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Tuesday
Aug232016

Protecting the Vaccine Science Communication Environment (new paper)

 

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Reader Comments (4)

I agree that Merck should be faulted for diverting from the conventional CDC path for vaccine approval.

However I am very disappointed to see this article omits many of the interesting cultural and science based twists and turns of this story. Merck's decision to go to the states for approval was, in my opinion, based on the fact that they faced a multiple cultural conundrum, from both the left and the right. And a scientific one, in promoting a vaccine that uniquely did not provide immunity to all forms of the targeted virus.

I think that the historic analysis of the HPV vaccine approval process needs to include two very big issues:


1. In the case of cervical cancer, treatment which avoids cancer is possible if women get regular pap smears.
(Since the time of introduction of the vaccine there is now firm evidence of HP virus linkage to other cancers.)

2. Unique among vaccines, the HPV vaccine only targets some forms of the human papillomavirus.


Like HPV, for HBV the vaccine is of scant immediate benefit to the children to whom they are given. In both cases, funding for addressing current needs is lagging. In the case of HPV, there is a very long lag time between human papillomavirus and onset of cancer. The vaccine has no effect on cancer outcomes for those deemed too old for the vaccine. Infants with Hepatitis B, a blood born infection, generally got them in utero from their mothers, frequently IV drug addicts. If the nation was seriously interested in addressing this public health issue, publicity and funding ought to be first directed at stemming spread of existing cases of the disease, by programs that address IV drug needle contamination, safe sexual practices, and also by insuring that infected infants get an immune boosting HBIG shot within 12 hours of birth.

But still, especially given that we haven't fully addressed existing Hepatitis B cases and thus have not effectively contained spread of the disease, there is some threat that infants and children might encounter a Hep B contaminated blood transfusion or become infected by later sexual contact or IV drug use. If vaccinated, the chance that one subsequently gets Hepatitis B are quite low. I think that both parents and doctors can see that this is an open/shut easy decision case.

Regarding Point #1:

When viewed as it was initially, through the now known to be too narrow prism of potential for causing cervical cancer, the situation seemed not so simple. Even with the vaccine, pap smears would still be necessary. They also continued to be necessary for the generations of women who were older than the 26 years of age threshold set for administration of the vaccine. Additionally, as initially proposed by Merck, this vaccine was administered only to girls. I think that this article is overlooking the impact of the concerns of feminist gynecologists and other women's health professionals that making girls responsible for STDs was sexist, and that promotion of the use of the vaccine as a solution would decrease support for women's health clinics and access to pap smears. I would imagine that having Texas governor Rick Perry be the one governor that endorsed the vaccine was not helpful in this regard. Concerns about access to Pap smears and subsequent cervical cancer rates are unfortunately playing out, cervical cancer rates are, in fact, up.

This feminist opposition has now abated as the vaccine is administered to both boys and girls, and as it has been firmly demonstrated that the human papillomavirus is a significant factor in other cancers, such as throat cancers. Concerns about women's clinics and overall public health funding still remains a factor.

Regarding Point #2:

The vaccine is now demonstrated to substantially reduce infections of HPV in teenagers and young adults (especially females, to whom it was first administered). This is also demonstrated to have reduced the populations of these particular forms of the human papillomavirus more generally. This is a success.

However, issues remain, because the efficacy is incomplete. As shown in this article, http://www.livescience.com/50563-hpv-vaccine-infections-prevalence.html some of the now young women who got the initial forms of the vaccine ought to return to get vaccinated with the more comprehensive forms of the vaccine now available. More disconcertingly, as noted at this link, it seems that infections with high risk forms of the virus not covered by the vaccine are actually up. Clearly, much more research needs to be done to improve this vaccine. And also to find diagnostic methods, analogous to a pap smear that can be used for other potential cancer locations, so that earlier treatment can be undertaken.

In my opinion, since this is a preliminary draft of a working paper, I'd like to see Merck's latest ad campaign on HPV included. This can be seen here: https://www.ispot.tv/ad/Ap1V/merck-hpv-vaccination. The science communicators in the popular press seem to have fallen into line with the Merck parental guilt trip message as shown for example here: https://www.washingtonpost.com/news/to-your-health/wp/2016/08/11/do-the-new-merck-hpv-ads-guilt-trip-parents-or-tell-hard-truths-both/. But why is Merck doing this now, and why is the chosen venue for TV ad placement the Olympics in Brazil? Is there any relationship between guilt tripping parents and their own lack of action on Zika vaccine development? Is this the clever placement of an alternative vaccine narrative? It is a much smaller, much less well funded company that is taking the lead and assuming the financial risks on Zika; https://globenewswire.com/news-release/2016/07/26/858976/0/en/Inovio-Pharmaceuticals-Doses-First-Subject-in-Zika-Vaccine-Clinical-Trial.html.

