TB Notes 2000

Think TB!

Christmas Seal Campaign, 1945. Recognize possible signs and symptoms of tuberculosis. Early diagnosis and treatment reduces spread.

Tent colony for TB patients, TB sanitorium, TB cases reported annually in the U.S. from Colorado Springs, Colorado. 1953, the first year of national TB surveillance.

Community x-ray screening campaign. Dr. Robert Koch, discoverer of the tubercle Drugs used to treat TB disease. From left to right: bacillus, the cause of TB. isoniazid, rifampin, pyrazinamide, and ethambutol.

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

______Centers for Disease Control and Prevention (CDC) Atlanta GA 30333 TB Notes No. 1, 2000

Dear Colleague:

This has been planned as a special issue to commemorate “TB Control at the Millennium.” We wanted to take the occasion to note what has been accomplished in TB control over the years, and to look forward to the challenges of the future. Our focus is mainly on progress made in this country, since that is our charge and our responsibility, but one cannot talk about TB control without talking about the important work of researchers and workers in other countries, and therefore we have included articles about international efforts as well.

In this issue you will find information about the history of the interaction between mankind and Mycobacterium tuberculosis; the many accomplishments of our partners in TB contol; the past and present activities of the Division of TB Elimination (DTBE); a timeline of some of the highlights of TB control over the past century; educational materials available from DTBE; and photos of historical people, places, events, and memorabilia that we believe you will find interesting.

I also take this opportunity to thank all who answered our invitation to contribute articles to this very special issue. I have both learned immensely from and thoroughly enjoyed these various contributions.

Please feel free to share this with individuals and organizations with an interest in TB control. We have printed extra copies to be able to accommodate requests for additional copies.

Kenneth G. Castro, MD A Century of Notable Events in TB Control

Introduction: A Glimpse at the Colorful History of TB: Its Toll and Its Effect on the U.S. and the World, Dan Ruggiero...... 1

Where We’ve Been and Where We’re Going: Perspectives from CDC’s Partners in TB Control...... 7 Changes I’ve Seen in TB, 1949 - 1999, William Stead...... 7 TB Control in New York City: A Recent History, Paula Fujiwara and Thomas Frieden...... 9 Not by DOT Alone, Mike Holcombe...... 12 Baltimore at the New Millennium, Kristina Moore and Richard Chaisson...... 13 From Crickets to Condoms and Beyond, Carol Pozsik...... 15 The Denver TB Program: Opportunity, Creativity, Persistence, and Luck, John Sbarbaro...... 16 National Jewish: The 100-Year War Against TB, Jeff Bradley and Michael Iseman...... 18 Earthquakes, Population Growth, and TB in Los Angeles County, Paul Davidson...... 20 TB in Alaska, Robert Fraser...... 22 CDC and the Americal Lung Association/American Thoracic Society: an Enduring Public/ Private Partnership, Fran DuMelle and Philip Hopewell...... 23 The Unusual Suspects, Lee Reichman...... 27 The Model TB Prevention and Control Centers: History and Purpose, Elizabeth Stoller and Russ Havlak...... 29 My Perspective on TB Control over the Past Two to Three Decades, Jeffrey Glassroth...... 32 History of the IUATLD, Donald Enarson and Annik Rouillon...... 33 Thoughts about the Future of TB Control in the United States, Charles Nolan...... 37

A Century of Advances in TB Control, United States (2-page chart)...... 40

Where We’ve Been and Where We’re Going: Perspectives from CDC...... 42 Early History of the CDC TB Division, 1944 - 1985, John Seggerson...... 42 CDC Funding for TB Prevention and Control, Patricia Simone and Paul Poppe...... 46 Managed Care and TB Control - A New Era, Bess Miller...... 47 Early Research Activities of the TB Control Division, George Comstock...... 49 The First TB Drug Clinical Trials, Rick O’Brien and George Comstock...... 51 Current TB Drug Trials: The Tuberculosis Trials Consortium (TBTC), Andrew Vernon...... 52 TB Communications and Education, Wanda Walton...... 54 TB Control in the Information Age, Jose Becerra...... 56 Field Services Activities, Patricia Simone...... 57 TB’s Public Health Heroes, Dan Ruggiero, Olga Joglar, and Rita Varga...... 58 Infection Control Issues, Renee Ridzon...... 60 A Decade of Notable TB Outbreaks: A Selected Review, Scott McCombs...... 62 International Activities, Nancy Binkin and Michael Iademarco...... 65 The Role of CDC’s Division of Quarantine in the Fight Against TB in the U.S., Paul Tribble....68 The STOP TB Initiative, A Global Partnership, Bess Miller...... 70 Seize the Moment - Personal Reflections, Carl Schieffelbein...... 72

Description of DTBE Training and Education Resources...... 75 Notable Events in TB Control

A Glimpse at the Colorful History of TB: Its Toll and Its Effect on the U.S. and the World by Dan Ruggiero Division of TB Elimination

In their 1969 book Tuberculosis, Lowell et al. tell us that “Tuberculosis is an ancient disease with a lineage that can be traced to the earliest history of mankind . . . In the last millennium it has been universally distributed among all branches of the human race.” Evidence of TB in ancient human bone Evidence of TB appears in Biblical scripture, Phthisis (from the Greek word to waste away), in Chinese literature dating back to around scrofula (swellings of the lymph nodes of the 4000 BC, and in religious books in India neck), the white plague (the TB epidemic in around 2000 BC. In ancient Greece Europe during the 18th century), consumption Hippocrates mentions TB around 400 BC, as (progressive wasting away of the body), TB does Aristotle, who talked about “phthisis and (the presence or products of the tubercle its cure” (ca. 350 BC). bacillus) are all words for tuberculosis marking a specific point in history. Each has a signifi- It was widely believed that European explor- cant connotation and meaning to millions of ers, sailors, and the settlers who followed people about a disease that has afflicted hu- Columbus to the new world brought with mans from the dawn of history and continues them many infectious diseases, among them to ravage mankind in large numbers. During TB. However, paleopathologists suspected that World TB Day 1999 it was reported that an TB existed in the New World before 1492, estimated one billion persons died of the based on ancient skeletons and bones that disease worldwide during the 19th and early contained lesions resembling those caused by 20th centuries alone. This invisible enemy TB. Evidence to that effect was found in 1994, continues to challenge man’s knowledge and when scientists reported that they had identi- mock his efforts; the “Captain of the men of fied TB bacterium DNA in the mummified death” continues to march forth leaving remains of a woman who had died in the behind a trail of human misery, economic Americas 500 years before Columbus set sail chaos, and death. What is the origin of this for the New World. invisible predator that even today has been able to adapt and survive by fending off the The TB epidemic in Europe that came to be many remedies and cures that the best minds called the “Great White Plague” probably in science have placed before it? started in the early 1600s and continued for the next 200 years. The epidemic reached its The tubercle bacillus, the organism that causes peak in western Europe and in the United TB disease, can be traced as far back as 5000 States in the late 1700s and early 1800s. In BC when archeologists found evidence in early 19th century England, TB was so perva- human bones of the existence of TB. Evidence sive a killer that it dwarfed other dreaded was found in ancient Egyptian mummies diseases like cholera and typhus. So common which showed deformities consistent with TB and so little understood was TB that death disease. Paleontologists have concluded that from the disease was accepted as inevitable. TB the disease must have been prevalent in that in the early 19th century may have accounted part of the civilized world. for one third of all deaths. Death from TB

1 TB Control at the Millennium was clearly evident in the literature of the time now called “old tuberculin,” was to be later in the writings of John Keats (1795-1821) in used as the screening tool (tuberculin skin the Ode to a Nightingale, of John Bunyan tests) for identifying people and animals (1628-1688) in The Life and Death of Mr. infected with tubercle bacilli. Badman, of Charles Dickens (1812-1870) in Nicholas Nickleby, and of other famous writers A further significant advance came in 1895 of the time. when Wilhelm Konrad von Roentgen discov- ered the radiation that bears his name. This In 1720, in his publication, A New Theory of allowed the progress and severity of a patient’s Consumption, the English physician Benjamin disease to be accurately followed and Marten was the first to conjecture that TB reviewed. could be caused by “wonderfully minute living creatures,” which, once they had gained a Another important development was provided foothold in the body, could generate the by the French bacteriologist Calmette. To- lesions and symptoms of the disease. He gether with Guerin, he used specific culture continued that “It may be therefore very likely media to lower the virulence of the bovine TB that by an habitual lying in the same bed with bacterium, thus creating the basis for the BCG a consumptive patient, constantly eating and vaccine still in widespread use today. drinking with him, or by very frequently conversing so nearly as to draw in part of the TB in America during the colonial period was breath he emits from the Lungs, a consump- accepted as a scourge of humanity that was tion may be caught by a sound person . . . I common to the poor and rich alike. The first imagine that slightly conversing with con- available mortality figures from Massachusetts sumptive patients is seldom or never sufficient in 1786 indicated 300 deaths per 100,000 to catch the disease.” For a physician living in population. The peak mortality figure reached such an early era, Dr. Marten showed much in New England was 1,600 per 100,000 in medical insight. 1800. With the industrial development, the epidemic traveled to the Midwest in 1840 and In 1882, at a time when to the West in 1880. Though the disease TB was raging through occurred in blacks at a lower rate than in Europe and the Ameri- whites before the Civil War, the increase was cas, killing one in seven massive among blacks after the war, when people, a German biolo- emancipation and urbanization created an gist by the name of ideal atmosphere for transmission of TB. The Robert Koch presented American Indians and Alaskans were the last to the scientific commu- American populations to become affected by nity his discovery of the the TB epidemic. organism that caused Robert Koch TB. It was called a At the turn of the century it was estimated tubercle bacillus because small rounded bodies that 10% of all deaths in the United States (tubercles) occurred in the diseased tissue and were due to TB. By 1904 the TB death rate were characteristic of the disease. Through his for the United States was 188, by 1920 the rate many experiments with the organism, Dr. was 100 per 100,000, and by 1955 the rate had Koch worked on developing a cure for TB. decreased to less than 10 per 100,000 people Koch was able to isolate a protein from the per year. tubercle bacillus that he tried as an immuniz- ing agent and later as a treatment for TB; in The TB sanatorium movement, which was both cases it failed. However, the substance, started in Germany by Dr. Hermann

2 Notable Events in TB Control

Brehmeris in the 1850s, did not take hold in both communicable and preventable. Some of the United States until after 1884. Edward the recommendations made to the Board in his Livingston Trudeau, a physician who recov- report were the need to ered from TB disease, started a sanatorium in 1) educate the public of the dangers that the Saranac Lake, New York, based on the Euro- disease posed to the person and his/her con- pean model of strict supervision in providing tacts, fresh air and sunshine, bed rest, and nutritious 2) properly dispose of and immediately de- foods. stroy sputum or the “discharges from the lungs” of individuals with disease, 3) have all physicians of pulmonary cases report such cases to the health department, 4) have health inspectors visit the families where TB exists and deliver proper literature and take specific measures to disinfect the areas as may be required, 5) obtain and submit sputum specimens to the laboratory for analysis, and 6) create a consumptive hospital to care for indigent patients. “Little Red,” first cottage for tuberculous patients at Trudeau Sanatorium. The Board adopted most of the recommenda- tions made by Biggs, including the creation of As infection control measures took hold in “The Consumptive Hospital.” These recom- large urban centers of the country, TB patients mendations created a storm of controversy who could not be treated in local dispensaries among the medical community. Many private were removed from the general population doctors objected to the mandatory reporting, and placed into sanatoriums. Soon a great believing that it violated physician-patient movement was underway to build TB sanato- confidentiality. Because of the resistance from riums. By 1938 there were more than 700 the medical community, reporting practices sanatoriums throughout the United States, yet were not fully implemented for several years. the number of patients outnumbered the beds In the end, Biggs’ recommendations to the available. Board and their implementation in New York City created the model for TB control pro- For those households in which the adults could not be placed in a sanatorium, children were removed from infected parents and placed in preventoriums that were created for children.

A milestone in the history of TB control in the United States occurred in the autumn of 1893, when the New York City Board of Health called on Dr. Hermann Michael Biggs, the Chief Inspector of the Division of Pathol- ogy, Bacteriology, and Disinfection, for a report on TB. In the report, Biggs stated that TB, which was responsible for more than 6,000 deaths in New York City in 1892, was With no drug therapies, past TB suffers like these in 1953 were isolated in sanatoriums.

3 TB Control at the Millennium grams that was emulated by other health Pennsylvania Society for Prevention of Tuber- departments across the country and laid the culosis. The organization was instrumental in groundwork for a campaign called the “War helping organize free hospitals for poor con- on Consumption.” sumptive patients in Philadelphia. In 1902, Dr. S. Adolphus Knopf of New York was one During the first part of the 20th century, great of the men responsible for the movement that emphasis was placed on improving social launched the Committee on the Prevention of conditions and educating the general public Tuberculosis of the Charity Organization about good hygiene and health habits. If you Society of New York City. The aim of the went to public school anytime between 1900 committee was to disseminate information and 1930, you got the TB message, which said that TB was a communicable, preventable, and essentially that spit is death. In hospitals it curable disease. The Committee advanced the was common to see signs that read “Spit Is movement for hospitals, sanatoriums, and Poison.” Notices were plainly printed in dispensaries for consumptive adults and chil- public places and government buildings that dren. As a result of his focus on the need for a stated “Do Not Spit on the Floor; To Do So national TB association, in 1904 a voluntary May Spread Disease.” health agency was organized under the Na- tional Association for the Study and Preven- In the 1920s, when fresh tion of Tuberculosis, later renamed the Na- air and bed rest did not tional Tuberculosis Association (NTA) and secure improvement in now known as the American Lung Associa- the patient’s condition, tion. physicians sometimes performed surgery or To fund the activities of the many local affili- collapsed one of the ates, the Association adopted a method that lungs (pneumothorax). was originated in Denmark in 1904 by Einor During this time there Holboll, a Danish postal clerk, who sold were many other “sure- Christmas Seals. In 1907, many TB sanatori- cure” remedies being advertised by many firms ums had sprung up all and physicians. around the country; most were small and make- In 1902 at the first International Conference shift. One in Delaware on Tuberculosis held in Paris, Dr. Gilbert was in such urgent need Sersiron suggested the adoption of the Cross of funds that it was going of Lorraine, used by the Knights of the First to have to close unless Crusade, as the symbol of a new movement, a $300 could be raised. crusade for good health against sickness and Dr. Joseph Wales, one of death, and against TB. The double-barred cross the doctors working at was adopted as the international symbol for that sanatorium, con- the fight against TB. This symbol was later Emily Bissell tacted his cousin, Emily adopted in 1904 in the United States by the Bissell, to help raise the forerunner of the American Lung Association. money. Emily was a welfare worker in Wilmington, Delaware; she was also active in It was not until the turn of the century that the American Red Cross and had fund-raising private voluntary groups in the United States experience. After reading an article about the joined the fight against TB. In April 1892, Dr. Christmas seals in Denmark, she created a Lawrence F. Flick organized the first Ameri- design, borrowed money from friends, and can voluntary anti-TB organization, the had 50,000 Christmas seals printed. The seals

4 Notable Events in TB Control were sold for a penny each at the post office. Success came in 1943. In test animals, strepto- She worked hard to make the campaign a mycin, purified from Streptomyces griseus, success, personally presenting the idea to all combined maximal inhibition of M. tuberculo- sorts of groups and officials, including the sis with relatively low toxicity. On November Philadelphia North American newspaper, 20, 1944, the antibiotic was administered for emphasizing how buying Christmas seals the first time to a critically ill TB patient. The would help children and adults with TB. The effect was almost immediate and impressive. idea took hold, and by the end of the holiday His advanced disease was visibly arrested, the season, $3,000 had been raised — 10 times the bacteria disappeared from his sputum, and he amount she had set out to raise. By 1946 at made a rapid recovery. The new drug had side least 10 million people were purchasing seals effects — especially on the inner ear — but the or giving to the Christmas seal fund. The fact remained, M. tuberculosis was no longer a Christmas seal campaign was so widely adver- bacteriological exception; it could be assailed tised on buttons, milk caps, postcards, school and beaten into retreat within the human booklets, billboards, book marks, rail and bus body. passes, etc., that it permeated many aspects of social life. The National TB Association said A rapid succession of anti-TB drugs appeared at that time that “No in the following years. These were important nationwide program because with streptomycin monotherapy, has rested for so many resistant mutants began to appear within a few years on so broad a months, endangering the success of antibiotic base made up of mil- therapy. However, it was soon demonstrated lions of small gifts.” that this problem could be overcome with the combination of two or three drugs. Then, in the middle of World War II, came Although there were some attempts at provid- the final breakthrough, ing guidance on TB control measures through the greatest challenge publication and conferences, the federal con- to the bacterium that trol of TB did not occur until the mid-1940s, had threatened human- when the 1944 Public Health Service Act ity for thousands of years: chemotherapy. (Public Law 78-410) authorized the establish- ment of a TB control program. On July 6, In fact, the chemotherapy of infectious dis- 1944, the Surgeon General established a Tuber- eases, using sulfonamide and penicillins, had culosis Control Division in the Bureau of State been underway for several years, but these Services of the Public Health Service (PHS). compounds were ineffective against Mycobac- Doctor Herman E. Hilleboe was appointed terium tuberculosis. Since 1914, Selman A. medical director of the new division. The Waksman had been systematically screening Public Health Service provided supplemental soil bacteria and fungi, and at the University fiscal support to state and local health depart- of California in 1939 had discovered the ments for TB control activities through for- marked inhibitory effect of certain fungi, mula grants and special grants-in-aid. These especially actinomycetes, on bacterial growth. grants were to assist states in establishing and In 1940, he and his team were able to isolate maintaining adequate measures for prevention, an effective anti-TB antibiotic, actinomycin; treatment, and control of TB and focused however, this proved to be too toxic for use in greater attention on the need for case finding. humans or animals.

5 TB Control at the Millennium

In 1947, the PHS organized and supported TB control. The cutback in TB control pro- mass x-ray screening in communities with grams across the country left a dismantled and populations greater than 100,000. Over a frail public health infrastructure, too weak to period of 6 years more than 20 million people ward off the emergence of a new epidemic were examined; the program ended in 1953. wave that was brewing. Little did the experts The mobile x-ray know that a new illness that was first observed vans continued to be among gay men in New York City and San used in the commu- Francisco (HIV/AIDS) would have a dramatic nities into the mid- impact on TB morbidity. 1960s. It was com- mon use to show The mid-1980s and early 1990s saw an increase well-known figures in TB morbidity. It was not long before the such as Santa Claus country started to see TB and HIV posing for x-ray coinfections as well as cases with multidrug pictures, stimulating resistance. Facilities with poor or no infection the population’s control measures experienced numerous compliance with nosocomial outbreaks, and there were high being tested. death rates in hospital wards and correctional facilities throughout the country. A new era was advancing with the introduc- tion of TB drugs, resulting in a declining The unprecedented morbidity. The mainstreaming of TB treat- media coverage of TB, ment to general hospitals and local community a disease barely no- clinics reduced the need for and dependency ticed for more than 20 on sanatoriums. In 1959 at the Arden House years, gave rise to Conference, sponsored by the National Tuber- increased funding by culosis Association and the U.S. Public Health state, local, and fed- Service, recommendations were made for eral agencies for TB mobilizing community resources and applying control activities. the widespread use of chemotherapy as a With the infusion of public health measure along with other case- funds came the task of finding activities under the control of public rebuilding a national health authorities. With the natural decline in infrastructure to control TB and the introduc- disease and the introduction of chemotherapy tion to TB control programs of a concept that in the 1940s and 1950s, TB disease started to was old, yet new: that of directly observed take on a dramatic decline in the United therapy (DOT), in which the TB patients States. Morbidity declined at a rate of about ingest or take their therapy in the presence of 5% per year until 1985, when 22,201 cases a health care worker. were reported in the U.S. for a case rate of 9.3 per 100,000 population. By 1970, only a As the numbers of TB cases continue to handful of sanatoriums still remained in the decline in the United States, nearly half of the United States and by 1992 there were only new cases reported are occurring in people four TB hospitals with 420 beds providing who have immigrated to the United States. In care. 1998, of the 18,361 cases reported in the United States, 7,591 or 41.3% occurred in Between 1953 and 1979, along with the declin- foreign-born persons. Most of these persons ing morbidity came declining funding from came to the United States from countries state, local, and federal agencies responsible for where TB is still endemic (e.g., Mexico, the

6 Notable Events in TB Control

Philippines, Viet Nam, China, and India). Where We’ve Been and Where We’re While the United States continues to bring its Going: Perspectives from CDC’s TB problem under control, it must be realized Partners in TB Control that the United States is not an island unto itself, isolated from the rest of the global Changes I’ve Seen in TB, community. 1949 - 1999 by William W. Stead, MD, MACP In 1993, the World Health Organization Former Director, TB Program declared TB a global emergency. Approxi- Arkansas Department of Health mately 8 million new cases and 2-3 million Professor of Medicine Emeritus, UAMS deaths occur each year around the world from TB. In an effort to reduce TB morbidity and When I took a junior staff position with the mortality worldwide, we must share our TB Service at the Minneapolis Veterans Hospi- expertise, successes, and failures, if we are to tal in July 1949, under Drs. J.A. Myers and move toward national and global TB elimina- W.B. Tucker, I had no interest in TB. In my tion. spare time I worked with Drs. Richard Ebert and Don Fry in the physiology of emphysema. We have the power to relegate this ancient The TB dogma at the time was that primary TB occurred in childhood and almost never enemy to the confinement of laboratory vials became serious except in infants. TB in adults and store it in a deep freeze. As we journey was the challenge and was said to be caused by into a new century and a new millennium, we catching a new infection on “previously will face new opportunities and challenges and sensitized tissues.” write new chapters in the history of TB. Will we learn from the past? Will we develop and I lived with this paradigm until 1953 when I use new technology to the utmost efficiency? was recalled by the army as the Assistant Will we utilize our resources prudently, and Chief of the TB Service at the Fitzsimons share information with our neighbors? Will Army Hospital in Denver. We had an 80-bed we devote our energies and talents to the ward full of young men returning from Korea elimination of our common enemy? How with what was then called “idiopathic pleural long will it take us to accomplish our goals? effusion.” Because of the occasional need to How many more lives will be sacrificed to explore one of these, we learned that such TB? The answer to those questions rests in effusions were due to soiling of the pleura by a each of us who works in TB control. small subpleural lesion of primary TB in the lower half of one lung (Am Rev Tuberc Pulm In 1956, the Minnesota Tuberculosis and Dis, 1955). Health Association encouraged school chil- dren to be Knights of the Double-Barred Cross My real immersion in TB came in 1960 at and to pledge “. . . to do everything . . . to Marquette University as Chief of the Pulmo- overthrow the enemy, TB.” Are we willing to nary Disease Section of the Milwaukee take the same pledge today? County Hospital/Muirdale TB Sanatorium. This was 3 years after the death of my 83-year- old father, whose autopsy showed cavitary TB in the right upper lobe and active renal in- volvement. I felt pretty sure he had not been reinfected, because there were old scars on the screening chest x-ray (CXR) done on admis- sion to the extended care facility 3 years earlier

7 TB Control at the Millennium

and all patients were x-rayed annually to At about the same time we showed that screen for TB. It seemed pretty evident that primary TB in adults can produce the full his TB was due to reactivation of some of spectrum of pulmonary lesions seen in cases of those old scars. reactivated TB (Ann Intern Med, 1968).

So, I sought the help of my four older siblings It was not until the 1970s as TB Controller for (including Eugene, who is 10 years my senior Arkansas that I really began to understand TB. and at the time was Chairman of Medicine at In 1976 we encountered an outbreak of TB in Duke). We were able to piece together a likely our state prison with evidence that it had been scenario. Dad’s father had died of “consump- going on for at least 5 years. Ten active cases tion” in 1890 when Dad was a healthy 15-year- among 1,500 inmates gave an incidence of 667/ old. In 1902 he had some illness of which we 100,000 vs 21 in the state at large that year. had no details except that a doctor had sug- We found about 100 TST converters, evenly gested that Dad sleep out-of-doors as much as split between black inmates and white inmates possible. Later, as a traveling salesman over (JAMA, 1978). At the time I did not realize four southern states, he would sleep in a tent that there were about 1,000 white and only at the edge of whatever town he happened to 500 black inmates. So, I missed the difference be in at dusk. Eugene traveled with him some in their infectibility. I held a monthly Chest summers and attests to this story. Clinic at the prison for 8 years to screen new inmates for TB and to see that TST reactors I can recall that Dad commonly “hawked and got INH therapy. spit” a greenish-yellow sputum. Gene recalled that he required frequent massage of a “boggy” My next shock came in 1978 when we found prostate gland and that he had a number of an outbreak at a nursing home. I was not episodes of painless hematuria, all of which surprised at finding a case of TB in a nursing suggested chronic renal TB. Finally, in 1941 a home, because most of the population would sister returned home with a pre-school son be TST positive from living through the 1920s who at age 6 developed an illness with a and 1930s when TB was so common. cough, positive tuberculin skin test (TST), and Hermione Swindol, PHN, argued that it abnormal CXR. He was confined to bed for 6 would spread and she proved to be right. months. At the time Dad was not suspected as What I did not know then was that healthy the source. Two of my siblings and I had elderly people often outlive their TB germs positive tuberculin tests. Mother remained and the TST reverts to negative. Only 15%- well but I have no information on her TST. 20% of new admissions were TST positive, leaving 80%-85% susceptible to a new infec- With this scenario suggesting a long and tion. We found 60 converters, 10 of whom largely healthy life with TB, I began to ques- had active TB (Ann Intern Med, 1981). tion the dogma of adult TB being due to an exogenous reinfection. Fortunately, the Because of these findings we got the 225 Sanatorium had vast numbers of old CXRs, nursing homes in Arkansas to do two-step some back to glass plates. With these I was TSTs on all new admissions not known al- able to find old scars in a fairly large percent- ready to be positive. Twice a year they report age of our active cases of TB and published TSTs of their new admissions and update the two papers on the natural history of TB in data on other residents. At first I kept the man (Am Rev Respir Dis, 1967, and New Engl J records in a Radio Shack TRS80 Model 1 Med, 1967). computer. I now have demographic, skin test, and TB data on 115,000 nursing home resi- dents from 1984 through 1998 (Int J Tuberc

8 Notable Events in TB Control

Lung Dis, 1998). Only 5%-10% of admissions TB Control in New York City: to our nursing homes are TST positive now. A Recent History by Paula I. Fujiwara, MD, and Perhaps the principal discovery that has come Thomas R. Frieden, MD, MPH from these data is that there is a significant Current and former Directors of the difference in innate resistance to TB infection NYC TB Control Program between whites and blacks. In addition, study of our TB case data base from 1976-1997 Many of the tenets of modern TB control shows that blacks with active TB are 50% were developed more than a century ago in more likely than whites to be sputum-smear New York City by Dr. Hermann Biggs, a positive and thus highly infectious. physician working for the Department of Health. These included the policies of free, high-quality sputum examination, the manda- tory reporting of cases, health department supervision of isolation and treatment, educa- tion of the public regarding TB, and the fostering of a social movement for control of the disease. The City’s TB control program waxed and waned over the next 100 years, with the lowest number of reported TB cases in the city occurring in 1978.

