Vaccine to Prevent Cervical Cancer Cause

May 21, 2010

The extraordinary complexities of shepherding a life-saving vaccine from its invention in the laboratory through myriad scientific, social, legal and economic hurdles to delivery to hundreds of thousands of needy patients around the world were brought to vivid and lively relief by a distinguished panel hosted by Georgetown University Medical Center.

The two hour symposium highlighted the journey of Gardasil, the first-ever vaccine that prevents infection by the human papillomavirus (HPV). HPV causes nearly all of the 400,000 cases of cervical cancer that strike women world-wide every year. Cervical cancer is the second-leading cause of cancer deaths among women. HPV also causes anal cancer and many oral cancers.

Georgetown’s C. Richard Schlegel, MD, PhD, academic chair and professor of pathology, was a co-inventor of the vaccine, which the US Food and Drug Administration approved in 2006. Schlegel’s laboratory currently is developing second- and third-generation vaccines that do not require refrigeration, are more easily transported and less costly and so could be used to prevent HPV in the developing world, where it is needed most.

Entitled “Cervical Cancer Prevention: A Global Intervention,” the panel was a featured GUMC event at the university’s 58th Annual John Carroll Weekend. Howard J. Federoff, MD, PhD, executive vice president for health sciences and executive dean of the School of Medicine, hosted and moderated the event.

The other blue-ribbon panelists were Catherine D. DeAngelis, MD, PhD, Johns Hopkins University School of Medicine professor of pediatrics and editor-in-chief of JAMA, the Journal of the American Medical Association; Margaret Little, PhD, director of the Kennedy Institute of Ethics and associate professor of philosophy at Georgetown; and, Anup Malani, PhD, University of Chicago professor of law, editor of the Journal of Law and Economics and a fellow at Resources for the Future.

Noting that HPV is the most common sexually transmitted disease, Schlegel said that twenty years of laboratory work had yielded an “incredibly effective, safe” vaccine. But, he said, at $120 each for three inoculations, the vaccine is out of financial reach where it is needed most urgently, primarily in Africa, South America and India.

Schlegel’s current laboratory work, funded by the Bill and Melinda Gates Foundation and the National Cancer Institute, aims to create a version of the vaccine that is only a few dollars for each shot and does not require refrigeration. He said he hopes to see such a vaccine administered eventually to boys as well as girls because HPV also causes 100 per cent of anal cancers and 30 to 40 per cent of oral cancers.

Community education, whether here or abroad, about the benefits of the vaccine is critical to prevention of such cancers, he said. For example, in the District’s Ward 8, only 15 per cent of those eligible for free vaccinations are getting them, a disturbing statistic that is mirrored globally, Schlegel said.

Gardasil provides a case study of the issues of trust and mistrust that often surface between medical authorities and people who may need treatment, Little said. Such questions can be particularly confounding when the vaccine, like Gardasil, appears to be an “altruistic” vaccine that best protects public health when it becomes a “herd” – or widely used – vaccine and therefore helps others in the community by stemming the spread of the virus among most.

Medical officials currently recommend that girls as young as nine years get vaccinated, a suggestion that has caused some controversy among parents. “When do we get it [the vaccine]? Before infection, says science. Not so fast, says ethics,” Little mused.

“The broad lesson of American medicine,” particularly in a case such as this involving sexual behavior and youth, is that people’s values and their distrust of authority play a pivotal role, Little said. Sexual activity among girls varies, often in a way that coincides with income level, race or ethnicity. Medical providers urging vaccination can appear to invoke racial profiling or “behavioral profiling,” she said.

DeAngelis echoed the quandary of community mistrust of medicine and science, arguing that the marketing of Gardasil is “the biggest problem,” because it is only effective for about 8 years and routine pap smears, nearly universally available in developed countries, also provide early detection for cervical cancer. An unwanted outcome of wide spread HPV vaccinations could be that some women stop getting pap smears, she said.

“Would you advise vaccinating a nine-year-old girl,” DeAngelis asked, adding that she had advised against vaccination for her own young nieces. “What would you do?”

Developing countries have less money and more immediately fatal issues than cervical cancer, which typically develops 20 to 25 years after exposure to HPV, said Malani. Economists conduct cost benefit analyses that factor in sometimes overlooked issues that may increase the vaccine’s implicit cost, he said. The time value of money – today’s costs will be valued differently in the future when health benefits are realized --- and whether the price includes subsidizing drug research and development can cause wide ranges in cost to benefit ratios, Malani said.

Yet all the panelists seemed to agree that science-based medicine that is responsive to the needs of the community of patients can best address the myriad, confounding complications at the intersection of medicine, ethics, economics and human nature.

“It’s complicated, like the movie. The key here is who do you trust,” quipped DeAngelis, whose humor evoked occasional laughter from the audience of medical and nursing and public health alumni, faculty and staff. “When push comes to shove, this is a decision you make with yourself but you discuss it with a physician you trust.”

Little agreed. “We need evidence-based medicine but evidence alone is not enough. Humans are complicated. Medicine is at its best when it has robust evidence and humility.”

Shortly before the cervical cancer panel convened, Federoff, discussing the future of medicine at GUMC, said, “We are always going to be a relatively small academic medical center but that does not mean that we can’t have big ideas and undertake them.” It was as though he was summing up the tale of Georgetown’s leading role in global cervical cancer prevention.

Author: Victoria Churchville, GUMC Communications