Work on Cervical Cancer Vaccine Puts NIH Duo in the Running for Major Award

Work on Cervical Cancer Vaccine Puts NIH Duo in the Running for Major Award

Washington Post
September 10, 2007

It started as one of those basic science projects, trying to understand the mysterious ways of a virus.

It ended with a discovery that led to a vaccine for the sexually transmitted virus that causes cervical cancer, the No. 2 killer of women worldwide.

The research that led to the breakthrough was conducted by two government scientists -- Douglas R. Lowy and John T. Schiller -- who have worked together for nearly 24 years. Their collaboration was made possible because of where they work -- a federal lab that is mostly free of commercial pressures and the academic red tape that goes with selling ideas to obtain research grants.

Lowy and Schiller are among 31 finalists for Service to America Medals, the awards sponsored by the nonprofit Partnership for Public Service to honor civil servants for their innovations and dedication. The award winners, including Federal Employee of the Year, will be announced Sept. 19 at a Washington gala.

For Lowy and Schiller, the honor of being a medal finalist in 2007, selected from nearly 600 nominations, is a reminder that most scientific research is a long-haul proposition. They are being recognized for a series of scientific discoveries that began in 1992.

Since then, they moved to other research, but found themselves still involved in their original project as others extended their findings in the large-scale clinical trials and studies needed before the vaccine could win federal approval for use by doctors. That approval was granted by the Food and Drug Administration in June 2006.

Lowy and Schiller work together at the National Institutes of Health, where Lowy is the lab chief and Schiller the senior investigator in the National Cancer Institute's Laboratory of Cellular Oncology. Wags like to joke that NIH stands for Not Invented Here, but Lowy and Schiller are immune to such teasing. They are the first and second inventors on government-owned patents for their discovery, making them eligible for limited royalties.

They began their research with a broad interest in the role of viruses in making cells grow abnormally and began to focus on human papillomavirus, or HPV, when other scientists provided evidence for HPV's link to cervical cancer.

But HPV was especially difficult to study, in part because it only grows in the skin or other body surfaces. Lowy and Schiller, however, found that 360 copies of the protein encoded by a single HPV gene could assemble into a particle that looks like the outer shell of the virus and that these protein particles could be mass-produced.

When these protein particles were injected into rabbits, their immune systems produced antibodies that could prevent the real tumor virus from infecting cells. "That was sort of the eureka moment," Schiller said.

The findings implied that a safe vaccine could be developed, because the protein particles did not contain the genes that cause cancer. "All you really need is this one protein," Lowy said.

Because they are laboratory-based researchers, Lowy and Schiller called upon clinical scientists at Johns Hopkins University to run early trials and validate that the vaccine was safe and induced a robust immune response in people.

Although some pharmaceutical companies had doubts whether the vaccine would stop a sexually transmitted disease, views began to shift in the mid-1990s. Merck and GlaxoSmithKline undertook large-scale human clinical trials that showed cancer-causing HPV infections could be prevented. Merck received its license in 2006 and is producing a vaccine for females ages 9 to 26. GlaxoSmithKline applied for its license this year.

The clinical trials have shown the vaccine is effective for at least four to five years. The National Cancer Institute is conducting independent trials on the vaccine, and Lowy and Schiller hope the vaccine proves to have a long-lasting protection and will someday be manufactured at lower cost for distribution in developing countries, where fewer women receive annual Pap smears to reduce their risk of cervical cancer.

Lowy, who has a medical degree, and Schiller, who has a doctorate in microbiology, prefer to share credit with others for their breakthrough. They emphasize that their work built upon decades of research by other scientists and was made possible through improvements in technology.

They also said their research was made much easier because of the freedom that NIH provides scientists. Because senior researchers have stable funding, they can jump into a project without having to spend time writing up justifications and applying for grants.

"You are given wide latitude on what you work on," Lowy said. "The assumption is that you will work on important problems."

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