During the 1980s, the rapid rise in TB was fueled by the human immunodeficiency virus (HIV) epidemic; growing poverty, homelessness, and incarceration rates; and immigration from countries with high TB I am now preparing a paper to show the prevalence. In this context, the infrastructure important public health implications of such a of TB control had been dismantled, the victim difference in TB risk. While health depart- of a one-two knockout punch of a fiscal crisis ments routinely try to identify all close con- in the City and a change to a system of block tacts with infectious cases of TB, a particularly grants for federal funding. One long-time great effort should be made among the African employee, when asked how it felt to see the American and Native American contacts increase in cases year after year, said, “We because of their greater risk both of infection thought that’s just the way it was.” Staff were and of becoming infectious. It is important trapped in a cycle of reporting cases, starting for such reactors to take the full course of treatment on those they could locate, but chemoprophylaxis to prevent development of losing many of them. Staff knew they should TB and further spread. This applies especially be searching for the lost patients but were to exposures in close living quarters, i.e., distracted by the overwhelming number of dormitories, nursing homes, shelters, and new infectious cases. Citywide, less than half prisons. of the patients completed treatment. Repeated warnings from experts and panels did not lead It has been an interesting half century. The to increased concern or funding. best part was the quarter century in public health in Arkansas from 1973-1998.

9 TB Control at the Millennium

treatment. In 1991, one of the authors (TF), then working at the New York City Depart- ment of Health as an Epidemic Intelligence Service Officer, conducted the citywide survey of drug resistance mentioned above in re- sponse to Dr. Brudney’s concern. Working in one of the Department’s chest clinics since 1990, he had seen the TB problem first-hand. Margaret A. Hamburg, who was the Commis- sioner of Health at that time, appointed Dr. Frieden the Director of the Bureau of TB Control (changed in September 1999 to the NYC TB Control Program). At the height of It was not until 1991 that TB got the attention the epidemic in early 1992, in a meeting with it warranted. The first alarm was a series of the entire staff of the Program, Dr. Frieden nosocomial outbreaks of multidrug-resistant surprised staff by stating that he was “proud to TB (MDR TB) in various hospitals in New be part of the organization that would control York City. The second alarm was the an- TB in New York City.” The basic tenets of nouncement of the results of a month-long the program were developed: the patient is the citywide drug resistance survey, which re- VIP, directly observed therapy (DOT) is the vealed that 19% of all M. tuberculosis cultures standard of care for TB treatment, laboratories in New York City were resistant to isoniazid need to be supported and monitored, comple- and rifampin. Remarkably, half of all patients tion of treatment is the report card of how with positive cultures had been treated before, well the program is performing, and every many of them for months. These patients staff member is accountable for his or her represented a failure of the system to ensure performance. Against considerable barriers, that patients were reliably treated, and fully doctors, nurses, outreach workers, and other one third of these patients had MDR TB. By staff were hired, chest clinics were opened on comparison, a nationwide survey during the Saturdays and evenings, and the TB Program first quarter of 1991 showed that only 3% of became a significant source of income for the all cultures were multidrug-resistant (with Department of Health through improved New York City accounting for two thirds of billing practices. TB control doctors and the cases), a proportion similar to that in New nurses even performed new employee physi- York City just 7 years earlier, in a 1984 cals so staff could be hired without the typical survey. months-long delays. The TB program had the crucial and unwavering support of Commis- Phase I: the battle sioner Hamburg. Dr. Karen Brudney, an astute clinician with international experience in TB control who At every opportunity, it was emphasized that had worked with Dr. Karel Styblo in Nicara- outreach workers were “modern public health gua, called the City Health Department to heroes.” The TB Program worked on multiple report that she suspected that drug resistance fronts, simultaneously striving to improve the was increasing. Dr. Brudney had written medical care of TB patients, promote standard- highly publicized (and accurate) articles high- ized treatment guidelines, expand surveillance, lighting the dismantling of the TB control improve laboratories, expand social services infrastructure in New York City and docu- for TB patients, control outbreaks in hospitals menting that in Central Harlem, only 11% of and correctional facilities, encourage and patients started on treatment completed the conduct epidemiologic studies, educate and

10 Notable Events in TB Control train doctors and other staff, and delineate the the same powers to use increasingly restrictive proper use of increasingly restrictive measures measures against the patients who do not take against TB patients, including detention. treatment for LTBI. Some physicians in New After a visit by Dr. Karel Styblo to New York York City, including many trained outside of City, the TB Program implemented a cohort the country, do not believe that treatment for review process, in which the Director person- LTBI is important, and pass this belief on to ally reviewed every one of the thousands of their patients. cases for treatment details and completion. The outcome was a steep increase in comple- Facing the next century, one of the program’s tion rates and, beginning in 1993, a steep biggest challenges is to improve completion of decline in the number of reported TB cases. treatment for LTBI while at the same time More impressive was the even sharper decline effectively treating the more than 100 new in the number of reported cases of MDR TB, cases of TB that arise every month. from 441 cases in 1992 to just 38 cases in 1998. Cases of TB in US-born persons decreased Phase III: New York City in the context of from 2,939 in 1992 to 700 in 1998. global TB control During the late 1980s and early 1990s, HIV Phase II: new frontiers fueled New York City’s TB epidemic. This After completion rates increased, cohort masked the slower rise in the number of cases review meetings began to include information in persons born outside of the United States. on contact evaluation and preventive treat- In 1997, the percentage of cases in foreign-born ment. The efficacy of this process was recog- persons in New York City exceeded the nized when, in 1998, the NYC TB Control number of cases in United States-born persons Program was honored as one of 25 finalists, for the first time in recent history. The rise in out of a field of more than 1,300 nominees, for cases in the foreign-born has created new the prestigious Innovations in American challenges. Bicultural and bilingual staff have Government Award, given by the Ford Foun- been hired. People’s fears that the TB control dation and the Harvard School of Govern- program is connected to the Immigration and ment. Naturalization Service must be quelled. People from Ecuador, the Dominican Republic, After TB case completion rates improved, Puerto Rico, and Mexico may share a common program staff began to concentrate on treat- language, but have disparate beliefs about TB ment of patients with latent TB infection transmission and risk. It is not possible to have (LTBI), especially those at high risk of devel- a one-size-fits-all approach to identifying oping TB disease, such as the HIV-infected, patients, encouraging them to present for close contacts, recent immigrants from TB- evaluation and treatment of TB disease or endemic countries, and persons with evidence infection, and helping them adhere to treat- of “old” TB. A unit to monitor treatment of ment. TB control activities must be specifi- immigrants and refugees was created, and an cally tailored not only to the patients, but also expanded contact investigation unit evaluated to those who provide their care. When pa- cases of TB in workplace as well as congregate tients move back to their country of origin, and school settings. Treating those who “only” New York City’s program staff communicate have TB infection rather than disease has been with patients’ health care providers to ensure in many ways even more difficult than treat- that adequate treatment continues. It is not ing those with TB disease. It has been difficult unusual for staff to call Costa Rica, Pakistan, to convince people to take medications when Mexico, or the Ivory Coast to glean informa- they do not feel sick. The City’s health code tion on treatment completion in order to does not allow (nor should it) the TB program “close the loop” for cohort reporting!

11 TB Control at the Millennium

What is the role of New York City in the tion. However, DOT is not a programmatic global fight against TB? Many people migrate cure-all, a stand-alone solution, or the prover- to places such as New York City to better bial yellow-brick road. Not what you expected their economic lot, and many of these people to hear from Mississippi, is it? come from areas of the world where TB is endemic. New York City’s TB cases represent We know that DOT is the best way to treat a microcosm of TB around the world; in 1998, TB. It might not always be the most conve- these cases came from 91 countries, led by nient or the easiest, but with the correct drugs, China, the Dominican Republic, Haiti, Ecua- dosing, monitoring, and delivery, it is unsur- dor, India, and Mexico. In some instances, passed at present. When it comes to DOT and people (including those with MDR TB) come its impact, we must remember the Chinese to New York City specifically to be treated, proverb, “Hear and forget; see and remember; having heard of the program’s success. do and understand.”

With full implementation of universal DOT on a statewide basis in the mid-1980s, TB program performance indicators began to improve. Patients’ sputum converted faster, reducing the potential period of infectiousness; a greater percentage of patients completed therapy; a greater percentage completed therapy in a timely manner; the number of patients acquiring drug resistance decreased rapidly; the number of program admissions for inpatient care dropped dramatically; the One of New York City’s contributions to the average length of an inpatient stay dropped; global battle against TB is to support interna- and the number of new TB cases began to fall. tional colleagues’ TB control efforts, to advo- The reduction in morbidity allowed more cate for more funding for these programs, and time for contact follow-up, the expansion of to be gracious hosts and teachers when offi- targeted testing, and the implementation of cials from different countries visit to learn directly observed preventive therapy in select about New York City’s success. In 1900, the high-risk populations. This increased the TB control program of the New York City number of patients on preventive therapy and Department of Health, under the leadership of the percentage of patients completing preven- Herman Biggs, was an international model. tive therapy. Today, New York City’s experience provides global hope and evidence that even in the To further support the strengthened efforts, context of an HIV epidemic and a high rate of laws were modified to improve our ability to multidrug resistance, the battle against TB can protect the public from patients who fail to be won and the disease can be controlled. cooperate with treatment or isolation, and rules were changed to improve reporting. We placed emphasis on outpatient care and priva- Not by DOT Alone tized elements of the program best and most by J. Michael Holcombe, MPPA, CPM efficiently provided by private providers — Mississippi TB Controller radiology services, for example — to expand availability, improve quality, and ameliorate Mississippi proved directly observed therapy cost. (DOT) to be a great tool toward TB elimina-

12 Notable Events in TB Control

Many told us universal DOT could not be the way DOT happens: good people doing done; a few said it should not be done. But we good things. No bells, whistles, or wreaths of continue to truly believe DOT is the best laurel — just another great stride taken in service we can offer our patients and the silence and out of public view. public. We believe DOT offers the surest and best chance for a timely cure. Why should we Public health nurses, of course, don’t work in treat anyone with less than what we believe is isolation or independently. Without a doubt, the best we can offer? Their future is our each stride is made easier by the clerk who future. greets the patient kindly and patiently, then helps expedite the visit. Each stride is made True, Mississippi has made great strides in TB easier by the outreach worker who helps control. But we’ve made those strides not by ensure each dose of medication is ingested and DOT alone. each appointment is kept. Physicians who take time from their busy practice to conduct Each and every one of those great strides was regular clinics at the health department also made by everyday people: nurses, aides, clerks, make each stride easier, more sure, and more outreach workers, doctors, disease interven- purposeful. And the advances in science, the tion specialists, and volunteers — hard work- effective anti-TB drugs available, and the ing, dedicated, and passionately devoted emerging technology for more rapid and individuals who were, and are, determined to accurate diagnosis have been and are unques- make a difference one patient, one facility, one tionably essential to the progress we have community at a time. made.

From the establishment of our sanatorium Yes, DOT has been a vital tool for ensuring early in the century through its demise and the progress and managing cost. We used it as the rise and continuing refinement of our outpa- fulcrum to move Mississippi from a deepening tient treatment delivery system, public health rut and to change the direction of TB control. nurses have made most of those great strides But, DOT was only part of the plan. Progress possible. Usually, the nurse comforts, edu- cannot be achieved by DOT alone. DOT cates, and gives hope to the distressed patient requires achievement goals; community sup- who has been notified of exposure or disease. port; good legislation; adequate infrastructure The nurse confronts and calms the angry, and funding; a dedicated, determined public hostile, and all-too-often dangerous patient health field staff; and the strong support of who has given up and no longer cares about administration. himself or others. The public health nurse persists through heat or snow, wind or rain, dogs, gangs, or alligators and finds the patients Baltimore at the New Millennium and persistently guides, cajoles, or bribes them by Kristina Moore, RN, and through treatment. If, along the way, that Richard E. Chaisson, MD, means baking a few extra cookies, making an Professor of Medicine, Epidemiology, extra trip after work to deliver a home-cooked and International Health meal to a homeless or lonely patient, buying Johns Hopkins University an extra can of soup or a chicken for an im- poverished patient while grocery shopping, or Mr. C, a Baltimore City resident, knows he taking the time to put a grubby little 4-year- was diagnosed with active pulmonary and old on the lap and reading a story in hope of lymphatic TB in May 1999. He receives his making the treatment seem a little more TB treatment through the Baltimore City palatable . . . that’s nothing special. That’s just Health Department (BCHD)/Eastern Chest

13 TB Control at the Millennium

Clinic (ECC) by directly observed therapy In Baltimore, DOT was the brainchild of the (DOT) in his home on Mondays and Thurs- late Dr. David Glasser, Baltimore City’s days. Provided he does not miss either of his Director of Disease Control/Assistant Com- twice-weekly intermittent supervised doses missioner of Health. Implemented in 1978 for (TWIS) of TB medications, he receives two $5 high-risk clinic TB patients, DOT was ex- food coupons on Thursdays to fortify his panded in 1981 to a community-based, nutritional intake. If Mr. C needs to come citywide program. As a result, between 1978 into the ECC for a clinician evaluation, his and 1992, TB case rates in Baltimore declined transportation is provided by BCHD. A nurse by 81%, and the city’s national rank for TB outreach team manages Mr. C’s case. His case dropped from second in 1978 to 28th in 1992, manager is a registered nurse and his DOT despite the emergence of an HIV/AIDS epi- manager is a licensed practical nurse. Mr. C’s demic. Cases and case rates have continued to case is reviewed by the nurse team weekly and decline to a record low of 84 cases (13 per by a BCHD clinician monthly. As a result of 100,000) in 1998. contact with Mr. C, his family and friends have all been offered TB screening evaluations Baltimore’s declining TB case rates are also and follow-up, free of charge. Mr. C is also attributable, in part, to another of participating in a national TB research proto- Dr. Glasser’s novel approaches to TB control. col, one that is evaluating the efficacy and In the mid 1970s he convinced Baltimore’s safety of a rifabutin-based treatment regimen City Council to pass an ordinance mandating for HIV-related TB. His BCHD/ECC clini- pharmacies to report any issuance of anti- cian is also his HIV care provider at the Johns mycobacterial drugs to the BCHD. Pharmacy Hopkins Hospital HIV Clinic. reporting led to improved TB case reporting, improved treatment regimens, and an increase What Mr. C may not know is that the com- in DOT through BCHD managed cases. These prehensive care he is receiving through the treatment and management improvements also BCHD took years to develop, research, and explain, in part, Baltimore’s low incidence of refine. He also may not know that as a result drug resistance (5.9% in 1998), and high inci- of the once innovative, now national standard dence of treatment completion (96.5% in of care he is receiving, the Baltimore TB case 1997). rate is at the lowest level ever recorded, and that the resurgence of TB that occurred else- Yet another of Dr. Glasser’s foresights was to where in the US between 1985 - 1992 did not develop an outreach and liaison program with affect Baltimore (see graph). the City’s methadone maintenance clinics. Recognizing injecting drug use as an important risk factor for TB, Dr. Glasser implemented a TB screening and preventive treatment pro- gram at the city’s methadone clinics. By the mid-1990s, BCHD had bridged TB efforts with nearly all of the city’s drug treatment programs.

Dr. Glasser’s ideas laid the foundation for the hard-working members of Baltimore’s TB program, who have continued to build upon his TB control legacy through the years. Baltimore has implemented additional innova- tive TB control strategies in the last two

14 Notable Events in TB Control decades. The development of liaisons with From Crickets to Condoms and Beyond Maryland Department of Health and Mental by Carol Pozsik, RN, MPH Hygiene, Maryland Division of Corrections, South Carolina TB Controller and private providers has improved case reporting, case management, case follow-up, It’s history now but people still chuckle about and case prevention efforts. Forging a treat- the story of the man who was given crickets ment, prevention, and research collaboration for fishing as an incentive when he couldn’t be with nearby Johns Hopkins University’s located to take his TB medications. Clearly, (JHU) Center for TB Research has also con- fishing was more important that his TB treat- tributed to improved BCHD TB control ment. His public health nurse recognized that measures. BCHD/ECC’s Medical Director, it was going to take an unusual motivator to clinician staffing, and radiology support are all get him to meet her for directly observed provided through a contractual agreement therapy, and thus was born the story of the with JHU. In addition, this cooperative rela- crickets given to the fisherman. It wasn’t the tionship has resulted in several exciting TB first time that nurses or other health care research projects, including neighborhood- workers had given incentives to encourage based TB screening, TB prevention studies in patients to comply and it certainly wasn’t injection drug users, and DNA fingerprinting going to be the last. For TB nurses in South studies. BCHD and JHU have also collabo- Carolina, incentives and enablers became rated to form a contract site for the TBTC something that they could not do without. (Tuberculosis Trials Consortium). The concept has spread nationwide, and is now an accepted intervention in the treatment The challenges for Baltimore City TB Control of TB infection and disease. in the new millennium will involve continu- ing the successful case reduction efforts of the Enablers and Incentives past century through new initiatives. A main priority will be focusing efforts on the treat- ment of latent TB infection (LTBI). Efforts to evaluate the possibilities of even shorter course therapy and additional treatment options for TB both active cases and LTBI will also be para- Tuber culosis mount. Another key interest will be partici- Contr ol pating in the efforts to develop a more effica- cious TB vaccine. All of these new initiatives For many years the American Lung Associa- will depend upon the development of national tion of South Carolina (ALASC) had given and international collaborative networks in money for patient needs to the State Tubercu- TB research. For TB elimination to finally losis Sanatorium. As the sanatorium popula- take its place in history, a global approach is tion dwindled in 1981, the Executive Director an absolute necessity. of the Lung Association began to wonder how the Patient Needs Funds could be used to help As the new millennium begins, Baltimore City TB patients who were not in the hospital. It TB Control is ready to join the world in was at that time that the fisherman’s TB nurse meeting its challenges. Patients like Mr. C will approached the ALASC and appealed for continue to benefit from the dedication of a funds to provide incentives to more patients City Health Department committed to the who needed them. That was the beginning of ultimate goal: treating the last case of TB. the use of incentives and enablers in the South Carolina TB Program.

15 TB Control at the Millennium

At first some of the nursing staff resisted the so that they might begin to use incentives. idea of using incentives. Change was difficult With the help of the ALA of South Carolina, to accept; about that same time, the program the booklet Using Incentives and Enablers in a was also starting what was then called SIT Tuberculosis Control Program was published. (supervised intermittent therapy), and is now The book gives the history of incentives and called DOT (directly observed therapy). Some helpful advice about their use. Still popular nurses could be heard griping about “spoon- after many printings, the book continues to feeding” the patients. (Translated, this meant help TB workers in their use of incentives that they felt that the patients should take both in the United States and in other coun- total responsibility for their treatment, and tries. TB workers and others love to hear the that the nurses shouldn’t have to give them stories and see the pictures of real patients anything to get them to be responsible.) For with their caregivers. The pictures give a real some staff, it was all too much: asking them to face to TB and give encouragement to new not only watch patients take their medicines, staff in the program that they too can be but then, asking them to give the patients successful with incentives. Whenever I am small gifts as well — it was just more than they asked to speak about improving compliance, could bear! However, as time wore on, these naturally I also talk about the importance of same nurses became zealous about doing DOT using incentives and enablers to make our and giving incentives. (In fact, one nurse fell work easier, but more importantly to bond and broke her leg during the course of giving the caregiver with the patient in a trusting DOT and, in spite of a compound fracture, relationship. she demanded that the ambulance drivers take her on to her next two visits so she could The successful use of DOT and DOPT in complete her DOT rounds.) Those big hearts South Carolina could not have ever happened in the TB nurses were hooked and the con- without the use of incentives. Who would cepts of DOT and incentives really took hold. have thought that something as unscientific as Soon everyone in South Carolina was using a red bridle for a mule, a cold drink on a hot DOT and the stories of the incentives that day, a pair of warm socks, or an old were used were told and the success rate of overstuffed chair would contribute signifi- completion of therapy got better and better. cantly to the successful treatment and preven- tion of TB in the United States? In those early days the incentives were simple: juice, hamburgers, chicken snacks, fruit, The Denver TB Program: candy, even condoms. Today, the staff have Opportunity, Creativity, Persistence, moved to more sophisticated incentives such and Luck as smoke alarms for fire protection in substan- by John A. Sbarbaro, MD, MPH, FCCP dard housing and swimming lessons for under- Professor of Medicine and Preventive Medicine privileged children. TB nurses and DOT University of Colorado Health Sciences Center workers have big hearts and they dig deep to personalize the incentives and enablers for Four words — opportunity, creativity, persis- their patients. tence, and luck — summarize the successes of Denver’s TB program. Dr. Dixie Snider, former Director of CDC’s Division of TB Elimination, knew about the For decades, Colorado had been a mecca for success of the incentives and enablers program the victims of TB. However, along with the in South Carolina and gave us encouragement demise of the sanatorium era, Denver’s TB to publicize the stories about incentives and control program had progressively deterio- DOT in order to educate other TB programs, rated. As in other large cities, the insured

16 Notable Events in TB Control disappeared into the private sector, while the to implement. By early 1966, both DOT and poor and those from the street continued to be the nurse-directed TB clinic had indeed arrived housed for months upon months on a forgot- in the US. And what nurses do, they docu- ten floor of the public hospital. ment — every action and every outcome — and with that documentation, Denver’s ongo- In 1965, Denver was awarded a CDC TB ing research program was established. Innova- Branch grant, which included the assignment tion, when measured, becomes meaningful of one of the CDC’s first six TB medical clinical research. A long list of skilled TB officers. The project award was designed to nurse specialists such as B.J. Catlin, Jan Tapy, enhance the city’s decimated TB clinic. How- and Maribeth O’Neill not only provided care ever, the standard of treatment, 24 months of to thousands of patients but served as the daily INH and PAS, presented a daunting cornerstone for Denver’s contributions to the obstacle to the ambulatory treatment of a large scientific and social understanding of TB population of chronic alcoholics and disadvan- control. taged, socially isolated inpatients. How to treat effectively yet compassionately was the question. However, organizations either continue to grow or they die, and growth requires change. A little-noticed report in a foreign journal As new knowledge emerged and new drugs provided an answer. In Madras, India, the became available, so did new opportunities. British Medical Research Council (BMRC) Fortunately, the arrival of Mike Iseman early appeared to have successfully treated patients in the program and subsequently of Dave with high doses of INH and streptomycin Cohn ensured that no opportunity would pass given intermittently over one year. The unnoticed. Program components were evalu- regimen made sense scientifically and pro- ated for cost-effectiveness and community grammatically. If directly administered impact. Denver was amongst the first to throughout treatment, the opportunity for eliminate the mobile chest x-ray in favor of cure would be maximized and a concerned selected population skin testing; to focus on public assured that these ambulatory patients the effect of inducements and enforcement on did not place the community at risk because patient compliance; and to create a meaningful they were receiving adequate treatment role for community outreach workers. New (“chemical isolation”). Fortunately, at that short-course DOT regimens were developed moment there was no local health department and tested; screening programs were evaluated; authority to say “no” and the regimen was the effect of TB drugs in infected human implemented, although modified to include a macrophages documented; and “molecular three-drug intensive phase and an 18-month epidemiology” was applied to a long-standing two-drug continuation phase. database and a freezer stored with isolates of mycobacteria. The uniqueness of this treatment approach spawned widespread changes in Denver’s The emergence of HIV stimulated new ques- ambulatory TB program. The resultant emer- tions, new initiatives, and an opportunity to gence of one-to-one relationships between further build upon 30 years of close working nurses and patients led to a major role expan- relationships with, and support from, the sion, with nurses encouraged to function more CDC. Denver’s long history of integrating independently, including reading x-rays and federal, state, and private grants into a single determining which standing treatment orders local program encouraged its early inclusion in multicenter national studies sponsored by CDC and the National Institutes of Health

17 TB Control at the Millennium

(NIH). Strong academic ties with the Univer- Denver’s TB program was, and is, based upon sity of Colorado’s Health Sciences Center, the principle that it is responsible for curing collaborative teaching at the National Jewish the patient. In the long run, the persistence of Medical and Research Center, consultation that belief is the true foundation of Denver’s with the IUATLD and WHO, and member- success. ship on ACET provided expanded opportuni- ties to share the “Denver experience” and to National Jewish: learn from colleagues throughout the world. The 100-Year War Against TB by Jeff Bradley and During these years, the recruitment of Michael Iseman, MD Denver’s retired TB “greats” such as Gen. Carl Director, National Jewish Medical Temple and Drs. Roger Mitchell and Jack and Research Center Durrance to work regular hours each week in Denver, Colorado the clinic ensured that the knowledge of the past would not be forgotten in the excitement National Jewish Medical and Research Center, of the future. Unhappily, their days of contri- which celebrated its centennial in 1999, is bution have passed, but the camaraderie known today for its expertise in a wide array established between physicians, nurses, and of respiratory, immunologic, allergic, and clinic staff produced an environment in which infectious diseases. At the time of its founding, professional creativity continues to flourish. however, it had a single purpose: the care of Challenging existing beliefs and methods has impoverished victims of TB. become standard operating behavior. The entrance of Randall Reeves and later of Bill The need for a TB hospital became acute in Burman ensures that it will continue, high- Denver in the 1880s. In those days, people lighted by their scientific leadership in the TB believed that the dry climate of the high plains Trials Consortium. on which Denver is located would cure tuberculars (i.e., persons with TB disease). The underlying philosophy driving the Den- Consequently, many TB sufferers spent their ver TB Clinic is perhaps best summarized in last dollars coming to Colorado. By the 1890s, two quotes from a 1970 publication, “The it was estimated that one out of every three Public Health Tuberculosis Clinic, Its Place in residents of the state was there for respiratory Comprehensive Health Care” (Am Rev Respir reasons. Dis 1970;101:463-465):

In the private sector, “even with the best intentions of the physicians and staff, the actual responsibility for care rests with the patient. In TB control, the responsibility for care rests with the clinic.”

