTC advertising. Christ, just look at any survey," said a brand-marketing director at one of the top five drug-makers, referring to surveys and studies that show some physicians feel pressured by patients to prescribe drugs they saw in an ad. "Tell me some of them aren't going to use this watchdog program to their advantage.’”

One can only hope.

The FDA’s new program asks doctors to report any ads that omit or downplay the risk, overstate the effectiveness, or promote off-label use, of any drug. They can do so anonymously, which of course opens things up to everyone—the average pissed-off consumer who’s fed up with his kids watching sleazy primetime Viagra and Cialis commercials; angry parents who have watched a child suffering from what they believe to be side-effects from the heavily-promoted Gardasil vaccine; or any number of people who were convinced by sophisticated ads that they were suffering from ‘social anxiety disorder’ or ‘overactive bladder disorder’ and then found themselves hooked on crappy meds.

Truthfully, all pharmaceutical ads are bad ads. They market never previously heard-of conditions or hype others to the point that you’re certain you must have whatever it is. They recite side-effects, as required by law, only while playing happy, hopeful music and showing scenes of relief, joy, hope, love and Hallmark-style family life—with never a mention of the estimated 270 Americans who, according to journalist Melody Petersen, die every day from prescription medicines used as prescribed.

It’s curious that we ban ads for cigarettes but allow ads for medications. ‘DTC’—direct to consumer—refers only to pharma advertising, because for no other business do advertisers need to score an end run around a gatekeeper. After all, shouldn’t it be your doctor saying, “oh, you’re occasionally incontinent? Hey, do some Kegels and knock it off on the coffee—and if things get really bad, there’s a drug I can prescribe,” rather than the patient saying, “Doctor, I suffer from a Overactive Bladder Disorder and I can cure it with this excellent drug I heard about during MacGyver—give it to me, now!”?

Heck, no. There’s no money in that.

And it’s not just the annual $5 billion in DTC advertising that’s a concern, although there are now terrifying rumblings about ‘product placement’ ads (how do you think they’ll get in those mandated risk disclosures? Don’t worry; they’ll think of something). Pharma markets deceptively to doctors, too.

There was the scandal about a very convincing fake medical journal designed to fool doctors into prescribing Vioxx (read about it here).

Then there was that study that found that much of the drug trial information that’s written up in medical journals is skewed and often ghost-written by Pharma (read about it here).

There was even a UM study that found that “where a potential conflict (of interest, due to pharma funding or financial interest) existed, randomized trials were more likely to link patient survival to a particular treatment.” Read about that here.

And I’ve recently been dipping into Melody Petersen’s fascinating book, Our Daily Meds. Read it and weep. (No, really. I wept from sheer frustration with the perversion of pharma's power to heal, and you will, too.)

So should we call the FDA about the Gardasil campaign? Eminently watchable girl-power ads with smart girls and slightly emo skateboarders, all taking charge of their health and vowing to be one less? Is that bad advertising?

Well, I’m not necessarily going to take issue with calling it a cancer vaccine, despite the inevitable inference that it will put an end to cervical cancer—which it certainly won’t—and despite the risk of replacement disease, alteration of natural immunity, etc. that could lead to new causes of cervical cancer. Accepting surrogate endpoints isn’t unreasonable, although so far Gardasil isn’t exactly setting the world on fire results-wise.

But I can certainly take issue with Merck’s overstatement of the case for Gardasil. Heck, even the Journal of the American Medical Association did that. Drs. Sheila and David Rothman wrote in JAMA that “by making the vaccine’s target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to adolescents was maximized, and the sub-populations most at risk practically ignored…the material [put out by Merck-funded PMAs] did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on the risks and benefits.”

Here's my Truth in Advertising version of Gardasil ads from last year.

Anyway, if you’re, ahem, a doctor, and want to report a Bad Ad, here’s where to do it: email badad@fda.gov or call 877-RX-DDMAC. Be prepared to state your case; you’ll need to provide very specific and concise information about how the ad violates the law if you want to be taken seriously.

Now whether any Pharma ads at all should be legal—well, that’s another matter. You need to have a chat with your legislative representatives about that.

© 2010 http://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 pros and cons

Gardasil has been hailed as the first vaccine against cancer, protecting women against some of the strains of human papillomavirus. HPV can, in a tiny percentage of cases, cause cervical cancer. Gardasil also been reviled as oversold and potentially dangerous. Here’s what you need to know:

• Up to 80 percent of people will get HPV, a virus akin to the common cold, in their lifetime. There are more than 100 strains of HPV, multiple strains of which COULD cause cancer in limited circumstances.

• 95 percent of those infections are self-limiting—they’ll be beaten off by your immune system, leaving you immune to further infection with the same strain.

• Only if an infection becomes persistent could it cause pre-cancerous lesions.

• Your behavior dramatically affects the chances of an infection becoming persistent.

• If you smoke, you have up to a 2,700 percent greater chance of getting a persistent HPV infection. (Anthony Gunnell, M.A.Sc., Karolinska Institutet, Stockholm; November 2006, Cancer Epidemiology, Biomarkers & Prevention)

• If you don’t eat vegetables and fruit regularly, you are 50 percent more likely to get a persistent HPV infection. (Rebecca L. Sedjo, MSPH, et al: University of Arizona, US; Cancer Epidemiology, Biomarkers & Prevention)

• If you have multiple sexual partners, you will exponentially increase your chances of getting a persistent HPV infection.

• Oral birth control and having sex at a young age may increase HPV risks.

• Being uncircumcised or having an uncircumcised partner increases HPV risks.

• Insufficient sleep on a regular basis, drug use—anything, in fact, that depresses your immune system—will increase your chances of getting a persistent HPV infection.

• With all that, if you get regular Pap smears, the chances of an infection progressing to pre-cancerous lesions and then cervical cancer are very small, and if it does, it is extremely curable when caught early. About 4000 women, some 60 percent of whom have not had smear tests, will die of cervical cancer in the US this year. It is twice as likely to affect Hispanic women and 50 percent more likely to affect African American women, probably because of economic factors. The number of cases drops by about 4 percent annually.

Gardasil
• Gardasil protects against the two strains of HPV, 16 and 18, that currently cause close to 70 percent of cervical cancer, plus two wart-causing strains. There are more than 100 strains of HPV. Merck’s research shows a small degree of cross-protection against strains not covered by the vaccine.

• Gardasil is a novel type of genetically engineered vaccine.

• Although ads imply that you will not get cervical cancer if you get Gardasil, Gardasil does not protect against many oncogenic strains of HPV. So far, Merck’s research has shown a rather meager 17-45 percent reduction in all cervical abnormalities in vaccinated girls. Recent figures of 89 percent reduction refer only to abnormalities and persistent infections caused by the four vaccine-type strains and do not include abnormalities caused by other strains.

