4:31 PM
 | 
Sep 07, 2017
 |  BioCentury  |  Strategy

What if you build, but they don’t come

Why Michael Becker says industry must help promote HPV-related cancer prevention

Vaccination is widely considered one of the greatest medical achievements of modern civilization. Diseases that were commonplace less than a generation ago, such as polio, smallpox and diphtheria, are now increasingly rare because of vaccines.

HPV-related cancers could be added to that list, but only if our industry helps to persuade parents concerned about rumored health risks from immunizations that their decision whether or not to vaccinate isn’t a risk-free choice. Unfortunately, the challenge of trying to get parents to do what’s right for their kids is made even harder by some consumers’ negative view of the pharmaceutical industry.

Prior to my diagnosis of Stage IV HPV-related oropharyngeal cancer in December 2015, I didn’t appreciate the connection between HPV and six different cancers -- and I’m someone who has been around biotechnology for decades. Once I went through chemotherapy and radiation therapy and suffered the associated debilitating side effects, I realized how many people were missing out on the HPV vaccine that could prevent these cancers and my “walk with purpose” became clear: Raise awareness for HPV’s link to cancer and available vaccines.

HPV has become a recognized driver of six cancers affecting more than 30,000 people each year. There are available vaccines to prevent about 28,000 of these cases from ever occurring. That figure is close to the average number of tickets sold per Major League Baseball game in the 2016 season!

The challenge of trying to get parents to do what’s right for their kids is made even harder by some consumers’ negative view of the pharmaceutical industry.

Cervarix is GlaxoSmithKline plc’s bivalent vaccine against HPV16 and 18, and Gardasil is Merck & Co. Inc.’s tetravalent vaccine against HPV6, 11, 16 and 18. The company’s newer Gardasil 9 adds HPV31, 33, 45, 52 and 58.

The vaccines are safe and usually covered by insurance, but HPV vaccination still lags far behind other recommended vaccines for adolescents. The Centers for Disease Control and Prevention (CDC) analyzed new data from the 2016 National Immunization Survey-Teen representing 20,475 adolescents ages 13-17. The survey found 60.4% of teens had received at least one dose of HPV vaccine, up from 56.1% in 2015. Using the new two-dose benchmark, 43.4% of teens were up to date with HPV vaccination -- 49.5% of females and 37.5% of males.

Facing very low market demand, GSK pulled out of the U.S. market in late 2016 with Cervarix.

These data beg the question, if we can’t sell the public on cancer prevention, has our industry somehow failed?

Reframing the conversation 

To be fair, there are some challenges that may be unique to the HPV vaccines. One is that because HPV is described as a sexually transmitted disease, discussions surrounding HPV can be uncomfortable and/or embarrassing.

According to the CDC, nearly all sexually active men and women get the virus at some point in their lives. And most of the time, people get HPV from having vaginal and/or anal sex with an infected partner. In fact, genital HPV is the most common sexually transmitted infection in the U.S.

However, the same types of HPV that infect the genital areas also can infect the mouth and throat. Only a few studies have looked at how people get oral HPV, and some show conflicting results. Some studies suggest that oral HPV may be passed on during oral sex (from mouth-to-genital or mouth-to-anus contact) or open-mouthed kissing; others do not.

The likelihood of getting HPV from kissing or having oral sex with someone who has HPV is not known. According to the CDC, more research is needed to understand exactly how people get and give oral HPV infections.

We must reframe the conversation and refute popular misconceptions by parents who are worried that vaccinating kids against a sexually transmitted disease will make them promiscuous. Implementing evidence-based family, school and community-based educational programs that address risk and protective factors would be a good start.

In addition, HPV vaccines should be repositioned as “cancer prevention vaccines.” While this is how the vaccines may have been positioned with respect to cervical cancer in young women, the same cannot be said for oral cancer in men.

There are nearly 200 distinct HPV genotypes, which can be divided into “low risk” and “high risk” groups based on their capacity to drive cancer transformation. Most people with HPV never develop symptoms or health problems; 9 out of 10 HPV infections go away by themselves within two years.

HPV vaccines should be repositioned as ‘cancer prevention vaccines.’

Sometimes HPV infections will last longer and can cause cancers, warts and other diseases. Unfortunately, there is currently no simple blood test to find out a person’s “HPV status.” Cervical cancer screening, an essential part of a woman’s routine healthcare, includes two types of screening tests: cytology-based screening, known as the Pap test or Pap smear, and HPV testing. Cytology-based screening is designed to detect abnormal cervical cells, including precancerous cervical lesions, as well as early cervical cancers. HPV testing is used to look for the presence of high-risk HPV types in cervical cells.

