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Drug shows promise fighting infection
By WES ALLISON © St. Petersburg Times, published February 10, 2001 For critical care doctors and their patients, sepsis is the Grim Reaper of the ICU, a blood infection that kills thousands in hospitals each week. And despite decades of research, medicine has been able to do precious little about it. That soon could change. A large international study reported Friday says a new drug can significantly cut the death rate from sepsis, a bacterial blood infection that affects 500,000 to 700,000 people each year and is the leading cause of death in non-coronary intensive care units. The best treatments often fail. The drug, called Zovant, has not yet been approved for sale by the federal government, but it appears to cut a patient's chances of dying from severe sepsis by nearly 20 percent. These results were deemed so important that the New England Journal of Medicine took the highly unusual step of publishing the study on its Web site Friday, four weeks before its scheduled publication. "In all-comers, it's 30 percent fatal. In sicker or older people like we have in St. Petersburg, you can probably double that," said Dr. Clinton Holder, an infectious disease specialist and chairman of the infection control committee at Bayfront Medical Center. "It is a major problem, and anything that can help is needed." The drug's manufacturer, Eli Lilly and Co., hopes to win approval from the Food and Drug Administration by year's end. The study was coordinated by researchers at Vanderbilt University in Nashville and funded by Lilly, but an independent Journal editorial said that its science is good and that the drug appears promising. Sepsis kills up to 1,000 people in U.S. hospitals every day and often follows trauma, burns, surgery or disease, such as cancer, AIDS or pneumonia. Doctors employ a variety of weapons against it: antibiotics, intravenous fluids to raise falling blood pressure, mechanical assistance for failing lungs or kidneys and surgery to remove the source of infection. But as the body fights infection, it creates blood clotting and inflammation of blood vessels, setting into motion a cascade of events that can end in fatal organ damage. Even when the antibiotics work, irreversible organ failure may already have begun. In fact, many people who die of complications from cancer, pneumonia or AIDS actually die of sepsis, doctors say. "In the past 15 years, several treatments designed to reduce the mortality rate associated with sepsis have been unsuccessful, leading some investigators to conclude that any adjunctive therapy is destined to fail," Dr. Michael A. Matthay of the University of California at San Francisco wrote in the Journal editorial. "At last, however, there has been progress." Unlike other treatments, Zovant is an antibody derived from a natural anti-clotting element of blood, called protein C. It appears to ease the natural inflammation and clotting that occurs as the body fights infection. "This is a treatment that works above and beyond treating bacteria," explained Dr. Roland Schein, chief of critical care medicine at Miami's Jackson Memorial Hospital, one of the study sites. "If the data holds, and if it's approved, this is going to be a very useful drug," he said. "This is quite a substantial drop in mortality, in my mind." Researchers in 11 countries followed 1,690 patients at 164 sites, including the University of South Florida in Tampa and the University of Miami. Half got the drug, half got a placebo, and all of them got traditional sepsis treatment as well. They were followed for 28 days or until death. Of those who got the placebo, 31 percent died, compared with 25 percent of those who got the drug. That equals an improvement of 19.4 percent. And it worked even on patients who already were in the latter stage, called septic shock, or who already were on a ventilator, the study said. Ironically, with this drug, Lilly has taken a somewhat back-to-the-future approach, Bayfront's Holder noted. Before the advent of antibiotics, in the 1930s, researchers were trying to use antibodies to control infection in just this way. Since 1980, Lilly says, at least 30 new sepsis drugs have been tested, including several that tried the same approach as Zovant, but none helped enough. Holder participated in a trial for one of them, "but they could never prove it was any better than the placebo in terms of long-term effect," he said. Lilly recently established a "compassionate use program" that makes the drug available on a case-by-case basis. Patients must meet the same criteria as those enrolled in the clinical trial, and doctors can learn more about it by calling (800) 545-5979. But as with any new drug, this one comes comes with caveats and concerns. In the study, a small percentage of patients suffered increased bleeding, potentially fatal for some people. And while the study was relatively large, it still has been tried in a minuscule percentage of potential patients. Side effects often don't reveal themselves until a drug hits the general population. Meanwhile, doctors and hospitals can expect lots of marketing pressure to use it. Lilly is hoping this drug will help make up its potential losses when Prozac, the world's most popular anti-depressant, loses its copyright protection and faces generic competition this summer. Lilly's stock closed at $80.75 a share Friday, down 24 cents. Even though FDA approval for Zovant is likely months away, Lilly drug representatives already are pitching it to Tampa Bay infectious disease and critical care specialists, doctors say. Two weeks ago, many medical writers received a handy guide to sepsis that made no mention of Zovant, but was clearly intended to grease the skids for the upcoming Journal study. Dr. John F. Breen, an infectious disease specialist at St. Joseph's Hospital in Tampa, said the drug deserves more study. Hospital workers also need to focus more on preventing sepsis in the first place, he said. "In this particular study (it) looks effective . . . but this has to be looked at very carefully," Breen said.
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