This Merck ad is also remarkably content-less when it comes to explaining what HPV is or how one might acquire it.


What does all this mean when it comes to good science communication on health policy matters? I think it means that it is very important to avoid framing the issue in lockstep with Big Pharma narratives.

I think that it is important to note that: "The largest majority of physicians commented on the high cost of the vaccine (HPV) and lack of reimbursement as the primary barrier to discussion and administration. " http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3828557/.

Those costs are justified by Big Pharma with the idea that high drug and vaccine costs are justified by their research and development costs. But as is true in many such instances, the underlying science for the HPV vaccine was developed by government researchers; http://jnci.oxfordjournals.org/content/98/7/433. And much of the development work is preformed by smaller pharma startups. As the Zika example demonstrates.

In our science communication efforts, what we ought to be focusing the public attention on is overall public health. This means that we ought to be focusing public health efforts aggressively on public health in the here and now.

That would mean focusing on public health outcomes.

This would include:

The need for a publicly funded emerging disease vaccine development pipeline.

Vaccine follow up to assure that immunity was maintained, so that boosters could be added before disease outbreaks become apparent.

Research into what can be done to mitigate areas where exposures of one infected individual can vastly exceed herd immunity assumptions (ie Disneyland type situations).

Efforts to make hospitals able to handle individuals infected with highly transmittable diseases (such as measles) as well as those on immune suppressing drugs.

Discussions of HPV and HBV ought to also include matters of general public health. Such things as assuring that all older women got regular pap smears, and, for diseases such as Hepatitis B that are transmitted by contaminated blood, that IV needle exchanges were set up. Additionally, that means that we need to communicate, to teens and others, the details of how sexually transmitted diseases are actually transmitted.

Now that we can test for individual strains of human papillomavirus, it should be possible to test older adults, and administer a vaccine to those forms covered by the vaccine for which they have no immunity (as in cases where they might be anticipating new sexual partners).

More generally, we need mechanisms for expanding vaccine coverage to adults, both boosters and for immigrants and others that may have missed the childhood vaccine schedule.

In my opinion, a communication environment that involved including vaccines as a public benefit from overall public health would be more likely to elicit positive public response.

I think that fits with the calls in section 4 of this paper.

August 23, 2016 | Unregistered CommenterGaythia Weis

To go with my comment which should have been already posted, I'd add the following, from the book "Our Bodies, Ourselves" which I think offers a good summary of the current state of public health matters regarding cervical cancer and HPV vaccine:

http://www.ourbodiesourselves.org/2012/01/ending-cervical-cancer-requires-ending-disparities-in-access-to-pap-tests-and-hpv-vaccines/

HPV vaccines do not protect against all types of HPV associated with cervical cancer, and it is currently unclear how long they remain effective or whether booster shots will be needed to maintain protection throughout adulthood. Thus, regular Pap tests among sexually active women remain essential for cervical cancer prevention. Resources should not be diverted away from Pap screening programs to pay for the unusually expensive cervical cancer vaccine. Because Merck marketed Gardasil with a campaign that unnecessarily frightened girls, young women, and parents, many people now have a distorted view of this disease, the vaccine, and the continued importance of Pap screening.

There is no question that HPV vaccines represent an important scientific advance in the field of vaccine research, but exaggerating their potential benefit in places such as North America will not serve us well. In countries where there is little or no access to Pap screening, current HPV vaccines might have much more potential for saving lives if their costs were reduced considerably and if adequate infrastructure to prove them responsibly were securely in place.

The District of Columbia and dozens of states — many of which have been lobbied by vaccine makers to expand vaccination requirements — have introduced legislation to require, fund, or educate the public about the HPV vaccine. However, since 30 percent of infections are now caused by virus types for which the HPV vaccines do not provide protection, universal access to Pap tests remains critically important. Unfortunately, many girls in underserved communities (where HPV infection rates are often high) have less access to both the Pap test and the HPV vaccine.

For example, as of September 2009, when the CDC released its first state-level statistics for Gardasil, only 15.8 percent of girls in the relatively poor state of Mississippi had received the vaccine, compared with 54.7 percent of girls in the relatively wealthy state of Rhode Island. Partly because of greater access to Pap testing, the cervical cancer mortality rate in Rhode Island was already 50 percent lower than in Mississippi — which means the girls in Rhode Island are at much lower risk of contracting HPV to start with.

