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Editor’s note: This is the first in a two-part series examining federal funding for behavior modification approaches to increase uptake among teens of the human papillomavirus vaccine.

The U.S. Department of Health and Human Services (HHS) is funding a scientist who also is a paid consultant for Merck to conduct research on how to increase teen uptake of the human papillomavirus (HPV) vaccine, documents obtained by Children’s Health Defense (CHD) via a Freedom of Information Act (FOIA) request revealed.

Merck manufactures Gardasil, the only HPV vaccine available in the U.S.

Documents show that the National Cancer Institute (NCI) at the HHS in 2021 awarded a $4.7 million, five-year grant to the University of North Carolina (UNC) at Chapel Hill.

The grant’s principal investigator, Noel Brewer, Ph.D., a psychologist and professor in the Department of Health Behavior at the UNC Gillings School of Public Health, consults for Merck and is also the recipient of commercial research grants from Merck, Pfizer and GlaxoSmithKline (GSK).

The HHS grant builds on Brewer’s previous industry and HHS-funded research investigating different “research-tested interventions” intended to reshape the behavior of physicians and patients by “improving” the ways providers “announce” the vaccine to potential recipients, in order to get more teens to take the HPV vaccine.

The grant is focused on further developing “Announcement Approach Training,” which involves having providers skip the step of discussing with families in “open-ended conversation” whether or not they want their child vaccinated for HPV and instead “presume” the family wants the vaccine and announce the child will receive it as if it were a routine part of the office visit.

Brewer and others’ previous research has shown this method reduces the time a provider needs to spend talking with their patients and increases vaccine uptake.

Other projects funded by the grant consist of conducting randomized controlled trials to see how best to get clinics and clinicians to implement this approach to increase HPV vaccine uptake, according to the FOIA documents obtained by CHD.

One trial investigates how clinics can rework their “standing orders” — the protocols for all practitioners — to standardize how clinicians talk to their patients, for example, using the announcement approach, or to otherwise change the nature of doctor-patient interactions.

Another trial investigates how financial incentives affect providers’ willingness to strongly recommend the shots. A third trial tests whether training by “trusted messengers” works to better alter provider behavior.

The overall project will compare the effectiveness and cost of the different methods and model them in rural areas, which typically have lower HPV rates.

U.S. government awarded more than 50 grants worth $40 million to increase HPV vaccine uptake

The $4.7 million grant to UNC was by far the largest awarded by the HHS to increase HPV vaccine uptake, however, it was not the only one.

CHD’s search of USAspending.gov identified more than 50 grants totaling more than $40 million awarded by the HHS to universities, healthcare systems and departments of public health to increase HPV vaccine uptake.

Two of the smaller grants came from the U.S. Department of Defense rather than HHS.

All of the grants — awarded since 2009, with most awarded since 2016 — fund projects either to test or to implement different methods to change people’s behaviors at the community, provider and patient level with the goal of getting more young people to take the shot.

Some of the more recent grants also focused on increasing HPV uptake by combating “misinformation” on social media.

This approach to vaccine uptake is part of a larger turn in American healthcare toward applying lessons from behavioral economics, like “nudging” to healthcare.

Nudging” figured prominently during the COVID-19 pandemic and was heavily utilized by governments and public health officials throughout the world to implement restrictions and countermeasures.

Economist Richard H. Thaler and legal scholar Cass R. Sunstein defined the concept in their bestselling 2008 book — “Nudge: Improving Decisions About Health, Wealth, and Happiness” — as a method that “alters people’s behavior in a predictable way without forbidding any options or significantly changing their economic incentives.”

Thaler and Sunstein presented nudging as a technocratic solution for tricky policy issues involving a perceived need to encourage, in a “voluntary manner,” policies or measures that would otherwise be unpopular.

The strategy made its way into public health long before COVID-19, with Big Pharma, regulatory agencies and doctors applying this behavioral approach to the clinic, trying to “nudge” patients toward desired choices by changing the “choice architecture” they are operating in so that they would choose differently.

