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Monday
Jan212013

A case study: the HPV vaccine disaster (Science of Science Communication Course, Session 1)

This semester I'm teaching a course entitled the Science of Science Communication. I've posted general information on the course and will be posting the reading list at regular intervals. I will also post syntheses of the readings and the (provisional, as always) impressions I have formed based on them and on class discussion. This is this first such synthesis. I eagerly invite others to offer their own views, particularly if they are at variance with my own, and to call attention to additional sources that can inform understanding of the particular topic in question and of the scientific study of science communication in general. 

 

1. The HPV vaccine disaster

HPV stands for human papilomavirus. It is a sexually transmitted disease.

The infection rate is extremely high: 45% for women in their twenties, and almost certainly just as high for men, in whom the disease cannot reliably be identified by test.

The vast majority of people who get HPV experience no symptoms.

But some get genital warts.

And some get cervical cancer.

Some of them--over 3500 women per yr in U.S. -- die. 

In 2006, the FDA approved an HPV vaccine, Gardasil, manufactured by the New Jersey pharmaceutical firm Merck. Gardasil is believed to confer immunity to 70% of the HPV strains that cause cervical cancer. The vaccine was approved only for women, because only in women had HPV been linked to a “serious disease” (cervical cancer), a condition of eligibility for the fast-track approval procedures that Merck applied for. Shortly after FDA approval, the Center for Disease Control recommended universal vaccination for adolescent girls and young women.

The initial public response featured intense division. The conflict centered on proposals to add the vaccine—for girls only—to the schedule of mandatory immunizations required for middle school enrollment. Conservative religious groups and other mandate opponents challenged evidence of the effectiveness of Gardasil and raised concerns about unanticipated (or undisclosed) side-effects. They also argued that vaccination would increase teen pregnancy and other STDs by investing teenage girls with a false sense of security that would lull them into engaging in unprotected, promiscuous sex. Led by women’s advocacy groups, mandate proponents dismissed these arguments as pretexts, motivated by animosity toward violation of traditional gender norms.

In 2007, Texas briefly became the first state with a mandatory vaccination requirement when Governor Perry—a conservative Republican aligned with the religious right—enacted one by executive order. When news surfaced that Perry had accepted campaign contributions from Merck (which also had hired one of Perry’s top aids to lobby him), the state legislature angrily overturned the order.

Soon thereafter, additional stories appeared disclosing the major, largely behind-the-scene operation of the pharmaceutical company in the national campaign to enact mandatory vaccination programs.  Many opinion leaders who previously had advocated the vaccine now became critics of the company, which announced that it was “suspending” its “lobbying” activity. Dozens of states rejected mandatory vaccination, which was implemented in only one, Virginia, where Merck had agreed to build a vaccine-manufacturing facility, plus the District of Columbia.

Current public opinion is characterized less by division than by deep ambivalence. Some states have enacted programs subsidizing voluntary vaccination, which in other states is covered by insurance and furnished free of cost to uninsured families by various governmental and private groups. Nevertheless, “uptake” (public health speak for vaccination rate) among adolescent girls and young women is substantially lower here (32%) than it is in nations with inferior public health systems, including ones that likewise have failed to make vaccination compulsory (e.g., Mexico, 67%, and Portugal, 81%). The vaccination rate for boys, for whom the FDA approved Gardasil in 2009, is a dismal 7%.

2. What’s the issue? (What “disaster”?)

The American pubic tends to have tremendous confidence in the medical profession, and is not hostile to vaccinations, mandatory or otherwise (I’ll say more about the “anti-vaccine movement” another time but for now let’s just say it is quite small). When the CDC recommended vaccination for H1N1 in December 2009, for example, polls showed that a majority of the U.S. population intended to get the vaccine, which ran out before the highest-risk members of the population—children and the elderly—were fully inoculated. In a typical flu season, uptake rates for children usually exceed 50%.