• Although HPV16 and 18 caused the majority of invasive cervical cancer in a sample of women in New Mexico, the overall proportion attributable to HPV16 has dropped over 20 years, giving way to non-18 types. (C.M.Wheeler, PhD, University of New Mexico; Journal of the National Cancer Institute 2009).

• There is some concern that non-vaccine HPV types will fill the biological niche, an effect known as replacement disease. Merck does not think this likely, although it has happened with the vaccine Prevnar.

• The effect on natural immunity and duration of protection is currently unknown. Nor is the effect of new HPV infection in older adults when immunity has worn off.

• Merck’s research showed initially that Gardasil caused a 44.6 percent increase in the highest grade of pre-cancerous lesions in women who were already infected with vaccine-type HPV. Merck determined that the study was unbalanced and that those women also had high risk factors such as smoking. After ‘balancing’ the study, the combined figure for subgroup studies showed an enhanced risk of disease of 11.7 percent for females who had vaccine-type HPV at the start of the study.

• If you are already sexually active, get an HPV test prior to vaccination, particularly if you smoke or are otherwise high-risk.

• A neurologist has expressed concern about unusual immune response-mediated inflammation in the spine of a girl who died from an unusually rapid onset ALS-type disease and believes it may be associated with Gardasil.

• The FDA associates Gardasil with heightened risks of syncope and blood clots.

• Gardasil has also been associated anecdotally with Graves Disease, paralysis, Guillaine-Barré syndrome, seizures, chronic headache, and various autoimmune diseases although not at statistically extraordinary levels. Merck’s studies showed a slightly elevated risk of various types of arthritis. Incidence of autoimmune disease, which is triggered in susceptible people by environmental factors, is rising rapidly and an ever-increasing lifetime burden of vaccines and accompanying adjuvants may be a factor. This has not been proven, however. In trials of Gardasil, placebo vaccinations used an aluminum-containing adjuvant, something that could mask sideeffects.

• You should still get regular Pap tests, even if you have been inoculated with Gardasil.

It’s important to honestly assess your family medical history and lifestyle prior to getting the course of vaccinations. Read up on the facts. Gardasil may well be right for you, but it is not 100 percent effective or safe. Know its limitations—and yours.

JAMA Nails the Problem with Gardasil — and Our Healthcare System

With all the debate about the state of American health care going on, it’s interesting that this month’s Journal of the American Medical Association (JAMA) has—perhaps unintentionally—presented the Gardasil vaccine against the HPV virus as a microcosm of what’s wrong with our current system. Over-prescribing, “skewed” information for doctors, “surrogate endpoint” approval that can lead to ineffective or harmful drugs, irrational risk/benefit scenarios that are influenced by financial interests, medication rather than intelligent living—sound familiar?

More health care for those who don’t need it.

American health care, for those who can afford it, is often as excessive as a Hardee’s Thickburger. The Congressional Budget Office estimates that 700 billion per year, or 5 percent of the US GDP, goes to tests and procedures that don’t improve health outcomes in the least.

Drs. Sheila and David Rothman note that in “creating a market out of thin air,” as PharmExec aptly put it when naming Gardasil 2007 Brand of the Year, Merck’s HPV vaccine was pushed to the entire population, rather than to those who really need it.

Cervical cancer kills around 4,000 people every year in the US. The death rate has dropped impressively since annual Pap smears were introduced in the 50s, and continues to drop by about four percent each year. Indeed, a large percentage of deaths from cervical cancer can be attributed to lack of access to, or inattention to, routine health care. Roughly 40 percent of women in the US are unwilling or unable to get regular Pap smears, and Kaiser Permanente found that more than half of its members with cervical cancer had not done so.

The Gardasil campaign, say the Rothmans, “bypassed public health officials who would have spear-headed a risk-sensitive vaccination campaign…this manufacturer understandably wanted as many adolescents as possible to be vaccinated. But the pursuit of this goal was neither cost-effective nor equitable. It meant rather than concentrating on populations in geographic areas with excess cervical cancer mortality, including African Americans in the south, Latinos along the Texas-Mexico border and whites in Appalachia, the marketing campaign posited that every girl was at equal risk.”

At least impoverished girls in the regions the Rothmans describe can sometimes get the shots at taxpayer expense. Women in the developing world, alas, are far more vulnerable to cervical cancer than the average American woman; it is the leading cause of cancer-related deaths among women there and kills some 215,475 women annually. Limited or non-existent access to routine health care means that an HPV vaccine would probably be well worth the small risk—but it’s currently unaffordable.

One of the more compelling arguments for the current private health care system in the US is that without being able to eye the highly lucrative American market, many lifesaving technologies and medications would never be developed and implemented around the world. It’s possible…maybe…that Merck has it in mind to pay for Gardasil development costs and huge profit margins by over-selling to the American market—at $360 plus administration costs per kid—and then offer the vaccine at a fractional cost to the market that actually needs it.

Oops. Maybe not. In India the series runs at about $173; far, far out of reach for the average woman in a country where 42 percent of the population lives below the international poverty level of $1.25/day. Absent a massively expensive and ill-afforded government program, only the rich, who already have access to preventive health care, are able to get it. And with a population of 1.2 billion, any government program will necessarily have limited coverage.

Then again, Americans have to ask ourselves about the morality of injecting substances into our children partly in order to defray the cost of overseas health care, if that’s what we’re looking at. There’s a big difference between subsidizing MRI technology with your money and subsidizing a vaccination with your child’s body.

Better living through chemistry.

We Americans (and increasingly other nations, too) have shown that we’re willing to be told that pills, potions, and now vaccinations are a convenient answer to epidemics like Type 2 diabetes, heart disease, ADD and now HPV. Way better, in fact, than taking responsibility for our own health and using medications only as a last resort. We’re apparently quite willing to transfer our dollars from the farmers’ market to the pharmaceutical market.

What the Rothmans didn’t say: A good deal of the potential physical trauma caused by persistent (not transient) HPV infection can be avoided by lifestyle changes, particularly if they’re made early. People who smoke, eat a lousy diet with a tiny or non-existent vegetable/fruit component, and/or have multiple sexual partners, are at a dramatically greater risk of getting a persistent HPV infection that might lead to abnormal cervical cells. A healthy immune system enables people to shrug off the vast majority of highly prevalent HPV infections. Your initially tiny risk of getting a persistent infection increases by as much as 15 percent with each sexual partner, by at least 50 percent with a bad diet, and by up to 2,600 percent with a smoking habit. But Merck is not inclined to tell you that, and neither are most doctors—or at least, not with the same force that they’ll put into the vaccination sales job.

Who cares about ultimate effectiveness? Just approve it already!