Providers directed to ‘presume’ families want the vaccine

Over the past several years, much research has been dedicated to studying how “nudge” strategies can be applied to vaccine uptake, particularly the COVID-19 vaccine.

A study posted in BMJ Global Health in 2021 called for further research into whether methods such as the “Announcement Approach” could effectively “nudge” people to take vaccines.

The documents related to the $4.7 million HHS grant obtained by CHD include detailed proposals for the randomized controlled trials in the “Improving Provider Announcement Communication Training” project, which investigates this approach.

The university webpage shows a total grant of $11.7 million, which appears to include administrative overhead costs.

The broader project is divided into four sub-projects, each led by a different faculty member with Brewer as the lead investigator.

Much of Brewer’s professional work is dedicated to increasing HPV vaccination uptake. He chairs the National HPV Roundtable, which brings together medical associations, nonprofits, health insurance providers and pharmaceutical companies, with funding from the Centers for Disease Control and Prevention (CDC) to raise HPV vaccination rates.

He also advises the World Health Organization, the CDC and other organizations on “vaccine communication.”

Brewer is also a consultant who has served on different paid Merck HPV advisory boards since 2011 and has been a general consultant for the company since 2019.

According to his curriculum vitae, he has given numerous talks at Merck events on how to increase HPV vaccine uptake.

Merck awarded Brewer more than $500,000 in grant funding to study HPV vaccine uptake and he received more than $400,000 from Pfizer to study how trainings might improve physician perceptions and recommendations of the HPV vaccine. He has also received funding from GSK.

He is a member of HHS’s National Vaccine Advisory Committee working group on the HPV vaccine and his website says he was a paid advisor to the U.S. Food and Drug Administration (FDA).

The FOIA documents included support letters from Brewer’s colleagues celebrating how Brewer had “already changed the national landscape for increasing HPV vaccination.”

Brewer and his colleague Melissa Gilkey, Ph.D., associate professor of Health Behavior, developed “Announcement Approach” training specifically for the HPV vaccine and in this project are conducting randomized controlled trials to determine how best to put the approach into practice.

The research premise is that provider recommendations are key to increasing uptake of the HPV vaccine, but that providers either don’t recommend the vaccine — in part because they know parents have doubts about it — or don’t use the most effective method, “presumptive recommendation,” rebranded here as Announcement Approach, to make their recommendation.

A “presumptive recommendation” is made when the provider does not offer the option of not taking the vaccine to the family, thereby limiting the landscape of available choices.

This method directs the provider to act as if the family has already decided to vaccinate their child — to “presume” they want to be vaccinated — rather than opening space for dialogue or conversation around the vaccine.

Brewer et al.’s previous research that found training doctors to give announcements rather than have conversations with their patients, where they might raise more questions, led to higher rates of vaccine uptake.

Brewer’s team found clinics that used the presumptive or announcement approach had a 5.4% increase in uptake and physicians had to spend 40% less time discussing the vaccine with families.

The grant documents provide an example of the announcement approach:

“Announcements should indicate that HPV vaccination is part of routine care …

“We recommend that announcements 1) note the child’s age to establish what follows as part of routine care; 2) say the child is due for several vaccinations (noting the diseases prevented, not the vaccine names); and 3) say that the child will receive vaccines today.

“An example of a presumptive announcement is, ‘Now that Sophia is 12, she is due for 3 vaccines. Today, she’ll get vaccines to prevent meningitis, HPV cancers, and whooping cough.’”

For “hesitant parents” who don’t submit to the HPV vaccination with the initial approach, the provider should “connect and counsel.”

To do this the provider:

“1) connects with the parent by showing empathy and confirming the parent’s main question without reinforcing misinformation; and

“2) counsels the parent using a research-tested message and encourages them to vaccinate today.”

According to the grant proposal, “Messages in the counsel step increase parents’ intentions to vaccinate in our prior randomized experiments (e.g, ‘This vaccine is one of the most studied medications on the market. The HPV vaccine is safe, just like the other vaccines given at this age.’)”

If parents decline same-day vaccination, the team member makes a note in the patient’s chart and addresses HPV vaccination at the next visit.

