Merck has been hitting major television markets hard with commercials for its product Gardasil, which is a vaccine for human papillomavirus, or HPV. These ads are well-timed as they are appearing at the start of this year’s back-to-school season, which is a time when many children are already being seen by their physicians. This is an excellent time for parents and physicians to have a conversation about the benefits of the Gardasil vaccine. Sadly, research from 2015 shows this is often a missed opportunity on the side of the physician.
The vaccine Gardasil was first approved by the Food and Drug Administration on June 8, 2006, for use in the prevention of cervical cancer in females. On September 15, 2008, the FDA approved the expanded use of Gardasil for the prevention of certain vulvar and vaginal cancers. On October 16, 2009, the FDA approved Gardasil for use in boys and young men. On December 22, 2010, the FDA approved Gardasil to prevent anal cancer. The FDA grants additional approvals for a drug or vaccine based on new clinical data submitted by the drug or vaccine manufacturer that proves the drug or vaccine works for the additional uses.
Gardasil works best if administered before the first sexual activity of any kind occurs, which is why the vaccine is recommended for optimal administration to children, both boys and girls, between the ages of 11 and 12.
Some American parents seem to have some difficulties coming to grips with the notion that their children will have sex one day. Those parents either put off giving their children the Gardasil vaccine or do not ensure their children complete the entire Gardasil vaccine regimen.
The sexual aspect of HPV is the main reason physicians are dropping the conversational ball with parents, according to an article published by NPR in 2015.
The article explained that physicians were uncomfortable talking about the HPV vaccine with parents of 11- and 12-year-olds due to the interpersonal conversations about sex that can potentially come up regarding the vaccine. These same children are receiving the Tdap (tetanus, diphtheria, pertussis) and meningococcal vaccines at this age as well; those vaccines do not come with any sexual conversational static and therefore do not face opposition from either physicians or parents.
The HPV vaccine conversation should not focus on sexual behaviors, either present or future; the HPV vaccine conversation should focus on cancer prevention and use research and data on reproductive cancers to support that conversation. Merck’s advertisements drive home the cancer prevention side of the HPV vaccine conversation.
“HPV is the most common sexually transmitted infection in the United States, with an estimated 6.2 million persons becoming newly infected every year,” according to the Centers for Disease Control and Prevention. An estimated 9 out of 10 people will become infected with HPV at some point in their lives.
Over 100 individual types of HPV have been identified, with 40 of those types infecting the genital area. HPV types are given numbers to identify them individually and are classified as low-risk or high-risk depending on their association with the development of cancers.
HPV can be found in the mouth and throat. Studies show these HPV infections are possibly contracted during oral contact with HPV-infected genitals. The CDC reports that every year about 9,000 Americans are diagnosed with cancers of the oropharynx (or middle part of the throat) that may be caused by HPV. Men are four times more likely than women to develop these types of throat cancers.
Gardasil is a quadrivalent vaccine, meaning it was designed to help protect people from four strains of a single virus. The four types of HPV targeted by Gardasil are 6, 11, 16 and 18. In females age 9 to 26, Gardasil “helps protect against two types of HPV that cause 70 percent of cervical cancer cases, 70 percent of vaginal cancer cases and up to 50 percent of vulvar cancer cases,” states Merck’s Gardasil website, which was no longer available online when this blog was published.
The site further explains, “In males and females ages 9 to 26, Gardasil helps protect against about 80 percent of anal cancer cases and 90 percent of genital warts cases.”
On December 10, 2014, the FDA approved Merck’s Gardasil 9 vaccine for use in females ages 9 to 26 and in males ages 9 to 15. Gardasil 9 offers protections against HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58. Gardasil 9 adds protection against five additional types of HPV that cause 20 percent of cervical cancers, which gives females who complete the vaccine regime protection from 90 percent of all cervical cancers.
HPV is asymptomatic, meaning there are no symptoms, which is why it is so commonly transmitted. People do not know they are infected with the viruses and unintentionally spread the viruses to others as a result. Men are the usual carriers of HPV. A man will become infected with the virus from a single partner and will then go on to infect subsequent partners. This cycle of infection will continue for as long as the HPV virus is alive and active in their bodies. It is possible to be infected with several types of HPV at the same time.
When a female who has not been vaccinated with Gardasil is infected with HPV types 16 and/or 18, the HPV virus cells can cause precancerous cells to form in her cervix. The only way to detect precancerous and cancerous cells in the cervix is through a yearly Pap smear and pelvic exam.
A common treatment for the removal of precancerous cervical cells is laser surgery, also called photoablation or photocoagulation, in which the precancerous cells are burned away using a laser, or intense beam of light. Side effects of laser surgery include pain, which is common, and bleeding and infection, which are very unlikely to occur due to the natural cauterization effect of the laser used during the procedure.
The Gardasil and Gardasil 9 vaccines are given as three injections over a six-month time period. The regular Gardasil vaccine costs about $120 per injection or $360 for the entire vaccination course. Commercial insurance plan coverage for Gardasil varies among plans. Parents of children who are eligible for Gardasil should call their insurance carriers for their plans’ exact pricing of Gardasil.
The Vaccines for Children program (VFC) is a federally-funded program that provides vaccines for children aged 18 and younger who are uninsured, Medicaid-eligible, American Indian or Alaska Native. Gardasil is one of the vaccines covered by VFC.
William Schaffner, a professor of preventative medicine and infectious diseases at the Vanderbilt University School of Medicine, said in an NPR article, “… For a long time, an anti-cancer vaccine was a sort of a holy grail in medical research. This is a fabulous advance in women’s and men’s health, and we’re letting young people grow into adulthood without that protection.”
If you are a young adult who was not vaccinated against HPV as a child, it may not be too late to receive the HPV vaccine because some protection is better than none, especially if your family has a history of cancer. Talk to your health care professional about Gardasil.