Several weeks ago, the U.S. Food and Drug Administration approved the Cobas HPV test as a primary screening method for cervical cancer. As the first alternative to the familiar Pap smear ever to be green-lighted by the agency, this is big news. If gynecologists and other health practitioners adopt the FDA’s recommendations, it could change women’s experience of and relationship to cancer screening, a process we undergo throughout our adult lives. The HPV test probably won’t replace the Pap smear anytime soon, but it could pose a challenge to the diagnostic’s sixty-year standing as the undisputed first-line defense against cervical cancer.

The Cobas HPV test, manufactured by Roche, works by detecting fourteen high-risk strains of the human papilloma virus, including HPV 16 and HPV 18, the pair responsible for 70% of all cervical cancers. (The Centers for Disease Control estimates that 90% of cervical cancers are caused by a strain of HPV.) If a patient tests positive for HPV 16 or 18, the new FDA guidelines recommend a colposcopy to check for cervical cell abnormalities. If she tests positive for one of the other twelve high-risk HPV strains, the recommended follow-up is a Pap smear to determine the need for a colposcopy. But critics fear that the new guidelines will lead to overtesting and unnecessary procedures, especially in younger women, many of whom have HPV but will clear the virus on their own within a year or two. Biopsies and colposcopies are more invasive, painful, and expensive than Pap testing, and might increase the risk of problems with fertility and pre-term labor down the road.

When George Papanicolaou began the experiments in the 1920s that would lead to the development of his namesake test, cervical cancer was among the most widespread forms of the disease in women, and was by many accounts the commonest. It was also deadly. With no routine method to detect early-stage cancers, many patients weren’t diagnosed until the disease had already metastasized. Even for those who heeded the symptoms of irregular bleeding and discharge, medicine offered little by way of treatment or cure. As Joseph Colt Bloodgood, a prominent surgeon at Johns Hopkins Hospital, grimly observed in 1931, cervical cancer “is today predominantly a hopeless disease.”

Papanicolaou, a Greek-born zoologist and physician, spent his days studying the menstrual cycle of guinea pigs at Cornell University Hospital in New York City. Using a nasal speculum and a cotton swab, he extracted and examined cervical cells from the diminutive animals. Eventually he extended his work to “human females,” using his wife, Mary, as a research subject. He discovered that his technique allowed for the identification of abnormal, precancerous cells shed by the cervix. After a few false starts—his first presentation of his work was at a eugenics conference in 1928 and was panned by attendees—he went back to the lab, spending another decade on swabs and slides. By 1941 he had gotten his ducks in a row, and with a collaborator he published his results in a persuasive paper that was quickly embraced by colleagues. Thus was born the Pap smear.

The Pap smear is not an infallible diagnostic. It can’t distinguish between cells that will become invasive and those that will never spread outside the cervix. Results can be ambiguous and slides are sometimes misread. Nonetheless, the Pap smear was a breakthrough at the time because it detected precancerous changes in cervical cells. It upended the customary timeline of cervical cancer, pushing the clock back by enabling diagnosis of the disease at a stage when lesions could be treated with relative ease and success. Since its introduction, it has contributed to a remarkable reduction in American mortality from cervical cancer, from 44 per 100,000 in 1947 to 2.4 per 100,000 in 2010, a roughly eighteenfold decrease in just over sixty years.

When women in the U.S. die from cervical cancer today, it’s generally because they never had a Pap test, hadn’t had one within the past five years, or failed to follow up on abnormal results with appropriate treatment. The problem isn’t with the test itself; it’s with uneven access to screening and follow-up care. These are issues of class, geographic location, insurance status, and health literacy that the HPV test will do nothing to address. The Pap smear may not be perfect, but when utilized correctly it does a pretty good job of detecting cervical cancer. The FDA’s approval of the Cobas HPV test as a first-line defense and its new cervical cancer screening guidelines have the potential to subject millions of women to decades of invasive, expensive procedures, upending six decades of established practice for a protocol with no clear gains in effectiveness. And that is a very big deal.

Sources:

Siddhartha Mukherjee, The Emperor of All Maladies: A Biography of Cancer. New York: Scribner, 2010.

Ilana Löwy, A Woman’s Disease: The History of Cervical Cancer. New York: Oxford University Press, 2011.

Monica J. Casper and Adele E. Clarke, “Making the Pap Smear into the ‘Right Tool’ for the Job: Cervical Cancer Screening in the USA, circa 1940-95,” Social Studies of Science 28 (1998): 255-90.

Joseph Colt Bloodgood, “Responsibility of the Medical Profession for Cancer Education, with Special Reference to Cancer of the Cervix,” American Journal of Cancer 15 (1931): 1577-85.

Statistics on cervical cancer from the National Cancer Institute at http://seer.cancer.gov/statfacts/html/cervix.html.

Last week marked the fiftieth anniversary of the landmark 1964 publication of the U.S. Surgeon General’s report on smoking and health. The 386-page document detailed the link between cigarette smoking and a number of diseases, including emphysema, chronic bronchitis, and coronary heart disease. Crucially, it stated in unambiguous, unadorned language the causal link between cigarette smoking and lung cancer. The average smoker was nine to ten times more likely than a non-smoker to develop lung cancer; for a heavy smoker, the risk rose to twentyfold. Smoking, moreover, hastened death. “Cigarette smoking,” the report read, “is associated with a 70 percent increase in the age-specific death rates of males, and to a lesser extent with increased death rates of females.” The greater the number of cigarettes smoked, the higher the death rate.