The FDA commonly accepts “surrogate endpoints” when approving drugs. Because it can take too long and cost too much to take drug trials to the ultimate outcome, and because doing so could deprive other patients from potentially life-saving treatments, the FDA often looks instead at interim markers. For instance, it might approve a drug because it lowers blood pressure rather than waiting to see how many people in the study die of a stroke instead of sheer old age.

That’s very reasonable—except that we are then often “surprised” by the ineffectiveness or negative side effects of drugs like Avandia, Vytorin, Zetia, Vioxx. Medications are effective for some 60 percent of treated patients at best.

The approval of Gardasil was an even bigger jump than usual. The assumption was that if we can defeat the two oncogenic strains of HPV that are responsible for 70 percent of cases of cervical cancer, then we can reduce the number of cases by 70 percent. That’s how it’s sold to parents, at least by implication.

“No data were available to establish the duration of efficacy, possible adverse effects on natural immunity, whether vaccinated women will forgo Papanicolaou tests, and whether after suppressing HPV-16 and HPV-18 ‘other strains may emerge as significant oncogenic serotypes,’” note the Rothmans.

The last trial data showed Gardasil to be 17-45 percent effective in preventing pre-cancerous cells, with the most dangerous types at the lower end of the range. It is too early to tell much about potential replacement diseases and longevity. When a healthy system shrugs off a particular HPV strain, it virtually always retains a life-long immunity to infection with that type; we’re many years from knowing that about Gardasil and from understanding the implications of an infection in later years. Plus, the many oncogenic HPV strains not covered by Gardasil may move into the post-vaccination void. We just don’t know yet.

The FDA has also been curiously incurious about the growing burden of vaccines on developing bodies. At 50, I’ve had few vaccines in my life, and those mostly later; today’s average child will have had 26 by the time he’s just two years old. And they just keep coming. Spurred by the blockbuster success of Gardasil, there’s wild speculation in the vaccine industry and several new vaccines are well along in development.

Although the FDA requires “concomitant use” studies to prove that a new vaccine doesn’t affect the safety or effectiveness of existing vaccines given at the same time, little or no attention is given to the total lifetime burden of adjuvants like aluminum injected directly into the circulatory and lymphatic system. Some girls who have been hit with post-Gardasil autoimmune issues have been given lumbar punctures, which have revealed “high” levels of aluminum.

It’s all about the marketing/money, baby.

An even bigger jump was Merck’s saturation of the airwaves and doctors’ offices with the message that, as consumers inevitably inferred, not getting Gardasil equals cervical cancer. And here’s where the Rothmans really got going.

Their article lashed the professional medical associations (PMAs) that took Merck’s money to promote Gardasil to other health professionals—notably the American Society for Colposcopy and Cervical Pathology, the Society of Gynecologic Oncologists, and the American College Health Association.

The campaign was a shocking piece of marketing, and “that these arguments were delivered by PMAs is cause for concern,” wrote the Rothmans. “(PMAs) are obligated to provide members with evidence-based data so they can present relevant risks and benefits to their patients. To this end, PMAs must become more transparent about their relationship with industry, disclosing both the precise funding and technical assistance they have received to develop the promotional products. Under no circumstances should PMAs administer product-specific speakers’ bureaus, nor should they accept funding that requires them to report activity to the donor” (as actually happened).

Well, color me surprised. Pharma’s aggressive marketing techniques and slanted information have long permeated the entire medical profession.

A UCSF study found that doctors frequently make decisions about which drugs to prescribe based on “skewed” reports that are essentially written by the drug companies and then published in medical journals, typically emphasizing the positive reports of the trials and selectively reporting data. Trials with favorable outcomes were about five times more likely than those with unfavorable outcomes to be published. There were often many discrepancies between the results the FDA received and the published data; and one-fourth of the results of trials testing the effectiveness of new drugs were not published at all within five years after FDA approval.

Then there was the revelation that Merck had published an entire medical fake journal to push its products as well as keeping a list of researchers and doctors to be ‘discredited’ or ‘neutralized.’

Next, a UM study that found that researchers often didn’t properly disclose potential conflicts of interest in cancer studies. Where a potential conflict existed, randomized trials were more likely to link patient survival to a particular treatment.

Frankly, it’s a wonder that anyone trusts the medical industry at all. And that’s a shame. Good doctors, good researchers, imaginative and disciplined scientists, and effective, life-saving medications and treatments abound, but they’re drowned out by the shrill clamor of—shills.

Risk/benefit assessment

We all resent doctors who think they’re God, but we let them take on that role when we are not given, or do not search out, sufficient information. We should be able to trust them, but sometimes we can’t. Sometimes they themselves get skewed info.

Here’s how Dr. Charlotte Haug sums up Gardasil in JAMA. “If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened. So rationally, she should be willing to accept only a small risk of harmful effects from the vaccine.

“When weighing evidence about risks and benefits, it is also appropriate to ask who takes the risk, and who gets the benefit. Patients and the public logically expect that only medical and scientific evidence is put in the balance. If other matters weigh in, such as profit for a company or financial or professional gains for physicians or groups of physicians, the balance is easily skewed. The balance will also tilt if the adverse events are not calculated correctly.”

And they’re not. As Deborah Kotz reported in the US News and World Report yesterday, 68 percent of reports of adverse events were filed in the VAERS system by Merck itself, and 89 percent didn't include "sufficient identifying information to allow medical review of the individual cases." The VAERS passive reporting system is notoriously fallible.

Kotz goes on to say that the results of the autopsy of Jenny Tetlock, who died of a mystery progressive paralysis after getting her Gardasil shots, showed that Jenny died from a “neurological disease that was ‘mediated by immune responses,’ leading to extensive damage in her spinal cord.” Her tissue samples will now be compared with those of Whitney Baird, who died of similar problems, but whose illness was never noted in the VAERS data base until Jenny’s case hit the internet.

It gave me great joy to read Dr. Haug’s words about rationally looking at the risk/reward ratio of Gardasil. I’ve been trying to look at the vaccine rationally since 2006, but maybe now that Dr. Haug,the Rothmans and JAMA have weighed in, our pediatrician will stop saying I’m an idiot for doing so.

Now if we can only apply the lessons to our healthcare system.

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.

How to Make Gardasil Side Effects Disappear

Since Gardasil made its debut, 15,716 suspected and actual side effects of the HPV vaccine have been reported to VAERS, our oh-so-fallible watchdog system. Just 15,716 bad reactions to who knows how many millions of vaccinations given—statistically insignificant, one might say, especially since so many were minor. Pain at the injection site, perhaps, or a little fainting spell.

The 736 suspected serious Gardasil side effects to date include 24 deaths, 147 life-threatening reactions, 255 permanent disabilities, 496 hospitalizations, 127 prolonged hospitalizations, and 544 emergency room visits.

