Why, Medscape, why? Or: Gardasil is hunky-dory except when antivaccinationists say it’s not.

THWOMP!

THWOMP! THWOMP!

TWHOMP! THWOMP! TWHOMP!

That’s the sound of me hitting my head against the table. Hard.

What provoked this reaction in me is Medscape, specifically an article that my blog bud PalMD turned me on to. That the article, entitled HPV Vaccine Deemed Safe and Effective, Despite Reports of Adverse Events, seems to have been written in response to criticism of its previous article on the HPV vaccine Gardasil, both by me and others, criticism that led Medscape to quietly pull the old article, makes the resultant article seem even worse, particularly in wake of a truly dumb poll Medscape tried to do about the vaccine. Truly, Medscape would have been better off just staying quiet after that debacle. This new article, although an improvement in several ways, is a major step downward in others, if that’s possible. I’m not sure if the improvements outweigh the sheer hunk o’ hunk o’ burnin’ stupid that makes up one major section of the article. On balance, I don’t think it does.

The article begins:

Editor’s note: This article replaces “HPV Vaccine Adverse Events Worrisome Says Key Investigator,” which was posted on July 26, 2008, and was removed after editorial review.


That’s all very nice, but I really wish the same level of editorial review had been applied to the article that replaced it. I will admit that the new Medscape article even starts out pretty positive and definitively:

August 8, 2008 — Reports of adverse events after administration of the human papillomavirus (HPV) vaccine (Gardasil, Merck) have been making headlines, and questions over the safety of the vaccine have been raised by consumers, parents, healthcare professionals, and others, notes a recent joint statement from the US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). But having analyzed the available data, the agencies offer reassurance.

“Based on ongoing assessments of vaccine safety information, the FDA and CDC continue to find that Gardasil is a safe and effective vaccine,” the agencies said in a statement released on July 22, 2008. “The benefits continue to outweigh the risks,” they said. “This vaccine is an important cervical cancer prevention tool,” they added.

The manufacturer also issued a statement, dated July 10, 2008, saying it too had analyzed available data and it “believes that no safety issue related to the vaccine has been identified. These types of events are events that could also be seen in the general population, even in the absence of vaccination.”

So far, so good. All of the above is true, and it points out the problems with using the Vaccine Adverse Event Reporting System (VAERS) to try to infer causality of adverse events as being due to a vaccine. Dr. Maurie Markman, an advisor to Medscape Oncology, was quoted, and he was quite emphatic about the often coincidental nature of adverse events that may or may not have anything to do with any vaccine and where only carefully controlled epidemiological evidence can provide evidence suggestive of of causality. It’s also pointed out that some events, such as Guillain-Barré syndrome, are so rare that causality is unlikely ever to be able to be confirmed, a point further explained by John Iskander, MD, acting director of the Immunization Safety Office at the CDC, who further reinforced these points and the problems with using the VAERS system to infer causality. (If you want to know more about how easily the VAERS system is swayed by publicity or even trial lawyers, read my post on the subject from a couple of years ago.)

You might think that I’d be unhappy that Dr. Diane Harper was cited again as the “skeptic” who is not so positive about Gardasil. You’d actually be wrong. As I pointed out in the first post I did on the topic, even as the resident vaccine defender on ScienceBlogs, I’m not yet entirely sold on the contention that it’s necessary to make Gardasil or another HPV vaccine one of the mandatory regular vaccines in the childhood vaccine schedule. My doubts are based more on the expense and whether the evidence is convincing that the vaccine’s benefits outweigh its expense and risks by a margin comparable to that of other vaccines in the routine childhood vaccination schedule, which is what I consider a necessary burden of proof to be met before the vaccine is added as a routine part of the overall vaccination schedule. So it bothers me not at all when Dr. Harper says things like:

However, there is also another very important part to the cervical cancer prevention story, Dr. Harper said, and that is regular Pap tests. Even women who are vaccinated need to have regular Pap testing, as otherwise they are still at risk of developing cervical cancer. And women who decide not to have the vaccine can still protect themselves by undergoing Pap testing.

Dr. Harper feels this message has not been made clear to the general public and that it has been overshadowed by what she considers to be aggressive and inappropriate promotion of Gardasil. As a gynecologist dealing with the general population, her advice on the HPV vaccine is that “if you are at all concerned, then don’t have the vaccine — have regular Pap smears and you will be equally protected from cervical cancer.”