Old National Jewish Hospital “...the clinic is the best way to husband the meager resources of personnel and In Denver, TB patients were literally dying on money and the only way to fix respon- the streets. Boarding houses often banned sibility on the providers of service “lungers,” as they were called, and many of rather than on the recipients... ” them were too sick to support themselves. A woman named Frances Wisebart Jacobs recog- nized the need for a TB hospital and, after

18 Notable Events in TB Control joining forces with a young rabbi, the two roughly equivalent to $62,000 today — for just raised enough money to buy some land and 120 patients. erect a building, which was ready for patients in 1893. Unfortunately, however, Denver was In 1914, National Jewish erected a building for hit with the Silver Crisis that year, and there the study of TB; this was the first place in was not enough money to open and run the which research on the disease was done out- hospital. side of a medical school setting. Other ad- vances included the nation’s first self-con- This setback convinced the organizers that tained facility for treating children with active they should expand their fundraising efforts cases of TB and work on anti-TB drugs such as beyond Colorado. The thinking in Denver isoniazid (INH) in the early 1950s. Later in was that, since patients came there from all that same decade, doctors at National Jewish over the nation, people all over the United came up with a new protocol for TB that States should help support the hospital. They included abandonment of bed rest and a turned to B’nai B’rith, a national Jewish substitution of physical activity; use of micro- service organization, and contributions came biological assay measurements to determine in from across the country. The building the proper dosage of INH; and combined drug finally opened in 1899 as the “National Jewish therapy using streptomycin, INH, and para- Hospital for Consumptives.” aminosalicylic acid.

National Jewish was the first hospital in the As TB gradually came under control in the nation to focus exclusively on indigent TB United States, National Jewish expanded its patients. As expressed in a singular motto, this mission to include asthma and other respira- philosophy was “None may enter who can tory diseases, but maintained a strong presence pay, none can pay who enter.” From day one, in TB. Research continued on better drugs, National Jewish was non-profit and non- and the institution expanded its education sectarian. efforts. In 1963, the 1- to 2-week TB control course was offered for specialists from all over The hospital opened with a capacity of 60 the world, a course that is still offered today. patients; the goal was to treat 150 patients per Indeed, over the past 20 years, nearly 5,000 year. This was made possible by putting a 6- physicians and nurses have visited Denver for month limit on patient stays. Furthermore, the course. National Jewish only accepted patients in the early stages of TB. At least that was the plan. Rifampin, the most widely used drug for TB In reality, however, several chronic sufferers today, was tested at National Jewish in 1970. were admitted, and after a few months, the 6- Two years later, federal funds established a month limit was lifted. state-of-the-art laboratory to study difficult TB cases. This helped establish National Jewish as The treatment at National Jewish was in line a highly specialized center for drug-resistant with the protocols at other turn-of-the-century TB and atypical mycobacterial infections. TB sanatoria: plenty of fresh air, lots of food, moderate exercise, and close scrutiny of every Today, National Jewish continues to be a aspect of patients’ lives. The inhabitants of steady contributor in the fight against TB. National Jewish, thus, could expect to sleep The hospital offers compassionate care to outside — or with their heads outside — every victims of MDR TB, often providing treat- night, and were all but stuffed with food. In ment for the poor at no charge. Leading 1911, for instance, the annual report records pharmaceutical companies collaborate with that National Jewish spent $3,631 on eggs — National Jewish to test new drugs. Perhaps

19 TB Control at the Millennium the greatest contribution of National Jewish is in education. In addition to the TB course, During the past 30 years there have been the hospital maintains a Mycobacterial Con- numerous changes in Los Angeles County that sult Line, a free service whereby physicians have impacted upon the TB problem. A anywhere in the world can call up and receive dramatic increase in the population has oc- advice from our specialists. Over the past 5 curred. Many of the new residents are immi- years this service has responded to over 2,000 grants from countries where TB is prevalent calls annually. and in many cases increasing in incidence. By the end of the 20th century nearly 75% of all At the opening of National Jewish back in the new cases in Los Angeles occurred in the 1899, the president of the institution, speaking foreign born. Poverty and homelessness have of TB in the exalted rhetoric of that day, been a persistent social and cultural factor declared that it was his dream for the hospital supporting continued spread of TB. By the “that its doors may never close again until the late 1980s, the emergence of HIV infection and terrible scourge is driven from the earth.” disease contributed to the number of TB cases, Now, at the time when the World Health reaching a peak of 15% of all the cases being Organization estimates that one out of every HIV positive in 1991. three people in the world is infected with TB, those doors are still open. In the 1980s efforts were increased to fight the TB problem among the homeless. A satellite Earthquakes, Population Growth, and TB clinic in the Skid Row area of downtown Los in Los Angeles County Angeles was established. This clinic depended by Paul T. Davidson, MD on outreach workers to find and transport Los Angeles TB Controller patients to the clinic for directly observed medication and medical management. Because In the late 1960s, Los Angeles County built a many of the homeless still defaulted on treat- state-of-the-art TB hospital. Most of the 1,300 ment and spent repeated episodes in the hospi- or more persons being diagnosed with new tals, a pilot project funded by the State of cases of this disease each year were spending California was instituted. It provided housing many months in the hospital before receiving and food incentives to the homeless in Skid treatment as outpatients. The Sylmar earth- Row in exchange for taking medication and quake of 1971 essentially destroyed the hospi- completing TB treatment. The results were tal and propelled the County into considering dramatic, with better than 95% of the partici- other approaches to managing this disease. pants completing therapy and the number of Some patients were transferred to Rancho Los hospital days being much reduced. The pro- Amigos Hospital, a long-term rehabilitation gram was eventually funded by the County facility. The majority were referred to the and extended to other areas where over 40 Public Health Centers then in exist- homelessness is also a problem. This program ence throughout the county. This began what continues, and the number of TB cases among has since become a largely outpatient system the homeless is declining more rapidly than for the follow-up and care of TB patients. Six the overall number of cases. county hospitals have continued to diagnose and treat many TB patients. Liaison nurses In the late 1980s an HIV/TB program was assigned by the TB Control Program facilitate established to provide liaison with HIV pro- the transfer of these patients to the Public viders. Screening guidelines for TB were Health Clinics. Approximately 25% of TB established regarding admission of HIV pa- patients are diagnosed and followed by the tients to hospitals, hospices, and other congre- private health sector. gate living facilities. The liaison nurse essen-

20 Notable Events in TB Control tially case-managed all known HIV/TB cases Angeles County. The Public Health Labora- and helped to facilitate their care throughout tory for the county was given personnel the healthcare system. To date, there have resources and the latest technical equipment to been no known outbreaks of TB in any of the better serve the needs of the TB control pro- health care facilities within the County. grams. Today the HIV/TB liaison program continues to work closely with the many early interven- The State of California has been very active in tion clinics where TB testing is a standard of addressing many of the problems that have care for all patients. hindered TB control. For example, a law is now in place that requires health care facilities to obtain permission from the local health officer or TB controller before any person suspected or diagnosed with TB is discharged. The health officer can refuse discharge if the follow-up plan is inadequate or the patient continues to be a threat to the public health of the community. Another law establishes a process for the legal detention of patients with TB who represent a threat to the public The 1990s have been a time of rapid influx of health. The State has also appropriated money both federal and state funding for the elimina- to pay for the detention of TB patients and tion of TB. This allowed the implementation also to pay for housing of the homeless. Los of a number of new programs. Directly ob- Angeles County has taken full benefit of these served therapy (DOT) is now the standard of actions. The Surveillance Unit at the TB care and in 1998 more than 75% of public Control Program and the Liaison nurses at the health clinic patients were on DOT. The TB county hospitals have been given the responsi- Control Program has contracted with a num- bility for approving hospital discharges under ber of community-based organizations (CBOs) the Director’s supervision. The County, with to screen high-risk persons for TB and provide the help of State funding, has recently opened preventive therapy. This has resulted in thou- a Southern California regional center for the sands of persons being screened and given detention of TB patients at one of our county preventive therapy who otherwise would not facilities. This facility can also provide long- have been reached by the health department. term skilled nursing care for any TB patient A project to screen homeless persons for TB needing it and the services of a drug and by using a mobile radiology unit detected alcohol treatment center. dozens of cases of TB that were treated earlier than otherwise, preventing further transmis- An earthquake of another nature occurred in sion of infection to this vulnerable population. 1995. The Los Angeles County Department This helped to accelerate the decline of TB of Health Services faced the possibility of disease in the homeless. An MDR unit was bankruptcy. A huge, complicated reorganiza- established to monitor and consult on every tion of the department resulted. TB services as MDR patient in the county whether under well as all public health services were con- private or public care. The percentage of such densed into 11 locations throughout the cases has been kept below 2% of the total cases county where previously there had been more for many years. Most of the cases that do than 30. This created trying times, but fortu- occur come into the county from other loca- nately TB cases were not lost. On the other tions already with MDR. Most of them are hand there was a significant drop-off in the successfully treated while remaining in Los number of patients being screened and placed

21 TB Control at the Millennium on preventive therapy. In addition, the Public In a large land area like Alaska with poor Health Programs and Services Division of the transportation, case finding was a major Department of Health Services has continued challenge. In the early 1950s the territory of to undergo extensive reorganization, redirec- Alaska operated three health boats that visited tion of priorities, and change of leadership. coastal communities and communities along the Yukon River. These ships carried x-ray The 20th century has clearly ended with a facilities, a physician, a dentist, and public period of constant change. One can only health nurses. By the mid-1950s most commu- predict that the new century will continue in nities had “bush” air service, which enabled the same mode, possibly as the norm. In the portable x-ray facilities to be taken into com- meantime, the number of TB cases continues munities and chest x-rays taken. Hospital to decline, to an all-time low by the turn of facilities also improved with the availability of the century. Hope, tempered by the reality of the facilities at the old naval base in Sitka, a huge problem with TB in the world as a which was turned over to the Bureau of Indian whole, suggests that the goal of elimination of Affairs, and the construction of a new hospital TB can be reached in Los Angeles County facility for the Bureau of Indian Affairs, which during the early decades of the 2000s. opened in Anchorage in 1953. At the same time, medication effective against M. tuberculo- TB in Alaska sis became available, with streptomycin avail- by Robert Fraser, MD able in 1946, PAS in 1947, and INH in 1953. Former Alaska TB Controller These treatment modalities permitted the effective treatment of TB. TB is probably a relatively new disease in the Alaska population that was introduced by In the mid-1950s the TB reactor rate among early explorers and other newcomers to the children in rural Alaska was about 50% in territory of Alaska. One of Captain Cook’s school enterers and approached 90% in the mates died of TB at the time of his voyage in third grade. Deaths from TB in some years 1786 to Alaska. By the early part of the 20th approached 500, and thousands of residents of century, TB was widespread in the villages of Alaska awaited hospitalization for treatment Alaska, and treatment options were very of their disease. The initial studies using INH limited. Attempts at isolating individual to prevent TB were effectively carried out in a family members in the home was the major number of villages in the Bethel area of treatment available. In the late 1940s a small Alaska, demonstrating better than 80% effec- TB hospital was opened in Skagway. In the tiveness in preventing the development of TB early 1950s coordinated efforts by the Bureau in infected individuals. The results also raised of Indian Affairs and the territory of Alaska the possibility of treating people with active were directed to this major public health disease outside of the hospital. Subsequently problem. most patients with TB had been treated in Alaska with either no hospitalization or short hospitalization followed by outpatient treat- ment.

As the incidence of TB fell, supervision of the infected individuals in smaller communities was possible using traveling x-ray technicians and the identification of problem communities was done on the basis of tuberculin testing. Tuberculin testing programs were imple-

22 Notable Events in TB Control mented in selected age groups in the schools. Review of immigrants coming to Alaska from Southeast Asia and South America allowed public health personnel to identify and treat active disease, thus minimizing the spread of TB into Alaska.

Effective treatment of TB has increasingly required directly observed therapy, or DOT, for successful management of the disease. Prevention of Tuberculosis in Philadelphia in Many communities in Alaska have few tuber- 1892. Twelve years later, in 1904, under the culin reactors among school age children, but guidance of many of the luminaries of Ameri- there still remains a significant reservoir of can medicine at that time — Osler, Trudeau, individuals who have had TB infection in the Welch, Janeway, Knopf — the National Asso- past and who may potentially develop disease, ciation for the Study and Prevention of Tuber- posing a challenge for public health. How to culosis (NASPT) was founded. Although the identify new cases of TB at a time when NASPT was largely composed of physicians concern for the disease has diminished and and other health professionals (only two how to provide direct administration of laymen were included on its first 29-member medication to infected individuals in remote board of directors), its mission was public areas are continuing challenges. education and public policy, not clinical care or research. As Alaska enters a new century, there is a potential to eliminate TB from the population In 1918 the NASPT changed its name to the and there is also the potential that the disease National Tuberculosis Association (NTA), a will remain a chronic problem. The new name it retained for the next 50 years. Because century will pose new challenges with dimin- the organization was progressively involving ished public awareness of TB, and with HIV itself in a broader range of activities, in 1968, infections in rural communities complicating after considerable discussion and debate, the the problem. name was changed to the National Tuberculo- sis and Respiratory Disease Association CDC and the American Lung Association/ (NTRDA). After being burdened with this American Thoracic Society: an Enduring unwieldy name for 5 years, the NTRDA Public/Private Partnership became simply the American Lung Associa- by Fran DuMelle, MS tion in 1973. Deputy Managing Director, ALA and Philip Hopewell, MD In 1905, a year after NASPT was chartered, a Associate Dean, Univ of California, San Francisco subgroup — the American Sanatorium Asso- ciation (ASA) — was formed by physician The origins of the American Lung Association members of NASPT who, for the most part, (ALA) and the American Thoracic Society were directors of TB sanatoria. This group was (ATS) and of their collaborations with the focused on the science of TB and on the CDC lie within the anti-TB movement of the clinical care of patients with the disease. late 1800s and early 1900s. The potential value Although comprising initially only sanato- of an organized voluntary society constituted rium-based physicians, the ASA subsequently of both physician and lay members was recog- became more inclusive, with membership nized in the late 1800s and marked by the open to all physicians and researchers in the founding of the Pennsylvania Society for the field. In 1939 the name of the ASA was

23 TB Control at the Millennium changed to the American Trudeau Society, facilities for TB, was jointly funded by COS honoring Edward Livingston Trudeau and and NASPT, and was the first project of the recognizing the broader interests of the mem- new society. Subsequent editions of the “Di- bers. Finally in 1960 the name was again rectory” were funded and published entirely changed to the American Thoracic Society by NASPT and provided the focus for the (ATS) in keeping with the evolution of the society’s major advocacy program: to increase medical specialty area from pthisiology to public funding for TB and to have TB control pulmonology, including TB and the whole programs in all departments of public health. range of respiratory disorders. In 1916 the NASPT adopted a resolution stating that participation of the federal govern- The involvement of the ancestral ALA and ment in TB control is “desirable and neces- ATS with organized TB control efforts in the sary” and that the “proper federal agency for United States began well before there was even the purpose is the US Public Health Service.” a United States Public Health Service A bill providing that a division of TB should (USPHS), let alone a CDC. In fact, a major be set up in the US Public Health Service was activity of the NASPT was promoting the introduced in the House of Representatives in establishment of public health departments 1916. This plan was not realized, however, with TB control programs in every commu- until nearly 30 years later, in 1944. nity in the country. Lawmakers were urged to support such programs and to use taxes to In 1961 the federal government instituted the make care for TB free to all patients. Thus, funding of state programs that were designed from its inception, the progenitor of the ALA to support community-based outpatient care had as its core mission advocacy for effective efforts, to shift TB control away from TB control and accessibility of clinical services inhospital treatment. Funding increased for patients with the disease. progressively through the 1960s but declined precipitously in 1970 as federal support was Among the factors recognized as limiting the shifted to block grants. By 1973 there were no ability to mount a countrywide TB control categorical funds for TB control at the CDC. program were the lack of data describing the After several years’ experience with block magnitude of the disease and the absence of grants, it was clear that the states were spend- any assessment of the availability of facilities ing few or none of these funds for TB control. for the care of patients with TB. The first of these voids was filled by an analysis conducted It was logical, therefore, that when the ALA on behalf of the Charity Organization Society opened its first full-time government relations (COS) of the City of New York by Miss office in Washington in 1980, among its first Lillian Brandt in 1903. This report, “The priorities was funding for TB control. In fact, Social Aspects of Tuberculosis, Based on a the first victory logged by the fledgling office, Study of Statistics,” compiled the data avail- under the leadership of long-time ALA and able for the US and presented in a systematic ATS employee Robert Weymuller and its fashion both the scale and complexities of TB legislative counsel Harley Dirks, was the in the United States in the early 1900s. Congressional authorization of the “Project Grants for Tuberculosis for Preventive Health Miss Brandt also provided the initial collection Projects” (replacing block grants). This bill of data describing existing facilities and pro- restored categorical funds for TB control to grams for patients with TB, “A Directory of the CDC in 1980 after an 8-year hiatus. Fol- Institutions and Societies Dealing with Tuber- lowing this success, the ALA/ATS proceeded culosis in the United States and Canada.” This with an intensive advocacy campaign to secure survey, which served to highlight the dearth of funding — $1 million in FY1982, a significant

24 Notable Events in TB Control amount in 1982 dollars. Throughout the 1980s increasing interna- the ALA/ATS continued to advocate for tional focus of the increased funding for the CDC, but it was not CDC. Soon after until 1993, after the resurgence of TB in the its founding, the US had peaked, that funding increased dra- NASPT became matically. involved in inter- national activities, The success in gaining increased funding for hosting the sixth TB was facilitated by having in place the International Advisory Council for the Elimination of Congress on Tuberculosis (ACET), an advisory group to Tuberculosis in the CDC that was specifically authorized by Congress as a result of ALA/ATS lobbying An illustration from Huber the Tuber, a book about tuberculosis efforts. Among the first tasks of the ACET written and illustrated by H. A. Wilmer, MD, and published by the National Tuberculosis Association in 1942. was the development of the Strategic Plan for the Elimination of Tuberculosis. This plan, 1908. True to its origins, the ALA currently plus the newly-created National Coalition for is an important constituent of the Interna- the Elimination of Tuberculosis (NCET), tional Union Against Tuberculosis and Lung provided new energy and focus for the advo- Disease (IUATLD). Additionally, the ALA cacy efforts, and funding levels grew to their and the ATS are founding partners of the Stop current level of approximately $120 million by TB Initiative, together with the CDC, the 1995. World Health Organization, the World Bank, the IUATLD, and the Royal Netherlands The creation of NCET harkens back to the Antituberculosis Association. The Initiative is early days of the ALA and its activities in a global partnership to accelerate TB control community organization. NCET was formed worldwide and in part is a product of the at a time when TB cases were increasing and successful efforts of the ALA/ATS in advocat- there was rising concern about drug resistance, ing for funding of international TB control yet public apathy and Congressional inaction through the US Agency for International continued. The goals of ALA in fostering the Development. creation of NCET were nearly identical to the goals of the NASPT almost 90 years earlier: At the first annual meeting of NASPT in 1905, increasing public awareness of TB and advocat- two committee reports were read, “Early ing for adequate public funding of control Diagnosis” and “Clinical Nomenclature.” programs. As noted above, NCET played an These reports, which served to define the state important role in the intensified response to of the art on one hand and standard terminol- the resurgence of TB in the 1990s. In 1998 ogy on the other, set the pattern for future NCET reevaluated its role and structure and is activities of both the NASPT and ASA. The focusing on advocacy at the state level for Society’s journal, the American Review of funding and for ensuring an appropriate legal Tuberculosis (subsequently the American framework for TB control, while not aban- Review of Tuberculosis and Pulmonary Disease, doning it national activities. then the American Review of Respiratory Disease, and now the American Journal of Both the ALA and the ATS have concerns Respiratory and Critical Care Medicine) was with international, as well as domestic, TB first published in 1917. The first issue carried control — concerns that are consistent with an article, “The Classification of Pulmonary the traditions of the organizations, with Tuberculosis,” which was the first of an current epidemiologic realities, and with the ongoing series of statements entitled “Diagnos-

25 TB Control at the Millennium tic Standards and Classification of Tuberculo- informal basis through the 1950s and early sis” (first so-named in 1920). The “Diagnostic 1960s. In the 1960s there were several instances Standards” document continues to provide in which the ATS specifically endorsed important guidance to TB control efforts in USPHS reports (the US Public Health Service the US. The most recent revision has just been Task Force Report on Tuberculosis Control; completed. the USPHS Recommendations on the Use of BCG Vaccine in the United States.) In addition to the “Diagnostic Standards,” the early ATS developed expert opinions, pre- It was not until 1971 that the first formally sented in the form of committee reports, on acknowledged joint ATS/CDC statement was various clinical, research, and public health published (Preventive Treatment of Tubercu- aspects of TB. Obviously, because there was losis: A Joint Statement of the American no TB control agency within the federal Thoracic Society, National Tuberculosis and government until 1944, when the Division of Respiratory Disease Association and the TB Control was established, these reports Centers for Disease Control). Since that time were not collaborative ventures but were, joint statements have also been published on nevertheless, intended to guide the public BCG vaccines (1975), eradication strategies health aspects of TB. Although persons em- (1978), short-course chemotherapy (1980), TB ployed in various federal agencies were mem- control (1983), treatment and prevention bers of some of the committees, there was no (1986, 1994) and diagnostic standards and official USPHS representation (at least none classification of TB (1990). Currently, there identified in published committee reports) are three joint statements: “Diagnostic Stan- until 1943 when, in the “Report of the Com- dards and Classification,” and “Targeted mittee on Tuberculosis Sanatorium Stan- Testing and Treatment of Latent Tuberculous dards,” it was noted that a Dr. Sharp was Infection,” both of which have been revised representing the USPHS. Additional involve- recently, and the “Treatment of Tuberculosis” ment of the ATS with the Division of Tuber- that is now undergoing revision. culosis Control was noted in the “Report of the Committee on Postgraduate Medical Although the historical and ongoing collabora- Education” in 1946. Dr. Herman Hilleboe, the tions between the ATS and the CDC are first director of the Division, requested sugges- exemplified most clearly by the formal joint tions for the training of medical officers in TB statements, the interactions go well beyond control and asked for the committee to review these activities. Staff of the Division of Tuber- courses that he had outlined. culosis Elimination are active and valued members of the ATS, participating especially In the same year the Committee on Rehabilita- in the programs of the Assembly on Microbi- tion (of patients with TB) reported that the ology, Tuberculosis, and Pulmonary Infec- USPHS, the NTA (and ATS), and the Federal tions, and assuming leadership roles in many Office of Vocational Rehabilitation would of the Assembly’s undertakings. Likewise ATS jointly provide a team to study rehabilitation members, both as Society representatives and programs in the US. Also in 1946, the NTA as individuals, are regular participants in a and ATS, together with the USPHS and the variety of CDC activities, including serving in American Hospital Association, developed an advisory roles, contributing to training informational package describing how hospi- courses, and conducting program evaluations tals should conduct mass radiography screen- (often organized by state ALAs). ing (“Report of Committee on Tuberculosis Among Hospital Personnel”). These sorts of It is striking to note the degree to which the collaborations continued on a more or less current collaborations of the ALA and the

26 Notable Events in TB Control

ATS with the CDC Division of Tuberculosis control in the world as well as in the United Elimination are consistent with the goals and States will only occur when the players are no activities of their forebears and adhere to longer exclusively from that “in” group. The traditions established early in the lifetimes of new outside players could be characterized as the organizations — to support and advocate unusual suspects. for scientifically sound, publicly funded, government-based TB control. In the past I’ve been very publicly critical of the WHO’s ex-Global Tuberculosis The Unusual Suspects Programme staff for all too often going it by Lee B. Reichman, MD, MPH alone, but I’d like to now commend them and Professor of Medicine, their successes, tentatively at least, for adopt- Preventive Medicine and Community Health ing and leading more of a team approach to Executive Director, deal with worldwide TB. And their leadership New Jersey Medical School National TB Center in the “Stop TB” Initiative, which necessarily A Founding Component of the International Center requires partnerships, will hopefully be one for Public Health more important (if seriously overdue) ex- ample. There is now increasing evidence that TB people have always been an “in” group. they have reached out to many other “unusual They always tend to talk to each other, and suspects.” In March 1998 WHO called to- meet at their own meetings such as the Inter- gether an Ad Hoc Committee on the Global national Union Against Tuberculosis and TB Epidemic (the London conference). This Lung Disease, the American Thoracic Society, certainly isn’t big news. However, the Ad Hoc and the National Tuberculosis Controllers Committee of 19 consisted not only of physi- Association. Before 1992, if you went to cians; more importantly, it included several meetings of other groups (the Infectious unusual suspects: the Commissioner of the Diseases Society of America, the American Securities Commission of Jordan, an econo- Public Health Association, the American mist from Zambia, a civil service administra- College of Physicians, the European Respira- tor from India, a nonphysician university tory Society to name a few), there was pre- professor from Indonesia, and others. When cious little TB, if any, on the program. this group called on heads of state, parliamen- tary leaders, finance, planning, and health But TB docs aren’t the only ones who treat minsters, as well as the Director General of TB, and since TB remains a serious global WHO, each to exercise his or her own pivotal problem, they shouldn’t be the only ones role, it certainly carried more weight than the concerned about TB. opinions of a cadre of self-serving TB doctors and nurses, TB controllers, or TB researchers. TB in the United States is now in a downward And when the committee called upon govern- spiral. Even though TB in the world remains mental leaders to address TB as an issue out- rampant, in the United States TB rates are side the health sector which, if not dealt with down 7 years in a row including 1999. But, properly, must increase costs for the labor paradoxically, during this period of decline, force and reflect negatively on tourism and interest in TB seems to have markedly in- foreign investment, it also carried important creased, and such interest apparently has influence. When they suggested that TB increased outside the parochial TB commu- should be handled as a defense program rather nity. This to my mind is the factor that is than a social program, such a theme stood a reinvigorating TB and TB control worldwide. better chance of success than if broached by It leads me, on the basis of present evidence, to the usual interested parties. humbly suggest that the salvation of TB

27 TB Control at the Millennium

For several years many in the TB community public health America had ever faced. He have pleaded with USAID to get involved in likened the link of the three epidemics to international aspects of TB control, if only Cerberus, the mythological three-headed dog because of the realization that this is the best guarding the gates of Hell! way to control TB in the United States, where increasing numbers of cases (now 42% in 1998) Mr. Califano, another unusual suspect as far as are in the foreign-born. But it wasn’t until TB is concerned, would likely be pleased to Ralph Nader’s Princeton Project 55 (unusual know about the progress made in TB domesti- suspects, to say the least) got involved, that cally since introducing his metaphor, but USAID made a commitment to worldwide global TB still remains a major problem. control of TB and properly made the United States a significant donor nation in the global I’d like to suggest that the proper approach to fight against TB. dealing with the global TB epidemic is also three-headed; however, not a Cerberus, but a In a similar vein, the Public Health Research three-headed or three-pronged thrust into the Institute of New York and the Open Society 21st century, reflecting a new collaboration Institute (the George Soros Foundation) — between usual and unusual suspects. again, at least for TB, unusual suspects — were able to get Russia to mount significant TB I think we all must agree that government, involvement in Russian prisons, which will whether it be WHO, CDC, or individual necessarily require prison as well as civilian ministries of health, cannot do the job alone, DOT, something that WHO and CDC had and it is hoped that they will continue to reach been unable to do for years. out meaningfully both for advice as well as assistance. Nongovernmental organizations The recognition that DOTS works in drug- such as IUATLD, ALA/ATS, or KNVC sensitive cases but may amplify already exist- (Royal Netherlands TB Association) cannot do ing drug resistance and that MDR TB can be this job alone either, and need to include effectively treated by tailored second-line academe and foundations, which are unusual regimens was made not by TB physicians, but suspects. But the third prong, previously by Partners in Health, a group from Harvard totally neglected except as a source of dona- University specializing in anthropology and tions and therefore a very unusual suspect as human rights, and which has led to acceptance far as TB goes, is commercial industry! by WHO of the so-called DOTS Plus move- ment (tailored treatment of MDR TB). Industry is the one potential player that has usually demonstrated the ability to create and We stand at a crossroads. Some of the players maintain an infrastructure, motivation, exper- have now acknowledged that teamwork and tise, and perhaps most importantly, an ability partnerships are needed to realistically deal to get things done. They get things done, to with TB. A fresh look at a thorny problem by my mind at least, because they are in it for unusual suspects can have lively and useful profit, and profit still seems to be a stronger results. motivation than “doing good.”