The flu, of course, is not an STD. But Hepatitis B is. The vast majority of states implemented mandatory HBV vaccination programs—without fuss, via administrative directives issued by public health professionals—after the CDC recommended universal immunization of infants in 1995. Like the HPV vaccine, the HBV vaccine involves a course of two to three injections.  National coverage for children is over 90%.

There are (it seems to me!) arguments that a sensible sexually active young adult could understandably, defensibly credit for forgoing the HPV vaccination, and that reasonable parents and reasonable citizens could for not having the vaccine administered to their children and mandated for others’. But the arguments are no stronger than—not not at all different from—the ones that could be made against HBV vaccination. They don’t explain, then, why in the case of the HPV vaccine the public didn’t react with its business-as-usual acceptance when public health officials recommended that children and young adults be vaccinated.

What does? That question needs an answer regardless of how one feels about the HPV vaccine or the public reaction to it—indeed, in order even to know how one should feel about those matters.

3. A polluted science communication environment

The answer—or at least one that is both plausible and supported by empirical evidence—is the contamination of the “science communication environment.”  People are generally remarkably proficient at figuring out who knows what; they are experts in identifying who the experts are and reliably discerning what those with expertise counsel them to do. But that capacity—that faculty of reasoning and perception—becomes disabled (confused, unreliable) when an empirical fact that admits of scientific investigation provokes controversy among groups united by shared values and perspectives.

Most of us have witnessed this situation via casual observation; scholars who carefully looked at parents trying to figure out what to think about the HPV vaccine saw that they were in that situation. They saw, for example, the mixture of shame and confusion experienced by an individual mother who acknowledged (admitted; confessed?) in the midst of a luncheon conversation with scandalized friends (also mothers) that she had allowed her middle-school daughter to be vaccinated (“what--why? . . .”; “Well, because that’s what the doctor advised . . . .” “Then, you had better find a new doctor, dear . . . . ”).

Scholars using more stylized but more controlled methods to investigate how people form perceptions of the HPV vaccine report the same thing.  In one, researchers tested how exposure to two versions of a fictional news articles affected public support for mandatory HPV vaccination.  Both versions described (real) support for mandatory vaccination by public health experts. But one, in addition, adverted without elaboration to “medical and political conflict” surrounding a mandatory-vaccine proposal. The group exposed to the “controversy” version of the report were less likely to support the proposal—indeed, on the whole were inclined to oppose it—than those in the “no controversy” group. This effect, moreover, was as strong among subjects inclined to support mandatory vaccination policies generally as among those who weren’t/

The study result admits (I admit!) of more than one plausible explanation. But one is that being advised the matter was “politically controversial” operated as a cue that generated hesitation to credit evidence of expert opinion among people otherwise disposed to use it as their guide on public health issues.

Another study done by CCP bolsters this interpretation. That one assessed how members of the public with diverse cultural outlooks assessed information about the risks and benefits of HPV vaccination. Subjects of opposing worldviews were inclined to form opposing beliefs when evaluating information on the risks and benefits of the vaccine. Yet the single most important factor for all subjects, the study found, was the position taken by “public health experts.” Sensibly & not surprisingly, people of diverse values share the disposition to figure out what credible, knowledge experts are saying on things that they themselves lack the expertise to understand but that are important for the wellbeing of themselves and others.

Whether the subjects viewed experts as credible and trustworthy, however, was highly sensitive to their tacit perception of the experts’ cultural values. This didn’t actually have much impact on subjects’ risk perceptions--unless they were exposed to alignments of arguments and (culturally identifiable) experts that gave them reason to think the issue was one that pit members of their group against another in a pattern that reinforced the subjects’ own cultural predispositions toward the HPV vaccine. That’s when the subjects became massively polarized.

That’s the situation, moreover, that people in the world saw, too. From the moment culturally diverse citizens first tuned in, the signal they were getting on the science-communication frequency of their choice was that “they say this; we, on the other hand, really know that.” 