That’s a perfectly valid comment about Gardasil from a medical standpoint. I would quibble that Dr. Harper seems to think the vaccine is far more risky than the evidence, in fact, says it is, but she’s not so far off the rails as to provoke a heapin’ helpin’ of not-so-Respectful Insolence. If Dr. Harper had been the only “skeptic” of Gardasil quoted, I’d have no problem at all with the article. She’s harsh, but she can (mostly) back her criticisms with reasoned argument and science.

Sadly, though, the author Zosia Chustecka seems to have felt the need to find a rabid antivaccinationist to interview and quote extensively. I’m talking Barbara Loe Fisher-rabid.

Oh, wait. She actually went and interviewed Barbara Loe Fisher for the article.

Yes, that Barbara Loe Fisher, founder of one of the oldest antivaccine websites in existence, the National Vaccine Information Center (NVIC) and the blogger behind the prominent antivaccine blog Vaccine Awakening. I’m talking about the very same Barbara Loe Fisher who recently showed up at Netroots Nation to try to push her antivaccine agenda and then whined about criticism. Quoting Fisher about vaccines is akin to quoting Count Dracula about garlic, sharpened wooden sticks, and that man Abraham Van Helsing. Indeed, Arthur Allen described her in his book Vaccine: The Controversial Story of Life’s Greatest Lifesaver, thusly:

To be sure, Barbara Loe Fisher and Kathi Williams defined themselves as consumer safety advocates, denying that they were “antivaccine.” But this self-definition was problematic, because they viewed mass vaccination itself as a dangerous process of questionable value. They felt that vaccines were a small or negative contribution to health and should be optional. When I asked Fisher whether she felt there were any “good” vaccines, she declined to mention any specifically but resopnded that she supported “the availability of the safest, least toxic, most advance vaccines that can be produced as a health care option for anybody who wants to use them.”

In other words, Fisher was peddling the “Green Our Vaccines” lie back when Jenny McCarthy was still posing for Playboy and doing gross-out humor for MTV. Indeed, Fisher is later quoted by Allen as saying this about thimerosal and vaccines and how autism rates have not decreased since thimerosal was removed from vaccines:

“Thimerosal is only part of the problem,” she [Fisher] told me. Vaccines, Fisher was convinced, cause the immune system to go awry in a way that affected the mind. Perhaps microbial poisons crossed the blood-brain barrier, or vaccines overwhelmed the immune system, or the very absence of diseases that vaccines prevented somehow threw the body off kilter.

Suffice it to say that Fisher is not a reliable or in any way authoritative source of information about vaccines. Period. She is a major antivaccine activist, crank, and advocate of pseudoscience–and dangerous pseudoscience at that. Because she is implacably and irrevocably opposed to the very concept of mass vaccination, her website and blog are chock full of anti-vaccine rants, exaggerations of vaccine dangers, and pseudoscience about vaccines, while the NVIC website is festooned with an image of the Statue of Liberty with the logo, “No forced vaccination, not in America.” She does not belong in Medscape, at least not in a serious story about medicine and vaccines and certainly not if Medscape really wants to be science- and evidence-based in its reporting. She proves me correct in this assessment in spades with what she says, too:

The NVIC, self-billed as “America’s Vaccine Safety Watchdog,” has also accessed VAERS reports and made them available in a searchable database on its Web site. These data show that during 2008, reports about Gardasil have accounted for 20% to 25% of all VAERS reports on all vaccines, Ms. Fisher said. “This is striking, as Gardasil isn’t a mandatory vaccine while many other childhood vaccines are, but we don’t know what this means.”

No, it’s not “striking” at all. As I pointed out before time and time again, VAERS is very, very sensitive to publicity, which can cause spikes in reports due to the advocacy of well-meaning (or not-so-well-meaning) groups or by lawyers trying to game the database in their favor. Remember, VAERS is an entirely self-reported database. Minimal effort is made to verify reported adverse events, and anything can be reported, whether it can reasonably inferred to have been from vaccines or not. Indeed, two most unusual reports of vaccine “reactions” have been submitted to the database, including a report of a vaccine turning a man into The Incredible Hulk. Indeed, people entering reports don’t even have to originate from the U.S. A couple of years ago, a British father of an autistic girl entered a VAERS report in which he claimed that vaccines turned his daughter into Wonder Woman. VAERS, as I said, is useless for longitudinal studies or determining causality. That’s not its purpose; its purpose is to serve as a “canary in the coalmine,” an early warning system. Although this Medscape article got that part of VAERS function mostly right in the story, it greatly undermined the point by including such moronic antivaccination idiocy from Fisher as though it had any authority whatsoever.