In 1992 at the National Commission on AIDS, In 1996 at the Lancet conference and then in Joseph A. Califano, Jr., who had been Presi- 1997 at the IUATLD annual conference in dent Jimmy Carter’s Secretary of Health, Paris, I castigated industry. I asked why, Education and Welfare, warned that the currently, the most widely used diagnostic test conjoined epidemics of AIDS, TB, and drug for TB infection was introduced in 1880. I also addiction form the most frightening threat to asked why there was essentially only one drug

28 Notable Events in TB Control company trying at that time to license a new too fragile and important to attack with only drug with admitted TB indications. the usual suspects. Adding unusual suspects as full participants, such as nongovernmental At that time I stated that drug companies organizations, academe, foundations and don’t sit with us at the TB table because as industry, is the only way we can ever imple- public corporations they must ask, “What’s in ment and carry out the global plan, rectifying it for us?” To a great extent, if we want them the continuing worldwide embarrassment and with us, there must be something in it for danger of TB. them beyond “doing good,” a virtue that shareholders and financial analysts probably In 1955, soon after the introduction of wide- understand less well than even politicians. spread use of TB drug therapy, Professor James Waring at Colorado pointed out in I’m not the only one suggesting this. In Busi- JAMA that TB was unique in that, essentially, ness Week, April 6, 1998, the cover story it stayed around and spread until it was prop- stated: “Still, TB, like malaria, attracts fewer erly treated. In other words, it doesn’t go resources than other infectious diseases. And away. it’s not hard to figure out why. . . There’s been the least effort to develop new anti- The global situation with TB reminds me of infectives (against these diseases) because of the the man who advertised FRAM Oil Filters on inability of the population in the most affected television several years ago. In that commer- areas to pay. That’s just one reason the war cial, a scruffy garage-mechanic type ap- with microbes may never be fully won. Com- proached the camera holding an oil filter in panies and nations need to launch — and one hand and a burned out car engine in the maintain — effective campaigns not only other. He stated: “Last week the owner of this against strep and flu but also against the car could have had a new FRAM Oil Filter for scourges that ravage far too many of the $4.95. He decided not to buy it. Today he has world’s people. Only then would we have a to buy a new car engine for $1,275.00. chance of relegating these killers to the pages of our history books.” “You can pay me now. . . or you can pay me later.” So in response, we need to define strategies to allow drug and technology companies to be The Model TB Prevention and Control full prospective players, along with govern- Centers: History and Purpose ment and nongovernment organizations, by Elizabeth J. Stoller, MPH academe and foundations. Let’s find out what Former Director, Francis J. Curry National TB Center they need and want, and then let’s provide and Russ Havlak them with incentives and enablers; let them Former Assoc. Dir. for Special Projects, DTBE promote their wares as well as promote our needs. And let’s let them earn a fair and On January 22-23, 1992, a conference on proper profit for what they do. multidrug-resistant TB (MDR TB) was held at CDC in Atlanta. Part of the strategy outlined Many years ago, the IUATLD Council (I in the resulting National Action Plan to Com- think it was 1979 in Brussels) held an exten- bat Multidrug-Resistant Tuberculosis was to sively prolonged discussion over whether the establish centers of excellence for treating Bulletin of IUATLD, the predecessor to the difficult-to-manage TB cases, especially MDR International Journal of Tuberculosis and Lung TB cases. The Plan also called for developing a Disease, would be irreparably corrupted if it cadre of health-care professionals with exper- accepted paid advertising. But TB control is tise in the management of TB and MDR TB

29 TB Control at the Millennium through training. In 1993, the CDC Division The programmatic emphasis of each Center of TB Elimination released a request for was designed to address the needs of each proposals for Model TB Prevention and respective target area. New Jersey developed Control Centers as a competitive supplement an integrated approach to managing high-risk to the Surveillance, Prevention, and Control/ urban populations through interdisciplinary Elimination cooperative agreements. The teams and a nurse case management model, federal funds appropriated to support emer- telephone information services for health care gency TB grants were targeted to the 13 states professionals and the general public, and a and cities that had reported the largest num- comprehensive training program. The bers of TB cases in 1992. Harlem Center featured enhanced clinical services, a clinic-based DOT model, and Model TB Centers were to be located in high- training of house-staff and community incidence urban areas. The recipient health physicians. The San Francisco program was department was required to utilize a current, designed to replicate local successful program or establish a new, relationship with a school components in surrounding jurisdictions in of medicine or public health for Center opera- the target area, as well as offer enhanced tion. The Centers were to provide regional surveillance, laboratory and 1. Comprehensive, coordinated state-of- institutional “hazard evaluation” services, the-art diagnostic, treatment, clinical and epidemiologic consultation prevention, and patient education services, and a comprehensive training services for TB cases, suspects, contacts, program. and recipients of preventive therapy (treatment for latent TB infection); In 1997, Kenneth Castro, MD, Director, 2. Innovative approaches for ensuring Division of TB Elimination, CDC, called a adherence with drug therapy and for meeting of the Model Center principals to carrying out other prevention and discuss a change in programmatic emphasis for control activities; and the Centers. While the expectation was that 3. Training for all levels of health care activities would continue, efforts should be workers providing TB screening, made to “capture” the outcome of each major prevention, and control services within effort in some sort of enduring product. This the targeted area. would allow other TB Control programs in the nation to make use of the strategies and Three sites were selected for Model Center tools developed, tested and/or perfected by awards: Newark, NJ, New York City, NY, each of the Centers. The Centers were asked and San Francisco, CA. to redesign their programs in accordance with the new directive and submit proposals with The New Jersey National Tuberculosis Center exhibits organized under three headings: State- is located at the University of Medicine and of-the-Art Care, Training, and Innovative Dentistry of New Jersey, serving Newark and Activities. Effective January 1998, the Centers Essex County. The New York City operation shifted into “product” mode. In less than 2 is located at the Harlem Hospital Center, and years, the Centers have developed and serves Central and East Harlem. The San disseminated the following innovative Francisco Center is operated by the TB program products: control program of the San Francisco Department of Public Health, and includes the surrounding Bay Area counties as the target area.

30 Notable Events in TB Control

San Francisco: • A series of guidelines on institutional infection control measures • A videotape on engineering methods for institutional M. tuberculosis prevention • A CD-ROM on patient management • A searchable database of TB training and education resources from throughout the US and international programs • A software program (TB Info) for real- time program data analysis

The three Centers have undertaken several collaborative efforts, including the development of a national strategic plan on Harlem: tuberculosis training and education; a national • Six case studies to be used for training satellite broadcast series for health care physicians in clinical management of providers; and print-based educational TB infection and disease materials for civil surgeons and panel • Improving Treatment Completion for physicians. Collectively, the Centers have Latent Tuberculosis Infection among provided training to tens of thousands of Health Care Workers, a guide for health care providers and the public health employee health services and chest workforce, and consultation to providers from clinics a broad range of practice settings. • Tuberculosis Training for International Medical Graduates, a guide for The Centers continue to operate in response residency program directors, health to the needs of the programs in their administrators and TB control respective target areas and, with guidance from programs the CDC, the National TB Controllers • Social Support Services for Association (NTCA), and the National TB Tuberculosis Clients, a guide to help Nurse Consultant Coalition (NTNCC), providers establish and enhance social increasingly in response to the needs of the support services nation. These Centers are designed to meet your program needs: be sure to contact them New Jersey: for assistance or for resources. • A TB School Nurse Handbook • Guidelines for a School-Based Directly- Francis J. Curry National Tuberculosis Center Observed Therapy Program (San Francisco) • Tuberculosis Preventive Therapy Web address: www.nationaltbcenter.edu Database for patient tracking and Telephone: 415/502-4600 outcome evaluation • TB drug treatment pocket card for Charles P. Felton National Tuberculosis clinicians Center at Harlem Hospital (New York) • Standardized patient scenarios Web address: www.harlemtbcenter.org Telephone: 212/939-8254

31 TB Control at the Millennium

New Jersey Medical School National boosting when sequential tuberculin tests were Tuberculosis Center (Newark): applied. Much of what was underlying those Web address: www.umdnj.edu/ntbc efforts with tuberculin skin testing actually Telephone: 973/972-3270 reflected concerns and frustrations with the use of isoniazid (INH) for treating latent TB My Perspective on TB Control over the infections, so-called TB prophylaxis. On the Past Two to Three Decades one hand prophylaxis was effective but, on the by Jeffrey Glassroth, MD other hand, it came with a risk of side effects, Prof of Medicine, Univ of Wisconsin Medical School most notably hepatitis. The challenge was to President, American Thoracic Society identify, via skin testing, the persons most likely to derive benefit from INH and least In 1975 case rates for tuberculosis (TB) in the likely to be harmed by it; a classic benefit/risk United States were in double digits per “equation.” BCG vaccination, though widely 100,000. Increasingly, those patients were used outside the US, was rarely used here, individuals with serious social problems. A because of perceived limited effectiveness and major concern at CDC that year was the problems with skin test interpretation. screening for TB of newly arriving Vietnamese refugees; the treatment of active cases was The intervening quarter century has seen provided, and notification to local health remarkable changes with respect to TB but, in departments of latently infected individuals some ways, little has changed. A number of was undertaken. There was also concern about years ago, then–CDC Director Dr. James the quality of immigrant screening done Mason urged that CDC’s TB unit not think in overseas, but the major focus of “imported” terms of TB “control” but of “elimination.” TB was along the border with Mexico. The name of the unit changed to reflect this Monitoring of TB drug resistance, particularly new, more ambitious mission. Indeed, in the primary resistance (i.e., among persons not US, after some years of rising rates, TB rates previously treated), was pursued and, are again falling and are a fraction of what reassuringly, indications were found that these they were 25 years ago. However, in many rates were generally stable and low, ways the challenges to TB elimination in the particularly with respect to rifampin. A major US are greater today than a quarter century treatment study was beginning and it would ago. Worldwide, TB prevalence is increasing, help to define the role of rifampin in so-called and today over 40% of cases reported in the “short-course chemotherapy,” meaning 9 US are “imported” in the person of months of daily treatment as opposed to the immigrants from high-prevalence countries. standard of 18-24 months that existed at the The worldwide TB burden is fueled by HIV time. “TB Today!,” an intensive educational infection, an entity unknown in 1975, which program that provided essential knowledge to facilitates every aspect of the natural history of TB control staff from around the country, TB from transmission to disease. In presented material on TB microbiology and recognition of this, and to more efficiently diagnosis that emphasized the (then) state-of- combat these interrelated public health the-art methods; a description of classical problems, the TB division at CDC is now microbiologic techniques that had changed administratively “housed” with the HIV little in the near-century since Koch described division. Moreover, CDC has dramatically the tubercle bacillus. Also taught in the course increased its worldwide collaborations to assist was a segment on optimizing the use and in efforts at containing TB abroad. interpretation of the tuberculin skin test for identifying TB infection. A study was about Rifampin is now well entrenched as a to begin to assess the importance of skin test cornerstone of treatment, and several related

32 Notable Events in TB Control rifamycins have come into use. Short-course therapy has been further abbreviated to a Preventive treatment of latent TB infection standard of 6 months’ duration by adding still emphasizes the use of INH. However, pyrazinamide during the first 2 months of because of occasional concerns about resistance treatment. Moreover, the proven efficacy of to INH, and also in an effort to reduce the intermittent treatment has facilitated the time required to complete a course of widespread use of directly observed or preventive therapy, other regimens — supervised therapy (“DOT”) as a means of particularly those using rifampin — have been improving adherence to treatment and is a increasingly used and shown to be effective major factor in treatment success. (though more costly) alternatives to INH. Unfortunately, drug resistance has become an Although additional studies have documented additional issue contributing to treatment the limitations of BCG vaccination, there is problems. Moreover, resistance is increasingly increasing interest, in the US and abroad, that a problem with the rifamycins (almost through the technical developments of recent unheard of 25 years ago), and outbreaks and years, more effective vaccines are feasible. sporadic cases of multidrug-resistant TB (MDR Given the worldwide problems I have noted, TB) represent a major concern for clinicians application of a truly effective vaccine would and public health officials alike. be a logical strategy for dealing with this disease. Perhaps nowhere has change been more dramatic than in the area of diagnostics. So what has happened in TB in the last 25 Although skin testing is fundamentally years? Lots of change and technologic unchanged, the microbiologic approach to TB development but fundamental challenges diagnosis has been revolutionized by the remain. Worldwide the number of cases is application of molecular biologic techniques. rising and treatment is becoming more Thus, laboratories are now capable of difficult in some regions. In the US, numbers obtaining genetic material from small numbers have declined but current cases often require of tubercle bacilli in more resources and sophistication to treat than specimens, amplifying or they did even just a few years ago. multiplying that material, and then History of the IUATLD testing the resulting by Donald A Enarson, MD “soup” for specific and Annik Rouillon, MD segments of DNA or International Union Against TB and Lung Disease RNA that are unique to 68 boulevard Saint-Michel, 75006 Paris FRANCE TB. Refinements of these techniques also The International Union Against Tuberculosis permit the identification and Lung Disease (known to its members as of resistant strains in “the Union”) is the only international some cases and the voluntary organization dealing specifically tracking of outbreaks or with TB. It is very special in terms of its mini-epidemics, and help structure, membership, and diversity of us better understand the activities. epidemiology of the disease as it currently exists. Such techniques hold the very real Roots of the Union, 1867-1914 promise of rapid, highly sensitive, and TB was presented as a communicable disease specific diagnostic tests for TB disease. in the first international conference of Powerful tools indeed! medicine specialists convened in Paris in 1867.

33 TB Control at the Millennium

Conferences specifically addressing TB continued publication until mid-1940, the final followed in Paris in 1888, 1891, 1892, and editions containing the main reports to have 1898. The 1899 conference took place in Berlin been given at the 11th conference planned for and, for the first time, official representatives Berlin in September 1939, the very month from both governments and nongovernmental when the Second World War commenced. agencies were present. The independent developments of sanatoria (1854), the Relaunching of the Union, 1946-1961 discovery of the bacillus (1882), the opening of At the first reunion of the Executive TB dispensaries (1887), the development of the Committee after the war in 1946, the IUAT voluntary movement (1890), and the recommended to the planners of the future organization of periodic conferences called for World Health Organization “establishment of a centralized agency for coordination and a strong Division of Tuberculosis.” Official communication. The Central Bureau for relations with the WHO were then established Prevention of Tuberculosis was formalized in which continue to the present time. Berlin in 1902, and the double-barred cross was adopted then as its symbol. Periodic The first postwar conference in 1950 in international conferences systematically Copenhagen, with participation of 43 nations, addressing clinical, research, and sociological was followed by a series of conferences, with aspects of TB were held until the outbreak of the 29th world conference in Bangkok in 1998, the First World War in 1914. when 105 countries participated. Conferences outside North America and Europe were held Establishment of the Union, 1920-1939 in Brazil in 1952, India in 1957, and Turkey in In 1920, a conference on TB was convened in 1959. During this period a series of Paris in which 31 countries participated, international symposia were also organized, including Australia, Bolivia, Brazil, Chile, generally in Paris, addressing a variety of China, Colombia, Cuba, Guatemala, Japan, topical issues such as TB in Africa, strain Panama, Paraguay, Iran, and Thailand, in variation in BCG, radiography for TB, new addition to those of Europe and North drugs, and the role of voluntary agencies, America. In an impressive procession, among others. delegates one by one pledged “to agree on the means to fight TB, to make a consensus on the In order to strengthen the administration of strategy, to jointly apply the most effective the growing agency, a post of full-time weapons to combat this common enemy,” Executive Director was established in 1952. A thus establishing the International Union system of quotas was devised for membership Against Tuberculosis (IUAT) in its present contributions. Over many years, the form. It was conceived as a federation of American Association has continually national associations (130 by 1999). Ten maintained a high quota share. Fees were also international conferences followed until 1939. levied from individual members. In 1951, scientific committees were commenced and In order to supplement the routine reports of met annually for intensive discussion of the the conferences, a regular publication was emerging strategy for the fight against TB. In commenced in 1923. In this prewar period, the 1953, regions were established in order to Bulletin included administrative reports and remain close to where the needs are. In 1958, statistics (subsequently compiled by WHO) as the first international collaborative clinical well as information on the strategy and trial for treatment of any disease was policies for the fight against TB and results of undertaken, with a total of 17,391 patients numerous surveys on specific aspects of the from 17 countries evaluated for drug disease and the campaign. The Bulletin resistance. This was followed by a

34 Notable Events in TB Control collaborative controlled clinical trial starting 10,000 events analyzed. Also in 1968, A in 1960, to evaluate the efficacy of Technical Guide for Sputum Smear Microscopy chemotherapy in previously untreated was published; the 5th edition of this guide was patients. In this period, the IUAT contributed published in 1999. to annual international courses on TB control sponsored by WHO in Istanbul, Prague, In 1965, the Tuberculosis Surveillance Rome, and Caracas. Research Unit was established under Dr. Karel Styblo. It developed an index to evaluate A global view 1961-1978 infection and its trends, clarified the natural In 1961, at the suggestion of the Executive history of the disease (including transmission Director, Dr. Johannes Holm, the Mutual probabilities and risk factors), and estimated the impact of control measures. In 1969, in collaboration with the then–Communicable Disease Center of the United States and seven member countries in Eastern Europe, an international trial of preventive chemotherapy for fibrotic lesions of the lung in 25,000 individuals was commenced and was evaluated over 5 years of follow-up. In 1973, it was proposed that the mandate of the IUAT be extended to include other lung diseases. However, the name of the organization was Assistance Program was launched to not changed to reflect this extension until 13 encourage transfer of technology, resources, years later. and information from industrialized to newly independent countries, through the agency of In 1975, Dr. Halfdan Mahler, Director national associations in the developing General of WHO, publicly acknowledged the countries. This was followed by travelling crucial role played by the IUAT in the fight seminars in Africa and in Eastern and Middle against TB. In early 1976, 18 NGOs East regions, and by field projects in Mali, Sri (nongovernmental organizations) responded to Lanka, Peru, and India, among many others. IUAT’s invitation to consider jointly the role which NGOs may and should play in primary In this period, the scientific committees health care (PHC) programs. The resulting continued to focus on the strategy for TB position paper was presented at the joint control. Some examples of the activities UNICEF / WHO International Conference follow. In 1961, two international on PHC in Alma Ata in 1978. collaborative studies evaluated the test characteristics of 1,099 films read by 90 readers from 7 countries and WHO. A subsequent study evaluated sputum smear microscopy. Starting in 1965, an international collaborative study on tuberculin skin testing evaluated 75,000 children in 21 countries. Further controlled clinical trials addressed the issue of previously treated patients and daily self- administered versus intermittent supervised regimens. In 1968, a survey evaluated adverse reactions to BCG vaccination, with over

35 TB Control at the Millennium

In 1989, the Burden of Health Study carried out by Harvard University was pivotal in demonstrating the cost-effectiveness of the IUATLD model, which was instrumental in convincing planners and policymakers to adopt the strategy as a part of the general health services.

A global fight, 1991-present The principles of the model National TB Program, outlined on the occasion of the retirement of Dr. Styblo in 1991, were subsequently enumerated as the “DOTS” Modeling the global fight against TB, 1978- Strategy, promoted as the official policy of the 1991 WHO. In that year, the international TB In 1978, in response to a request from the training course of the IUATLD was first held Minister of Health of Tanzania, the IUAT in Arusha, Tanzania, to illustrate the proposed the establishment of a National TB principles of the model program. From 1993 Program under the direction of the to 1996, the training and technical support government and with support and activities of the IUATLD were extended from coordination of the IUAT. This proposal was a largely African base to represent every the basis of a new program of Technical region of the world. In 1996, the IUATLD Assistance of the IUAT and became the basis entered into a formal agreement to provide in 1979 for the first edition of the TB Guide. training fellowships with support from the Such assistance eventually extended to nine International Fogarty Foundation. low-income countries and became the basis of the current DOTS Strategy of the WHO. By 1998, field activities involved 10 countries in the Eastern Region, 5 in the Middle East, 10 In 1981, the IUAT became the first in Africa, 15 in Europe, 8 in Latin America, organization to adopt a policy that its and 2 in North America. The network of meetings be designated “non-smoking” courses in management included Tanzania, conferences. In 1982, the Koch centenary was Benin, Nicaragua, and Viet Nam, and the celebrated at the 25th conference in Buenos courses on research methods included Turkey, Aires, where the Koch Medal of the IUAT Kenya, South Africa, Mexico, Chile, was awarded to Drs. Johannes Holm and Argentina, Brazil, Peru, Malaysia, and China. Wallace Fox. That same year saw the During this period, more than 1 million establishment of World TB Day on March 24 patients with TB were cared for in the context each year, following a proposal by the Mali of the collaborative programs of the IUATLD. Association. In 1984 the IUAT was officially In 1998, the IUATLD joined with the WHO registered with USAID, a very rare privilege and other international partners to form the for a non-US agency. The IUAT officially “Stop TB” Initiative in the hopes of extending changed its name in 1986 to the IUATLD to the model to all countries of the world. reflect the inclusion of other lung diseases in its mandate. In 1987, a delegation from the These activities were made possible thanks to IUATLD visited WHO to encourage it to funds entrusted to the Union from richer consider the problem posed for TB by the associations and by governments of a number emergence and spread of HIV infection that of affluent countries. had been noted in the collaborative projects.

36 Notable Events in TB Control

Characteristics of the IUATLD case numbers and rates into the indefinite The distinguishing qualities of the IUATLD, future, until we finally arrive at our goal, the besides its universality, its spirit of solidarity, elimination of TB from the US? Even though and its tolerance, are its continual striving for we are good people, working toward a noble quality and its independence. Thanks to these, cause that we deserve to achieve, I submit that it provides the international community with this optimistic view of an inevitable future an invaluable asset, namely, its pioneering role decline of TB in the US is not necessarily our in devising and encouraging or testing destiny. I fear that as we continue to work innovations. It provides a neutral platform for against TB in its current epidemiological international collaboration, exchange of expression in the US, we may be destined to information, friendship, mutual esteem and reach a point at which the force of TB control education, and a reduction of prejudice. It is balanced by the force of the disease in our maintains not only a program of scientific population. In that scenario, with neither conferences and publications but also a opposing force having the upper hand, TB program of action for health in the morbidity in the US will not continue to community, comprising technical assistance, decline but will become level. education, and research. Dr. Gro Harlem Brundtland outlined the future in the I am emboldened to hypothesize, in the following statement to the 51st session of the absence of new factors in the equation, a World Health Assembly in Geneva in 1998: forthcoming equilibrium between TB and TB “We must reach out to the NGO community. control in the US, and a stabilization in the Their reach often goes beyond that of any TB incidence rate in the US, because that is official body. Where would the battle against precisely what has happened in recent years in leprosy, TB, or blindness have been without my community. The accompanying figure the NGOs?” portrays the numbers of TB cases reported in

Thoughts about the Future of TB Control in the United States by Charles M. Nolan, MD Director, TB Control Program Seattle-King County Dept of Public Health

It is gratifying, isn’t it, to be back on the pathway toward TB elimination. I guess it’s true that we who work in TB control had more prominence and visibility in the recent era during which TB was resurgent; a declining public health problem is never very newsworthy. Still, speaking personally, the satisfaction of watching the regular declines in Seattle-King County, Washington, and in the US TB morbidity each year since 1992 exceeds US from 1990 through 1998. Even though the the cheap thrill of being interviewed by local numbers of cases represented in the two TV news personalities about the looming jurisdictions differ dramatically, the trend is threat to our community of resurgent TB. unmistakable; during a period in which the TB morbidity in the US declined by 35%, that in But what does the future hold for TB Seattle-King County remained basically stable. controllers? Will we continue to see our efforts rewarded by predictable declines in TB

37 TB Control at the Millennium

(If annual incidence rates rather than case community. In other words, we appear to numbers had been presented, the trends would have reached an equilibrium with our target have been the same). disease, given its current epidemiological pattern in our community. This experience is Here is my explanation for the trends shown the basis for my suggestion that it is possible in the figure. At the national level, we are now that the nation as a whole will also reach such reaping the harvest of reinvesting in good TB an equilibrium point, once its excess TB control. We have secured the necessary morbidity has been “mopped up.” When that funding and have applied those funds point may be reached, and at what level of strategically throughout the country to morbidity, I of course cannot say. strengthen surveillance and case finding, to expand directly observed therapy for TB cases I don’t want to leave the impression that we in order to increase completion rates and have passively accepted the current status quo reduce acquired drug resistance, and to stop in Seattle. We are aggressively attempting to nosocomial transmission and other pockets of disrupt the equilibrium between TB and TB current transmission of TB. control by learning more about the epidemiology of TB in our community and by Speaking in terms of a theory of TB control, increasing the effectiveness of our community- our investment has allowed us to regain the based TB control plan. For example, in our ground that was lost during the resurgence by community, persons born outside the US applying to their best advantage our current account for 70%-75% of cases, and RFLP tools (this fact was noted in a JAMA editorial survey data suggest that nearly all of our cases written in 1997 by Drs. Bess Miller and Ken in foreign-born persons arise through Castro of the Division of TB Elimination). In reactivation of latent infection, including that sense, the drop in cases and case rates persons who have received preventive therapy. nationally represent a reduction in “excess This information suggests that we need to morbidity” that arose during the time when expand treatment of latent TB infection in the national infrastructure was weakened in high-risk foreign-born persons; to accomplish relation to the strength of the dual epidemics that, we have established a Preventive Therapy of TB and HIV, increased immigration from Partnership Program with a number of health high-prevalence areas, and person-to-person care facilities that provide primary health care transmission of TB, including nosocomial to high-risk foreign-born persons. Also, given transmission. that we regularly see TB occur in foreign-born persons who have received preventive therapy Some places such as Seattle, however, did not in the past, we are reevaluating the traditional experience the full power of the TB approach to preventive therapy, and have resurgence. For example, we were only secured funding to develop new approaches to modestly impacted by the HIV/TB increase the uptake and completion of phenomenon, with rapid person-to-person preventive therapy by newly-arrived spread of disease, and MDR TB. Our immigrants and refugees. infrastructure had not been dismantled, and we experienced less excess morbidity in those Should the nation encounter such a “mud bad days. In the decade of the 1990s, however, hole” in the road to TB elimination, similar even though we believe we have a good strategies will be required to move beyond it. program structure, a talented staff, and ACET, in its recent publication, TB funding sufficient to allow us to do good TB Elimination Revisited: Obstacles, Opportunities, control work, we have failed to effect a and a Renewed Commitment, has made several meaningful reduction in TB morbidity in our practical suggestions, including the need for

38 Notable Events in TB Control every locale and/or state to understand the unique nature of its own TB problem, in order to apply current tools for TB control to their best advantage. The establishment of new partnerships to reach locally-identified high- risk groups is another important new concept.