And of course it’s important to remember that just because a report has been made to VAERS, that doesn’t mean the connection with Gardasil has been proven. In fact, some of the deaths almost certainly weren’t connected. It’s just as important to note that the system is notoriously fallible and that as few as one in ten reactions are reported, perhaps in part because information sheets handed to parents guide them to make a VAERS report only in the case of an immediate allergic reaction; there’s no mention at all of more subtle reactions.

But still, statistically insignificant.

Unless you think about the lesson we learned—or should have learned—from a doctoral student’s refinement of her thesis advisor’s study.

Remember that scandal, just a few years back? Harvard’s Dr. Chester Douglass took a research grant from the NIEH to study the possibility that fluoride in our water supply could cause osteosarcoma, a very rare bone cancer usually resulting in amputation or death. Douglass looked at 139 males and females with osteosarcoma and 280 matched controls, all of whom drank fluoridated tap water, and duly reported back that nope, there was no problem. Statistically speaking. Unfortunately for him he quoted a thesis study by Elise Bassin, his graduate student, as if it supported his conclusions. The thesis itself, though, was mysteriously unavailable to health researchers.

Eventually some terriers from the Environmental Working Group obtained limited access. And discovered that smart Elise had worked a lot harder and a lot more intelligently than her professor. Theorizing that children are much more likely to be susceptible to any harmful effects of fluoride at a time when their bones are growing rapidly, she focused only on the under-20s and their matched controls, and furthermore verified fluoride levels in the tap water drunk by all the children for each year in their lives, rather than just looking at the water they were drinking at the time of the study.

I won’t overload you with the details of her very plausible theory. The end result, however, was that yes, according to her study fluoridated water indeed appeared to raise the (tiny) risk of osteosarcoma in young males by 500 to 700 percent, with a particular risk between the ages of 6 and 8. Certainly a very different conclusion from that reached by Douglass, who moonlighted as editor-in-chief of the Colgate Oral Report and who chose to merge the statistics into the general population.

So back to Gardasil. If you look at the VAERS numbers with a traditional view to collateral damage, i.e. that a) a few will necessarily suffer for the greater good and b) numbers for nasties like motor neurone disease aren’t really all that different from what you might reasonably expect in the general population, then you probably see no cause to study Gardasil any further. You can make the side effects effectively disappear. by merging them into the general population.

But if you look at people rather than statistics; if you’re one of the young women affected, or the parent of one, you might wish like hell that you had an Elise Bassin looking at these happy statistics and applying a curious mind to them.

A curious scientific mind might look, for instance, at 97 cases of arthralgia, 4 of rheumatoid arthritis, 4 of juvenile arthritis and 3 of arthritis reported to VAERS, plus 2 cases of rheumatoid arthritis, 5 of arthritis, 1 of reactive arthritis, and 1 of juvenile arthritis seen in Merck’s initial study—a three-fold increase over the controls, who also received the aluminum-containing adjuvant—and wonder if these girls came from a subset. A subset of some kind that required only an environmental trigger, such as a vaccine, to wreak havoc on young bodies. Find the subset and you find a future group that should avoid Gardasil, that would be the way a Bassin-style mind would look at it.

A read through the VAERS reports suggests all kinds of subsets that should be studied by someone with a fine and open mind, someone who’s willing to put in the time to get exhaustive histories from these girls. Someone who might look at Jenny Tetlock’s devastating bout with extraordinarily rapid-onset ALS-like symptoms—the symptoms that killed her at 13—and at the two Gardasil girls just like her, and be consumed with the desire to know about any common factors and how they might have made those girls vulnerable. Someone who might study 68 reported cases of convulsions and 11 of epilepsy. Who might put out a call for similar cases in the general population, cases that went unreported just as the two ALS-type cases like Tetlock’s went unreported until her parents put up a blog.

Who might wonder why so many different immune diseases appear to be triggered by Gardasil, and instead of saying “Statistically, it doesn’t merit studying” would say “Damn, I just have to figure this out, so that we know which girls shouldn’t get the vaccine in future.”

We can make potential side effects statistically disappear alright. But we shouldn’t want to.

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?

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.

Are Gardasil Benefits Worth the Potential Side Effects?

The Gardasil results so far are in: a 17 to 45 percent reduction in abnormal Pap smears.

Merck’s newest press releases publicizes a study that showed a 96% protection against HPV strain type 16, (which causes some 53.2% of invasive cervical cancers) over 8.5 years—and sure, that’s impressive. But the drug company’s marketing department probably hoped that journalists wouldn’t read the rest of the press release too closely, particularly on a Friday. Or, come to that, ask about type 18, which causes 13.1% of cervical cancers and goes curiously unmentioned.

But about those reductions in abnormal Pap smears.

Two 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, the results were as follows:

· 17 to 22 percent reduction in ASC-US: atypical squamous cells of undetermined significance associated 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.

Now, if you’re one of the women who’s suffered an abnormal Pap smear and/or cervical cancer, those results probably look pretty good to you.

But—seriously? That’s it? 17 to 45 percent reduction?

And I’m curious. Given that type 16 supposedly causes the vast majority of 66-70 percent of cervical cancer (18 trails it by a mile) but was shown in a study published in the Journal of the National Cancer Institute to be losing ground to non-18 types, did anyone check the results for evidence that other strains of HPV are becoming more common? Does anyone care?

Heck, I was starting to waver again on the news that cases of genital warts have dropped dramatically, according to recent reports from Australia. And I’m constantly looking at the Gardasil issue. I always keep in mind the possibility that at some point the pros might outweigh the cons (cons like the potential for some particularly nasty, if unproven, side effects as well as the unknown of replacement diseases like those that popped up with Prevnar.)

But if that’s all the protection we’re looking at just in the short-term, when women have been less exposed to HPV of all kinds than they probably will be later in life, not vaccinating seems like a no-brainer.

Cervarix versus Gardasil

The battle’s on. And let the marketing campaigns and medical sniping begin.

GlaxoSmithKline said today that the results of a comparative HPV vaccine study it had sponsored showed that Cervarix generated between two and six times as many antibodies as Gardasil.

Both vaccines utilize novel “virus-like particles,” VLPs. These are created by inserting DNA into yeast cells to make a genetically-engineered ‘seed stock’. The resulting paste is cultured in a fermenter to increase cell mass and then incubated; eventually the antigen VLPs are filtered from the paste and blended with adjuvants. The paste is then cleaned and reused.

Both vaccines protect against HPV strains 16 and 18, thought to be responsible for 66 to 70 percent of cervical cancers, although one study recently showed 16 to have been losing ground to strains other than 18 (there are believed to be up to 120 strains of HPV) for some years. Gardasil also protects against two wart-causing strains.

