HPV is the most common sexually transmitted infection in the U.S. Most people will get the infection at some point in their lives, but more than 90% of infections clear on their own with no residual health consequences on clinical follow-up.
The National Institute of Dental and Craniofacial Research (NIDCR) awarded over $685,000 to HealthPartners Institute to test strategies for getting dentists to recommend the human papillomavirus (HPV) vaccine to children and young adults ages 11-26, documents obtained by Children’s Health Defense (CHD) via a Freedom of Information Act (FOIA) request revealed.
The NIDCR operates under the government’s taxpayer-funded National Institutes of Health (NIH).
The HealthPartners study is being conducted three years after the U.S. Food and Drug Administration (FDA) added prevention of oropharyngeal cancer, a form of head and neck cancer, to a growing list of indications for the HPV vaccine — despite a lack of clinical evidence to support the claim.
Dentists remain generally reluctant to recommend or administer the vaccine to their patients, studies show.
The NIDCR funding covers the first two years of a six-year, $3.5 million proposal for the healthcare nonprofit to experiment with training dental providers to deliver scripted messages to their patients about why they should get the HPV vaccine.
HealthPartners will then run a clinical trial in 21 dental clinics to determine whether the training and messages lead more dental providers to recommend the vaccine, and more patients to take it.
The grant is one of nearly 50 identified by CHD in June — totaling more than $40 million — awarded by the U.S. Department of Health and Human Services (HHS) to universities, healthcare systems and public health departments to increase HPV vaccine uptake among adolescents.
The NIDCR is the latest of several HHS sub-agencies to fund behavior modification research aimed at providers and patients in order to increase vaccine uptake.
Why would dentists be charged with recommending the HPV vaccine?
Dentists are uniquely positioned to promote the HPV vaccine because they tend to have more regular contact with young patients than other healthcare providers, the HealthPartners proposal states.
The Centers for Disease Control and Prevention (CDC), the American Dental Association and the American Academy of Pediatric Dentistry all recommend that dental providers promote HPV vaccination — but most dental providers don’t see vaccine promotion as part of dentistry.
HPV is the most common sexually transmitted infection in the U.S. Most people will get the infection at some point in their lives, but more than 90% of infections clear on their own with no residual health consequences on clinical follow-up.
High-risk HPV types can cause cervical cell abnormalities that are precursors to cancer, however, HPV infection is not the sole risk factor for cervical cancer.
Regular pap screening has been found to reduce the incidence of and mortality from cervical cancer among women by at least 80%.
Merck’s Gardasil 9 — the only HPV vaccine marketed in the U.S. — is a widely used vaccine commonly administered to teens and young adults before they are sexually active to protect against nine of more than 200 strands of HPV that can be sexually transmitted later in life.
Despite Merck marketing Gardasil as a vaccine that protects against some forms of cancer, clinical trials for Gardasil did not test whether the vaccine protected against any cancer — only whether it had efficacy against the indicated strains of HPV.
Gardasil has been associated with a number of serious adverse events.
Some of the signature impacts observed following HPV vaccination include permanently disabling autoimmune and neurological conditions such as postural orthostatic tachycardia syndrome (POTS), fibromyalgia and myalgic encephalomyelitis/chronic fatigue syndrome.
More than 80 lawsuits against Merck now pending in federal courts allege the drugmaker fast-tracked Gardasil through the FDA’s approval process and deceptively conducted clinical trials to mask serious side effects and exaggerate the vaccine’s effectiveness.
In June 2020, the FDA added the prevention of oropharyngeal and other head and neck cancers to the list of indications for the HPV vaccine under the “accelerated approval licensure pathway.”
That pathway allows treatments to be approved before clinical data demonstrating benefit exists, based on early clinical predictions that the treatment will likely produce a benefit.
Later, if a clinical benefit is never found, the FDA “can seek withdrawal” of the drug from the market.
According to the HealthPartners grant proposal, HPV is the leading cause of oropharyngeal cancers in the U.S., However, the references cited to support that claim are from 2014 — and they don’t appear to support the claim.
The CDC estimates 70% of oropharyngeal cancers in the U.S. are “thought to be” caused by HPV, and qualifies even that claim by adding, “It is unclear if having HPV alone is enough to cause oropharyngeal cancers.”
There is no evidence that the HPV vaccine prevents oropharyngeal cancers, but some trials have found that it does have efficacy against vaccine-type oral strains of HPV.
Top NIH-funded Merck consultants in the field, like Noel Brewer, Ph.D. — who developed and promotes the “announcement approach” to increasing vaccine uptake — have long looked to expand HPV vaccination into settings outside of primary care.
On that basis, the HealthPartners study aims to change dental providers’ behavior so they consistently recommend the HPV vaccine to their patients. Dr. Brad Rindal, a dentist, and Patricia Mabry, Ph.D., a clinical psychologist, are co-leading the study.
