• 10/24/2007
  • Newport Beach, CA
  • Keri Kramer
  • Forbes.com

For the public health, we need to fast-track research and approvals now, says foundation

On the heels of a study published this month in the journal Cancer, and recent supporting science related to HPV and oral cancer in the New England Journal of Medicine, the Oral Cancer Foundation is urging researchers to expedite investigations on the safety of human papillomavirus (HPV) vaccinations for males, and the FDA to fast track the approval once scientific due diligence has been accomplished.

“The study affirms what we have long believed, namely that the vaccine can reduce oral cancer rates if given to both males and females,” says Brian Hill, Founder and Executive Director of the foundation.

Currently, the vaccine, which shields against HPV strains 6, 11, 16 and 18, is administered to girls and adolescent females to protect against cervical cancer.

Deaths from cervical cancer, which number about 3,700 annually, have steadily declined due to improved methods of early detection, and a population that knows the importance of annual screenings. Oral cancer also lends itself to early detection through a simple visual and tactile examination which could easily be implemented, but does not have a nationally adopted program of public awareness and compliant professionals engaged in such a screening process. In the US, 93 people per day will develop oral cancer, and one person will die from it every hour. This is more than double the death rate of cervical cancers, and is higher than that of many other cancers we commonly hear about. Because it is frequently painless and goes unnoticed in its early stages, the cancer is usually not found until late stages, when prognosis is poor. Opportunistic screenings like those done for cervical cancer could change this were they being done routinely.

In fact, oral cancer, which occurs in those very visible parts of the mouth that we all are familiar with, but also includes the tonsils, base of the tongue, soft palate, and side and back of the throat (oropharynx), is one of the few cancers on the rise in the United States, despite years of declining tobacco use. Tobacco use has been historically considered the most significant risk factor for the disease.

“Fewer people are using tobacco, but more people are getting oral cancer,” Hill says, “What seems like a paradox actually illuminates the expanding role HPV-16 plays in acquiring this disease.”

HPV is the most common sexually transmitted disease in the United States. About 20 million men and women currently have the disease, and close to 80 percent of sexually active adults will acquire the virus at some point in their lives. The virus can be transmitted either through genital or oral-genital contact.

HPV-16, one of the most destructive strains out of over 100 versions of the virus, was first linked to oral cancer more than a decade ago, but research since 2001 has removed any ambiguity about its role as a causative factor in oral cancer in both men and women “Widespread use of the vaccine for both males and females, even if just in relationship to cervical cancer, will reduce the reservoir of the virus in the US, and in slightly more than a decade we could begin to see the positive collateral benefits in the oral and head and neck cancer world. Hill says. Vaccinating males will also eliminate them as a vector for the virus.

On the other hand, the foundation cautions that while Pharma giants Merck and GlaxoSmithKline are doing studies on the current vaccines and males, delaying research and subsequent FDA approvals will likely come at a cost: As our society’s sexual behaviors change, adolescents have engaged in oral-genital sex at younger ages, and transmission of HPV will increase and the attendant risks for cancer of the mouth, cervix, vulva, vagina, anus and penis will increase exponentially. “Significant pre approval research was done on these vaccines and proper due diligence review conducted by the FDA prior to approvals. There is no scientific evidence that indicates that this virus behaves differently at the cellular level in males than in females,” says Hill.

He further stated, “What we know about HPV-16 as a cancer-causer is just the tip of the iceberg,” Hill says, “These vaccines are the first major breakthrough against a cause of cancer in decades. We must act now.”

The Oral Cancer Foundation, founded in 2000, is a national IRS 501c3 non-profit based in California. The foundation advocates for better public understanding of the disease and engages the medical and scientific communities to develop more effective methods of early detection. The foundation conducts screenings across the country and maintains a Web site with information for patients, the public and health care providers at http://www.oralcancer.org

Contact: Brian Hill (949) 278-4362