Another way that an equilibrium between TB and TB control may become tipped in favor of TB control is by the introduction of new tools for the diagnosis, treatment, or prevention of TB. This point was also made by Dr. Miller and Dr. Castro in their JAMA editorial. Consider, for example, the advantage of being able to identify, among a population of 100 persons screened and found to have positive tuberculin skin tests, the handful that are destined to develop TB in the future, and to offer treatment only to those who are truly at risk, rather than to the entire cohort. Likewise, based on forthcoming ATS/CDC recommendations, we now have a range of options for treatment for latent TB infection, which should result in more effective use of that preventive intervention. Finally, given the events of the past year, with burgeoning interest in a TB vaccine on the part of the US government, private philanthropic organizations, and the pharmaceutical industry, the notion of a TB vaccine at last (in the immortal words of Ken Castro) “passes the laugh test.”

Even as Seattle’s current impasse with TB has served to motivate us to redouble our efforts, to think creatively, and to engage new partners in our struggle, I am confident that, should our trend become a national one, the nation will be equal to that challenge. “The man (or woman) who is tenacious of purpose is not shaken from his firm resolve by the tyrant’s threatening countenance.” Horace, 23 BC.

39 TB Control at the Millennium 1895 X-ray Roentgen discovers A CENTURY OF ADVANCES IN TUBERCULOSIS CONTROL, UNITED STATES UNITED CONTROL, TUBERCULOSIS IN OF ADVANCES ACENTURY 1 2 5 50 20 10 0.5 500 200 100

40 Notable Events in TB Control

A CENTURY OF ADVANCES IN TUBERCULOSIS CONTROL, UNITED STATES

500

200

100

50

20

10

5

1895 Roentgen discovers X-ray 2

1

0.5

41 TB Control at the Millennium

Where We’ve Been and screening did not effectively cover large city Where We’re Going: populations and by 1947, the PHS Division of Perspectives from CDC TB Control was operating mobile x-ray unit teams in some 20 cities of more than 100,000 Early History of the CDC TB Division, population which participated in this PHS big 1944 - 1985 city program. By 1953, after some 20 million by John Seggerson people had been x-rayed for TB, the program Associate Dir. for External Relations, DTBE was discontinued owing to declining yield and high cost. Many health department and TB In 1944, Congress passed the Public Health association community x-ray screening pro- Service Act, which authorized grants to the grams were also discontinued, although some states for TB control and established the continued until the late 1960s. “Division of Tuberculosis Control,” then located in Washington, DC. At the time of the In 1959, a group of nationally recognized TB creation of the TB Division, TB drugs were experts was convened in Harriman, New not available, and the primary method of TB York, to review the status of US TB control, control was the isolation of persons with and they issued the “Arden House Report,” active disease in TB sanatoria where they were which recommended the eradication of TB “treated” with healthful living, bed rest, with effective treatment programs to cure calorie-laden meals, fresh air, sunshine, and disease and prevent spread. The Arden House sometimes with surgery and/or collapsed lung group also recommended isoniazid treatment therapy. of latent TB infection based on extensive PHS chemoprophylaxis trials.

In late 1960, the PHS TB program, by then renamed the “Tuberculosis Branch,” was transferred from Washington, DC, to Atlanta, to what was then called the Communicable Disease Center. The TB research activity remained in Washington for the time being, then was also transferred to Atlanta in the early 1970s.

In the 1960s it became increasingly obvious that long-term hospitalization of patients with

PHS mobile x-ray unit active TB was no longer necessary because of the availability of effective chemotherapy, and From the beginning of the 20th century, the the TB Branch began to advocate that patients National Tuberculosis Association (later the receive most or all of their care on an out- American Lung Association), and its state and patient basis. The sanatoria began to close, local affiliates, played a major role in establish- with most of them being closed by the end of ing and supporting the TB sanatorium move- the 1970s. It has been estimated that the ment in the US. During the post-WW II closing of the sanatoria represented a savings period and into the 1950s, TB associations and of more than $400 million to state and local health departments employed small-film x-ray governments. units to conduct TB screening in general populations, with one x-ray unit often screen- In 1963, in response to a special Surgeon ing as many as 500 persons per day. The General’s Task Force report on TB, categori-

42 Notable Events in TB Control cal TB grant programs were established and INH could be effectively and inexpensively funds were utilized to address the two newly used to prevent TB infection from progressing emerging major challenges in TB control: to disease. In the mid-1960s, the TB Branch establishing outpatient TB control services and began to promote and fund the implementa- designing ways to effectively identify and treat tion of the “Child-Centered Program,” which TB and asymptomatic latent TB infection. prioritized the screening of school children to Long before the hospitals all closed, sanato- identify TB infection and ensure that identi- rium clinicians began lowering the hospitaliza- fied children completed a preventive course of tion period from the entire treatment period INH. Part of the “Child-Centered Program” of 18-24 months gradually down to only the was a concerted effort to conduct “cluster first 6 months or less. This meant that patients testing” or follow-up of contacts to children with uncomplicated TB were treated on an with TB infection to identify the infecting outpatient basis for up to 18 months. There “source case” and also to identify other in- literally were no outpatient clinic programs in fected children who may have been exposed to most of the country; and in many places, and infected by the same source case. when patients were discharged to outpatient In addition to providing health department care, they had to return frequently to the categorical funding to help address these sanatorium for outpatient exams and medica- challenges, the TB Control Branch and the tion refills. Public health nurses had for years ALA’s American Thoracic Society regularly been doing routine contact investigations in updated and widely disseminated guidelines the field, but most health departments did not for the diagnosis, treatment, prevention, and have the outreach staff needed for all these TB control of TB. patients suddenly being treated on an out- patient basis. Acquired drug resistance due to Almost since its inception, the TB Branch had outpatient treatment lapse became an impor- collected, analyzed, and reported national tant problem. So as TB sanatoria began to morbidity, hospitalization, and screening data, increasingly discharge patients early, health and has also provided consultative staff to departments had to provide both the TB support and review TB prevention and control clinics and the follow-up staff needed to ensure efforts at the state and local levels. During the completion of treatment and preventive early 1960s, the TB Branch also began work- therapy. The TB branch consulted with health ing with health departments to establish the departments in this undertaking which in- TB program management reports to evaluate cluded establishing or improving TB registers the effectiveness of TB prevention and control needed to effectively monitor and track TB efforts. Program management reports continue treatment and follow-up for TB patients. to be an important component for evaluation of national, state, and local TB prevention and INH had been introduced in 1952, but its control efforts. Don Brown managed this prevention possibilities were not realized until activity from the early 1960s until the mid- Edith Lincoln in New York noted that chil- 1990s. A new concept in the type of assistance dren with primary TB treated with INH had a provided by the TB Branch was initiated in much lower incidence of serious TB complica- the mid-1960s with the assignment of CDC tions. She suggested controlled trials to look at TB Public Health Advisors to assist health the possibility of using INH as preventive departments in the operation and evaluation of therapy for TB. Soon, the controlled trials TB prevention and control programs. The TB conducted by TB Research Section staff Branch also began recruiting and assigning TB (Shirley Ferebee, Carol Palmer, George Medical Officers to health departments for 2- Comstock, Lydia Edwards, and others) and year periods. These Medical Officers, along other institutions began demonstrating that with CDC Public Health Advisors, began

43 TB Control at the Millennium working as a team with state and local TB who works in New Jersey with Dr. Controllers and their staff. These assignees Reichman. were in effect “on loan” to the health depart- ments and operated as state or local employ- No early history of the TB Division would be ees, although they were subject to frequent complete without a mention of the “TB transfer by CDC among the health depart- Today!” course, which was conducted by the ments. By the mid-1960s, almost every state TB Division from the late 1960s until the early plus Guam and Puerto Rico had a TB project 1990s. The course evolved from courses taught grant (Wyoming did not). at National Jewish Hospital in Denver and Battey Hospital in Rome, Georgia. Seth The number of TB Medical Officers began to Leibler directed the development of this decline after 1967 as recruitment became more course, working closely with the Director, Al difficult and the categorical grants were phased Holguin, and Don Kopanoff, who later served out. However, Public Health Advisors contin- as the TB Division’s Associate Director for ued to be requested and effectively work in External Affairs. Later the course was imple- health department TB programs where they mented by Ginny Bales, now CDC Deputy were supported by Partnership for Health and Director for Program Management, and Kathy later prevention block grants. The Advisors Rufo, now Deputy Director of the Diabetes and TB Medical Officers had a major impact Translation Division; they were all essential to on TB control in the areas where they were the design and early conduct of this course. assigned and afterwards. After serving in the Later, Barbara Holloway (currently Deputy field, many of the TB Medical Officers contin- Director of the CDC Epidemiology Program ued on in public health and national TB Office) directed the course. It was designed for leadership. Larry Farer and Dixie Snider key TB program managers including physi- started as TB Medical Officers in Utah and cians, TB Controllers, TB nurses who had Oklahoma, respectively, and both later went management responsibilities, and other TB on to become directors of the TB Division. program managers. The course was presented There is a long list of other former TB Medical in a workshop format with heavy emphasis on Officers who continued in leadership roles in program evaluation and management by TB including current ATS president Jeff objectives. The attendees worked through the Glassroth, John Sbarbaro, Phil Hopewell, course using their own program’s TB morbid- Tony Catanzaro, and others. The last of the ity and program evaluation data. They devel- original TB Medical Officer field group was oped objectives for their program based on Eric Brenner. (The concept of field Medical their unique problems, and developed strate- Officers was revived on a smaller scale in the gies for achieving the objectives. They went early 1990s and continues today.) The TB back to their programs and began to imple- Branch in the late 1960s and early 1970s also ment the plans and achieve the objectives. supported a number of “Clinical Associates” Many of the TB Controllers from that era will who were not PHS medical officers but testify the course changed their whole ap- worked like “TB fellows” in pulmonary proach to TB from a perspective of clinical training and were assigned to key institutions. management of TB patients to one of manag- For example, Mike Iseman was assigned to ing programs and effectively supervising Harlem Hospital under Julia Jones. These people. Since the late 1960s, nearly every state clinical associates were basically pulmonary and major city TB Controller and head TB fellows working in pulmonary clinics who nurse has attended the course, which has been concentrated on TB and worked in the TB revised over time. clinics. Lee Reichman was also a TB Branch Clinical Associate, as was Ray McDonald, The 1970s were belt-tightening times for TB

44 Notable Events in TB Control control staff at CDC and across the nation. program consultants.) The last of the special TB project grants were phased out by 1973. The TB Research Section 1980 was an especially difficult time for TB was transferred from Washington to Atlanta programs when the block grants were com- with Jerry Weismeuller as Chief, but many of pletely phased out for a short time, there were the TB Research Section staff retired or moved no categorical TB grants, and TB program on to other positions rather than move to managers had to scramble to cover lost re- Atlanta. In 1974 the TB Branch again became sources. This was a tough time also for TB the TB Division. In 1976, Larry Farer became Division Public Health Advisor field assignees, Director of the TB Division and Dixie Snider some of whom had to accept assignments in became Chief of the Research Branch. John other programs, while many stayed on in TB Seggerson came to CDC as the Chief of Field field assignments where local health depart- Services in late 1977, replacing Larry Sparks ments were able to cover their salary costs who had served there before going to the with state or local funds under the Intergov- CDC Washington office and later serving as ernmental Personnel Assignment Act. Things Executive Director for NIOSH and then as began to look up again in 1981 and 1982 when Deputy Director of NCIPC. Jerry Brimberry categorical TB project grants were again worked as a TB consultant with Larry Sparks funded, although initially on a very small and later moved on to Executive Officer of the scale. Since the TB Medical Officer field Diabetes Field Services Branch. The last of the assignee activity had been phased out by 1978, original TB Medical Officer field assignees, the Division began recruiting physicians and Eric Brenner, left the field for Atlanta and the other scientists from the EIS officer group for TB Division in 1978. In the late 1970s and TB Division medical posts beginning with early 1980s, the role of the TB Division pro- Rick O’Brien, George Cauthen, Ken Powell, gram consultants was enhanced and they Bess Miller, Hans Reider, and Alan Bloch, became the lead contacts with health depart- who were the first of this respected group. ment TB control programs for the Division, establishing ongoing contact and close work- The TB individual case report was introduced ing relationships between the Division and the in the mid-1980s, enhancing the national TB field. A long parade of very effective and surveillance system. Nonetheless, through the motivated TB program consultants moved late 1970s and early 1980s, many TB programs through the Division and on to higher level increasingly felt the impact of cutting re- positions: Charlie Watkins transferred to the sources that began in the early 1970s. The first regional offices and then to CDC Chief of documented outbreak of drug-resistant TB Regional Affairs; Wilmon Rushing became occurred in 1976 and 1977 in rural Alcorn one of the first CDC AIDS officials and County, Mississippi. TB-related resources and moved up to the NCID Associate Director for infrastructure continued to deteriorate in most Management; Willis Forrester became Chief of areas, and in the early 1980s, HIV/AIDS Field Services for the AIDS program; Chris began to affect TB, at first in Florida and then Hayden became Chief of the TB Communica- in the New York City metropolitan area and tions and Education Branch; Mack Anders elsewhere. Because of the decline of the headed the TB Division field staff; George infrastructure, many health departments were Rogers is the PHS Deputy Regional Health simply unable to cope with the emerging TB- Administrator Director (Chicago), and Carl related problems associated with AIDS, along Schieffelbein is the current DTBE Associate with increasing numbers of foreign-born TB Director for Special Projects. (The current patients and other problems having an impact DTBE Field Services Section Chiefs, Joe on TB. By the mid-1980s the long-time de- Scavotto and Greg Andrews, were also DTBE cline in the Nation’s TB morbidity trend

45 TB Control at the Millennium ended and outbreaks of MDR TB in hospitals, federal funding (approximately $1 million to prisons, and other institutions were underway. $9 million per year) available for TB control until fiscal year 1992. The following articles by the lead staff of DTBE’s branches and programs will provide a Despite an overall decline in funds being spent more current perspective on division activities. for TB control, the number of reported TB cases continued to decline nationally through CDC Funding for TB Prevention and 1984. However, from 1985, the number of Control cases began increasing and continued to rise by Patricia Simone, MD through 1992. Recognition of the outbreaks Chief, Field Services Branch, DTBE of multidrug-resistant TB, the high mortality and Paul Poppe associated with TB in HIV-infected persons, Deputy Director, DTBE and transmission to health-care workers resulted in strong recommendations for en- Federal fiscal support for TB control began hanced funding for TB prevention and control with the passage of the Public Health Service programs and more stringent infection control Act, which was created to assist states in practices. In fiscal year 1992 the appropriation establishing and maintaining adequate mea- was increased to $15 million from the previous sures for the prevention and control of TB. year’s funding of $9 million. It increased again To enhance case-finding activities, the 1955 in 1993 to $73 million, when Congress appro- Appropriation Act (Public Law 83-472) di- priated $34 million for the continuation and rected federal grants with local matching funds expansion of the TB cooperative agreements to be used only for prevention and case- and $39.2 million in emergency funds for use finding activities. In 1961, Congress provided in the areas of the country most heavily for project grants that were to be used for affected by the increased cases. Congress improving services to known TB patients appropriated yet another increase for categori- outside of hospitals, examination of contacts, cal TB grants in 1994, and the appropriation and diagnosis of suspects. In December 1963, for TB project grants was increased to over the Surgeon General’s task force issued a $117 million. In addition, approximately $25 report recommending a 10-year plan to en- million in redirected HIV funds have been hance the federal role in national TB control available for TB control activities each year through increased grants for services for since 1992, for a total of over $142 million in unhospitalized cases and inactive cases, contact funding for CDC for TB-related activities. As investigations, school skin test screening, and a result of this infusion of funding, TB pro- hospital radiograph screening programs. By gram infrastructures have been rebuilt and the 1967, there were 82 TB control programs in results are evident with six consecutive annual the United States, with federal appropriations decreases in the number of reported TB cases of $3 million in formula grants and $14.95 in the United States. million in TB project grants. TB Funding History vs. Reported Tuberculosis Cases 1977 - 1998 In millions However, in 1966 the Public Health Services $144 Act was amended, changing project grants to 160 140 block grants. These new grants did not require 120 that any funds be used for TB control, and 100 many health departments eventually redistrib- 80 TB Cases 60 TB Funding uted the funds to other programs. While 40 categorical TB appropriations were restored in 77 80 83 86 89 92 95 98 1982, there were very modest amounts of Ye ar

46 Notable Events in TB Control

Since 1994, however, CDC has received partners at the local level, and strengthening approximately level funding for TB-related coalitions by revitalizing the National Coali- activities. The Tuberculosis Elimination and tion for the Elimination of Tuberculosis Laboratory Cooperative Agreement was (NCET) to garner more private support, and revised for FY2000 to ensure prioritization of strategically utilizing the media to inform the the core TB activities (completion of therapy, general public and legislators regarding TB. contact investigation, surveillance, and labora- tory) for all TB programs, with separate Managed Care and TB Control – funding provided on a competitive basis for A New Era targeted testing and treatment of latent TB by Bess Miller, MD, MSc infection for high-risk groups in programs Associate Director for Science, DTBE demonstrating good performance on the core activities. After the TB sanatoria were closed during the 1960s and 1970s, typically both clinical care Federal funds are intended to supplement the and public health functions for TB control state and local activities for TB control and were carried out in the health department prevention, and in many states, federal funds setting. However, during the past three de- represent only a small fraction of the total cades, there has been an increasing trend funds available to the TB program. However, toward the provision of clinical care for in many other states, federal funds represent patients with TB by the private sector. By the majority of TB funding available. Further- 1998, about 50% of the care for patients with more, some areas are actually reporting a TB was provided either partially or totally by reduction in their state or local TB funding. the private medical sector. More recently, the Yet the level of federal funding is expected to managed care transformation has increased again remain the same in fiscal year 2000 and this movement of patients with TB away from 2001, which will result in a decreased amount clinical care in health department settings. of available funds when inflation factors are Patients with TB may be enrolled in managed applied. Although cases have declined since care organizations as a result of coverage under 1993, the case rate of 6.8 per 100,000 in 1998 is employee benefit plans, privately purchased still far short of the target of 3.5 per 100,000 insurance policies, or as a result of enrollment by the year 2000 set by CDC, and aggressive in Medicaid or Medicare programs. The TB prevention and control efforts must be Omnibus Budget Reconciliation Act of 1993 sustained to continue on a successful course to (OBRA) permitted states to extend Medicaid elimination. This will require the continua- coverage to persons with TB, and some states tion of our current efforts and the develop- have used this legislation to enroll such pa- ment of new or increased funding initiatives at tients in their Medicaid programs. In addition, every level, including federal, state, and local. as part of overall Medicaid managed care restructuring, a few states have expanded The Advisory Council for the Elimination of coverage to include previously uninsured Tuberculosis (ACET) published “Tuberculosis persons. The vulnerable populations among elimination revisited: obstacles, opportunities, the newly insured are likely to include persons and a renewed commitment” in the MMWR, at high risk for TB. The shifting of care of August 13, 1999/Vol. 48/No. RR-9, and also patients with TB into managed care plans, stated the need for additional resources to fully with the emphasis on management of costs, implement effective elimination strategies. In has raised new concerns in the public health addition to fiscal resources, ACET recom- community with regard to the ability to mended building a stronger advocacy at every maintain adequate community TB control as level of government as well as engaging new well as to provide optimal management of

47 TB Control at the Millennium patient care in light of these changes. During the past several years, there have been a number of symposia addressing the impact of A survey of state and big city TB controllers managed care on TB control, which were conducted in collaboration with the National conducted at national meetings of the Ameri- TB Controllers Association in late 1997 can Public Health Association, the National revealed the following: 1) health departments TB Controllers Association, and the Centers are still acting as the traditional provider of for Disease Control and Prevention. In these TB clinical services in most areas of the coun- symposia, a number of themes have emerged, try; 2) in some areas, however, managed care including the urgency of ensuring quality care has changed the way TB clinical services are for TB patients by health care providers with being delivered (examples of these new ar- expertise in treating TB; continuous treatment rangements included managed care organiza- and completion of therapy with the use of tions as providers of clinical services to their DOT; use of laboratories with expertise in enrollees with TB, health departments acting mycobacteriology; timely reporting of cases to as members of managed care organizations the health department and initation of contact provider networks, and health departments investigations; development and use of perfor- acting as non-network, fee-for-service provid- mance measures to monitor patient care and ers to managed care organizations); 3) health “public health performance”; and systems to departments are providing the majority of ensure ongoing dialogue between health public health services for TB patients who are department staff and managed care organiza- enrolled in managed care organizations (con- tion providers. tact tracing, providing directly observed therapy, and returning lost patients to care); At the same time, there is recognition that the 4) many managed care organizations are using delivery of health services through managed their own or other private laboratories to care organizations presents opportunities to process TB specimens, rather than state labora- public health leaders, including improved tories; and 5) in many areas, health depart- access to high-risk populations for preventive ments are not being consistently reimbursed services and to health care providers for for providing TB services to patients with training and education on best practices. In private insurance coverage or Medicaid addition, the administrative data systems of coverage. managed care organizations may provide opportunities for improved surveillance and evaluation of quality of care. The Division of The pioneering industrial social worker Lee Tuberculosis Elimination has collaborated Frankel envisioned insurance as a powerful with Harvard Pilgrim Health Care, a large means toward improving the lot of the mixed model health maintenance organization underprivileged. When he was hired by the in New England, to review the use of adminis- Metropolitan Life Insurance Company, he trative data systems to augment tuberculosis established MetLife’s Welfare Division. surveillance and the use of pharmacy records Frankel’s early work centered on the prevention of TB, the “white plague” that to assess the management of tuberculosis. accounted for 20 percent of all death claims. (Please see “Supplementing tuberculosis sur- He realized that public education was the veillance with automated data from health key. In 1909, 10,000 MetLife agents deliv- maintenance organizations.” Yokoe DS, ered Frankel’s pamphlet A War Upon Subramanyan GS, Nardell E, Sharnprapai S, Consumption to millions of urban poor, who McCray E, and Platt R. Emerging Infectious are most at risk for TB (source: Metropoli- Diseases 1999; 5:779-787, and “Using auto- tan Life Insurance Co. Web site). mated pharmacy records to assess the manage- ment of tuberculosis.” Subramanyan GS,

48 Notable Events in TB Control

Yokoe DS, Sharnprapai S, Nardell E, McCray The Student Nurse Study was initiated by E, and Platt R. Emerging Infectious Diseases Palmer, and was supported by the National 1999; 5:788-791). Administrative data sets Tuberculosis Association until the foundation provided useful information in both studies. of the Tuberculosis Control Division. During the period from 1943 to 1949, some 22,000 To assist health departments, State Medicaid student nurses in 76 schools were given tuber- Agencies, and managed care organizations in culin tests every six months by a specially the development of written agreements to trained team. On one of these occasions, ensure the provision of quality patient care approximately 10,000 nurses were also given and public health TB prevention and control chest radiographs. Comparison of skin test and practice, DTBE has collaborated with the radiographic findings showed that many Office of Health Care Partnerships of the pulmonary calcifications were due to histoplas- Epidemiology Program Office, CDC, and mosis, that histoplasmosis was concentrated in with the George Washington University certain areas of this country, and that many Medical Center’s Center for Health Policy positive tuberculin reactions were due to Research to develop model contract specifica- nontuberculous mycobacteria. tions. (Refer to the article “Tuberculosis control in a changing health care system: Confirmation of these results came from a Model contract specifications for managed research unit established in 1945 in Kansas care organizations.” Miller B, Rosenbaum S, City, Missouri, to study the epidemiology of Stange PV, Solomon SL, and Castro KG. histoplasmosis. Two little-known findings Clin Infect Dis 1998;27:677-686.) These deserve emphasis. In two midwestern counties, specifications can be accessed on the internet there was remarkable local variability in the at the following website: http:// frequency of histoplasmin reactions among www.gwu.edu/~chsrp. cattle. Farms with histoplasmin-positive cattle were interspersed irregularly among those with no reactors. (This marked small-area variability Early Research Activities of the TB was later found in Maryland among high Control Division school students, suggesting that risk factors for By George W. Comstock, MD, DrPH, FACE endemic and outbreak histoplasmosis are Alumni Centennial Professor of Epidemiology different.) Johns Hopkins University School of Hygiene and Public Health Studies of tuberculin, histoplasmin, and various nontuberculous mycobacterial antigens reached Herman E. Hilleboe was the first Chief of the their peak with the testing of more than a Tuberculosis Control Division of the United million US Navy recruits from 1958 to 1969. A States Public Health Service, with Carroll E. detailed report of the results of the first half- Palmer as director of the Field Studies Sec- million tests delineated the extent of these tion, the unit responsible for most of the infections in cities, counties, and states. Other Division’s research. This review is based important findings were as follows: a) in any largely on perusal of the 70 Tuberculosis area with nontuberculous mycobacterial Control Issues, published during the first week infections, the larger the tuberculin reaction, of every month as special issues of Public the greater the probability that its cause was Health Reports. This arrangement continued tubercle bacilli; b) the risk of developing TB from March 1, 1946, to December 7, 1951, after infection was high among underweight when Public Health Reports changed to a persons and low among the obese; c) there was monthly schedule. a suggestion that nontuberculous mycobacte- rial infections conferred some resistance against

49 TB Control at the Millennium

TB; and d) there was also a suggestion that finding involved the first 56 cases among social stress increased the risk of survey participants who did not have a known developing TB. case in the household. Some 13,000 possible contacts were identified (relatives, friends, A major purpose of the Muscogee County workers in the same factory, school mates, (GA) Tuberculosis Study, started in 1946, was etc.). Approximately 11,000 were examined, to evaluate the role of mass chest x-ray surveys with the identification of only one possible in TB control. The prospectus and a descrip- but unlikely source case. The facts that so tion of the coverage of the survey and preva- little TB developed among nonreactors (those lence of TB were included in the first two eligible for vaccination) and that BCG ap- papers published on this study. Calculation of peared to cause harm among school children participation rates was made possible by the and to afford very little protection to older population denominator provided by a private persons were major considerations in the census. Basic factors associated with participa- hesitancy to advise BCG vaccination in the tion and the prevalence among participants United States. Over a 23-year period, there were described, as well as reasons for not were slightly but significantly more cancer taking part in the survey. Subsequent papers, cases among vaccinees than controls, most building on this foundation, were able to markedly for tumors of the lymphoid tissues. provide information on the incidence of TB among tuberculin reactors and the risks of Many other studies were carried out by the reactivation among persons with inactive TB, Field Studies Section during this period. information that has been used to the present There were numerous reports relevant to mass time. chest x-ray surveys, then in their heyday, dealing with topics such as x-ray generators, The first report of the BCG trials in Muscogee fluorescent screens, films, protection of per- County and Russell County (AL) appeared in sonnel, and the feasibility of taking photofluo- 1951. The school children vaccinated in 1947 rograms without having participants disrobe. were retested 6 months later, and many con- The development of standardized fungal trols and vaccinees were tested with tuberculin antigens, notably histoplasmin, was also an again in 1950. Both groups had had less than 5- important endeavor. Finally, and far from mm induration to the 100-TU dose of PPD least important, was the publication of Carroll tuberculin in 1947. Although 46% of the Palmer’s ideas for research that could be done vaccinees had 5 or more mm of induration to in conjunction with the mass tuberculin 5 TU of PPD-tuberculin 6 months later, only testing and BCG vaccination then underway 24% of them had reactions this large in 1950; in the International Tuberculosis Campaign. at that time, only 3% of controls had similar reactions. Subsequent follow-up of persons in (Editor’s note: Dr. George Comstock con- these trials produced findings that were com- ducted the trials in Georgia from 1946 to 1955. pletely unexpected at the time of their initia- He continued to make major contributions to tion. In contrast to the belief that most TB the knowledge of TB and measures to prevent occurred very shortly after infection and that the development of TB. After retirement from those who survived this short-term risk were the PHS he became the Alumni Centennial relatively safe thereafter, approximately 80% Professor of Epidemiology at Johns Hopkins of TB developed among the initially positive University. Dr. David Sencer, a medical reactors who continued to be at risk. This officer, was then assigned to Georgia to con- finding dashed an early hope, namely that the tinue Dr. Comstock’s work. He subsequently source of a new case of TB ought to be readily rose through the CDC ranks to become the found among recent contacts. An unpublished Director of CDC, serving from 1966 to 1977.)