Under these conditions, the manner in which people evaluate risk is psychologically equivalent to the one in which fans of opposing football teams form their impressions of whether the receiver who caught the last-second, hail-Mary pass was out of bounds or in.  Anyone who thinks this is the right way to for people to engage information of consequence to their collective well-being—or who thinks that people actually want to form their beliefs this way—is a cretin, no matter what he or she believes about the HPV vaccine.

4. An avoidable “accident”

There was nothing necessary about the HPV vaccine disaster.  The HPV vaccine took a path different from the ones travelled by the H1N1 vaccine in 2009, and by the HBV vaccine in 1995 to the present, as a result of foreseeably bad decisions, stemming from a combination of strategic behavior, gullibility, and collective incapacity.

Information about the risks and benefits of HPV vaccine came bundled with facts bearing culturally charged resonances. It was a vaccine for 11-12 year old girls to prevent contraction of a sexually transmitted disease.  There was a proposal to make the vaccine mandatory as a condition of school enrollment.  The opposing stances of iconic cultural antagonists were formed in response to (no doubt to exploit the conflictual energy of) the meanings latent in these facts—and their stances became cues for ordinary, largely apolitical individuals of diverse cultural identities.

These conditions were all an artifact of decisions Merck self-consciously made about how to pursue regulatory approval and subsequent marketing of Gardasil. It sought approval of the vaccine for girls and young women only in order to invoke “fast track” consideration by the FDA. It thereafter funded—orchestrated, in a manner that shielded its own involvement—the campaign to promote adoption of mandatory vaccination programs across the states.  To try to “counterspin” the predictable political opposition to the vaccine, it hired an inept sock puppet—“Oops!”—whose feebly scripted performance itself enriched the cultural resources available to those seeking to block the vaccine.

Had Merck not sought fast-track approval and pushed aggressively for quick adoption of mandatory vaccination programs, the FDA would have approved the vaccine for males and females just a few years later, insurance companies plus nongovernmental providers would have furnished mechanisms for universal vaccination sufficient to fill in any gaps in stated mandates, which would have been enacted or not by state public health administrators largely removed from politics. Religious groups—which actually did not oppose FDA approval of the HPV vaccine but only the proposal to mandate it—wouldn’t have had much motivation or basis for opposing such a regime.

As a result, parents would have learned about the risk and benefits of the HPV vaccine from medical experts of their own choosing—ones chosen by them, presumably, because they trusted them—without the disorienting, distracting influence of cultural conflict. They would have learned about it, in other words, in the same conditions as the ones in which they now encounter the same sort of information on the HBV and other vaccines. That would have been good for them.

But it wouldn’t have been good for Merck. For by then, GlaxoSmithKline’s alternative vaccine would have been ready for agency approval, too, and could have competed free of the disadvantage of what Merck hoped would be a nationwide set of contracts to supply Gardasil to state school systems.

Is this 20/20 hindsight? Not really; it is what many members of the nation’s public health community saw at the time. Many who supported approval of Gardasil still opposed mandatory vaccination, both on the grounds that it was not necessary for public health and likely to back fire. Even many supporters of such programs—writing in publications such as the New England Journal of Medicine—conceded that “vaccination mandates are aimed more at protecting the vaccinee than at achieving herd immunity”—the same economic-subsidy rationale that was deemed decisive for mandating HPB vaccination.

These arguments weren’t rejected so much as never even considered meaningfully. Those involved in the FDA and CDC approval process weren’t charged with and didn’t have the expertise to evaluate how the science communication environment would be affected by the conditions under which the vaccine was introduced.

So in that sense, the disaster wasn’t their “fault.” It was, instead, just a foreseeable consequence of not having a mechanism in our public health system for making use of the intelligence and judgment at our disposal for dealing with science communication problems that are actually foreseen.

Whose fault will it be if this happens again?

