More on Texas HPV vaccine mandate backlash

There continues to be a tremendous amount of coverage of Gardasil in the media, most of it focused on reaction to Texas Gov. Rick Perry's nearly-three-week-old executive order rather than the vaccine itself, HPV, or cervical cancer.

Saturday's New York Times wrote about the "Furor on Rush to Require Cervical Cancer Vaccine." The story's premise:

"But a roaring backlash has some health experts worried that the proponents, including the vaccine's maker, Merck, have pushed too far too fast, potentially undermining eventual prospects for the broadest possible immunization."

Syndicated columnist Clarence Page writes, "Don't judge cancer vaccine by Austin political fallout," attempting to encourage the public to distinguish the political controversy created by Perry's actions from the merits and potential benefits of the vaccine itself. He argues,

"With emotions heated up, a lot of misinformation and unnecessary anxieties already are being stirred up over the new vaccine. The least grounded appears to be the fear that it will encourage more sexual activity outside marriage. Our society unfortunately has many larger reasons for that and it is a worthy debate for another time.

For now, Gardasil appears to be a very important and welcome life-saving step forward in the fight against cancer. Don't judge it by the political confusion it has caused."

For an example of emotions heated up, take a glance at this political cartoon at Newstarget.com.

A few more op-eds of note: In Newsday, Marc Siegel writes in favor of broad vaccination (though not explicitly addressing the question of mandates). In the Atlanta Journal-Constitution, Former Rep. Bob Barr writes against mandates, in part:

"None of these concerns will likely deter the legion of Big Government types out there who — allied with the many do-gooders populating state legislatures from California to New York, and prodded by companies willing to spend millions to make billions — will allow nothing to stand in the way of 'good government,' whether the people want it or not."

As far as news goes, the latest in Texas is an effort in the state legislature to effectively reverse Perry's executive order. According to this story, a hearing on the topic yesterday went well into the night. The Houston Chronicle has more.

Finally, the Arts and Leisure section of Sunday's New York Times took a closer look at the visual and creative elements of Merck's "One Less" television commercial.

Renewed attention to possible rotavirus vaccine link to intussusception

A fairly significant amount of alarm was raised by an FDA statement last week titled "Information on RotaTeq and Intussusception". The statement reports 28 cases of intussusception -- the significant intestinal complication that led to the removal of the first rotavirus vaccine, RotaShield, in 1998 -- in children following administration of RotaTeq.

But what may have seemed at first glance to be a major announcement about the vaccine's safety was clarified later in the statement...

"Intussusception can occur spontaneously in the absence of vaccination. Of the reported 28 cases of intussusception, the number that may have been caused by the vaccine, or occurred by coincidence, is unknown."

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"The number of intussusception cases reported to date after RotaTeq administration does not exceed the number expected based on background rates of 18-43 per 100,000 per year for an unvaccinated population of children ages 6 to 35 weeks (CDC, unpublished data)."

In other words, there's no reason to be alarmed about the number of cases reported to date, but the statement, not unsurprisingly, did just that. This AP story by Andrew Bridges originally did not include any information about the background rate, likely contributing to the Alliance for Human Research Protection (and others, no doubt) misinterpreting the FDA item. "Merck rotavirus vaccine linked to 28 reports of life-threatening effect," is how the AHRP item describes the announcement, not at all what the FDA said.

CDC promptly released a statement attempting to clear up confusion. Among the 'key facts' they list:

• "We are not surprised by the number of reported intussusception cases following RotaTeq vaccination."
• "Intussusception, a form of bowel obstruction, occurs spontaneously in the absence of vaccination."
  
• "This notice does not mean there is a problem with the RotaTeq vaccine."

There's been no detectable coverage of this topic in the media since the initial FDA statement last week. It will, however, be discussed at this week's meeting of the ACIP, the agenda for which can be viewed here.

Voices on HPV vaccination, Texas mandate

Of the many opinions expressed in the media over the past 10 days regarding the executive order by Texas Gov. Rick Perry, here are a few worth noting:

• Friday's USA Today included a point-counterpoint on the Texas mandate order. The USA Today editorial board questions the timing of the mandate. The headline and subhead of the story sums up their argument nicely: "Rush to require cancer shot threatens to promote backlash; HPV vaccine holds great promise, but Texas mandate is premature."

• On the same page, Gov. Perry (or more likely, a member of his staff) responded in a short commentary titled "My order protects life." It frames the decision less as a matter of instituting a 'mandate', but rather, implementing an 'opt-out' system of vaccination instead of an 'opt-in' system. Given the relative ease of obtaining exemptions (to the chagrin of vaccine advocates), that terminology is probably more precise than speaking about 'mandates', with its connotation of compulsion.