50 Notable Events in TB Control

The First TB Drug Clinical Trials Philadelphia, was the chairman of the Study by Rick O’Brien, MD Section’s Steering Committee. Ms. Ferebee, Chief, Research and Evaluation Branch, DTBE Chief of the Therapy Evaluation Branch, Field and George Comstock, MD, DrPH, FACE Studies Section, became the study administra- Alumni Centennial Professor of Epidemiology tor. With some grumbling from those who Johns Hopkins University had lost their streptomycin allocation, a School of Hygiene and Public Health controlled trial was conducted, although without the placebo controls Palmer and The United States Public Health Service Ferebee had wished. All investigators took (USPHS), together with the British Medical part in various reviews of clinical and radio- Research Council (MRC) and the US Armed graphic findings and in committees set up to Forces–Veterans Administration Cooperative consider appeals from the protocol, proce- Trials, played a key role in the development of dures continued in future PHS therapy trials the chemotherapy of TB. as a way to bring investigators together and give them a real part in major decisions. The first USPHS trial, a placebo-controlled study of streptomycin, was initiated by the The study demonstrated the remarkable Field Studies Section and the Tuberculosis ability of streptomycin to reduce mortality Study Section of the National Institutes of and improve clinical status. However, Health (NIH) in 1947, the same year as the monotherapy with streptomycin led to the much smaller but better known MRC study of development of drug resistance in a significant streptomycin. In the PHS study, a total of 541 number of patients. In 1951, the one-year patients with moderate to far-advanced pulmo- status was reported for the patients given nary TB were enrolled at 14 hospitals and streptomycin: 40% had negative cultures, 5% sanatoria throughout the US and Alaska. The had died, 17% still had tubercle bacilli sensi- published account gives no hint of how this tive to streptomycin, and 39% had resistant controlled evaluation of streptomycin was organisms. In another 1951 report, PAS was saved from being only the series of uncon- found to be highly effective in preventing trolled observations resistance to dihydrostreptomycin (similar in that was initially action to streptomycin but with a higher risk proposed. Funds for of ototoxicity.) a study of streptomy- cin in the treatment The second USPHS study, begun in 1949 at 11 of TB had been institutions, randomized a total of 315 patients allocated, probably to either streptomycin or streptomycin-PAS. in 1946, to a number After 6 months of treatment, over 40% of of prominent hospi- patients receiving monotherapy developed tals. When Carroll streptomycin resistance, compared to only Palmer heard that 12% of patients on combination therapy. there were to be no controls, he was A major advance in TB treatment occurred in upset and expressed 1952 with the initial report of an MRC study his concerns to Dr. Van Slyke, director of the of isoniazid. During the next 2 years, a total of NIH. Van Slyke agreed with Palmer, and 5,324 patients were enrolled in three USPHS directed that a controlled trial be planned and trials (which became known as Studies 1, 2, conducted under the general supervision of the and 3), examining a variety of combinations of newly convened Tuberculosis Study Section. the three drugs. The conclusion of these Dr. Esmond Long, from Phipps Clinic in studies was that the triple combination did not

51 TB Control at the Millennium appear to be more efficacious than the combi- Study 19 evaluated various dosages of rifampin nations of any two of the drugs. However, and found that the optimal daily dosage was 10 the combination of isoniazid and PAS was mg/kg or 600 mg for most adults. much better tolerated. Evidence from an MRC study indicated that initial streptomycin As rifampin-based short-course therapy be- did contribute to treatment efficacy in patients came firmly established, support for therapy with advanced disease. Another MRC study trials in the US began to wane. Study 20, the determined that the optimal duration of first USPHS study initiated after the research therapy with these drugs was 2 years. division moved to CDC, attempted to dupli- cate a smaller MRC study of a 6-month regi- With the scientific basis for TB chemotherapy men of isoniazid and rifampin and found that firmly established, the PHS turned its atten- the relapse rate of 10% was unacceptably high. tion to the next drugs that became available Study 21, which began enrollment in 1981, for clinical study, pyrazinamide and cyclos- was plagued by continuing shortages in finan- erine. However, initial evaluation of pyrazina- cial support such that the study was nearly mide at much higher dosages than are cur- terminated several times before it successfully rently used suggested that the drug was too completed enrollment. That study confirmed toxic for use in initial treatment, although it the results found by the MRC and led to the appeared to have a role in the treatment of adoption of 6-month therapy in the US. It drug-resistant disease. Subsequently, through was not until the resurgence of TB in the US, a series of elegant studies in Africa and Asia, with the concomitant increased support for the MRC defined the critial role of that agent TB research, that the capacity of the USPHS in modern short-course therapy. to conduct high-quality TB treatment trials was restored. While continuing to conduct treatment effi- cacy studies, the USPHS also embarked on Current TB Drug Trials: pioneering studies of isoniazid for the preven- The Tuberculosis Trials Consortium tion of TB in persons with latent TB infection (TBTC) (LTBI). Between 1955 and 1959, nearly 65,000 by Andrew Vernon, MD, MHS persons including children with primary TB, Research and Evaluation Branch, DTBE contacts of infectious TB patients, patients in mental institutions, and Alaskan villagers, were entered into placebo-controlled trials that demonstrated the efficacy of isoniazid for treatment for LTBI.

In 1960, CDC was given responsibility for TB control and research. However, the research division resisted pressure to move to Atlanta and continued its work from Washington. In USPHS studies 12 to 16, the role of ethambu- The USPHS and the Veterans Administration tol as a first-line drug replacing PAS was (VA) have a distinguished history of conduct- defined. In 1969, the USPHS began the first of ing clinical trials to evaluate new drug regi- a series of studies of rifampin, ushering in the mens for both the treatment and prevention of modern era of short-course therapy. Study 18 TB. In 1960, CDC assumed a major role in found that the combination of isoniazid and these studies when the USPHS Tuberculosis rifampin was superior to the best regimen that Division was transferred to CDC. Subse- had been evaluated up to that time. USPHS quently, CDC coordinated a series of

52 Notable Events in TB Control multicenter clinical trials that helped to estab- The consortium now provides a unique and lish rifampin-based, short-course therapy as important resource for further clinical studies, the standard for TB treatment. It also con- and has demonstrated its ability to play an ducted studies to provide the scientific basis important role in TB treatment and for preventive chemotherapy, which remains a prevention. major component of our TB elimination strategy. The original group of clinical sites included 12 academic centers and health departments (7 Support for the infrastructure required for contracts issued in 1993, and 5 more in 1994), these studies gradually diminished, so that the and 15 VAMCs (funded through a Memoran- last completed trial, USPHS Study 21, was dum of Agreement with the Washington, DC, nearly terminated several times during its VAMC). Enrollment into USPHS Study 22 course for lack of adequate funding. With the began in April 1995, and continued to comple- infusion of federal support for TB control and tion in November 1998. In 1997 CDC began elimination in the early 1990s, CDC estab- working with the USPHS Study 22 investiga- lished a consortium of clinical investigators for tors to develop a structure that would engage the specific purpose of conducting USPHS more fully the capacities of the study investiga- Study 22, a trial of once-weekly isoniazid and tors in the work of the group. The TBTC was rifapentine in the continuation phase of thus organized, with formal by-laws adopted therapy for pulmonary TB. This consortium, in 1998. Several working committees were whose sites include public health departments, established; these are composed of selected academic medical centers, and VA medical Consortium investigators and coordinators, in centers (VAMC), required both time and collaboration with CDC staff. One committee substantial financial resources to establish and (Core Science) oversees the scientific program support, but is now functioning efficiently. of research, a second (Implementation and Quality) supervises the conduct and quality of Did you know that... ongoing studies, and a third (Executive Af- Aspirin was developed as a cure for fairs) serves as the executive arm of the steer- tuberculosis? Researchers in Switzerland ing committee. This structure is modeled on looking for a cure for TB were excited to the Community Programs for Clinical Re- discover that one particular compound search on AIDS (CPCRA), which is supported was able to relieve the fever and pain of by the National Institute of Allergy and TB patients. They subsequently found that Infectious Diseases (NIAID). it only provided temporary relief, not a cure, and they put the drug aside. The In 1999 the TBTC underwent a formal exter- compound was later rediscovered and named nal re-competition. New 10-year contracts aspirin (from A. Karlen, Man and Microbes, were awarded to 13 offerors (7 prior TBTC Putnam & Sons, NY, 1995). members and 6 new sites). The VA side of the consortium underwent a similar process, and funded 10 VA Medical Centers to continue as Currently new drugs and regimens for both members of the TBTC. TB treatment and prevention, new diagnostic tests, and new vaccine candidates are becoming The current studies of the TBTC are as fol- available for clinical investigation. Concur- lows: rently, the challenges posed by the goal of TB elimination are increasing, as global rates of Study 22: Randomized open-label trial to drug resistance increase and as the costs associ- evaluate the efficacy of once-weekly isoniazid ated with assuring high rates of adherence rise. and rifapentine in the continuation phase of

53 TB Control at the Millennium therapy for pulmonary TB. Enrollment closed NAA Substudy: Study of the performance of in November 1998 with 1,004 HIV-negative several nucleic acid amplification participants. Follow-up will continue through methodologies in the diagnosis and mid-2001. management of active TB. CDC IRB approval granted in October 1999. Study 22 PK Substudy: Substudy to evaluate isoniazid, rifampin, and rifapentine pharmaco- Study 25: Phase I-II dose escalation study of kinetics in 150 patients enrolled in Study 22. rifapentine using same design as Study 22, with Currently in analysis. patients completing 2-month standard induction randomized to 600, 900, and 1200 Serum Bank Study: Collection of docu- mg of once-weekly rifapentine/isoniazid. mented serum specimens from patients with Expected to demonstrate safety and suspected or proven TB, from baseline tolerability of higher doses of rifapentine, through the course of therapy. Nearing which may improve efficacy, prevent acquired completion. rifampin resistance in HIV-infected patients, and permit use of once-weekly treatment in Study 23: Single-arm clinical trial to evaluate initial phase. Enrollment began July 1999. the safety and efficacy of rifabutin-containing short-course therapy for HIV-infected TB Study 26: Trial of short-course treatment of patients receiving HIV protease inhibitors. latent TB infection among contacts of active Aims to enroll 200 patients over 2 years, with cases, using a 3-month once-weekly regimen of 2-year follow-up. Enrollment began in March isoniazid and rifapentine, compared to the 1999. recently recommended 2-month daily regimen of rifampin and pyrazinamide. Protocol in Study 23a: Substudy to evaluate isoniazid and design. rifabutin pharmacokinetics in Study 23 TB patients with HIV receiving antiretroviral For further information about the therapy. Enrollment began July 1999. Consortium, please visit the TBTC web site at http://www.cdc.gov/nchstp/tb/tbtc Study 23b: Substudy to evaluate rifabutin and nelfinavir pharmacokinetics in TB patients TB Communications and Education with HIV receiving nelfinavir as part of by Wanda Walton, M. Ed. antiretroviral therapy. CDC IRB approval Chief, Communications and Education Branch granted in November 1999.

Study 23c: Substudy to evaluate rifabutin and efavirenz pharmacokinetics in TB patients with HIV receiving efavirenz as part of antiretroviral therapy. Enrollment began December 1999.

Study 24: Single-arm study of largely intermittent, short-course therapy for patients with INH-resistant TB or INH intolerance. Aims to enroll 200 patients over 2 years with 2 Training and education in TB have changed years of follow-up. Enrollment began dramatically over the years. In the not-too- September 1999. distant past, these efforts were primarily limited to face-to-face classroom instruction

54 Notable Events in TB Control and the distribution of print-based materials. variety of ways. Hard copies can be ordered Educational films, then later videotapes, were by mail, by telephone, by fax, or through the developed and distributed, but often these Internet online ordering system. Materials can materials had a very limited distribution also be downloaded and printed from the because of the costs of the films and tapes and Internet. The electronic files of the materials the limited availability of audiovisual available through the Internet can also be equipment for viewing. utilized as the basis for adaptation and development of site-specific or population- Today, through the availability of technology specific materials. and reduced production costs, we have a vast array of materials and courses that are Another big change in TB training and distributed through a wide variety of media. education is in the methodologies used to Some of the media include print-based influence health care providers’ curricula with slides (e.g., the Core implementation of TB recommendations. In Curriculum on Tuberculosis); CD ROM (e.g., the past, the primary method utilized was Tuberculosis: An Interactive CD ROM for information dissemination to increase the health care providers’ knowledge of the recommendations. However, we know that information alone is not sufficient to change the practice of many health care providers. In addition to knowledge or information, health care providers must be persuaded to try the new recommendations. This persuasion can occur if the health care provider thinks that the recommendations provide an advantage (is it better than what it’s replacing?); is compatible with the current system (no major conflicts created in the current system to implement); is not too complex (how hard is it Clinicians); satellite-based courses (e.g., the to do or use?); can be tried beforehand (can I Satellite Primer on Tuberculosis); videotapes try it before I decide to really use it with (e.g., the Skin Testing Video); audiotapes (e.g., patients?); can be observed (can I actually see the TB voice information system); and the result of using this innovation?); and is Internet-based courses (e.g., the Web-Based flexible to being adapted to the current system. Self-Study Modules). With the use of satellite- After being persuaded that there is an based courses, instructors can simultaneously advantage to the new recommendation, health reach thousands of health care providers in care providers must progress through a every US state and territory with accurate, up- decision process (adopt or reject), then to to-date information. Reduced costs for the implementation, then to continued, ongoing reproduction of videotapes and CD ROMs use of the recommendations. Behavioral allow for wide-spread distribution of theories and models can be utilized to guide materials. In addition, the Internet allows for the development of educational and training distribution of materials and courses to interventions to aid in this progress. audiences we may have never reached before, Interventions such as academic detailing and both professionally and geographically, at no the use of opinion leaders can be utilized to additional cost after initial production. facilitate the progress.

Print-based materials are also accessible in a For current and future efforts, utilization of

55 TB Control at the Millennium behavioral science and implementation of implemented. Regardless of names and operational research are essential for versions, TB information management systems developing effective interventions in TB pursue the same general objective: the use of communications, training, and education. meaningful data, that is, intelligence-added With decreasing TB cases in the United States, data, to perform organizational work and it becomes even more important to be vigilant, monitor outcomes. efficient, and effective in our efforts to keep health care providers aware of recommend- ations, and utilizing them appropriately.

Note: Please feel free to use the DTBE Educational and Training Materials order form included in this issue. Materials can also be ordered from the DTBE web site at http:// www.cdc.gov/nchstp/tb

TB Control in the Information Age TIMS is an integrated client-server application by Jose Becerra, MD, MPH in Windows, meaning that many users Chief, Computer and Statistics Branch (“clients”) may simultaneously access a fully relational database residing in a secure server “TRS is a computer-based within a computer network, using the system devised to furnish Microsoft Windows graphics user interface. current information on clinical TIMS has replaced the mailing of diskettes management of patients and up- with dedicated modem communications for to-date statistical summary data transfer purposes. Furthermore, TIMS reports for public health allows the generation of surveillance data from administrative purposes.” - the patient management module integrated Tuberculosis Branch, State and within TIMS. Soon, TIMS will also be able to Community Services Division, import surveillance data from other systems to National Communicable completely eliminate the need for double data Disease Center, Sept. 1969. entry.

Thus was recorded one of the first iterations of However, when TIMS was originally an electronic information management system designed, the Internet revolution that for the purpose of tracking the epidemiology nowadays dominates the informatics world and clinical management of TB in the United was just beginning. The World-Wide Web States. The Tuberculosis Record Service model, wherein interactive and secure data (TRS), a mainframe system using punch cards transactions are conducted using a common and computer tapes for data processing, was a viewer or “browser,” regardless of the original predecessor of the DOS-based SURVS-TB platform in which an application is developed, (Software for Expanded Tuberculosis poses new opportunities and challenges to the Surveillance). SURVS-TB, a microcomputer future of TIMS. Among these challenges are system depending on mailed diskettes for data 1) the speed with which information transfer, and the Tuberculosis Database technology is being adopted (and abandoned); System (TBDS), a patient management and 2) the call for fully “integrated” recordkeeping system, were used until 1998 information systems. when the Tuberculosis Information Management System (TIMS) was The transition of TIMS into a Web-enabled

56 Notable Events in TB Control

disease-prevention efforts in a patient-centered health care delivery model, but ultimately accountable for its funding. Therefore, TIMS will reflect this funding accountability by protecting TB data integrity and its proper use for program evaluation purposes.

Our organizational mission is to promote health and quality of life by preventing, Old TB recordkeeping system. controlling, and eventually eliminating TB from the United States. Our National application will eventually occur. We can Strategic Plan calls for a reduction of the TB envision a local department of health, with a case rate to less than one per million low-end (“thin”) computer and a browser, population by the year 2010. Therefore, we logging in to a state or regional server to need to leverage information technology to securely send in interactively validated TB manage, analyze, and synthesize practical data or to browse the results of some knowledge at the local, state, national, and descriptive trend analyses. We can also international level to facilitate the envision a health maintenance organization organizational work that will move us closer uploading data on a batch of TB suspects and to that organizational objective. contacts to be worked up by local health department staff. These data would be Data are processed; information is managed; subsequently sent to CDC without personal knowledge empowers. Information becomes identifiers, using a commonly agreed-upon knowledge, and thus power, when format. However, the speed with which systematically structured and functionally information technology is changing many organized for a specific purpose. But there is times hinders the wise selection of platforms, one crucial premise in this line of reasoning: software development tools, and practices that the existence of an organizational will. An permit the design of durable and reliable Web- organizational will requires commitment to based surveillance systems. accomplish a mission, and that commitment begins with a will to know. Once that The word integration is trendy nowadays. organizational will is present, and it certainly However, integration is a value-laden term is present in the TB prevention community, that may mean consolidation to some, as in TIMS is and will be ready to facilitate the block grants, while it may mean coordination organizational work that will move us closer of efforts to others. TIMS might be considered to achieve our organizational objectives for the an integrated system: it integrates patient year 2000 and beyond. management with surveillance data. And TIMS will become fully integrated with other information management systems once its data Field Services Activities import utilities are completed and a new by Patricia M. Simone, MD version is released complying with public Chief, Field Services Branch health, clinical, and laboratory informatics standards now in development as part of the In the early 1960s, with the initiation of CDC-wide surveillance integration efforts. categorical project grants, the Tuberculosis The future of TIMS hinges on the assumption Branch moved to Atlanta to join CDC, called that TB will remain a categorically funded then the Communicable Disease Center. In program, possibly integrated with other 1974, the Tuberculosis Branch became the

57 TB Control at the Millennium

Division of FIE TBE LD S Tuberculosis Control D TA The number of field staff positions grew from C F D F with two branches: the C a low of 25 in 1980 to over 60 by 1996. In Program Services addition to assigning more Public Health Branch (which also Advisors to the project sites for enhanced ✴✢ contained training and ✣❏■▼❒❏ capacity building, FSB has hired several field surveillance) and the medical officers serving as medical

Research Branch. In M epidemiologists and medical directors in A E 1986, surveillance K NC various TB project sites. These positions also ING RE became a separate A DIFFE serve as key training positions to develop TB branch. The Program clinical and programmatic expertise as older Services Branch was reorganized into two TB experts retire. In order to better meet the sections: the Program Operations Section and needs of the larger field staff, the Field Staff the Program Support Section. The Program Working Group was established to enhance Operations Section was responsible for communication between headquarters and the providing technical assistance and field, and a field staff training and career administering cooperative agreement funding development coordinator was added to the to the state and local TB programs. A team of headquarters staff of FSB. program consultants served as project officers for the project sites, and field staff were The last group of persons hired in the Public assigned to various state and local TB Health Advisor (PHA) series were recruited in programs to assist with program 1993. Through attrition and promotion, the implementation. The Program Support pool of PHAs has continued to diminish Section was responsible for training and without being replenished with new recruits, educational activities as well as program yet the demand for Public Health Advisors to evaluation through information collected in be assigned to the TB project areas continues. the Program Management Reports. FSB is in the process of completing work on a recruitment and training program for junior- In 1991, the name of the division changed to level field staff to be assigned to state and local the Division of Tuberculosis Elimination. In TB programs. 1996, the Division of Tuberculosis Elimination was reorganized. The Program FSB is looking to the future by continuing to Services Branch became the Field Services emphasize core TB prevention and control Branch (FSB). The Program Support Section activities, enhancing program evaluation of the Program Services Branch became the activities to help ensure that programs are as Communications and Education Branch, efficient and productive as possible, and although the program evaluation activities working toward TB elimination. remained in FSB. The Program Operations Section became two sections, Field Operations TB’s Public Health Heroes Sections I and II, with approximately one half by Dan Ruggiero, Olga Joglar, and Rita Varga of the project sites covered by each. A medical Division of TB Elimination officer was assigned to each of the new sections to work closely with the program consultants to enhance technical assistance and Tuberculosis is frequently called a “social program evaluation capacity. A third medical disease with medical implications.” The popu- officer conducts studies and other activities lations most affected by TB today are urban centered around program evaluation and and poor; they are the medically underserved program operations. low-income populations such as high-risk minorities, foreign-born persons, alcoholics,

58 Notable Events in TB Control intravenous drug users, residents in long-term the “fresh air treatment.” care facilities such as correctional facilities, and the homeless. Active tuberculosis with subse- In the 1950s, federal public health advisors quent spread of infection to contacts poses a were assigned to local health departments to significant threat to the community. Practicing provide technical assistance and treatment physicians, for the most part, focus on the guidelines and to assist local health depart- individual patient, and to some extent on the ments with TB surveillance and control activi- family; public health officials focus on patients ties. In the 1960s New York City hired “lay as a group, on families, and on the commu- tuberculosis investigators” to track down nity. So, in controlling TB, who are the real noncompliant patients. The workers would heroes? Who, on a daily basis, deals with the visit patients’ homes, and as needed, track patients, their families, and the health care them to unsavory locations, such as local bars, providers? Who does the leg work required to clubs, and hangouts. Since then, most state ensure patients are monitored through and local health departments have hired and completion of treatment, and that contacts are trained lay persons and nurses to carry out similar functions and activities. Who are these people that have played an important role in the fight against tuberculosis and why is it that we hear so little about them? They are the backbone of the TB control program, the foot soldiers who are willing to place their lives on the frontline each day in order to do battle against the common enemy - tuberculosis.