I grew up in a time when smoking was both accepted and widespread. I remember pulling on the glass knobs of cigarette vending machines in restaurants, coughing my way through smoke-filled transatlantic flights, and catching a hazy glimpse of my junior high school English instructor taking a smoke break in the teachers’ lounge between classes. I surveyed the cigarette advertisements that filled the pages of magazines delivered to our house, pondering the rugged masculinity of the Marlboro Man and the self-conscious, flapper-era feminism of the Virginia Slims women. In the 1970s, my parents, both nonsmokers by that point, kept an ashtray in the living room for the convenience of any guests who wished to light up.

The 1964 Surgeon General’s report was the work of a ten-member advisory committee made up of men from various medical fields. It included a surgeon, a pulmonary specialist, a bacteriologist, and a toxicologist. Appointed by Surgeon General Luther Terry, the group met at the National Institutes of Health in Bethesda, Maryland for over a year to review more than 7,000 articles on tobacco and disease. At the time, 42 percent of Americans smoked. Terry was so worried about the potential repercussions to the economy, given the report's negative findings, that he scheduled his press conference on a Saturday morning to minimize the effect on the stock market.

The association between smoking and disease documented in the report was not new. Epidemiologists had been exploring the link since the 1930s; their work established causal inference as an acceptable standard of proof and transformed what constitutes adequate knowledge in medicine and public health. In 1957, the previous Surgeon General, Leroy Burney, had noted the increasing implication of excessive cigarette smoking in the causation of lung cancer. But the comprehensiveness of the 1964 study and the overwhelming weight of the evidence were so convincing that Terry, a smoker himself, switched from cigarettes to a pipe in the months before the report was released, believing the latter to be less harmful. Another member of the committee quit altogether. A third, the heaviest smoker of the group, was diagnosed with lung cancer less than a year later and underwent surgery to remove a lung.

It was less the findings of the 1964 report than the publicity surrounding its release that catapulted the issue of tobacco use to the forefront of American public health. In the months following, smoking rates plummeted immediately—and temporarily—by 15 percent, a measure of the gravity with which the news was received. It raised the specter of lung cancer in the public consciousness, laying the groundwork for decades of legislation restricting the use, sale, and advertising of tobacco products. From the placement of warning labels on cigarette packages and constraints on television advertising to curbs on indoor smoking and limitations on sales to minors, it changed public opinion about smoking and generated pressure for politicians to act. It also strengthened the resolve of tobacco companies to create doubt about the link between smoking and serious disease. Until its dissolution under the terms of the Tobacco Master Settlement Agreement in 1998, the tobacco industry continued to dispute the scientific evidence by funding its own studies through its research arm, the Tobacco Industry Research Committee.

In my lifetime, I have seen the ways in which cultural attitudes toward smokers have shifted. No longer viewed as rebellious or sophisticated, the act of smoking has increasingly been vilified as smokers have been exiled from bars and shunted from entire offices to single rooms to the outdoors, where they huddle in doorways as they maintain their addiction. But while the luster and influence of the tobacco companies have dimmed, they have not disappeared. Today, 19 percent of Americans continue to smoke, or about 43 million people. Smoking remains the leading preventable cause of death and disease in the U.S., and rates are increasing in China and other parts of Asia as corporations search for new markets, preferably ones with fewer restrictions on the sale and advertising of their products.

Perhaps the most significant legacy of the 1964 report, in addition to the lives saved through anti-smoking measures, has been the promotion of an ideology of individual liberty regarding public health. After the U.S. began to require warning labels on cigarette packages, tobacco companies sought to portray smokers as adults whose freedom to indulge in the habit was being unfairly infringed upon. According to this line of thinking, the decision to smoke was a matter of personal choice, and the government shouldn’t be allowed to restrict someone’s ability to engage willingly in unhealthy behavior. If an individual knew the risks of smoking and still wanted to light up, then he should have the right to do so and bear whatever consequences might befall him. As public health agencies today struggle to enact laws limiting the size of sugary beverages and requiring calorie counts on restaurant menus, we can look to the previous fifty years of tobacco control for antecedents both to these attempts to regulate our behavior and to our understanding of their cultural meaning.

Sources:

Smoking and Health: Report of the Advisory Committee to the Surgeon General of the Public Health Service. Washington, DC: U.S. Department of Health, Education, and Welfare, 1964. Full text at http://profiles.nlm.nih.gov/ps/access/NNBBMQ.pdf.

Allan M. Brandt, The Cigarette Century: The Rise, Fall, and Deadly Persistence of the Product that Defined America. New York: Basic Books, 2007.

Background on the 1964 report from the National Library of Medicine at http://profiles.nlm.nih.gov/ps/retrieve/Narrative/NN/p-nid/60.

Current statistics and other data on smoking from the Centers for Disease Control at http://www.cdc.gov/tobacco/data_statistics/index.htm.