• Arthur Allen, author of Vaccine (which we noted previously and was reviewed this weekend in the Washington Post) wrote an op-ed that appeared in several papers last week. Titled "Idea behind the decision is sound, but Perry's timing is off," the piece makes an argument similar to that of the USA Today editorial. He writes, "By imposing the HPV vaccine in such a rushed, questionable way, Mr. Perry's action threatens to mobilize people who, under normal circumstances, would simply do what they were told, assuming it was best for them."

• In this AP story in the Seattle Post-Intelligencer, Washington Gov. Chris Gregoire voiced skepticism at Perry's decision. "'I told the medical association that I was reticent to dictate when I think there is a lot of public education that needs to go on,' Gregoire said. 'To go out and start just saying everybody mandatorily has to have this is a little bit troublesome for me.'"

• Finally, Art Caplan and James Colgrove appeared on "Radio Times," a Philadelphia-based NPR program, to discuss HPV vaccination, the Texas mandate, and related topics regarding the ethics of vaccines. You can listen to the one-hour program here.

Texas HPV vaccine mandate in the news

There has been a great deal in the news this week about Gardasil (and a corresponding spike in our traffic), much of which has been triggered by Texas Gov. Rick Perry's executive order on Friday requiring sixth-grade girls to be vaccinated against HPV. Here's the text of the executive order and an accompanying press release from the governor's office. Quoting Perry, "Requiring young girls to get vaccinated before they come into contact with HPV is responsible health and fiscal policy that has the potential to significantly reduce cases of cervical cancer and mitigate future medical costs."

Perry, a Republican, has received criticism for this decision from members of his own political party and conservative organizations, as this AP story and this Houston Chronicle story explain. Perry released a second statement over the weekend, saying, in part,

"Providing the HPV vaccine doesn’t promote sexual promiscuity anymore than providing the Hepatitis B vaccine promotes drug use. If the medical community developed a vaccine for lung cancer, would the same critics oppose it claiming it would encourage smoking?

"Finally, parents need to know that they have the final decision about whether or not their daughter is vaccinated. I am a strong believer in protecting parental rights, which is why this executive order allows them to opt out."

Indeed, likely lost in the headlines pointing to a "mandate" is the important point that the exemption policies already in place in Texas will apply to HPV vaccination in the same way, including parents having the ability to decline vaccination for 'philosophical reasons'. In fact, proponents of vaccine mandates will likely be disappointed to learn that the executive order also instructs state officials to make the exemption process easier by creating a system in which parents can decline vaccination online.

Today's New York Times includes an editorial praising Perry for the decision. In fairness, it argues far more convincingly for HPV vaccination generally than it does for a state mandate (though strong arguments can certainly be made for it.)

Independent of discussions about the appropriateness of philosophical exemptions from vaccination (such as Paul Offit's op-ed we noted here), the current state mandate system means that no parents will be forced to vaccinate their children against their will. However, years of experience have shown that state mandates provide the structures and encouragement necessary to maximize a vaccine's benefit across communities, particularly reaching those without regular access to medical care whom cervical cancer targets disproportionately.

When considering vaccine mandates, we should not focus our attention on those with strong beliefs opposing vaccination, as the exemption procedures provide, for better or worse, a relatively simple remedy. Instead, we must consider those silent in these debates, those not receiving even basic medical care, much less tracking the minute-by-minute developments regarding Gardasil. For them, state mandates have been shown repeatedly to provide the awareness and stimulus needed for the vaccine to reach all who could benefit from it.

Caplan on autism and vaccines

Our own Art Caplan weighs in on the increasingly hard to discount evidence rejecting a link between thimerosal (once included in vaccines) and the increasing prevalence of autism in children. (The short explanation: autism rates continue to rise years after thimerosal's removal from vaccines, suggesting very strongly -- if not proving -- that other factors are responsible.)

In today's Philadelphia Inquirer, Caplan writes in an op-ed titled "Fact: No link of vaccine, autism":

"This nation's future, its national security, the safety of its health-care institutions, and the safety of its citizens depends upon vaccination. It is way past time that message got heard by parents, teachers, nurses, doctors, hospital administrators, the media and politicians. If there has been a more harmful urban legend circulating in our society than the vaccine-autism link, it is hard to know what it might be. At a time when vaccines may be our last best hope in facing some of the greatest challenges we and our children face, this legend needs to be put to rest. Vaccination, not vaccine-bashing, is what this nation needs."

The continued focus on a vaccine link to autism (at the expense of other research directions) has long been a source of tension among many in the autism advocacy community. Even with this news, however, signs point to critics of U.S. vaccination policy continuing to argue that vaccines are still somehow linked to autism, via as an-yet-unknown alternate mechanism now that thimerosal is no longer a likely candidate. For more on this shift in strategy, see this post by Barbara Loe Fisher.