| Copyright 1999 The New York Times Company The New York Times October 28, 1999, Thursday, Late Edition - Final SECTION: Section A; Page 6; Column 1; Foreign Desk LENGTH: 1543 words HEADLINE: Study Says New TB Strains Need an Intensive Strategy BYLINE: By JUDITH MILLER BODY: International health officials and scientific experts say that strains oftuberculosis resistant to various drugs are spreading faster than anticipatedoverseas and that a new treatment strategy is needed to prevent what has alreadybecome an epidemic from spinning out of control. For five years, the World Health Organization has recommended that patientswith ordinary tuberculosis take up to four drugs, every day, for six to eight months, and that doctors and health workers watch them take their medicine and directly monitor them to insure that they are cured. The strategy has become widely known as DOTS, or Directly Observed Therapy Short-Course. But in a new report, doctors from the Harvard Medical School and the Open Society Institute, a foundation financed by George Soros, say more intensive treatment is needed in the former Soviet Union and other areas where rates of resistant strains are relatively high. In the intensive regimen, patients are required to take many additional expensive drugs over a longer period of time. Strains that are resistant to multidrug programs afflict on average 2 percent of victims, and nowhere more than 30 percent. The recommendation is being supported by the World Health Organization, whose director general, Gro Harlem Bruntland, is scheduled to be present today, when the 408-page report is made public in New York. But some health experts fear that the new approach could worsen the problem. In the new strategy, called DOTS Plus, doctors watch patients take up to seven drugs daily, for 18 to 24 months, at far greater cost per cure. "This is a landmark shift by the WHO, the most exciting step forward in the global effort to control TB in 25 years," said Michael D. Iseman, Director of TB Services at the National Jewish Medical and Research Center in Denver, a leading expert in tuberculosis treatment and research and a member of the advisory board of the group that wrote the report. The report, "The Global Impact of Drug-Resistant Tuberculosis," has a foreword that offers an unusual endorsement from WHO's leading specialists for the new treatment."In our zeal to implement DOTS everywhere," said Dr. Mario C. Raviglione, the WHO Coordinator for Bacterial and Viral Diseases, who signed the preface, "there was no clear policy in the program to take care of multidrug-resistant TB. PAGE 4 The New York Times, October 28, 1999 we realize that something more must be done." Dr. Raviglione said he did not know how much more the strategy would cost, because his group was just starting to study the problem. But he conceded that the expanded strategy would almost certainly cost hundreds of millions of dollars, "perhaps $1 billion more" than the current treatment, which is already underfinanced, many doctors complain. In interviews, several experts said the WHO recommendations were highly likely to intensify an already emotional debate on expanding the recommended treatment for some patients at a time when two million people a year die worldwide for lack of adequate care. At a meeting last month in Madrid, opponents of the expanded strategy argued that emphasizing the treatment would shift desperately needed resources away from patients with tuberculosis that was not drug resistant. "The WHO declared TB a global emergency in 1993," Dr. Thomas R. Frieden, a WHO medical officer for TB in Southeast Asia, said in a telephone interview from New Delhi. "But six years later, fewer than 20 percent of patients get even basic treatment." Dr. Frieden said efforts to combat multiple-resistant TB should focus on its cause, inadequate treatment of ordinary tuberculosis. Tuberculosis is known to acquire resistance to drugs that are given to patients inefficiently. If the wrong drugs or doses are given for too short a time or if the patients stop taking them, the bacteria that survive may become drug resistant. Dr. Frieden and other experts fear that if new more effective drugs are also given badly, the multiresistant strains will eventually become unresponsive to those drugs too, making a bad situation worse. The Director of the Program in Infectious Disease and Social Change at the Harvard Medical School, Paul E. Farmer, primary writer of the report, agreed that poor treatment had led to many cases of multiple-resistant TB. But he said inadequate treatment was no longer the sole cause of such strains. New data, he added, suggest that in some areas drug-resistant strains are spreading on their own person-to-person, even in countries with good control programs. He said multiresistant tuberculosis now threatened not just poorer countries, but also Europe and, eventually, the United States. The study finds that multiresistant TB has been reported in 100 countries and that its rates are rising faster in some countries than officials had anticipated. In the Ivanovo oblast