5. Wasted knowledge

The likely “public acceptance” of an HPV vaccine was something that public health researchers had been studying for years before Gardasil was approved. But the risk that public acceptance would be undermined by a poisonous science communication environment was not something that those researchers warned anyone about. 

Instead, they reported (consistently, in scores of studies) that acceptance would turn on parents’ perceptions of the cost of the vaccine, its health benefits, and its risks, all of which would be shaped decisively by parents’ deference to medical expert opinion. 

This advice was worse than banal; it was disarmingly misleading. Public health researchers anticipated that a vaccine would be approved only if effective and not unduly risky, and that it would be covered by insurance and economically subsidized by the government. Those were reasonable assumptions. What wasn’t reasonable was the fallacious conclusion (present in study after study) that therefore all public health officials would have to do to promote “public acceptance” was tell people exactly these things. 

Things don’t work that way. And I’m not announcing any sort of late-breaking, hot-off- the-press-of-Nature-or-Science-or-PNAS news when I say that.

Social psychology and related disciplines are filled with knowledge about the conditions that determine how ordinary, intelligent people make sense of information about risk and identify who they can trust & when to give them expert advice.  The public health literature is filled with evidence of the importance of social influences on public perceptions of risks—e.g., those associated with unsafe sex and smoking. 

That knowledge could have been used to generate insight that public health officials could have used to forecast the impact of introducing Gardasil in the way it was introduced.

It wasn’t. That scientific knowledge on science communication was wasted. As a result, much of the value associated with the medical science knowledge that generated Gardasil has been wasted too. 

Session reading list.

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    They would have learned about it, in other words, in the same conditions as the ones in which they now encounter the same sort of information on the HBV and other vaccines.

Reader Comments (5)

Several things make the introduction of HPV vaccine different than most other vaccines. I believe that some of these factors caused the introduction and public discussion of this vaccine to have a considerable undercurrent of questioning arising from public health officials as to whether or not this was good public health policy. This vaccine was introduced at a time when other vaccines were also being questioned, a factor that probably added to the atmosphere of public doubts.

1. The vaccine does not confer immunity to all forms of the virus.
2.There is a very long lag time between the time of initial infection and the onset of cervical cancer.
3. Pap smears are an effective way of recognizing cervical cancers and treating them before they become deadly. Because the vaccine is only partially effective, pap smear efforts would need to continue. But these are only available to wealthier women or women in countries with comprehensive health insurance.
4. Not all that much actually seems to be known about the course of HPV infection over time in women and what factors influence whether or not one acquires immunity or comes down with the disease. (combinations of virus types one is infected with, perhaps?).
5. In the US, the structure of legal liability laws puts pressure on vaccine manufacturers to position products for children.
6. We are learning more about how long immunity lasts. But at the time of introduction of this vaccine, this was given ony as "at least 5 years". Since the recommended age of administration of this vaccine is 12, immunity might be wearing off by 17 or 18, which is to say right when many young women might need it. there was considerable concern that campaigns not emphasizing a possible need for both boosters and pap smears may limit effectiveness of the vaccine policy.

With research, it probably would be possible to come up with tests that at least wealthier women could use to see if they had been exposed to the forms of HPV covered by the vaccine. Then you could have started immunization with women who were already sexually active, with emphasis on the idea that it would be best if the vaccine were given before they were sexually active. This would provide impetus for parents to desire to have this vaccine for their children.

I'd add to your reading list:
(Some are a bit dated, but still highly relevant to the debate that was going on at the time of introduction).

