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Ellen Daley, PhD, is living a researchers dream. She and her colleagues stand on the forefront of a veritable medical milestone and a major public health initiative a newly approved vaccine that will prevent the certain strains of cancer-causing HPV and, in turn, can virtually eradicate cervical cancer.
The Food and Drug Administrations approval was great news! This is a grand slam, said Daley of the FDAs June 8, 2006 approval of Merck's HPV vaccine, Gardasil. This kind of breakthrough should go down with other medical milestones, like the polio vaccine, and antibiotics.
Daleys research on the psychosocial aspects of HPV, or human papilloma virus, have been federally funded by the Centers for Disease Control and Prevention and the National Cancer Institute.
Linking sexually-transmitted HPV with cervical cancer
HPV is a group of more than 100 identified viruses today, some generating non-threatening warts on the hands and feet, while others lead to genital warts and still others produce deadly cancers. Thirty years ago the connection between certain strains of anogenital, or sexually transmitted strains of HPV and cancer was first postulated by Dr. Harald zur Hausen (professor emeritus at the GermanCancerResearchCenter in Heidelberg). At that same time, Daley was working with womens health centers and noticed an unusually high number of abnormal PAP smears among the younger, more sexually active patients. Hausens hypothesis became an exciting lead for Daley and eventually a confirmed findingcertain strains of sexually transmitted HPV cause cervical cancer.
Over the years Daley, an assistant professor in community and family health at the University of South Florida College of Public Health, focused her research on the psycho-social impacts of the disease, which gave her a true appreciation for the human pain and suffering endured by those infected with HPV.
Furthermore, the occurrence of cervical cancer made it a definite public health issue because, she said, its not an equal opportunity cancer.
Cervical cancer is virtually 100 percent preventable through screening (can take up to 10 years from infection with HPV to the development of cervical cancer). If caught early, it can be eliminated with a host of medical options. Daley found women were dying of cervical cancer anyway, either because they had never had a PAP smear due to insurance issues or transportation problems, or they did get screened but never had follow-ups. Questions of disparities became evident.
If you look at the numbers, said Daley, these are not typically wealthy women, but rather women who live in poverty.
Women as the glue holding families and communities together
Daley pointed out that although on the surface statistics only take into account each individual woman that died, each single woman represents a whole family, and in turn, a whole community. So the damage becomes multiplied exponentially because generally it is the woman who is the glue that holds the family together. When that one woman dies, be she wife, mother, and/or daughter, the whole family is adversely affected, said Daley, and then the whole community suffers.
A quick look at the numbers show how vast the problem really is. While very few of the HPV strains do cause cervical cancer, Daley said, there are more than 10,000 women in the United States that contract cervical cancer yearly, and about 3,700 of those cases result in death. Worldwide, the numbers are even more staggering because of insufficient screening. Those studies show almost 800 deaths every day, or almost 300,000 deaths a year, from cervical cancer.
There were also huge psychological ramifications. With the establishment of this concrete causal relationship, abnormal PAP screens led to intense stigma and anxiety for women in Daleys studies due to what she called the three punches.
First they found out they had an abnormal PAP smear, and they knew that was a test for cervical cancer, so that scared them, she said. Then they were told they had HPV, so now they know they have a sexually transmitted disease which they didnt know they had before. And then theyre told its a virus and it cant be cured.
Working toward a vaccine for cancer prevention
It was clear that while the secondary prevention, screening and detection, was working well, primary prevention was needed. Work began to produce a vaccine that would at minimum address the oncogenic strains of the virus, and now two pharmaceutical giants, Merck & Company, and GlaxoSmithKline, are poised to release their own versions of the vaccine sometime this summer.
But what should have led up to this moment in excitement and accomplishment was mired in several organizations expressing concern that the vaccine would be used to encourage promiscuous sexual relations between teenagers and/or adults.
People should have been shouting from the roof tops, said Daley but because HPV is attached to a behavior that people object to, we got this whole other issue that clouds the discussion. The entire dialogue about the HPV vaccine should not be associated with STDs. We need to keep this firmly in the area of cancer prevention.
In fact, some of the groups that earlier on expressed concerns with the vaccine are now revising their stance.
We welcome the development of an HPV vaccine and that may not have been communicated before, said Peter Sprigg, vice president of policy for the Family Research Council, a conservative religious lobby group in Washington, D.C. We do recognize the health benefits it will bring to millions, and the thousands of lives that will be saved.
But he did temper his endorsement with the caveat that, We do worry that people will get the understanding that promiscuous sex is safe, so we want to monitor that.
Sprigg noted that the concern about what he called sexual disinhibition was voiced at the most recent Advisory Committee on Immunization Practices conference held this past February, and he acknowledged its finding of no evidence that administering the vaccine will lead to more sexual encounters.
HPV awareness and vaccine education critical
Anna Giuliano, PhD, professor of interdisciplinary oncology at USF and program leader in the risk assessment, detection, and intervention program at the H. Lee Moffitt Cancer Center and Research Institute, said education is the key. Most people, she said, dont even know what HPV is, never mind the connection between the anogenital strains and cervical cancer.
Youd be surprised how many doctors dont even know, said Giuliano, who has been a leading researcher on HPV vaccine efficacy testing since 1999 and has authored over 75 publications on the topic. Until we raise the level of understanding about this disease, we wont have full acceptance.
In fact, even those in the know may be unaware that the current vaccine will not only prevent cervical cancer, but will most likely thwart other cancers as well. Weve seen there is a strong association with this strain of HPV and cancer at other sites including the head, neck, penis, anus, vulva, and vagina, so there will be a spillover effect, she said.
Even with the approval and subsequent dissemination of the vaccine, there is still enormous work ahead, said Daley. To begin with, it is anticipated that when the vaccine is issued, it will be earmarked for young children, but that will not address the thousands of women who have already contracted HPV. And as with any medical breakthroughs, it will take a long time, and a great deal of financial backing, to get the vaccine distributed worldwide.
This is going to be big here, she said. Now well have to get it to developing countries.
Source: University of South Florida