in Russia, a poor province with a vast prison population and shoddy public health, the WHO reported in 1997 that 4 percent of TB patients had multidrug-resistant strains. According to the new report, such cases now total 8.9 percent of the TB cases."Figures like these show that multidrug-resistant TB in some places is now out of control, and it shows we were doing something wrong, that more than DOTS is needed in such areas," said Dr. Raviglione. PAGE 5 The New York Times, October 28, 1999 But Dr. Frieden, who was the TB Control Director in New York from 1992 to 1996, pointed out that two-thirds of the people with multiresistant TB had developed it because the Ivanovo program did not insure that patients took their medications. "If medicines aren't being taken," he said, "it doesn't matter if you're being given two or four or seven drugs. And if resistance to reserve drugs emerges, our last line of defense against TB will be lost." Dr. Farmer agreed that the failure to take drugs remained a major problem in Russia and elsewhere. But, he added, the Ivanovo study also shows that "the drugs patients received were inadequate," which is primarily why just 5 percent of the multidrug-resistant cases were cured. Dr. Raviglione said adopting a DOTS-plus strategy would not mean WHO would abandon its current DOTS strategy. In fact, both experts stressed the need to insure that doctors everywhere made sure that patients took their drugs. Rather, the experts said, the report stresses the need for supplemental drugs and therapy where multiresistant strains already exist. Dr. Farmer said his team began to question the currently recommended therapy about five years ago, after a colleague who was a relief worker had died in a hospital in Massachusetts after having contracted drug-resistant TB in Peru, which has an excellent DOTS program. "That made us think that the one-size-fits-all treatment approach was not universally effective," Dr. Farmer explained. Ideally, the scientists agreed, there would be no competition among resources for treating nondrug-resistant and drug-resistant TB. But in view of the widespread indifferent response to the threat, said Dr. Lee B. Reichman, executive director of the National Tuberculosis Center in Newark, N.J., some doctors feared that there would be a contest. "DOTS-Plus is a sexy new strategy with Harvard behind it, and like any sexy new strategy there is some fear of it," said Dr. Reichman, who contributed to the report. "But I'm on the WHO's TB working group, and we've made it clear that won't happen." The study shows that multidrug-resistant TB emerged in Peru, despite the excellent control program. In Peru, Dr. Farmer and his colleagues were able to cure 85 percent of supposedly incurable multidrug-resistant patients by giving them up to seven drugs over 24 months. The treatment cost from $280 to $4,900, higher than the cost of the currently recommended therapy, but far less than what such treatment would cost in the United States. Dr. Reichman estimated that it cost his center in Newark an average of $4,800 a patient and six months to cure normal TB without hospitalization, as opposed to $200,000 and up to two years of treatment, including lengthy hospitalization, to cure patients with multidrug-resistant strains. In New York City in the early 1990's, an outbreak of multidrug-resistant tuberculosis cost up to $1 billion in extra health costs, Dr. Reichman said. PAGE 6 The New York Times, October 28, 1999 Because New York and other major cities have bolstered surveillance, treatment and control, rates of multidrug-resistant cases have recently been declining in the United States. Last year, according to the Federal Centers for Disease Control and Prevention, just 1.1 percent of American TB cases were multidrug-resistant. "The situation overseas has grown far more dangerous," said Alex Goldfarb, a microbiologist at the Public Health Research Institute, a private health group in New York and a co-author of the report. "Because there are ever more drug-resistant TB cases in hot zones, "each case is a walking time bomb." In one of its many ominous predictions, the study warns that even if the recommended DOTS treatment strategy is put in place, 171 million additional cases and 60 million deaths can be expected between 1998 and 2030. The worst-case situation predicts 249 million additional cases and 90 million deaths, even with the currently recommended treatment. http://www.nytimes.com GRAPHIC: Photos: In a prison in central Siberia, almost all the inmates have highly resistant tuberculosis. They line up for milk to wash down their daily medicine. Prisoners take pills under direct supervision. The former Soviet Union is a center for TB strains that resist treatment with many medicines. (Photographs by Chris Anderson/Aurora) Map/Chart: "AT ISSUE: Fighting a Disease That Fights Drugs" Map highlights countries at risk. (Estimates of annual new drug-resistant tuberculosis cases) ROMANIA: 985 (Sources: Harvard Medical School; Open Society Institute) LANGUAGE: ENGLISH
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