Chustecka then lets Fisher ladle some more stupid into the article:

In addition, the NVIC has been running its own private vaccine reaction registry for the past 26 years, and it currently has about 140 reports on Gardasil, Ms. Fisher said. “These include reports of injury and death, and we are seeing a pattern of what we have termed ‘atypical collapse,’ ” she commented. “These include cases where a girl suddenly passes into unconsciousness either immediately or within 24 hours of vaccination and then revives feeling weak and unable to speak properly or exhibiting other neurological signs. What we are concerned about is that girls are not aware of this possibility and could be crossing the road or driving a car and suddenly pass out.”

PalMD demolished this bit of antivaccine nonsense so that I don’t have to. Suffice it to say that Fisher is making it up as she goes along. This “atypical late collapse” is an invention of antivaccine people; nothing more. It’s not a recognized clinical entity. Finally, Chustecka gamely reports Fisher’s words as she pulls the dreaded antivaccine aluminum gambit:

Ms. Fisher added that the fact that the placebo used was aluminum based, and so the results may not give a true picture of the events associated with the vaccine, and noted the lack of any prelicensure data on administration of Gardasil simultaneously with other vaccines, in particular the meningococcal vaccine, which is targeted at a similar age range. She suggested that the vaccine was recommended for preadolescent girls prematurely.

This is all nonsense, and it should have been flagged as such by Medscape. Vaccines are always tested with the rest of the routine vaccination schedule; this nonsense about Gardasil not being tested with other vaccines is just that–nonsense. It’s nothing more than the standard antivaccine trope that it’s some undescribed “interaction” between different dreaded vaccines that causes all those horrible problems–except that there really aren’t horrible problems to be found when one looks at the data dispassionatedly. In addition, there is no evidence that aluminum in vaccines at the doses used causes neurological problems. Antivaccinationists harp on aluminum now because accumulating evidence has failed to find any link between mercury (their previous favorite whipping boy) and autism, and antivaccinationists need a new bogeyman in vaccines. That’s why they’ve switched their attention to aluminum, even though it has an 80 year track record of safety, and on “toxins.” Aluminum’s a metal, right? That makes it just like mercury or plutonium, right? Therefore, aluminum must be bad. Or at least so antivaccinationists seem to think.

Looking at this utter debacle on the part of Medscape’s recent reporting on Gardasil, I’m left scratching my head. I just can’t figure out what happened or why Medscape seems to find it so hard to avoid bringing pseudoscience into their reporting on this particular issue. What on earth were the editors thinking when they allowed the first execrable article to be published and then posted that utterly silly push poll? It seems to come down to that lazy journalistic mantra of “tell both sides” of the story. Indeed, I have to wonder if Chustecka counted up two doctors being very positive about Gardasil and only one (Dr. Harper) being negative or skeptical about the vaccine and decided that for “balance” one more “skeptic” was required to round out the article. The problem, of course, is that while Dr. Harper, although I disagree with a some of what she said and she fairly harsh, for the most part she was reasonable and (mostly) science-based in her comments, Barbara Loe Fisher was not at all reasonable. She’s about as hardcore an old school an antivaccinationist as there is in existence, so much so that it is not going too far to categorize her as the grande dame of antivaccinationism in the U.S. To quote such a crank as though she were a medical authority criticizing Gardasil is no different than quoting Ken Ham or Roy Comfort as “experts” criticizing evolution. To me, quoting Barbara Loe Fisher as though she had anything useful to say at all about Gardasil or vaccines in general is arguably worse than quoting Christiane Northrup in the previous article, who, although definitely a flake, is not implacably antivaccine.

The “tell both sides” mantra beloved of reporters and inculcated into them in journalism school is all well and good for political stories and many other types of stories, but it can easily become anathema in science or medical reporting. For example, there aren’t “two sides to the story” when it comes to the theory of evolution, at least not scientifically speaking; yet we continue to see stories quoting creationists as though they had a valid scientific point. This is no different. When it comes to science, there aren’t “two sides to the story” when it comes to vaccines, or if there is antivaccinationists have yet to be able to produce any compelling scientific evidence why we should take them seriously as the “other side of the story.” They’re excellent at manufactroversy, but when it comes to defending their viewpoints they’re all pseudoscience and misinformation. If Medscape wants to be taken seriously when reporting medical science, it needs to realize that not every story has two valid sides and to recognize when it’s dealing with a story with science on one side and nonsense on the other.