National Vaccine Injury Compensation Program
US Health Resources and Services Administration
http://www.hrsa.gov/vaccinecompensation/index.html

J Transl Med. 2010; 8: 105.
Published online 2010 October 27. doi: 10.1186/1479-5876-8-105
PMCID: PMC2988719
HPV vaccine: an overview of immune response, clinical protection, and new approaches for the future
Luciano Mariani1 and Aldo Venuti2
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2988719/

The Risks and Benefits of HPV Vaccination
Charlotte Haug, MD, PhD, MSc
JAMA. 2009;302(7):795-796. doi:10.1001/jama.2009.1215
http://jama.jamanetwork.com/article.aspx?articleid=184404#qundefined

World Health Organization
HPV and Cervical Cancer in the World 2007 Report
Vaccine 25, Suppl 3, 2007. Downloadable for free [pdf 16.96Mb]

And not related directly to HPV, but still my favorite vaccine story:
From Fort Collins CO: Have an disease outbreak causing at least 4 deaths. Get the local public health department to say NO! you don't need to have vaccinations for this. And what do people do? Organize a non-profit that does fundraisers and sets up vaccine clinics. This is still going strong. http://www.9news.com/news/story.aspx?storyid=141670

January 22, 2013 | Unregistered CommenterGaythia Weis

I found that HPV Vaccines has killed around 100+ girls on the U.S. because of it's side effects. I have to do some more research to find what is going on... Anyway I think it is wiser to postpone this vaccine until new medication arrive.

May 20, 2013 | Unregistered CommenterJoe Thomas

The HPV virus is a clear way to help the prevention of cervical cancer, it would somewhat of a long shot to consider that because of this it would open the floodgates for girls to consider being more sexually active, or engage in unprotected sex,.

Critical Misquote of NEJM article

Wrong: "vaccination mandates are aimed more at protecting the vaccine"

Correction: "protecting the vaccinee" - the person receiving the vaccine, not the vaccine. Big difference.

December 11, 2014 | Unregistered CommenterCortlandt

@Cortland:

Many thanks. Agree not only that there is “misquote”—obviously!—but that it is a serious one in need of correction. I've corrected the quote accordingly in the post.

This error on my part notwithstanding, though, the NEJM commentary was in fact raising the very concern attributed to it in the post: namely, that Merck’s commercially motivated campaign for legislative mandates was generating foreseeable cultural backlash that was in fact putting public health benefits of vaccine at risk.

Here's the sentence in full, along w/ additional ones to help make clear what the commentary's point was:

HPV-vaccination mandates, which are aimed more at protecting the vaccinee than at achieving herd immunity, have been attacked as an unwarranted intrusion on individual and parental rights.... Here the mandates act less as state imperatives and more as subtle tools to encourage vaccination. Whereas an opt-in program requires an affirmative effort by a parent, and thus misses many children whose parents forget to opt in, an opt-out approach increases vaccination rates among children whose parents have no real objection to the program while perfectly preserving parental autonomy....

Opposition to the HPV-vaccination mandates, then, would seem to be based more on an inchoate concern: that to recognize the reality of teenage sexual activity is implicitly to endorse it

The commentary writer was not against the vaccine or even universal HPV vaccine; on the contrary, she was anxious that Merck's resort to the political process to make vaccination with Gardasil mandatory before the "likely introduction of GlaxoSmithKline's not-yet-approved HPV vaccine, Cervarix" was complicating that objective by embroiling the vaccine in a "culture war."

This was the same anxiety of many others in the public health community. See Gostin, L. O., & DeAngelis, C. D. (2007). Mandatory HPV vaccination: Public health vs private wealth. JAMA, 297(17), 1921-1923. doi: 10.1001/jama.297.17.1921

They were raising the concern about the HPV vaccine becoming embroiled in at the time; the needless, sad entanglement of the vaccine in cultural conflict is not an insight gleaned only with the assistance of hindsight-- the point I was making in quoting the NEJM commentary.

Those who care about not wasting the value of advances in medical science need to reflect on the case of the HPV vaccine.

The need for a mechanism in our public health system for addressing concerns like the ones that these informed public health professionals were raising is one of the critical lessons that needs to be learned.

Or so I have concluded.

What do you think?

December 13, 2014 | Registered CommenterDan Kahan

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