The proposal falls within HHS’ mission to understand the mechanisms of behavior change in order to develop methods of “experimental manipulation or intervention” with providers and patients that can help it meet its targets in various aspects of public health.
HHS, through the NIH, has been funding behavioral studies to assess and influence providers’ willingness to recommend and administer the HPV vaccine in order to increase rates of vaccine uptake since shortly after the vaccine was first licensed in 2006.
Study design explicitly waives informed consent for patients
In the study, a team of researchers from HealthPartners — which provides healthcare, coverage, research and education to 1.8 million plan members — will train providers, teaching them about the relationship between the HPV vaccine and the risk of oropharyngeal cancer.
Trained providers also will receive scripts for use in patient conversations tailored to “reduce fear” that such conversations will negatively impact provider-patient relationships. They also will learn how to refer their patients to a vaccine scheduler.
Researchers will then measure changes in provider behavior through direct provider reporting — they press a button in their office when they make a recommendation — and follow-up surveys.
Patients or patient parents or guardians will receive follow-up survey calls after the office visits to assess how effective the provider communication was.
Researchers will measure changes in patient behavior by assessing how many patients receive initial and follow-up doses of the HPV vaccine within 30 days of their office visit.
In the first two years of the study — funded by the initial grant — the team will develop and pilot test their training and scripts. Their control group will receive patient education brochures and untailored scripts and their intervention group will receive the training and the tailored scripts.
In the next phase, they will test the efficacy of these interventions in clinic-randomized trials, comparing the control and intervention groups. Twenty-one HealthPartners Dental Group clinics and their providers will participate.
Patients 11-26 years old who go to HealthPartners dental clinics and whose electronic health records indicate they have not initiated or completed the HPV vaccine series will be automatically enrolled in the study without their knowledge. HealthPartners estimates there will be approximately 8,000 qualifying visits with HPV unvaccinated patients.
Verbal informed consent will be obtained for participation in the post-intervention patient/parent phone survey.
The patients will not otherwise be informed of the study.
The study requests a waiver of informed consent for patients by arguing that the dental providers will only be making recommendations already endorsed by the CDC, the American Cancer Society and the National HPV Roundtable, which is a joint venture of the CDC and the American Cancer Society.
“Therefore,” they state, “the recommendations conform to current standards of care and don’t present a risk to patients that exceed the risks that patients assume when they seek care within any healthcare system focused on disease prevention through vaccination promotion.”
They also argue that the research “would not be feasible without such a waiver” because it would bias the provider involvement and patient response.
They add that patients sign a HIPAA authorization form that allows them to opt out of using health data for research purposes and that they will be certain to check that list.
Finally, they note that “patients can elect not to pursue vaccination despite the recommendation of the dental care provider” — even though the intervention is designed to change their behavior so they don’t make such an election.
Merck, federal public health agencies, and WHO looking to grow market for HPV shots
Merck’s Gardasil was first licensed in 2006 for use in girls and women ages 9-26 to prevent four high-risk strains of HPV.
The FDA in 2009 expanded the license for use in males ages 9-26 for the prevention of genital warts and in 2011, the CDC’s Advisory Committee on Immunization Practices recommended it for routine use in boys.
In 2014, the FDA approved Gardasil 9, designed to protect against 9 HPV strains, for use in the prevention of HPV-related cervical, vaginal and vulvar cancers in females and HPV-related anogenital lesions and anal cancers in males and females.
The FDA also expanded the age range of potential HPV vaccines to males and females between the ages of 9 and 45.
Early marketing strategies focused on promoting the drug as guarding against HPV, a sexually transmitted disease. But in 2016, as vaccination rates lagged, the CDC recommended that doctors stress the HPV vaccine’s cancer-prevention benefits, rather than talking about STDs as a way to get more parents to vaccinate younger kids.
And in 2020, it added oropharyngeal and other head and neck cancers to the list.
Over the last several years, HHS has invested tens of millions of dollars in research to get U.S. HPV vaccine uptake numbers to HHS’ “healthy people” target rates of 80% of children and teens vaccinated by 2030.
Meanwhile, Merck has expanded its ad campaigns beyond teenagers to target parents of young children and adults.
In 2020, the WHO set a goal of vaccinating 90% of teenage girls by 2030. Gavi, the Vaccine Alliance, is currently launching a series of campaigns to vaccinate tens of millions of girls in Africa, following similar campaigns in India and Indonesia.
Last week Merck announced its third-quarter earnings from Gardasil were up 13% to $2.9 billion. Allied Market Research predicts the global HPV vaccine market — in which Merck is the primary player, although GSK also markets its Cervarix outside of the U.S. — will grow to $10.8 billion.