But Cervarix also uses a novel adjuvant containing aluminium salt and monophosphoryl lipid A (MPL), and according to GSK that makes a big difference in antibody levels—a claim that made a Merck spokesman sniff disparagingly, “It's disease efficacy that's really the most important, and we certainly have very high efficacy against some very important disease endpoints."

Cervarix has been used in the EU for some time and was chosen over Gardasil by Britain for its country-wide vaccination program. However, the FDA is currently looking it over for approval in the US, where Merck has had the market to itself up until now.

Both vaccines have been associated with side-effects including paralysis, convulsions and immune disorders, although no causal link has been proven and the CDC beleives that HPV vaccines are safe.

Approval for Cervarix in the US could come by the fall—so if you think the Gardasil campaign up to now has been aggressive, honey, you ain’t seen nothin’ yet.

The Gardasil Campaign Picks Up Some of Merck’s ‘Hit List’ Strategies.

It’s a classic case of, if you’re not white-hot with rage, you’re sure as heck not paying attention.

Last month The Australian reported that Julian Burnside QC (Queen’s Counsel) had produced in court internal Merck emails that contained a ‘hit list’ of doctors, researchers and academics it needed to neutralize or discredit. In some cases it was noted that a doctor had already been neutralized. “We may need to seek them out and destroy them where they live,” it read. (One can only assume that the advice was not meant to be taken Mafia-style.)

Why discredit these people? Because they had criticized Vioxx or Merck.

Now it turns out that New Zealand’s Health Ministry may have picked up a few tips from Merck.

Just to refresh your memory, the Merck e-mails were presented in a class-action lawsuit against Merck over its anti-inflammatory drug Vioxx. Julian Burnside also produced evidence that Merck had attempted to intimidate researchers with implied threats of funding cut-offs or withdrawn academic appointments. An infuriated James Fries, professor of medicine at Stanford University, had apparently written to Merck back in 2000 to complain about the way it had treated some of his researchers who had been critical of Vioxx.

“Even worse were allegations of Merck damage control by intimidation…This has happened to at least eight (clinical) investigators ... I suppose I was mildly threatened myself…”

Specific incidences of intimidation included one of Fries’ colleagues’ belief that his position had been put in jeopardy, and phone calls to another alleging his “anti-Merck” bias. Fries apparently told Merck that it had been ‘systematically playing down the side effects of Vioxx’ and that its behavior "seriously impinges on academic freedom."

"In every possible way the company exerted itself to present the impression to the world at large that Vioxx did not provide any increased cardio risk ... when (a) it probably would and (b) it probably did," the letter went on to say.

So, on to Gardasil and New Zealand’s Ministry of Health.

New Zealand is having a bit of a problem with implementing its country-wide Gardasil vaccination program. The 3-shot HPV vaccine is being administered through schools, and 78 schools, about 5 percent, have declined to take part.

Furthermore, New Zealand’s self-described “leading health and fitness magazine” Fitness Life produced an article critical of Gardasil because, according to the publisher, the drug had been heavily promoted by a glowingly positive Ministry of Health and Merck, and no-one had publicly discussed potential long-term effects.

The article was publicized with a billboard in the middle of Auckland. The Ministry of Health promptly filed a complaint with the Advertising Standards Authority (ASA) on the grounds that both billboard and article were “misleading, deceptive, and irresponsible.”

The magazine countered that it would be deceptive and irresponsible to “only talk Gardasil up, regardless of possible side-effects…The advertisement and article were commissioned with a keen sense of social responsibility and with the hope that, by asking entirely valid questions, we are opening the floor to fresh debate on an issue that is of great importance to families and their daughters.”

Fair enough. The ASA agreed on all counts and threw out the MoH’s complaint.

Now, here’s where it gets interesting.

The MoH’s next cannon-ball was a written response to the article, available online, from the Immunisation Advisory Center.

After an unprofessionally snarky introduction, it counters some errors, such as a statement in the Fitness Life article that Gardasil contains a dead virus (it’s neither dead nor alive; it in fact uses a new genetically-engineered process that produces “virus-like particles”). It clears up some “confusions” and reiterates the CDC’s stance that, regardless of VAERS data (which is raw and often unverified data, both under-reported and over-reported) Gardasil “has not been found to increase the risk of any of the serious conditions (other than anaphylaxis) noted in Wheaton’s article.”

I’m certainly not opposed to correcting statements of fact. As a writer, I do my damndest to get my facts straight, and I’m happy to correct any factual error that I might make. I get positively crabby, actually, when people do the Chinese-whispers thing with some fairly outrageous suggestions—and that certainly has been known to happen with Gardasil. Because Fitness Life is not online, I have no clue what the article actually said.

But what sticks in my craw, apart from the pettish tone of the response, is the rather blatant attempt to shut down debate.

And what really, truly sticks in my craw like a bowling ball in a drinking straw. is the little zinger at the end.

“A note on Diane Harper: After involvement with Merck and Gardasil clinical trials, Diane Harper disappeared and was found working for GSK on the Cervarix clinical trials. Her position on Gardasil may not be neutral.”

Wow. That comes straight out of Merck’s playbook.

I don’t know Harper from Adam. But I’ve liked the seemingly very realistic and sensible statements I’ve heard from her. She has said, pretty much, that Gardasil is a great vaccine that is very valuable for most women, BUT that it was marketed too aggressively, introduced too rapidly, and could be a no-no for people with a family or personal history of auto-immune disorder. In other words, she’d have liked to see Merck and medical authorities proceeding a little more cautiously with a brand-new vaccine. Which sounds completely reasonable to me.

Oh wait. It’s partially critical.

So let’s discredit her.

Yep. Sounds like good old New Zealand has been getting some advice from Merck.

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.

Double-Speak in Spain over Gardasil Convulsions

According to Reuters América Latina, Spain’s Agencia Española del Medicamento y Productos Sanitarios (AEMPS) and Europe’s Agencia Europea de Medicamentos (EMEA) have cleared Gardasil for take-off.

The two organizations have shrugged off any possibility that the continuing convulsions suffered by two young girls in Valencia, and by a third girl in the Balearic Islands, could be related to Gardasil. All the girls started convulsing and lost consciousness within hours of being injected with the anti-HPV vaccine. A few days later the entire batch of Gardasil was withdrawn, and although Spain’s vaccination program resumed shortly, its Ministry of Health convened a panel of experts to look into the matter.

The two girls in Valencia, at least, have suffered repeated and debilitating bouts of convulsions and have been rushed to Intensive Care several times. Experts are at a loss to explain or cure the problem and the families are, understandably, distraught and angry. Little is known about the third girl, whose case was far less widely publicized.

The two panels found no biological link between the girls’ convulsions and the shot, largely because they could find no similar cases in Spain despite the large number of vaccines given. They did, however, note that administration of the vaccine could well have “precipitated” the illness—in other words, it acted as a trigger.