TB control programs have used public health field workers with different backgrounds and expertise to monitor patients and assist them in adhering to and completing the recom- mended course of treatment. Responsibilities assigned to these workers vary by area and

Nurse crossing roofs to visit patients degree of complexity. Some workers conduct surveillance activities by visiting hospitals, identified and evaluated? Public health field laboratories, and infection control officials; workers are the real heroes in the fight against others provide services out in the field such as tuberculosis. conducting home visits or providing DOT, which can put them in risky situations. And Historically, in the United States, community even under difficult circumstances, field outreach workers have played an important workers continue doing their work. Field role in waging a successful battle in the war reports document clients and patients directing against tuberculosis. Hermann Biggs, in 1896, violent threats and hostile incidents to public called for health inspectors to visit homes of health workers. Field workers survive by TB patients and educate their families on how learning conflict resolution and field safety to deal with those suffering with the disease and by using precautionary measures when and how to prevent future cases. In the 1920s conducting their activities. The threat of and 1930s visiting nurses were climbing and violence that field public health workers jumping over New York City tenement roof experience while in the line of duty cannot be tops to visit TB patients who were being given controlled by detection devices used in office

59 TB Control at the Millennium facilities to provide protection to workers. purchasing pizza out of his or her own pocket Although these workers know of the risks to ensure DOT compliance, or a nurse driving involved, they continue to carry out their long distances to make sure that patients living efforts to control TB in their areas. in rural areas receive their medication or are transported to a clinic or hospital for tests, Many names have been used to describe the public health field workers do whatever is job of these dedicated individuals. Outreach necessary to achieve their objective: tuberculo- workers, public health advisors, case manag- sis control. ers, DOT workers, and epidemiology techni- cians are some of the titles given to the public What do we call these individuals who have health field workers. The heroes of TB come been central figures in the tuberculosis control from all backgrounds, education, and ethnic movement for the past 40 years? Public health groups. Hiring requirements vary from state heroes! to state, and while many have advanced col- lege degrees, others may be from the same Infection Control Issues population group as the patients they serve by Renee Ridzon, MD and have little or no schooling. Surveillance and Epidemiology Branch

Public health workers have the responsibility In recent years, transmission of TB within the of establishing effective communication with workplace has received much attention in the patients. The outreach workers are usually the scientific and popular press. However, the first contact the patients have with the health notion of TB as an occupational hazard is not department and TB programs. The ability of new, and since the beginning of this century outreach workers to use their interpersonal TB has been recognized as an occupational and communication skills in dealing with hazard for doctors and nurses. In fact, there patients will set the stage for a positive or have been several studies published in the first negative attitude toward the healing process, part of the 1900s documenting low rates of and consequently whether the patients will M. tuberculosis infection among medical and comply with the recommended regimen. Field nursing students prior to the start of training. After completion of clerkships caring for TB workers must be culturally sensitive and must patients, high rates of tuberculin skin test understand patients’ beliefs, cultures, and conversions and even cases of TB were seen. environment; in many instances they develop Concern about this occupational risk waned, relationships with patients that extend beyond however, with the dramatic fall in the number the duration of treatment. Just like the TB of TB cases in the US. heroes at the turn of the century, they bring with them a spirit, zeal, vision, and determina- With the re-emergence of TB in the mid-1980s, tion to assist those individuals afflicted with the emergence of multidrug-resistant TB TB disease and infection and to bring about an (MDR TB), and recognition of the increased end to this disease. morbidity caused by MDR TB and HIV- related TB, concern regarding TB was The dramatic decrease in the number of TB reawakened in this country. Media reports cases in the US since 1993 could not have been about the danger of TB were fueled by a accomplished without the persistent hard number of published reports regarding work of theses individuals. The success we explosive outbreaks of MDR TB in hospitals, enjoy today came about, and continues, mostly in New York City, among persons through the efforts of thousands of outreach with HIV infection. Concern was further workers. Whether it is a public health advisor heightened by episodes of transmission of

60 Notable Events in TB Control disease to health care workers caring for the patients involved in these outbreaks. Hierarchy of TB Control Measures

With recognition of the increased risk for TB among persons with HIV infection, in 1990 CDC issued Guidelines for Preventing the Transmission of Tuberculosis in Health-Care Settings with Special Focus on HIV-Related

Issues. Despite these guidelines, I. Source Control II. Environmental III. Protective devices (most effective, efficient) Control for workers (least implementation of appropriate infection effective, efficient) control measures was incomplete in many hospitals, and some of the published reports of nosocomial transmission documented lapses in nosocomial transmission of M. tuberculosis. or absence of infection control measures in the Included in the recommendations was a health care facilities. Because of its legal hierarchy of controls composed of, most mandate to ensure that no worker is harmed importantly, administrative controls as a result of his or her work experience, as (including assignment of responsibility, risk well as the outbreaks of MDR TB, in 1992 the assessment, development of a TB infection National Institute for Occupational Safety and control plan with periodic reassessment, and Health (NIOSH) recommended the use of tuberculin skin testing of health care workers), powered-air purifying respirators (PAPRs) by followed by engineering controls, and then by health care workers potentially exposed to personal respiratory protection. Personal M. tuberculosis. respiratory protection devices that were recommended for use in the health care setting As a result of the ongoing outbreaks of TB and needed to meet the following criteria: the NIOSH recommendation for the use of 1) ability to filter particles of 1 micron with a PAPRs, the adequacy of the 1990 guidelines filter efficiency of 95%, 2) ability to be fit was discussed at a large national meeting tested to obtain a face seal leak of 10% or less, convened in 1993. In attendance at this 3) ability to fit different face sizes, and meeting were representatives from multiple 4) ability to be checked for face-piece fit by groups concerned with nosocomial health care workers each time the respirator transmission of M. tuberculosis, including was used. At the time the 1994 guidelines were infection control practitioners, labor written, the only respiratory protection device representatives, and occupational medicine that was NIOSH-approved and met the above practitioners. The meeting concluded that in criteria was the high efficiency particulate air most of the outbreak settings, the 1990 (HEPA) filter respirators. In July 1995 guidelines had not been adequately NIOSH updated its respirator testing and implemented, and there was a need for revised certification requirements to permit the and expanded guidelines. In 1993 a draft of the approval of other respirators. Under the revised guidelines was published in the Federal updated testing, respirators that contain a Register for public comment. After a period of NIOSH-certified N-series filter with 95% comment and public meetings, the report efficiency (N-95) rating meet the Guidelines for Preventing the Transmission of recommendations of the CDC guidelines. Mycobacterium tuberculosis in Health-Care Facilities, 1994 was published in the Morbidity Like NIOSH, the Occupational Safety and and Mortality Weekly Report. This document Health Administration (OSHA) has a legal contained detailed, comprehensive mandate for the protection of workers; recommendations for prevention of however, unlike NIOSH, which can only

61 TB Control at the Millennium

issue magnitude of this risk depends on many recommendations, factors such as implementation of OSHA has the administrative and engineering controls, capacity to enforce its prevalence of patients with infectious TB standards. In 1997, within the facility, and risk for infection OSHA published a outside of the healthcare facility. All of these draft TB standard in factors need to be weighed in decisions the Federal Register. regarding recommendations or mandates for Following the TB control measures within health care publication of the facilities. As the rates of TB in the US draft standard, there continue to decline, these recommendations was a period for will need to be tailored to offer protection to public comment patients and workers within the health care followed by a series of hearings for testimony. setting, without an unnecessary burden of Detailed comments were submitted from a testing and expense. CDC committee including staff members of NIOSH, the Hospital Infections Program, and A Decade of Notable TB Outbreaks: the Division of Tuberculosis Elimination, as A Selected Review well as many other professional organizations. by Scott B. McCombs, MPH In July 1999, OSHA reopened the docket for Deputy Chief, Surveillance and Epidemiology Branch further public comment. The OSHA TB standard is currently undergoing revision, and The Surveillance and Epidemiology Branch is its final content and release date are not yet charged with monitoring TB morbidity and known. mortality in cooperation with state and local health departments. One of the most In order to better understand the risk of fascinating and important parts of our role is transmission of M. tuberculosis to health care to assist our partners in responding to workers, CDC undertook several studies outbreaks of TB when they occur. This article designed to examine rates of skin test summarizes a cross-section of some of the conversions in health care workers. The most more notable outbreaks from the 1990s. comprehensive of these was a study initiated in 1995 called StaffTRAK-TB. This study Extensive transmission of Mycobacterium included over 13,000 health care workers. tuberculosis from a child (Curtis, Ridzon, Data from this study demonstrate a rate of Vogel, et al. N Engl J Med 1999;341:1491- skin test conversions among health care 1495). workers of 4.4 conversions per 1,000 person- Although young children rarely transmit TB, years of follow-up. For US-born persons, the infectious TB was diagnosed in a 9-year-old rate was even lower at 3.2 conversions per boy in North Dakota in July 1998. The child 1,000 person-years. From data currently was screened because extrapulmonary TB was available from studies such as StaffTRAK-TB, diagnosed in his female guardian. The child, the risk of nosocomial transmission of TB who had come from the Republic of the appears to be quite low. As a result CDC is Marshall Islands in 1996, had bilateral cavitary considering revision of the 1994 guidelines, TB. Because he was the only known possible especially in the areas of frequency of source of his guardian’s TB, an investigation of tuberculin skin testing of health care workers. the child’s contacts was undertaken. Family, school, day-care, and other social contacts The risk of transmission of M. tuberculosis in were notified of their exposure and given health care settings is a real one. However, the tuberculin skin tests (TST). Of the 276

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contacts tested, 56 had a positive TST (10 mm al. JAMA 1997;278:1073-1077). induration), including 3 of 4 household In 1995, eight patients with MDR TB were members, 16 of his 24 classroom contacts, 10 identified in South Carolina; all were resistant of 32 school-bus riders, and 9 of 61 day-care to seven drugs and had matching DNA contacts. A total of 118 persons received fingerprints (Strain W1). Community links preventive therapy. The 9-year-old patient’s were identified for five patients (patients 1-5), twin brother had TB, but was deemed not but no links were identified for the other three infectious on the basis of a negative sputum patients (patients 6-8) except being hospitalized smear. This investigation showed that children at the same hospital as one community with TB, especially cavitary or laryngeal TB, patient. Patients 5 and 8 both died of MDR should be considered infectious, and that TB less than one month after diagnosis. screening of their contacts may be required. Patients 6 and 7 each had one positive culture for MDR TB; specimens were collected during Spread of Strain W, a highly drug-resistant bronchoscopy. Patient 6 had a skin test strain of Mycobacterium tuberculosis, across conversion after bronchoscopy. Neither the United States (Agerton, Valway, patient 6 nor patient 7 had a clinical course Blinkhorn, et al. Clin Infect Dis 1999; consistent with MDR TB, neither was treated 29:85-92). for MDR TB, and both are alive and well. Strain W, a highly drug-resistant strain of There was no evidence of laboratory Mycobacterium tuberculosis, was responsible for contamination of specimens, transmission on large nosocomial outbreaks in New York in wards, or contact among patients. All four the early 1990s. This article is a review of data received bronchoscopy in the same month. from epidemiologic investigations, national Observations revealed that bronchoscope TB surveillance, regional DNA fingerprinting cleaning and disinfection was inadequate and laboratories, and the CDC Mycobacteriology led to subsequent false-positive cultures in Laboratory to identify potential cases of TB patients 6 and 7, transmission of infection to due to Strain W. From January 1992 patient 6 and active through February 1997, 23 cases were MDR TB to patient 8. identified in nine states and Puerto Rico; 4 of the 23 cases transmitted disease to 10 An outbreak involving other people. Eighty-six contacts of the 23 extensive transmission cases were presumed to be infected with of a virulent strain of Strain W. The authors conclude that Strain Mycobacterium W TB cases will occur throughout the tuberculosis (Valway, United States as persons infected in New Sanchez, Shinnick, et York move elsewhere. CDC asked health al. N Engl J Med departments to notify CDC of cases of TB 1998;338:633-639). that were resistant to isoniazid, rifampin, From 1994 to 1996 there was a large outbreak streptomycin, and kanamycin. The references of TB in a small, rural community with a for this article include citations for earlier population at low risk for TB. Twenty-one investigation results that have been published, patients with TB were identified; the DNA including this next one. fingerprints of the 13 isolates available for testing were identical. To determine the extent Transmission of a highly drug-resistant of transmission, we investigated both the close strain (Strain W1) of Mycobacterium and casual contacts of the patients. Using a tuberculosis: Community outbreak and mouse model, we also studied the virulence of nosocomial transmission via a contaminated the strain of Mycobacterium tuberculosis that bronchoscope (Agerton, Valway, Gore, et caused the outbreak. The index patient, the

63 TB Control at the Millennium source patient, and one other patient infected retrospective cohort study with case the other 18 persons. In five, active disease investigation and skin test screening was developed after only brief, casual exposure. conducted in the school of approximately There was extensive transmission from the 1,400 students. DNA fingerprinting of three patients to both close and casual available isolates was performed. Eighteen contacts. Of 429 contacts, 311 (72%) had students with active TB were identified. positive skin tests, including 86 documented Through epidemiologic and laboratory skin test conversions. The growth investigation, 13 cases were linked. Nine of the characteristics of the strain involved in the 13 had positive cultures for M. tuberculosis outbreak greatly exceeded those of other with isoniazid, streptomycin, and ethionamide clinical isolates of M. tuberculosis. The resistance, and all eight available isolates had extensive transmission of TB in this outbreak identical DNA fingerprints. No staff member may have been due to the increased virulence at the school had TB. One student remained of the strain rather than to environmental infectious for 29 months and was the source factors or patient characteristics. case of the outbreak. Another student was infectious for 5 months before diagnosis and A nosocomial outbreak of multidrug- was a treatment failure. This student resistant tuberculosis (Kenyon, Ridzon, subsequently developed additional resistance Luskin-Hawk, et al. Ann Intern Med to rifampin and ethambutol. The initial skin 1997;127:32-36). test screening found 292 of 1263 (23%) This article details an outbreak of seven cases students tested had a positive TST. Risk of of MDR TB (in six patients and one health infection was highest among twelfth graders care worker, all of whom had AIDS) that and classroom contacts of the two students occurred in a hospital in Chicago. The with prolonged infectiousness. An additional hospital had a respirator fit-testing program 94 of 928 (10%) students tested later had a but no acid-fast bacilli isolation rooms. All positive TST; 22 were classroom contacts of seven M. tuberculosis isolates had matching the student with treatment failure and 21 of DNA fingerprints. Of patients exposed to M. these were documented TST conversions. tuberculosis, those who developed TB had This article documents extensive transmission lower CD4+ T-lymphocyte counts and were of drug-resistant TB along with missed more likely to be ambulatory than those who opportunities for prevention and control of did not. Of 74 exposed health care workers, the outbreak. Prompt identification of TB the 11 who converted their skin tests were no cases and timely interventions should help more likely than those who did not convert to reduce these problems. report that they always wore a respirator with a HEPA filter. Transmission of M. tuberculosis Transmission of multi-drug resistant occurred in a hospital that did not have Mycobacterium tuberculosis during a long recommended isolation rooms. A respirator airplane flight (Kenyon, Valway, Ihle, et al. fit-testing program did not protect health care N Engl J Med 1996;334:933-938). workers in this setting. In April 1994 a passenger with infectious MDR TB traveled on commercial-airline Outbreak of drug-resistant tuberculosis flights from Honolulu to Chicago and from with second-generation transmission in a Chicago to Baltimore and returned one month high school in California (Ridzon, Kent, later. We sought to determine if this passenger Valway, et al. J Pediatr 1997;131:863-868). infected any of her contacts on this extensive In the spring of 1993 four students in a high trip. Of 925 people on the airplanes, 802 school were diagnosed with TB resistant to responded to a request to complete a isoniazid, streptomycin, and ethionamide. A questionnaire and be screened by tuberculin

64 Notable Events in TB Control skin test. All 11 contacts with positive TST impact of the global TB epidemic led CDC to who were on the April flights and 2 of 3 officially organize an International Activity contacts with positive TST on the Baltimore- within the Division of TB Elimination to-Chicago flight in May had other risk factors (DTBE) in 1994 as international efforts are for tuberculosis. More contacts on the 8.75 part of the overall strategic plan of DTBE. hour flight from Chicago to Honolulu had a positive TST than on the other three flights. The mission of the International Activity is, Of 15 contacts with a positive TST on the first, to provide leadership and coordination Chicago-to-Honolulu flight, six (four with for CDC activities related to improving TB skin-test conversions) had no other risk prevention and control efforts among foreign- factors; all six sat in the same section as the born persons in the US. Its mission is, second, index patient. Passengers seated within two to contribute to global TB prevention and rows of the index patient were more likely to control efforts by conducting operations have a positive TST than those in the rest of research and providing technical support to the section. Transmission of M. tuberculosis in high-priority countries, i.e., those that have a this setting involved a highly infectious major TB burden or that are of strategic passenger, a long flight, and close proximity of interest for TB control efforts in the US. contacts to the index patient. Coordination and collaboration with other international public health partners are critical The Division of TB Elimination and our to accomplish our mission. partners in state and local health departments have benefitted tremendously from what has Immigrants from Mexico, the Philippines, and been learned from these and other outbreaks. Viet Nam are the leading contributors to the Our continued cooperation, diligence, and US foreign-born TB case burden and therefore timely systematic response to future outbreaks constitute a high priority for TB control are critical to our eventual success in efforts in the US. The aim of International eliminating TB from the United States. Activity efforts in these countries is to reduce the burden of TB by improving the TB International Activities control capacity of the respective national by Nancy Binkin, MD, MPH, programs, by providing technical assistance Chief, International Activity and and contributing to human resource Michael Iademarco, MD, MPH development. International Activity Historically efforts in As the rate of tuberculosis (TB) cases falls in Mexico and the United States (US), an increasing the percentage of TB cases occur among US Philippines residents born in countries with a higher have been burden of TB. The US rate of TB cases is hampered by relatively low compared with the rate in 22 ongoing high-burden countries where 80% of global TB political and cases occur and where 62% of the world’s social changes. More recently, however, population resides. Given the latency period progress has been made. between TB infection and disease, continued immigration into the US, and increasing Mexico international travel, efforts to eliminate TB in Because of their proximity and our shared the US must extend beyond our geographical border, persons born in Mexico represent the borders. Recognition of the public health single largest group of foreign-born persons in

65 TB Control at the Millennium the US with TB. Previously CDC worked diseases in the Philippines. Of those diseases in with the Mexican government to conduct the Philippines, TB has the most significant surveillance of drug-resistant isolates of TB in public health impact and therefore figures Mexico as part of a WHO collaborative study. prominently in the project. The broad, cross- More recently, DTBE has been working with cutting nature of the project design addresses the United States Agency for International the decentralized health care organization in Development (USAID) and the National TB the Philippines. DTBE is working with the program of Mexico to identify areas of DOH to organize and conduct operations potential collaboration as part of a proposed 5- research training, expansion of directly year project to improve TB control. Proposed observed treatment, short-course (DOTS) activities include expanding the number of pilot projects, and public-private collaborative directly observed treatment, short-course projects. (DOTS) pilot projects, improving operations research capacities, and developing activities to Viet Nam foster public-private health sector Collaboration with the National TB Control collaboration. Program of the Socialist Republic of Viet Nam (NTP) has been more longstanding. Since Additionally, DTBE has been a participating 1996, DTBE has worked with the NTP to member of Ten Against TB, a binational improve TB control. Several laboratory initiative developed initially by the Texas quality control projects have been conducted Department of Health beginning in 1995. The and others are ongoing with the national ten US and Mexican border states have reference laboratory responsible for southern collaborated to reach a consensus on Viet Nam. In 1997, DTBE conducted a 2-week addressing joint issues of TB control through operations research course for supervisory community-based public and private sector staff of the NTP and provincial TB managers partnerships. Along with other partners in the held in Hanoi. As a result of the course, six Division and in the health departments of the protocols were developed on operational border states, CDC has also been developing a topics such as risk factors for treatment failure series of recommendations to improve the and for default, reasons for patient delay in diagnosis and seeking initial TB treatment, and knowledge, management of attitudes, and beliefs about HIV and HIV cases along the US- testing and counseling among TB patients. Mexico border. Each group has been provided with a CDC mentor and funding to conduct the research. Philippines The work for one protocol is complete and In collaboration has been presented by the Viet Namese with the principal investigator at the International Department of Union Against Tuberculosis and Lung Disease Health of the World Congress in Madrid this past Republic of the September. Other projects are near Philippines (DOH) completion. Based on the success of the and the operations research course and with support Epidemiology from USAID, DTBE has initiated a 3-year Program Office of public health practice training program with CDC, DTBE is providing technical assistance the NTP. to a USAID-funded project. The objective of this 5-year project is to reduce the threat of Botswana HIV/AIDS and other selected infectious Other DTBE international efforts have aimed

66 Notable Events in TB Control

to contribute to the global level through the use of RFLP techniques. T O control of TB and HIV/ Another study underway is assessing the B AIDS co-epidemics. In malabsorption of TB drugs in patients with February 1995, at the TB and HIV, as well as conducting long-term request of the Ministry of follow-up of these treated patients to Health in Botswana, the determine risk factors for relapse, reinfection, BOTUSA Project was and death. Project established as a TB epidemiologic research Strengthening the capacity of laboratory collaboration located in Botswana. facilities to cope with the ever-increasing Approximately 25% of the adult population demands brought on by the TB and HIV and 75% of TB patients are HIV-infected. The epidemics has been a component of the BOTUSA Project activities have focused on BOTUSA project. Substantial support in improving TB surveillance and electronic terms of equipment, training, and supplies has reporting, improving Botswana National TB been provided to the national TB Reference Programme (BNTP) activities through Laboratory. BOTUSA also serves as an operational research, improving diagnostics important training site for EIS officers, US through laboratory and clinical research medical students, and public health students studies, and studying the epidemiology of the from UC-Berkeley. disease. At least 17 different formal studies have been completed to date and highlight the Russia and countries of the former Soviet tremendous impact of the HIV epidemic on Union the TB epidemic in the country. As a result of a joint Department of Health and Human Services and White House The site is collaborating with WHO and other conference, the Russian Federation and the countries on several projects, including countries of the former Soviet Union have involvement of the community in the care of been targeted for CDC TB control technical patients with TB and advanced AIDS, assistance efforts. The number of TB patients provision of TB preventive therapy to persons and the levels of drug resistance are increasing living with HIV, and improvement of TB at alarming rates. Contributory factors include surveillance through the use of a software tool an inability to financially support the previous initially developed by BOTUSA and recently infrastructure for TB diagnosis and treatment, adopted by the World Health Organization the lack of availability of quality drugs, high (WHO) for global application. Through levels of TB transmission in prison settings, collaboration with the US Food and Drug and reluctance to adopt the DOTS strategy as Administration, the site and DTBE have employed in the US and elsewhere and raised global awareness of the potential for recommended by the WHO. The DTBE, substandard TB drugs in the market through USAID, and WHO are collaborating to the pilot-testing of appropriate technology for institute basic DOTS programs in two oblasts the rapid screening of drugs. Specific research (territorial administrative divisions) that have projects completed in 1998 included a indicated a willingness to begin the DOTS spectrum of lung disease study in adults strategy, and to strengthen DOTS in Ivanovo hospitalized with AIDS, an autopsy study to oblast, where a WHO-supported program was determine causes of death in adults and implemented in 1995 but where cure rates children dying of AIDS, a validation study of remain unacceptably low. A recent study in the TB surveillance system, a study of risk this second oblast has documented further factors for TB transmission in the household, increases in the levels of multidrug-resistant and a study of transmission at the population (MDR) TB. DTBE will also implement

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DOTS-plus, the WHO strategy for the United States (US) immigration law mandates management of MDR TB treatment in low- an overseas health assessment for immigrants resource settings, in this oblast. In addition, and refugees, with the intent of denying DTBE has been involved in the establishment admission to persons with certain diseases of of a center of excellence for MDR TB in public health significance, physical or mental Latvia, which was formerly part of the Soviet disorders associated with harmful behavior, Union and which has a successful DOTS drug abuse or addiction, or likelihood of program, but nonetheless has one of the becoming a ward of the state. The conditions, highest levels of MDR TB in the world. the requirements as to who must be screened, Finally, an MDR TB training course run by and the examination and tests to be performed DTBE in collaboration with National Jewish are prescribed by the Secretary of the Medical Center was conducted overseas this Department of Health and Human Services, past year in Estonia for participants from with oversight by DQ. Russia and the Baltics. The current list of communicable diseases of The Role of CDC’s Division of Quarantine public health significance that are considered in the Fight Against TB in the US “inadmissible” are infectious TB, syphilis, by Paul Tribble lepromatous Hansen’s disease, HIV infection, Public Health Advisor, DQ and certain sexually transmitted diseases (STDs). The overseas health assessment, The Division of Quarantine (DQ), the oldest which is valid for 12 months, is carried out by organization in the United States Public local physicians known as “panel physicians,” Health Service, has had a rich and colorful who are appointed by the US embassy or history and plays an important role in the consulate. In some cases, clinics or hospitals nation’s fight against tuberculosis (TB), are designated as panel physicians in countries especially with respect to immigrants and where large numbers of immigrants originate refugees. DQ, which was established by the (e.g., Mexico, the Philippines, and Viet Nam). National Quarantine Act of 1878, was Panel physicians are provided with a booklet transferred to the Centers for Disease Control of technical instructions concerning the assessment process which, in addition to the TB evaluation, consists of a medical history, physical examination, and screening for physical and mental disorders, substance abuse, STDs, Hansen’s disease, and HIV infection.