There is no equivalent HPV screening for men.

By the year 2020, the annual number of cases of HPV-related oropharyngeal cancers is projected to outnumber the cases of HPV-mediated cervical cancer in the U.S. A group of oncologists from City of Hope described the emergence of HPV-related oropharyngeal cancers as an epidemic of our time in a 2015 Oncology paper.

Oral HPV tumors are more likely to be smaller and poorly differentiated, with a higher incidence of advanced lymph node metastases in comparison to HPV-negative tumors. Interestingly, despite a more aggressive clinical presentation, HPV-associated oral tumors are associated with a more favorable overall survival prognosis than HPV-negative oral tumors.

Men are particularly vulnerable to HPV-related cancers of the mouth, tongue and throat, called oropharyngeal cancers. According to a report by the CDC, the rates of mouth and throat cancers are more than four times higher among males than females.

One of the first large studies of the impact of HPV vaccination on oral HPV infections showed it may confer a high degree of protection. The prevalence of high-risk HPV infection was 88% lower among young adults in the U.S. who reported getting at least one dose than among those who were not vaccinated. The study was presented at the 2017 American Society of Clinical Oncology meeting in Chicago. However, as revealed by the 2016 National Immunization Survey, HPV vaccination rates remain low, especially among males, which limits population-level benefits of the vaccine in the U.S.

“The HPV vaccine can prevent oral HPV infections, but we know it only works if it’s used.”

Bruce Johnson, ASCO

“The HPV vaccine has the potential to be one of the most significant cancer prevention tools ever developed, and it’s already reducing the world’s burden of cervical cancers,” said ASCO President-Elect Bruce Johnson at the time. “The hope is that vaccination will also curb rising rates of HPV-related oral and genital cancers, which are hard to treat. This study confirms that the HPV vaccine can prevent oral HPV infections, but we know it only works if it’s used.”

It isn’t just parents that could benefit from increased education. Healthcare providers sometimes recommend the HPV vaccine late, half-heartedly or not at all. In addition, the disparity in HPV vaccine market penetration between boys and girls highlights the dated notion that these vaccines are mainly for girls.

To be an effective preventive strategy, HPV vaccination should start before sexual puberty. The CDC recommends routine HPV vaccination for girls and boys at age 11 or 12 (two doses six months apart, a 2016 revision of guidelines that previously recommended three doses). People who get vaccinated later (up to age 26 for young women and up to age 21 for young men) will need three.

This month, Douglas Lowy and John Schiller received the prestigious Lasker-DeBakey Clinical Medical Research Award for technological advances that enabled the development of HPV vaccines. Lowy and Schiller have been working together for about 30 years at NIH. The award is a strong endorsement of the vaccine. According to an article in The New York Times, Schiller said a high point in his career was taking his daughter to get the vaccine he helped create.

If you have a son or daughter, please talk to your doctor about the HPV vaccine. I only wish that such vaccines were available when I was a youth, as they could have prevented the cancer that’s killing me.

Michael D. Becker is president and founder of MDB Communications LLC. Previously, Mr. Becker served as president, CEO, CFO and director for several publicly traded biotechnology companies, including cancer companies Cytogen Corp. (acquired by EUSA Pharma Inc.) and VioQuest Pharmaceuticals Inc. and neurology company Relmada Therapeutics Inc. In December 2015, he was diagnosed with Stage IV HPV-mediated oropharyngeal squamous cell carcinoma (HPV-OPSCC) and has since authored the book A Walk with Purpose: Memoir of a Bioentrepreneur, available at Amazon.

Companies and Institutions Mentioned 

American Society of Clinical Oncology (ASCO), Alexandria, Va.

Centers for Disease Control and Prevention (CDC), Atlanta, Ga.

City of Hope, Duarte, Calif.

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K.

Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J.

National Institutes of Health (NIH), Bethesda, Md.

References 

Becker, M. “A walk with purpose: Memoir of a bioentrepreneur.” (2017)

Gillison, M., et al. “Impact of HPV vaccination on oral HPV infections among young adults in the U.S.” Presented at the ASCO meeting (2017)

Lewis, A., et al. “The new face of head and neck cancer: The HPV epidemic.” Oncology (2015)

Murphy, H. “Lasker prizes go to Planned Parenthood and developers of HPV vaccine.” The New York Times (2017)

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