That confuses me. Isn’t that a link?

According to VAERS (the Vaccine Adverse Event Reporting System) 359 cases of convulsions and 13 cases of epilepsy post-Gardasil have been reported in the U.S. to date—always bearing in mind that VAERS is a purely voluntary system and suffers acutely from both over-reporting and under-reporting.

If it were me investigating the relationship between Gardasil and convulsions, I’d certainly want to look into possible trigger mechanisms. It is distressing to see that the people entrusted with public health are willing to say that, statistically-speaking, of course there is no connection— “just” a potential trigger.

But heck, I’m just the parent of a potential statistic.

The Gardasil Vaccine and the Morality Issue

It’s absolutely inevitable. Whether I’m reading a seasoned journalist’s story, a rookie reporter’s college newspaper report, or a science junkie’s “we debunk the flat-earther viewpoint” blog, watch out, here it comes.

Some version of the chestnut about parents withholding Gardasil from their kids because they’re afraid the kids will immediately scream, “ooh, goody!” and run off to have lots of sex. Or even just a little bit of sex.

In fact, when my kids’ pediatrician discussed Gardasil with me at a scheduled check-up just after the 3-shot HPV vaccine first hit the market, and I said I thought we’d wait, she stiffened. “Oh,” she said, “We did worry that parents would be uncomfortable with thinking about their children having sex, or that the churches would come out against it, but fortunately that doesn’t seem to have happened. Most parents are very happy about it.”

Implication: You’re a) just a naïve prude, and/or b) a snake-handler church adherent.

But the funny thing is that even the Catholic Church, not exactly known for encouraging wild promiscuity, hasn’t condemned it. “The CMA supports widespread use of Gardasil® for girls and women in the age range for which the vaccine has been recommended by the ACIP, because it is effective, safe, and ethical to use, provided certain conditions are met…There is no ethical objection to the HPV vaccine either as a strategy against disease or in its production. Patients and parents must have the opportunity to give informed consent to its Administration,” reads the Catholic Medical Association’s policy paper.

Maybe I’m hanging out in the wrong church or with the wrong people, but for all the many parents I know who have chosen not to vaccinate with Gardasil—and for all those who have chosen to do so, too—morality has nothing to do with it at all. It's purely a medical issue. I wouldn't even feel compelled to discuss the reason for it with an eleven or twelve-year old before getting her the vaccine, any more than I'd go into the whys and wherefores of MMR. Crabby old Texas found the same thing.

“Local researchers have found that mothers' views about premarital sex don't affect their decisions on whether their pre-teen or teenage daughters should get the vaccine against the sexually transmitted virus that causes cervical cancer. The survey, by a team at the University of Texas Medical Branch at Galveston, appears to refute the perception that mothers who opt against their daughters receiving the vaccine for the human papillomavirus do so because they oppose sex before marriage.

"This is a decision about parenting, vulnerability and vaccine attitudes, not sexuality," said Susan Rosenthal, a UTMB pediatric psychologist and the study's lead author. "Mothers who haven't had their daughter vaccinated yet most often said they want more time to learn about the vaccine." (Reported by Todd Ackerman in the Houston Chronicle.)

Now, admittedly the study was funded by Merck and researched in Texas, which, as we now know, had a bit of a vested interest; and since then some of us who’ve had "more time” haven’t liked what we learned at all. And granted, there are always the odd comments about “if you were decent parents and taught your kids to keep their legs crossed…” and a few outbursts from the kind of reactionary professional mouths that make a damned good living out of screaming “I’m a politically incorrect straight-talker! Look at me!”

But, from my experience, I don’t think the study is far wrong.

So color me paranoid, but I’m wondering where all this talk about prudish, naïve parents worrying about enabling slutty behavior comes from. Could it have started with a marketing genius’ pre-emptive strike? Could it have been designed to cut through resistance and marginalize people who aren’t persuaded?

Who the heck knows? Merck’s marketing machine is certainly sophisticated enough. All I know is that, sure, like most parents, I’m not particularly comfortable with thinking about my daughters having sex sometime in the future, especially given the various physical and emotional risks. (And particularly, I should add, when I eyeball the various revolting specimens the older one drags home.)

However, I’m also realistic, and I remember (vividly!) my own misspent youth. I’ve also seen the daughter of the highly "moral" woman who organized the high school’s abstinence rally become what the British so picturesquely call “the town bike”. So I recognize my daughters’ right to make their own choices, teach them as well as I can about their responsibilities to themselves and to others, and do everything I can to protect their health. And that includes thinking hard and investigating thoroughly before I get them vaccinations that may be ineffective and possibly dangerous.

So, all you journalists, rookie reporters, and bloggers (and our pediatrician too, for that matter) please knock it off with the insults and assumptions.

One Click for Jenny: Gardasil Question Leads to Plea for Overhauling VAERS

So here’s the thing. We can trust in the safety of the HPV vaccine Gardasil—even though it was tested for only a relatively short time before hitting the market—because the government is monitoring it, right?

Sorry. VAERS, a.k.a. the Vaccine Adverse Event Reporting System, is very far from infallible. And one little personal blog, Jenny’s Journey, has proved that by outperforming it.

Jenny Tetlock developed a mysterious paralysis shortly after receiving the Gardasil vaccine. Despite extensive testing no-one could determine whether she was being rapidly killed by ALS or by an autoimmune disease that mimicked ALS. Jenny died last month, less than two years later, at the shatteringly young age of 15.

Jenny’s parents, although cautious about flinging the blame on Gardasil, had asked VAERS to investigate the possibility that Gardasil could have triggered Jenny’s condition. The mighty VAERS system came up with absolutely no comparables, and thus decided that a link was virtually impossible. A neurologist did later independently discover a possible comparable buried in the system; however there was insufficient contact information for verification.

Upstart site Jenny’s Journey, the Tetlock's personal blogsite, came up with two strong comparables. Two strong comparables that had up until then gone unreported to VAERS because the girls’ parents and doctors hadn’t even considered that their unusually rapidly progressing ALS could be connected to their recent Gardasil shots. And sadly, there's a real possibility that if a small and under-publicized site could find those two girls, there could well be even more.

We’re all busy people, so in case you have no time or inclination to read further, I’ll cut to the chase before describing the limits of VAERS: please go to http://oneclickonelife.org/ to sign a petition to get the “dinosaur” VAERS system overhauled. Regardless of whether you’re a Gardasil enthusiast, a no-vaccines-ever parent, or you’re simply concerned about making sure that vaccines “for the public good” are just as good as they can be, please check out the petition. It’s important. We need to fix VAERS.

Why is VAERS So Inadequate?

