Phinney Ridge resident Dr. Laura Koutsky didn't know what she wanted to do with her life when she joined the Peace Corps after college. When she left the Peace Corps, however, she knew public health was the field for her.
Now she is a primary participant in developing a vaccine for cervical cancer.
Half of all of the cases of cervical cancer are caused by lesions on the cervix, resulting from a sexually transmittable infection called the human papillomavirus type 16 (HPV-16).
Most of the time, the woman's immune system heals the cervical lesion within a year, Koutsky said.
"There are so many [harmless HPV cases], we don't even want to know about it," she said.
However, in a few cases, the lesions stay on the cervix and, within 10 to 20 years, can become cancerous. This results when women do not routinely have Pap smears that detect the lesions.
Approximately 20 percent of the worldwide adult population presently has HPV, and more than half of the adults in the United States have had it sometime during their lifetime, she said.
In the mid-1990s, Merck Research Laboratories in Pennsylvania acquired a license to make a protein, called a viruslike particle, that is part of HPV-16.
Administered to humans, this viruslike particle does not cause the infection but boosts the immune system into fighting the real virus. However, the mystery was in how to test a vaccine for cervical cancer on women since the lesions that cause the cancer can exist on the cervix for about 20 years.
Dr. Katherin Jansen, executive director of microbial vaccine research at Merck, knew that, ethically, scientists could not let women in any study of this vaccine run the risk of developing cancer 10 to 20 years down the road if lesions were detected; the lesions would immediately have to be treated. She needed a colleague who could explain the full, 20-year life of HPV, from transmission of the infection to the development of cervical cancer.
Enter Koutsky, whom Jansen met at a papollomavirus meeting in 1995. By this time, Koutsky had worked on HPV research in the public-health graduate program at the University of Washington, and she had worked for Dr. King Holmes, an expert in sexually transmitted diseases, there. With a doctorate degree in epidemiology, also from UW, Koutsky had extensive knowledge of HPV and cervical cancer.
"[Jansen] needed a collaborator studying the natural history of HPV," Koutsky said. "She needed information on the rates of infection."
Together, and financially backed by Merck, Koutsky and Jansen embarked on what most other scientists thought was impossible: to find a vaccine for HPV-16 and subsequently eradicate more than half of the cases of cervical cancer.
In 2002, the first study showed that the virus-like particle vaccine developed by Merck proved 100-percent effective in preventing HPV-16. The study tracked healthy women age 16 to 23 for two years and found that after that time, 3.8 women for every 100 women given a placebo tested positive for the HPV-16 infection.
None of the women given the vaccine tested positive for the infection. The results of the study were published in the New England Journal of Medicine in November 2002.
Since then, GlaxoSmithKline Pharmaceuticals, like Merck, came back with its own study on the same HPV-16 vaccine showing similar results, Dr. Koutsky reported.
Merck since created another vaccine against HPV-16 and HPV-18, which together cause 70 percent of the cases of cervical cancer. This new vaccine also will protect against HPV-6 and 11, which together cause 90 percent of the cases of genital warts.
This will give men - who are carriers of HPV-16 and 18 but are not harmed by them - incentive to get this vaccination since men can get genital warts, Koutsky said.
The vaccine - which is still in the testing phase and not yet FDA-approved - is given in three shots over a six-month period. The second injection is given a month later, and the third injection is given five months after that.
"Our immune system response improves a lot when we allow it to see the target," Koutsky explained.
Koutsky also explains that the vaccine will have the most use in countries where Pap smears are not regularly administered. Worldwide, about 250,000 women die of cervical cancer annually. Of these women, 41,000 are from the United States.
A vaccine, however, will prevent unneccessary scares from abnormal results of Pap smears, both in the United States and in foreign countries. It also will prevent the cost of biopsies or additional testing for the treatment of these abnormalities.
Currently, the testing of the vaccine is approximately a year into the Stage 3 trial, with 20,000 women volunteers being tracked worldwide.
In the Seattle area, 200 women are participating in the study. They are tracked through the University of Washington, where Koutsky is now a professor of epidemiology.
The study will track the women for three more years before having results.
It will be at least five more years before the vaccine is ready for market. However, women will not see any difference in the rates of cancer for some time.
"It will take 10 to 20 years for the vaccine to have any impact on cancer rates," Koutsky said.
In the meantime, Dr. Koutsky urges women to still get annual Pap smears. Annual Pap smears prevent the cervical lesions from getting cancerous.
"I feel very fortunate to be in the position I was in," she said. "It's been a tremendous experience. All of the people I have gotten to work with - we all have tremendous respect for each other."
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