Panel physicians make their own arrangements for the required radiologic and laboratory tests. Currently, no countries have on-site supervision beyond the local consular officer, except Viet Nam, which has a CDC Immigrants of the past awaiting medical clearance microbiologist consultant. Panel physicians (CDC) in 1967. DQ has had several previous do, however, receive periodic visits by CDC titles, including the Division of Foreign physicians and microbiologists based in Quarantine and Quarantine Division, and is Atlanta. Panel physicians are paid for their continuing to evolve with another proposed services by immigrant applicants on the basis name: the Division of Global Migration and of a fee scale set locally. In the case of refugees, Quarantine. the US Department of State reimburses the

68 Notable Events in TB Control panel physicians for providing the health by the US Department of State. assessment. Presently, there are approximately 650 panel physicians worldwide. Applicants whose chest x-ray is consistent with active TB disease but whose three sputum The TB component of the health assessment smears are negative for AFB are designated as consists of a chest x-ray for all persons 15 years having Class B1 (clinically active, not of age or older. (Children less than 15 years of infectious) TB. If the initial chest x-ray is read age who are suspected of having TB or who by the panel physician as consistent with old, have a history of contact with a known TB healed TB, no specimens of sputum need be case are given a tuberculin skin test. Those obtained, and the applicant is designated as with a positive skin test must undergo a chest x-ray.) If the x-ray is consistent with active TB disease, three consecutive early-morning sputum specimens are collected for acid-fast staining and microscopic examination. Persons whose sputum smears are positive for acid-fast bacilli (AFB) are classified as having Class A, infectious TB, which is an inadmissible condition for purpose of entry into the United States. Such persons may enter the United States by meeting either of the following two conditions. First, sputum smear–positive immigrants and refugees who successfully complete a recommended course of TB Current immigration clearance process treatment overseas can be medically cleared for US travel; they will have been reclassified having Class B2 (not clinically active, not as having Class B2 or old, healed TB (see infectious) TB. Both Class B1 and B2 description of TB classifications below). designations are considered significant health Secondly, they may enter the United States conditions, but neither is inadmissible for with a medical waiver, once they are no longer immigration purposes. infectious, by providing three consecutive negative sputum smears. To obtain a medical Class A and Class B designations for waiver, the US relative of the Class A immigrants are placed on the official immigrant must complete an application. This immigration documents collected by is signed by a US health-care provider and is inspectors of the Immigration and countersigned by the local health department Naturalization Service at one of 295 (or signed only by the local health department international airports, land crossings, or ports acting as the health-care provider) at the in the United States; refugees must enter the immigrant’s intended US destination, thus country through one of eight international guaranteeing that the provider will assume airports that are staffed by DQ inspectors. responsibility for the completion of TB This information is sent to or collected at one treatment. Class A refugees with TB are not of the quarantine stations, where a notification required to have a relative residing in the form is mailed to the state or local health United States, as the waiver is completed by department at the intended destination of the the resettlement agency at the intended site of arriving immigrant or refugee. Health destination. Immigrants are responsible for departments are expected to complete and paying for their own TB treatment overseas; return the forms to DQ, thus reporting on the in the case of refugees, the costs are assumed outcome of the evaluation. The immigrant or

69 TB Control at the Millennium refugee is informed of the need to be further to be counter-productive, as it may be difficult evaluated for their TB and to report to the to ensure that the drug regimens are adequate, local health department as soon as possible and that applicants are regularly ingesting the after arrival. Persons with Class A TB are required medications. In such a scenario, required to report to the local health incomplete treatment as well as development department, present all medical records and of drug resistance may be the result. chest x-rays from overseas, and submit to the necessary testing, isolation, and treatment The overseas screening process for identifying until discharged. They risk deportation and treating TB in immigrants and refugees is should they fail to do so. For persons having responsible for the identification of substantial Class B1 or B2 TB, the health department visit numbers of persons arriving in the United is considered voluntary. States who have active TB. However, not all cases in newly arrived immigrants or refugees Many health departments in the United States were identified overseas as having suspect TB, perform active follow-up of arrivals designated which is in part due to several limitations of as having Class B1 or B2 TB, on the basis of the screening process. Although panel the DQ notification. Studies conducted in the physicians do function under a contractual mid-1990s by the Division of TB Elimination, agreement with their respective US consulates, DQ, and health departments in various parts they receive no formal training or certification of the country have shown from 3% to 14% of per se. In 1997, a training needs assessment was Class B1 immigrants and refugees were performed on a sample of panel physicians in a diagnosed with TB disease within one year of study undertaken by the Division of TB their arrival; between 0.4% to 4.0% of those Elimination and DQ. The assessment with Class B2 TB were diagnosed with TB indicated that, although 98% of panel disease within one year of arrival. Of the physicians in the sample understood which remaining persons, many are high-priority immigrants and refugees should receive a chest candidates for preventive therapy regardless of x-ray, over 60% indicated a need for training. their age because they are tuberculin skin test positive with an abnormal chest x-ray Presently, efforts are underway to develop self- suggestive of TB disease. study training materials for panel physicians to enhance their ability to diagnose and treat TB, The current overseas TB evaluation and to improve their ability to monitor the procedures described above are based upon the performance of contracted laboratory and following three principles: 1) the requirements radiologic services. A training plan will be apply specifically to immigrants and refugees, developed, and self-study materials will be as they are most likely to become permanent pilot-tested later this year in countries with US residents; 2) the procedures reduce the large numbers of persons who immigrate to importation of active infectious TB that poses the United States and have a high TB an immediate public health risk by denying prevalence. admission to persons who have positive sputum smears; and 3) they allow those The STOP TB Initiative, persons with evidence of TB disease but whose A Global Partnership smears are negative to enter the United States, by Bess Miller, MD, MSc where a more complete medical evaluation can Associate Director for Science, DTBE be performed and appropriate treatment can be provided under supervision. Forcing Over the past few decades, when we have immigrants and refugees with noninfectious looked at the agendas of international health TB to undergo treatment overseas could prove

70 Notable Events in TB Control

international public health agenda and to substantially increase the investment in TB worldwide. It aims to increase involvement of international players at all levels, including international health agencies, donor agencies, governments, nongovernmental organizations, professional societies, and community organizations involved in TB at the country agencies, major donors to the health sector, level. The focus of the initiative is on the 22 government health ministries, academia, and so-called “high-burden” countries which civil society, we have wondered, Where is TB? WHO has identified as responsible for Why is TB on the back burner? The STOP approximately 80% of all reported cases of TB TB Initiative is a global campaign to move TB in the world. These include India, China, to the FRONT BURNER. Indonesia, Bangladesh, Pakistan, Nigeria, Philippines, South Africa, Ethiopia (Fed. Why now? Democratic Republic of), Viet Nam, Russian .Federation, Congo (Democratic Republic), With the arrival last year of the new Director Brazil, Tanzania (United Republic of), Kenya, General of the World Health Organization Thailand, Myanmar, Afghanistan, Uganda, (WHO), Dr. Gro Brundtland, there has been Peru, Zimbabwe, and Cambodia. In addition, an interest in intensifying the relationship countries with extremely high rates of TB, between WHO and its global partners. For a especially those impacted by the HIV number of diseases, but especially for malaria epidemic, will be targeted. and TB, WHO has initiated campaigns to join forces with other agencies and donors in the The STOP TB Initiative will focus attention public and private sectors to achieve global on addressing the specific constraints to action health objectives. on TB identified at the London Ad Hoc Committee Meeting on the Global TB Additional factors have added fuel to the Epidemic held in March 1998. The needs sparks of this new campaign. Over the past identified at this meeting include political will several years the World Bank has given an and commitment, human resource unprecedented number of loans to developing development, a secure supply of quality anti- countries to strengthen TB control efforts and TB drugs, research, financing, organization has established TB as one of its top priority and management, information systems, and diseases. There has been renewed interest in health sector reform. TB research in the areas of vaccine development, new drug development, and new The founding partners of the STOP TB diagnostics. Large donors such as the Soros Initiative are the WHO, the Royal and Gates Foundations have shown an interest Netherlands TB Association (KNCV), the and commitment to TB control and TB International Union Against TB and Lung research. The stars are aligned. Disease, the World Bank, the American Lung Association, the American Thoracic Society, In November 1998, at the annual meeting of and the Centers for Disease Control and the International Union Against Tuberculosis Prevention. New partners include UNICEF, and Lung Disease held in Bangkok, Thailand, UNAIDS, the National Institutes of Health, Dr. Brundtland launched the STOP TB the Japan Anti-TB Association, the Initiative, a WHO-led global partnership Norwegian Heart and Lung Association, the whose mission is to put TB higher on the Canadian International Development Agency,

71 TB Control at the Millennium the Soros Foundation, and the Rockefeller Yes, TB is on the front burner at last, and we Foundation. Many, many others are joining. plan to keep it there! The tremendous energy and inspiration these new partners bring to the Initiative cannot be Seize the Moment - Personal Reflections overstated. by Carl Schieffelbein Deputy Director for Special Projects, DTBE Current efforts of the STOP TB Initiative are directed at the following four areas: 1) the We all have opportunities during our careers creation of a global drug supply facility to to stand at critical decision points. Sometimes provide universal availability of quality TB it is clear that these are major events; at other drugs; 2) the development of a global times they appear routine, but subsequently it partnership agreement to catalyze and secure is seen that they had (or could have had) major public agreements among donor agencies and impact. During the past 33 years I’ve had the high-burden countries on specific steps to be opportunity to stand at many decision points taken to control TB; 3) the co-sponsorship of and now can look back to see where more an initiative to develop new drugs for TB; and could have been done, if the opportunities had 4) the co-sponsorship with the Government of really been fully utilized. I will outline a few the Netherlands of a Ministerial Conference in decision points in which I participated and try March 2000. This conference brought to share what went well and what I believe together the ministers of health as well as of could have been done better. I will also outline finance, development, and planning from the some of the decisions we will all face in 2000. highest burden countries to set the stage for expanded country action against TB across Decision point: late 1960s. Closing of the TB sectors of government and society. sanatoria. Due to advances in treatment, long- term sanatorium care was no longer needed. While many efforts are underway at the CDC supported efforts to close TB “global” level, TB control efforts take place at sanatoriums and move toward an outpatient the local level, and it is at this level that we system. We succeeded in reducing the need for will concentrate future efforts. This past long-term sanatorium care and more rapidly summer, the Initiative sponsored a series of got patients back to their families and regional workshops with the highest burden communities. The costs of maintaining countries to identify constraints to TB control sanatoria were reduced. However, we did not at the country level. Suggestions for the STOP do well in diverting the funds available as a TB Initiative made at these workshops result of the closings to the support of strong included the following activities: 1) expand TB outpatient care systems. As cases went beyond traditional partners for TB control; down, political will to support TB programs 2) strengthen advocacy; 3) develop a social also diminished in the early 1970s. We found mobilization campaign; and 4) increase that many existing TB control systems were operations research in affected countries. unable to effectively survive when federal categorical appropriations for TB were CDC is actively participating in the STOP TB eliminated in 1972. Initiative and is represented on the Steering Committee (Bess Miller, Associate Director Decision point: 1989. The Strategic Plan for the for Science and Carl Schieffelbein, Deputy Elimination of Tuberculosis in the United States. Director for Special Projects, DTBE), as well The plan articulated the goal of defined as the Secretariat in Geneva (Mark Fussell, elimination of TB by 2010. It caught the Public Health Advisor, DTBE). attention of some advocates and spelled out in broad strokes (still relevant today) the three

72 Notable Events in TB Control critical steps needed. However, we later dollars. We succeeded in making state and realized that we talked about the plan only local programs too dependent upon federal within the “TB family” and with our peers. dollars; this is a concern known all too well by We were not successful enough in getting those of us who remember the overnight influential leaders and policy and opinion elimination of categorical federal TB funds in makers to commit their organizations to full 1972. shared ownership and thus, the necessary advocacy to fully implement the Strategic Plan Decision point: March 1998. I had the at federal, state, and local levels. opportunity to participate in an ad hoc committee of the Global Tuberculosis Decision point: November 1991. The rise in Programme of WHO, convened in London, to TB cases, and the emergence of multidrug- evaluate TB control in the 22 countries that resistant TB (MDR TB). A small group of us represent 80% of the global TB burden. The met with Dr. Roper (then CDC Director) to committee concurred that most of these 22 discuss a plan of action. It was decided a countries would not meet their Year 2000 federal TB Task Force would be created to goals. The committee also outlined what was bring together all HHS/PHS agencies (and a believed to be shared constraints to progress. few others) to develop a coordinated response These included 1) weak political will and to the MDR TB outbreaks. The Task Force commitment towards TB control efforts; was created and moved quickly, and in 2) lack of adequate funding; 3) inability to hire January 1992 brought together more than 400 and keep trained staff; 4) organizational and experts to develop the National Action Plan to management issues, such as health sector Combat Multidrug-Resistant Tuberculosis reform, public and private sector interactions (published in April 1992). The Action Plan (or lack thereof), and integration and called for a total federal TB budget of decentralization issues; 5) an inadequate supply $610,280,000, of which CDC’s need was of quality TB drugs; and 6) lack of adequate $484,000,000. Along with many of our understanding of the magnitude of the partners, we were successful in getting federal problem and of the possibility of successful appropriations increased. We were successful interventions. I believe all but item number 5 in getting enough resources to meet our are also continuing threats to our national, immediate needs, but not enough to allow the state, and local TB programs. success of our 1989-stated mission of elimination. We had reached out to some new You and I stand at some unique moments of partners in the Task Force and through the decision in 2000. If each of us does not act National Coalition to Eliminate TB, but again, effectively, we will have missed some after the crisis was over, we had not built opportunities to move the fight against TB enough effective community partnerships or into the final rounds. Some of the decision new and long-lasting coalitions to help achieve moments at hand: the level of resources needed. Also, while we • The National Academy of Science’s were in the process of obtaining increased Institute of Medicine (IOM) will issue a federal funding, we saw many state or local report on TB control in the United areas reduce the amount of local resources States. How will you and I use the going into TB control efforts. In 1990 the results to evaluate and strengthen our Public Health Foundation reported that 13% programs? How will you use the IOM of TB funds at the state and local levels were report and local data to secure adequate federal dollars. In 1998, however, the National political will at your state or local level TB Controllers Association reported that 42% to secure necessary resources? of budgets were now composed of federal

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• The HIV/AIDS and TB epidemics I am aware there are many, many other continue to work together to create decision points that we all will face. Many of unnecessary devastation, both these opportunities last for very brief domestically and especially in some moments of time. I urge each of us to seize international communities. Yet we those moments, and if necessary move outside tend to still work mainly within our our areas of comfort, in order to be able to “TB family.” How will we work better truly eliminate TB in the United States and see with our colleagues in HIV to develop TB control in the world early in this century. effective collaborations to help those at risk of TB and HIV/AIDS? • There is growing interest and concern about TB both at the federal level and in many state and local areas. How will you and I create new partnerships and opportunities to build on the existing interest to ensure a firm base for operations and programs? • The Surgeon General has appointed a Blue Ribbon Committee to look into the development of a TB vaccine. How will you and your TB advisory committees work to support such an

effort? Carl Schieffelbein, in his first TB control • There are areas of social mobilization assignment (1967), adjusting x-ray equipment and community empowerment that have not been adequately addressed by the TB community. How will we work with not only lung associations, but other partners as well, to mobilize against TB? • WHO is hosting a “STOP TB” partnership to create a new global campaign against TB. How will you and I support these critically needed global activities and still ensure strong domestic programs?

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Description of DTBE Training and Education DTBE Home Page. DTBE has a Web site on Resources the Internet. The site provides access to TB- related Morbidity and Mortality Weekly Reports Resources for Health Care Providers (MMWRs), educational materials, and guide- lines. The DTBE home page can be accessed Automated information systems at http://www.cdc.gov/nchstp/tb/ CDC Fax Information System. CDC devel- oped a fax information system for health care DTBE On-Line Ordering System. DTBE professionals and others who would like to educational and training materials can now be receive health information by fax. Telephone ordered via the Internet. The on-line ordering callers first access the main CDC menu and system provides a convenient way to order then select TB-related topics. Designed to DTBE materials. Highlights of the system answer many routine questions about TB, the include order confirmation via the Internet system can provide up-to-date information by and, if an e-mail address is provided, order fax or mail. Callers can choose to receive confirmation when the order has been filled. general information about TB or specific The on-line ordering system can be accessed information about treatment, diagnosis, BCG, on DTBE’s Internet home page at http:// infection control, or screening. The Fax www.cdc.gov/nchstp/tb. Information System can be accessed by dialing toll free 888-CDC-FAXX (888-232-3299). To Materials receive a listing of documents available by fax, Controlling TB in Correctional Facilities request document number 250000. The fax Booklet and Slides - 1995. This booklet and sheet may also be viewed on DTBE’s Web site accompanying slide set, developed in 1995, at http://www.cdc.gov/nchstp/tb. have been updated in regard to the Advisory Council for the Elimination of Tuberculosis CDC Voice Information System. CDC (ACET) statement with recommendations for developed a voice information system for jails and prisons. It also provides a comprehen- health care professionals and others who call sive basic reference on TB specifically for for specific disease information. Callers first correctional facility staff. The booklets are access the main CDC menu and then select available from each state TB office or the TB-related topics. Designed to answer many DTBE. Slide sets were distributed to all state routine questions about TB, the system can and big city TB programs; however, additional provide up-to-date information by voice, fax, slide sets are available for purchase ($75 per or mail. Callers who choose to listen to the set) from the National Technical Information voice recordings can receive general informa- Service (800-553-6847 or 703-605-6000), item tion about TB or specific information about number AVA19830SS00. The slide set can treatment, diagnosis, BCG, infection control, also be viewed and downloaded from DTBE’s or screening. Callers who would like written Web site at http://www.cdc.gov/nchstp/tb. information can choose from a variety of topics and then receive information sheets by Core Curriculum on Tuberculosis Booklet fax or specific educational materials by mail. and Slides - 1994. The Core Curriculum on The TB component of the Voice Information Tuberculosis was originally developed in 1990 System can be accessed by dialing toll free 888- with the American Lung Association for use CDC-FACT (888-232-3228), then pressing in preparing and planning educational activi- options 2, 2, 1, 5, 2. ties or as a reference for the practicing clini- cian caring for patients with TB or TB infec- tion. The Core Curriculum covers TB epidemi-

75 TB Control at the Millennium

ology, diagnosis, treatment, prevention, and infection control. This document and accom- How You Can Assess Engineering Controls panying slide set were revised to include for TB in Your Healthcare Facility - 1999. A current recommendations for the diagnosis, video and viewer’s guide developed by the treatment, and control of TB in 1994. The Francis J. Curry National TB Center about newest revision will be available in 2000. The basic techniques that can be used to evaluate booklet is available from each state TB office engineering controls, including instructions or DTBE. Slide sets are available for purchase for bringing an isolation room into compli- ($62 per set) through the National Technical ance with CDC recommendations. Information Service (800-553-6847 or 703-605- 6000), item number AVA19830SS00. The Improving Patient Adherence to Tuberculosis Core Curriculum may also be viewed on Treatment Booklet - 1994. DTBE developed a DTBE’s Web site at http://www.cdc.gov/ guide for TB health care providers to help nchstp/tb. improve patient adherence to medication and follow-up care. This 1994 booklet replaces the Forging Partnerships to Eliminate TB - 1995. booklet Improving Patient Compliance in This print-based, self-study module was devel- Tuberculosis Treatment Programs. It is avail- oped in 1995 for TB program managers to able from each state TB office and the DTBE. provide information on forming partnerships, resource acquisition, marketing, and media Mantoux Tuberculin Skin Testing Wall Chart relations. The module includes information (1990) and Videotape (1991). Developed in from the Mobilizing for TB Elimination 1989, the videotape and wall chart are designed workshops, along with a selected bibliography for use by health department TB staff in listing other available resources. This module teaching tuberculin skin testing to other health is available from each state TB office or the care workers who are providing services to DTBE. persons at risk for TB (e.g., STD clinic staff, drug abuse treatment staff, correctional facility Guidelines for Preventing the Transmission staff, nursing home staff, etc.). Providers are of Mycobacterium tuberculosis in Health Care encouraged to contact their state TB program Facilities, 1994 Slide Series. A slide series to obtain these materials and to arrange for based on the 1994 MMWR supplement Guide- training. The wall chart was revised in Septem- lines for Preventing the Transmission of Myco- ber 1990 to reflect the latest recommendations bacterium tuberculosis in Health Care Facilities of the Advisory Council for the Elimination was developed in 1995 for use in training of Tuberculosis. These materials are available health care workers, infection control practi- from each state TB office or the DTBE. tioners, and others on how to effectively implement the guidelines. A limited number Multidrug-Resistant Tuberculosis - 1994. 8- of sets of the slide series were distributed to page article on causes, treatment, and control TB control programs. Additional copies are of drug-resistant TB. available for purchase ($80 per set) through the National Technical Information Service (800- Reported TB in the United States - 1998. The 553-6847 or 703-605-6000), item number most recently reported statistics on TB cases AVA19824SS00. The slide set can also be and case rates. viewed and downloaded from DTBE’s Web site at http://www.cdc.gov/nchstp/tb. Self-Study Modules on Tuberculosis (Modules 1 - 9). In 1995 DTBE developed a series of five self-study modules to train and educate new

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outreach workers. Modules 1-5 cover transmis- print-based Self-Study Modules on Tuberculosis sion and pathogenesis of TB, epidemiology of and the Satellite Primer on Tuberculosis. The TB, diagnosis of TB infection and disease, Web-Based Self-Study Modules on Tuberculo- treatment of TB infection and disease, and sis course has interactive features such as infectiousness and infection control. DTBE animation, study questions, case studies, and subsequently developed a second series, mod- links to other TB-related sites. The course can ules 6-9, consisting of four modules that cover be accessed at http://www.cdc.gov/phtn/ contact investigations for TB, confidentiality tbmodules. in TB control, TB surveillance and case man- agement in hospitals and institutions, and TB Facts for Health Care Workers - 1997. patient adherence to TB treatment. Both series This 14-page booklet is based upon the TB of modules are available from DTBE. The Fact Sheet that was originally developed in modules are also available through the Public 1984. It was updated in 1993 to include infor- Health Training Network for continuing mation on MDR TB and again in 1997 to education credit, free of charge; call toll free include current screening and treatment 800-418-7246 to register. recommendations. The booklet contains the key points to remember about the diagnosis, Self-Study Modules on Tuberculosis broad- treatment, and prevention of TB. The in- casts on videotape. Satellite Primer on Tuber- tended audience is health care professionals. culosis: Modules 1-5 (1995), and TB Frontline This booklet is available from each state TB - Satellite Primer Continued: Modules 6-9 office or DTBE. It can also be viewed on (2000). DTBE’s first five Self-Study Modules DTBE’s Web site at http://www.cdc.gov/ on TB were used as the basis for a series of live nchstp/tb. broadcasts via satellite entitled A Satellite Primer on Tuberculosis, conducted in May and TB Notes. This quarterly newsletter is distrib- June 1995. The second set of modules served as uted to state and big city TB control officers, the basis for a satellite training course entitled directors of pulmonary and infectious disease TB Frontline-Satellite Primer Continued, Mod- training programs, state epidemiologists, ules 6-9, conducted in January and February public health laboratory directors, and many 2000. Each broadcast provided information to other people involved in (or just interested in) supplement the training modules and allowed TB in the U.S. and worldwide. State and big participants to telephone their specific ques- city TB control officers are encouraged to tions to the presenters. Additional videotapes duplicate copies for TB workers throughout of A Satellite Primer on Tuberculosis are avail- their jurisdictions. TB Notes contains news able for purchase through the Alabama De- about DTBE activities as well as highlights partment of Public Health at 334-206-5618, or from state and local TB programs across the by FAX 334-206-5640. Videotape copies of TB country. It also contains a calendar of events Frontline-Satellite Primer Continued, Modules 6- describing training courses, meetings, confer- 9 are available on a limited basis from DTBE ences, and other educational activities of at 404-639-8135. potential interest to those working in TB. Current and previous editions of TB Notes are Self-Study Modules on Tuberculosis on the now available on the DTBE Internet home Web - 1999. The Web-based version of the page at http://www.cdc.gov/nchstp/tb. Self-Study Modules on Tuberculosis provides a base level of TB knowledge accessible world- Think TB Poster. This poster was reprinted wide through the Internet. The Web-based by the DTBE in 1992 with permission from course builds upon existing products: the the Mississippi State Department of Health,

77 TB Control at the Millennium the original designer of the poster. Prepared information by fax or mail. Callers can for health care providers and other service choose to receive general information about organizations serving high-risk populations, TB or specific information about treatment, the poster lists signs and symptoms of TB, and diagnosis, BCG, infection control, or screen- it reads, “Recognize possible signs and symp- ing. The Fax Information System can be toms of TB. Early diagnosis and treatment accessed by dialing toll-free 888-CDC-FAXX reduce spread. Contact your health depart- (888-232-3299). To receive a listing of docu- ment or physician for more information.” ments available by fax, request document DTBE collaborated with the Mississippi number 250000. Department of Health on the development of a Spanish version of the Think TB poster in CDC Voice Information System. CDC 1993. Both the English and Spanish versions developed a voice information system for are available from each state TB office or persons who call for specific disease informa- DTBE. tion. Callers first access the main CDC menu and then select TB-related topics. Designed to Tuberculosis Training and Education Re- answer many routine questions about TB, the source Guide. This resource guide was pro- system can provide up-to-date information by duced by the CDC National Prevention voice, fax, or mail. Callers who choose to Information Network (NPIN) in collabora- listen to the voice recordings can receive tion with DTBE, and provides information general information about TB or specific available through NPIN databases and other information about treatment, diagnosis, BCG, resources on topics relating to TB. The re- infection control, or screening. Callers who source guide includes educational materials, would like written information can choose consensus guidelines, journal articles, Internet from a variety of topics and then receive resources, and funding organizations. For information sheets by fax or specific educa- more information on NPIN services call 800- tional materials by mail. The TB component 458-5231 (800-243-7012 TTY) or visit the of the Voice Information System can be NPIN Web site at http://www.cdcnpin.org. accessed by dialing toll-free 888-CDC-FACT (This information is made available as a public (888-232-3228), then pressing options service. Neither CDC nor NPIN endorses the 2, 2, 1, 5, 2. organizations and materials represented. It is the responsibility of the user to evaluate this Materials information prior to use based on individual Questions and Answers about TB Booklet - needs and community standards.) 1994. A patient education booklet for persons with TB disease or infection, it provides information on TB transmission, pathogenesis, Resources for Patients and the General diagnosis, treatment (including medications Public and side effects), infection control, and follow- up care. This booklet is also appropriate for Automated information sytems use in educating those who provide services to CDC Fax Information System. CDC devel- persons with or at risk for TB (for example, oped a fax information system for persons staff of drug treatment centers, correctional who would like to receive health information facilities, homeless shelters). This booklet is by fax. Callers first access the main CDC available from each state TB program and the menu and then select TB-related topics. De- DTBE. This publication can also be viewed on signed to answer many routine questions DTBE’s Web site at http://www.cdc.gov/ about TB, the system can provide up-to-date nchstp/tb.

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Stop TB! Poster and Tear-Off Sheets - 1994. This pictorial poster was developed to educate persons with or at risk for TB. The poster displays the transmission of TB, progression from infection to disease, treatment, and prevention. A smaller version of the poster was developed for patients to take with them; this is available as tear-off-pads of 40 8 ½” x 11" sheets per pad. The poster and tear-off- pads are available from each state TB program and DTBE.

TB Fact Sheets - 1997. This series of five fact sheets was developed for persons with or at risk for TB. The fact sheets include “TB Facts — You Can Prevent TB” (item number 00- 5981); “TB Facts — TB and HIV (the AIDS Virus” (item number 00-5982); “TB Facts — Exposure to TB” (item number 00-5983); “TB Facts — The TB Skin Test” (item number 00- 5984); and “TB Facts — TB Can be Cured” (item number 00-5985). Each pad of 40 tear-off sheets is available from each state TB program and the DTBE. The fact sheets are also avail- able in Spanish.

TB: Get the Facts! - 1991. This pamphlet is for persons with or at risk for TB. The pam- phlet provides general information about TB, including signs and symptoms, risk factors, infection versus disease, skin testing, and preventive therapy. It is available in English and Spanish from each state TB office or DTBE.

Tuberculosis: The Connection between TB and HIV (the AIDS virus) - 1990. This pamphlet is intended for use with persons at risk for HIV-related TB. The pamphlet covers the TB/HIV connection and screening and prevention for HIV-related TB. The TB/HIV pamphlet is available in English and Spanish from each state TB office or the DTBE.

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