In an observational study, the “announcement” or presumptive method was associated with an increase in parental vaccine acceptance but also with reduced satisfaction in the clinical experience.

The participatory or conversational format — where providers offer the full range of options to patients and dialogue with them about it —showed the opposite pattern.

HPV vaccine generates profits for Merck and HHS, which funds the grant

Brewer receives research funding from both Merck and HHS/NCI, both of which stand to gain financially from increased HPV vaccine uptake.

Merck — the only producer of HPV vaccines in the U.S. since GSK pulled Cervarix from the U.S. market in 2016 — generates billions annually from Gardasil sales. It reported sales of $4 billion in 2020, despite the challenges of the pandemic.

Sales jumped to $5.7 billion in 2021. And with expanded production and global uptake, Merck anticipates “very strong sequential and year-over-year growth for Gardasil.”

The National Cancer Institute at the NIH developed the technology for the HPV vaccine and licensed it to Merck, which formulated its Gardasil vaccine and ran the clinical trials. The FDA granted Fast Track approval for Gardasil after only a six-month review process and it was licensed to Merck in 2006.

From 2007 through 2019, the HPV vaccine was among the NIH’s top four most commercially successful inventions, an assessment based on the royalties a product produces for the NIH.

The National Cancer Institute, which is housed in the HHS, receives the royalties from the Gardasil vaccine and is the agency funding the UNC study.

The inventors, who work for the NIH, also individually receive up to $150,000 per year for their patentable inventions, depending on how much the NIH receives in royalties.

It is unclear how much NIH receives from the HPV vaccine. A 2020 Government Accountability Office report found that the NIH had generated $2 billion in profits from 34 licensed drugs — with three drugs generating more than $100 million —  it created since 1991 and recommended that NIH ought to increase transparency around this process.

HPV vaccination, which requires multiple doses, was first recommended by the CDC for girls in 2006 and for boys in 2011. The CDC routinely recommends vaccination at ages 11-12 and says it can be started at age 9.

HPV infections may lead to the development of cervical cancer. However, most infections are benign and resolve on their own.

The UNC grant description states the HPV vaccine could prevent 32,100 cancers per year if it were administered at the target rate of 80% of the population.

But the efficacy of the vaccine is disputed.

Studying HPV vaccine efficacy for eliminating cervical cancer is challenging due to the long amount of time between infection and the development of cancer (mean time 23.5 years), lack of adequate informed consent, complexity between HPV infection and cervical cancer and the negative impact of girls’ sexual behavior, which may worsen the risks of cervical cancer.

In 2020, the CDC reported that about 75% of U.S. teens had gotten at least one dose in the two or three-dose HPV series, and about 59% had gotten the whole series — a rate that falls short of its goal of 80% coverage. That number dropped nearly 5% during the pandemic.

It also reported that uptake of the HPV vaccine is lower than that of other routinely recommended vaccines. A new study published May 23 in Pediatrics investigated why parents decide against the HPV vaccine for their children.

The study found that although uptake increased overall between 2010 and 2020, during that time, the number of parents citing “safety or side effects” as a reason for vaccine hesitancy increased by nearly 16% annually.

Since the Gardasil vaccine was introduced in 2006, numerous studies have linked it to debilitating autoimmune disorders, neurological side effects and other complications, prompting many families of injured children to file lawsuits alleging the company knew the vaccine could cause serious side effects, The Defender reported.

Until the COVID-19 vaccine became available, the FDA had received more adverse reaction reports related to Gardasil than any other vaccine in history.

The National Vaccine Injury Compensation Program has paid out over $70 million to people making claims regarding Gardasil. Merck now faces more than 80 complaints in federal court alleging that the HPV vaccine caused debilitating autoimmune complications. A judge consolidated 31 of these cases into a single bellwether pool, against Merck’s protest.

But Merck continues to work with national agencies to increase gardasil uptake. Merck’s researchers in March published a study in Pediatrics suggesting evidence shows that moving routine HPV vaccination to ages 9 to 10 may improve vaccination coverage rates.