For one thing, it’s totally voluntary and poorly advertised. Although parents, pharmacists, doctors and patients may all fill out the forms, it is estimated that perhaps ten percent of all side effects and adverse events are actually reported.

First, you’d have to connect the dots, perhaps days or weeks or even months after the event—something that is often difficult, particularly at a stressful time. Then you’d have to know what to do. Although parents are typically given a vaccine information sheet that includes the VAERS website and phone numbers at the time of their child’s shot, most don’t read it, tossing it immediately because they don’t expect a serious reaction. If they do get to the VAERS website, it can be cumbersome and confusing.

“I know the family of a young lady who just died of a debilitating neural disorder, possibly triggered by the Gardasil vaccine. Their attempts to use the Vaccine Adverse Events Reporting System were deeply disappointing,” commented one signer of the petition.

Doctors, already overloaded with paperwork and red tape, don't often tap into the system. Those that do use it report that it ain’t easy. Two comments from the petition:

“Improvement of the VAER is exactly the type of step we should be taking to allow technology to improve patient care, not harm it. I fully support the efforts of OneClickOneLife to harness technology to improve this vastly outdated system. As a practicing physician I have found it tremendously cumbersome to report any adverse effect of any drug therapy which is not only unfortunate but unconscionable given the technology that now exists.”

“I am an employee in the health care field whom has completed the VAERS form. It is not user friendly, complete in all needed documentation and is out dated.”

And something doctors don’t like to discuss: it’s not easy to admit that the vaccine you’ve advocated and administered may be causing problems. Many parents ask pediatricians, “Would you give it to YOUR child?” We’re almost always confidently told “of course!”

Furthermore, doctors, researchers, scientists and even pharmaceutical executives are only human. Dr. John Colquhoun, Auckland’s principal dental officer in the 80s, came to regret strenuously advocating the fluoridation of Auckland’s water while ignoring evidence that dental decay was already rapidly declining. Whether or not you’re a fan of fluoride, his conclusion is interesting.

“I now know that what my colleagues and I were doing is what the history of science shows all professionals do when their pet theory is confronted by disconcerting new evidence: they bend over backwards to explain away the new evidence,” he wrote. “They try very hard to keep their theory intact—especially so if their own professional reputations depend on maintaining that theory.”

Complete and Accurate?

And then there’s accuracy. Perhaps because of the archaic nature of the reporting system, many reports don’t have enough information for follow-up or verification; others are simply erroneous.

Deborah Kotz, who has written several thoughtful and informative articles about Gardasil for US News and World Reports, noted that Chris Tarsell’s sudden death after receiving a Gardasil shot was wrongly reported to VAERS. Her doctor informed VAERS that the autopsy found that Chris had died of “an inflammation of the spleen caused by a life-threatening virus.” Although some minor inflammation of the spleen had been found, the report had in fact concluded that the death was due to "cardiac arrest, cause undetermined."

There’s also jumping-to-conclusions-itis—something that the Tetlocks have tried hard to avoid. Parents hear that there are concerns about Gardasil, say, and immediately assume that any little thing is connected to the shots. While over-reporting is to my mind infinitely preferable to under-reporting, it can overload and confuse the system.

Follow-Up

Several comments on the petition highlight the lack of follow-up. One would think that if one reported a serious adverse effect, the FDA would be on your doorstep shortly; apparently one could well be wrong.

VAERS data should eventually get to the Clinical Immunization Safety Assessment (CISA) Network, a national network of six medical research centers with expertise in immunization safety which research immunization-associated health issues. But those particular mills appear to grind exceeding slow, and unless there is an unmistakable pattern with significant numbers of individuals affected, adverse events will be dismissed as “unlikely connections”. And the Vaccine Safety Data Link, developed in conjunction with several large HMOS, tracks vaccines but doesn’t necessarily connect dots with cases such as Jenny’s.

According to Kotz, the CDC is now finally investigating the three related cases of ALS and has acknowledged that the question of ALS triggered by a vaccine has occurred before, when military personnel were vaccinated against anthrax. CDC officials don’t believe there’s a link, however, but also acknowledged that the media is essential to getting the word out about vaccine issues and encouraging doctors to file reports. Oy vey. While I’m glad that reporters like Kotz are paying attention and following up, shouldn’t a tax dollar or two be spared for that?

Should Wal-Mart take Over VAERS?

Again and again I hear and read complaints about the sheer incompetence of the VAERS system. It’s enough to make me wonder whether Wal-Mart should take it over.

After all, if Wally World’s incredibly creepy information and tracking system is sensitive enough to send Pop-Tarts to soon-to-be hurricane-ravaged towns in an instant, wouldn’t it be infinitely more useful tracking and analyzing information that could save lives? It notoriously did a better job than our government after Hurricane Katrina. And Wally World sure seems to know how to get people’s attention.

OK, I’m Finished Now…

…but again, please go to oneclickonelife.org to sign the petition to bring our creaking VAERS system into the 21st century.

I strongly believe that vaccinations save lives, but I just as strongly believe that there are things about them that we don’t know yet. If VAERS can help to identify small patterns, not just large ones, that can help identify those people who ought not to get vaccinations because of, say, a family history of autoimmune disease, shouldn’t we make sure that it does so?And if your child has been vaccinated with Gardasil, follow through and insist that your doctor does the same by reporting on any side effects or adverse events at:

Vaccine Adverse Event Reporting System (VAERS) – A government program for vaccine safety, co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).

RateADrug.com – Quick 5 minute, anonymous Gardasil survey. RateADrug is a community site for sharing experiences and learning about risks and benefits of prescription medications and alternative treatments. Post comments and view other people’s experiences with Gardasil.

National Vaccine Information Center (NVIC) –Long questionnaire. This is a non-profit organization that advocates vaccine safety and preventing vaccine injury through education.

Why Gardasil Was Created: Jade Goody Dies of Cervical Cancer

Gardasil is such a controversial and flawed vaccine that it seems as if many people can think of it only as a much-hyped profit center for Merck.

But 27 year-old British celebrity Jade Goody’s death of cervical cancer on Sunday, Mother’s Day in Britain, reminds us that yeah, cervical cancer can kill. If an HPV infection is NOT shrugged off, as most are, and you don’t get an annual Pap smear to find pre-cancerous lesions early, then it can eventually kill. And we should take it seriously.

Which is why researchers probably saw the Gardasil vaccine as the Grail—regardless of what Merck did with it afterwards, by fast-tracking it to approval and marketing it aggressively; whatever your feelings about Gardasil, we have to give researchers credit.

Jade Goody was a dental assistant when she soared to fame on the reality TV show Big Brother which endlessly films contestants corralled in a house for weeks at a time. Born to drug-addicted and impoverished parents she was brash, ignorant, and opinionated, soon becoming notorious for malapropisms such as "They were trying to use me as an escape goat."

