In the flu-vaccine world, Jefferson’s call for placebo-controlled studies is considered so radical that even some of his fellow skeptics oppose it. Majumdar, the Ottawa researcher, says he believes that evidence of a benefit among children is established and that public-health officials should try to protect seniors by immunizing children, health-care workers, and other people around them, and thus reduce the spread of the flu. Lone Simonsen explains the prevailing view: “It is considered unethical to do trials in populations that are recommended to have vaccine,” a stance that is shared by everybody from the CDC’s Nancy Cox to Anthony Fauci at the NIH. They feel strongly that vaccine has been shown to be effective and that a sham vaccine would put test subjects at unnecessary risk of getting a serious case of the flu. In a phone interview, Fauci at first voiced the opinion that a placebo trial in the elderly might be acceptable, but he called back later to retract his comment, saying that such a trial “would be unethical.” Jefferson finds this view almost exactly backward: “What do you do when you have uncertainty? You test,” he says. “We have built huge, population-based policies on the flimsiest of scientific evidence. The most unethical thing to do is to carry on business as usual.”
Just after 6 p.m. on a warm Friday evening in July, Dr. David Newman is only minutes into a 10-hour shift in the emergency room of New York City’s St. Luke’s Hospital, and already he has assumed responsibility for 11 patients. The young Italian tourist sitting on the bed in front of the doctor has meningitis, and through an interpreter, Newman tells him he almost certainly has the viral form of the disease, which will do nothing more than make him feel ill for a few days. There is a tiny chance, says Newman, that the illness is caused by a bacterium, which can be deadly, but he is almost positive that’s not what the tourist has. He says to his patient, “I can’t tell you with 100 percent certainty that you don’t have it, but if you do, you’ll begin to feel worse and you’ll need to come back.” The tourist, on learning that he might be infected with a potentially lethal disease, looks down at his feet and confesses that he is much more worried about another illness: swine flu. Newman smiles patiently. “It would be nice if you had swine flu,” he says. “Compared to bacterial meningitis, swine flu is safe.”
Late last spring, as headlines and airwaves warned of a possible pandemic, patients like Newman’s began clogging emergency rooms across the country, a sneezing, coughing, infectious tide of humanity more worried than truly sick, but whose mere presence in the emergency room has endangered the lives of others. “Studies show that when there is ER crowding, mortality goes up, because patients who need immediate attention don’t get it,” says Newman, the director of clinical research in the Department of Emergency Medicine at the hospital, which is affiliated with Columbia University. In an average year the ER at St. Luke’s, a sprawling 1,076-bed hospital on 113th Street, takes in 110,000 patients, some 300 a day. At the height of the summer swine flu outbreak, that number doubled. The vast majority of panicky patients who came in the door at St. Luke’s and other emergency departments didn’t actually have the virus, and of those who did, most were not sick enough to need hospitalization. Even so, says Newman, when patients with even mild flu symptoms show up in the hospital, they vastly increase the spread of the virus, simply because they inevitably sneeze and cough in rooms that are jammed with other people.