To reduce disparities for Latinas and other under-served women, we will need to make systemic changes in our health care system to increase access to screening and vaccinations for those who need it most.

August 23, 2016 | Unregistered CommenterGaythia Weis

The vaccine related news storm of the morning is based on these stories:

http://www.latimes.com/science/sciencenow/la-sci-sn-pediatricians-vaccines-exemptions-20160828-snap-story.html

and https://www.statnews.com/2016/08/29/vaccine-refusal-survey/,

Which is based on: http://pediatrics.aappublications.org/content/early/2016/08/25/peds.2016-2146

The headlines, and the way the information is expressed in the first article involves an increase in reports from pediatricians of parents refusing vaccines. And the statement by some pediatricians that they want to dump said parents out of their practices. Which the American Pediatrics Society says it now supports.

I think that it is important to note that the underlying article clearly states that only 3% of parents are actually refusing all vaccines. And that pediatricians that make the effort to support good communication are seeing positive results with parents who originally express a reluctance to vaccinate:

"Countering Vaccine Hesitancy Can Be Challenging"
"Providing vaccine information is time consuming"

BUT

" A well-informed pediatrician who effectively addresses parental concerns and strongly supports the benefits of vaccination has enormous influence on parental vaccine acceptance."

AND

"It is important to present this safety information in a nonconfrontational dialogue with the parents while listening to and acknowledging their concerns. "

All pretty reasonable advice.

The vaccine schedule as it currently exists is a science informed compromise that promotes good public health in a cost effective manner. Different countries differ as to the details.

If we chose to invest in it, we could have a public health system with a much more personal and time consuming relationship between doctor and patient.

We could have individualized medicine. Perhaps one infant could have the measles vaccine early, say at 8 MO to accommodate a family visit to Disneyland. Other individual infants might be determined to be susceptible to adverse reactions and need a delay a bit beyond the normally set 1 year.

Parents are not actually beyond the pale in questioning the vaccine schedule.

In my opinion, British Columbia did an excellent job with a measles outbreak among Dutch Reformed Church members with a strongly anti-vaccination religious leader. This involved politely ignoring the leader, depriving him of his desired platform for jousting. And then opening clinics that administered vaccine to individual church members and their families in a confidential and non recriminatory way. Not as easy as if they had gotten the vaccines at well baby clinics but still, a major public health crisis was averted. And other parents or future parents were made aware that measles really was a thing they needed to have their families vaccinated for too.


Instead of a reasonable discussion between reasonable people leading to reasonable support of our public health system we get defensiveness.

In my opinion, too much of the reason is a science communication industry that itself is too primed to excite its base by jousting and a medical establishment that wants to protect itself from liabilities by absolute enforcement of protocols.

Yes there are nut cases and will always be nut cases. But most parents want what is best for their child and can become informed on how to do so. If you don't make them feel like nut cases for asking questions.

One of the things that our pre-med education system does is bias against doctors with good interpersonal skills. Or even good data analysis skills. Its too much about the grades. And handling time pressure with shortcuts like memorization.

Patients ought to be more sympathetic to doctors who after all are not the ones who set up a medical care system that leaves them very squeezed for time. But Doctors need to acknowledge that good patient care takes time, and not blame parents who need more time.

August 29, 2016 | Unregistered CommenterGaythia Weis

Two more articles:

This one has some good thoughtful physician interviews behind the click bait headline: http://www.forbes.com/sites/tarahaelle/2016/08/29/as-more-parents-refuse-vaccines-more-doctors-dismiss-them-with-aaps-blessing/#5ce182132629

This one misses the point that recent mumps outbreaks have been a result of an aging vaccine and a need for boosters: https://www.washingtonpost.com/news/to-your-health/wp/2016/08/29/more-parents-believe-vaccines-are-unnecessary-while-a-mumps-outbreak-grows/
and
http://www.medicaldaily.com/mumps-outbreak-2015-university-illinois-suggests-students-get-mumps-booster-shot-346532

My take is that we'd rather beat an all but 3% dead horse than address a pressing issue of our time, Zika.

(The 3% comes from the base article, here http://pediatrics.aappublications.org/content/early/2016/08/25/peds.2016-2146 " approximately 3% of respondents had refused all vaccines")

August 29, 2016 | Unregistered CommenterGaythia Weis

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