But her survivor nature won her many fans, and perversely, she soon became a celebrity just for being a celebrity. There was one hell of a row when she put a racist slant on bullying during the filming of a follow-up Celebrity Big Brother, calling Bollywood actress Shilpa Shetty “Shilpa Poppadum” and snickering at her accent. Mixed race herself, though, she not unreasonably explained that “I treat everyone like that.” The two made it up, and in fact Goody learned about her cancer on camera during the filming of an Indian Big Brother.

Her disease progressed in the glare of camera flashes. She was criticized roundly for selling her life, including the rights to film her fantasy wedding to fiancé Jack Tweed while she was dying: she answered that she was storing up as much money as possible for her two young sons so that they would never live as she did as a child.

Goody did a great deal in Britain to highlight the need for regular exams. Although cervical cancer is not prevalent—in the US it ranks 14th on the list of cancers—and it rarely presents itself in young women, serious lesions resulting from persistent HPV infection do appear to be increasing. In Britain the highest grade of pre-cancerous change, CIN3, in 20-24 year-olds has risen from 15.8 percent of all cases in 1999 to 19.3 percent of all cases in 2004.

Gardasil has its issues, and I won’t be getting it for my daughters. But at least Merck’s scare tactics have raised awareness of HPV and the need for precautions, and I thank them for leading me to look at the alternatives (February 9, March 10).

Hopefully my girls will be sufficiently aware of HPV that they will never suffer as Jade Goody has. My thoughts and prayers go with her.

Jenny’s Journey Ends: Gardasil Questions Remain

It’s impossible not to cry, reading that Jenny Tetlock, the impish 15-year old whose struggle with a mystery ALS-like disease is chronicled on the blog Jenny’s Journey, died on March 15th.

I first stumbled on the blog right after I’d hauled a carload of laughing, slightly obsessed young girls to their second viewing of the movie Twilight. To read that Jenny had had to make two attempts to see the movie just once broke my heart, and like so many other people, I returned to the blog again and again, hoping that someone smart, somewhere in the world, would crack her case.

Jenny’s struggle was especially moving not because of her parents’ private agony, but because of their measured public response. They made it very clear that they did not want Jenny to become “the poster child” for an anti-Gardasil outcry. What they wanted was for doctors and researchers to find the cause and cure, whatever it might prove to be, for Jenny’s devastating illness. But they also wanted them to take a possible connection with the HPV vaccine Gardasil seriously.

Jenny’s symptoms became apparent shortly after her third Gardasil shot when she was suddenly unable to clear a hurdle that the other kids in her class could clear easily. With startling rapidity she became a quadriplegic, unable to breathe on her own for more than a second or two.

“Despite over a year of intensive testing at several of the country’s top medical centers, doctors still aren’t sure what has caused Jenny’s paralysis,” reads a post on Jenny’s Journey. “Some (mostly neurologists) believe that she has an unusual, rapidly progressive form of juvenile ALS – the same disease that confines Stephen Hawking to a wheelchair. Others (mostly immunologists) think she may have a rare autoimmune disease that mimics ALS…her family hesitates to declare Gardasil the cause of her illness without scientific evidence, but some MDs at top hospitals see the connection as possible and even plausible.”

They appealed for people with similar issues, with or without the Gardasil HPV connection, to contact them. One such was Whitney Baird, who died last August at the age of 22, just 13 months after being vaccinated with Gardasil. Like Jenny she had had an autoimmune skin disorder and developmental delays as a child, and her condition also deteriorated extraordinarily rapidly, raising the possibility that Gardasil had triggered a reaction that had started killing off motor neurons.

Autoimmune diseases “arise in genetically predisposed individuals but require an environmental trigger,” according to the Lancet, and my posts about the autoimmune disease/ Gardasil connection (February 2 and 4) included this:

“As examples, Dr. Harper (Dr. Diane Harper, who was involved in Gardasil’s clinical trials) mentioned family history of motor neuron disease or autoimmune diseases, which could affect how the person reacts to the vaccine,” wrote medical journalist Zosia Chustecka. “She illustrated this point by saying: ‘Salt does not usually kill anybody, but for a person with congestive heart failure, it could lead to fatal pulmonary edema, so you could say that salt caused their death, as it was the last straw that broke the camel's back.’

There’s also the aluminum connection. A high incidence of ALS in the Western Pacific was linked to dietary toxins such as aluminum; research into a spike of possibly heavy metal-related ALS cases in Gulf War veterans is ongoing.

Jenny’s family notes that since going public with Jenny’s illness, they have found two other cases of ALS following vaccination with Gardasil (the families had not previously thought to report them to VAERS) and learned of two more possible cases. Five cases make two beyond the norm for this age group, and the VAERS system is notoriously fallible and under-used.

Jenny’s parents, quite rightly, don’t want to just throw her disease randomly on the HPV vaccine's doorstep. There may not be a connection at all, although there are certainly very reasonable grounds for suspicion and their questions deserve to be investigated.

Science can be loosely defined as “what we know so far.” The Tetlocks just want us to advance that knowledge a little.

Meanwhile, my heart goes out to Jenny’s family; losing a beloved child is utterly unimaginable. Thank you for your persistence and thank you for making us ask questions. I hope that you will find some measure of peace once we have answers.

And Godspeed, Jenny.

Further Post- Gardasil Convulsions Send Raquel and Karla Back to Intensive Care—Again

Raquel and Karla, the two Valencia schoolgirls who in February were both rushed to intensive care within hours of each other after receiving second Gardasil shots, were both readmitted yet again to the ICU on Wednesday. Raquel, the younger of the two reportedly suffered from convulsions for 90 minutes.

After the two girls lost consciousness and went into convulsions immediately after the inoculations, Spain withdrew the suspect batch of shots. On February 19, however, Spain resumed its vaccination program when the European Medicines Agency said that it had reviewed the cases of the two girls and determined that their illness was “unlikely” to be related to vaccination with Gardasil.

This is the fourth time in a month that Karla (15) has been admitted to intensive care and the fifth time for Raquel (14). “The worst thing is that we can’t see any end to all this,” one of Raquel’s family members told El País, Spain’s largest newspaper.

The two girls had no connection apart from the fact that both were vaccinated with their second shots, taken from the same batch of Gardasil, within two days of each other.

“The link between the vaccination and the appearance of identical symptoms is so obvious that one can only understand denying it if there are unjustifiable special interests involved,” said the families, calling for Health Minister Bernat Soria to intervene and advising other parents not to allow their children to be vaccinated.

Despite a battery of tests doctors have been unable to determine any cause for the repeated convulsions in the two formerly healthy girls. The health ministry has now assembled a panel of experts to help resolve the mystery and, hopefully, get Raquel and Karla back to normal.