Ask the Scholar

Document scope · 1 page
doc
Scholar
Ask about this object, its catalog metadata, its source description, or the page inventory. For page-specific OCR and visual context, open one of the page chats.

Scholar Source Context

Document identity
localId
34428491
label
Asthma
core
doc
dtoType
document
pageCount
1
Source metadata
Source extras
naId
34428491
levelOfDescription
fileUnit
otherTitles
42-t-7422560-20140536S-005-007-2016
recordType
description
ocrSource
nara-archive
Single page context
seq
1
pageIndex
0
type
document
mediaId
45c2cacff0e9ada6
ocrText
02/27/98 FRI 10:38 FAX 202 456 6210 LOWER PRESS THE NEW YORK TIMES NEW YORK FRIDAY, FEBRUARY 27, 1998 A26 NE Giuliani Withdraws Financing For Asthma Program in Bronx By ESTHER B. FEIN mentation of the program with a Mayor Rudolph W. Gluliani said flood of bureaucratic paperwork." yesterday that the city was with- Dr. Rediener, who is also the direc- drawing its money from a multi- tor of community pediatrics at Mon- million-dollar asthma education and tefiore, said the city wanted, for ex- treatment initlative in the Bronx. ample, monthly financial account- saying the organization selected to ings, approval of treatment plans for run the program was refusing to every patient, and weekly schedules agree to the city's plan for financial of doctors' hours. The Children's and program supervision. Health Fund, he said, had offered The program, which has been quarterly reviews of the accounts, championed by Hillary Rodham patient charts and schedules. Clinton, was to have been managed Dr. Redlener said that he was by the Children's Health Fund in stunned by the Mayor's announce- conjunction with Montefiore Medical ment yesterday at City Hall that the Center in the Bronx. In its Il-year city would no longer help finance the history, the fund has become a na- project, adding that he thought his tional model for providing health organization and the Health Depart- care to poor children and its asthma ment had been making progress. initiative would have cost $2.3 million Relations between the city and the per year for four years. with the city Children's Health Fund have been providing $1.5 million annually and strained almost from the start, with the state providing the remaining the two sides arguing over what the $800,000. Initiative's focus should be - the city Asthma is considered the worst favoring community and physician chronic health problem affecting education and the health fund favor- children, and is particularly preva- ing direct patient care. lent among the urban poor because Yesterday, city officials and Dr. of the lack of accessible health care Redlener both promised to carry on and the high number of allergens in their asthma Initiatives independent- the environment. If poorly managed, ty. Dr. Redlener said that Schering- asthma can lead to extensive hospi- Plough, a pharmaceutical company calization of children and many based in New Jersey, had pledged missed days of school $750,000 a year for two years toward The president of the Children's the program. Health Fund, Dr. Irwin Redlener, Fred Winters, a spokesman for the denied that his organization was city's Health Department, said the balking at sharing its financial and city would find another vendor to patient records with the city, but said provide asthma services to Bronx that the requirements being de- communities. "The money for asth- manded were SO onerous that "they ma will not be lost," he said "It will threatened to strangle the imple- be redirected." FEB-27-1998 17:16 DHHS REGION II 212 264 4600 P.02 Friday, February 27, 1998 Rudy kills 2.3M fund DAILY NEWS for asthma By FRANK LOMBARDI and JOE CALDERONE Daily News Staff Writers Mayor Giuliani yesterday abruptly canceled fund- ing for a $2.3 million asthma program that First Lady Hillary Rodham Clinton had touted in a visit to the South Bronx last year as a potential national model to combat the disease. The mayor pulled the plug The fund and the City Coun- after the program's president, cil last summer devised a four- Dr. Irwin Redlener, com- year plan to expand asthma plained in an interview with education and medical serv- the Daily News that the city ices. Health Department had been "Enough is enough," said dragging its feet on a contract Council Speaker Peter Val- to deliver the asthma services, lone (D-Queens). "We need to even though the funds had get this money away from the been set aside months ago. bureaucrats and get it deliv- Giuliani yesterday said ered to the thousands of chil- Redlener and the Children's dren who are suffering" Health Fund, which runs the The program called for in- program, were "unwilling to creasing staffing for asthma be accountable for spending." services at a South Bronx clin- "He has refused to live by ic affiliated with Montefiore the accountability standards Medical Center and to provide that we now have in our health increased services in Wil- care con- liamsburg. tracts of all Brooklyn. kinds," the "Doesn't the The fund also mayor said. planned to "Therefore, mayor realize dispatch two the Depart- specially ment of that people are equipped Health, on vans to the merits, dying?" schools and responsibly shelters decided not MAVELIN MORALES where asth- to do busi- ma rates are ness with him, and they're not high. going to do business with him. Outside the clinic yesterday. They are going to have those asthma sufferers said they were services provided in other disappointed with the mayor's ways." decision. "Doesn't the mayor Redlener yesterday said he realize that people are dying?" was willing to go along with said Mavelin Morales, 37, reasonable standards but ob- whose 5-year-old son, Benigno, jected to reporting require- is treated at the clinic. "They ments contained in a 14-page keep putting smokestacks and rider that was added to the Dumpsters in this neighbor- standard city contract. hood but not asthma clinics." "They wanted to approve A White House official called the purchase of every single the program's demise "unfortu- piece of equipment in ad- nate" but said the First Lady vance," he said. would not take sides. FEB-27-1998 17:17 DHHS REGION 11 COMING SUNDAY Asthma: A Guide for Life A special 8-page Arthur: The Sincerely Epidemic DAILY NEWS guide for A GUIDE asthmatics and FOR LIFE their families, showing how to detect Friday. February 27, 1998 the symptoms, where to get help and what to do in an emergency. TOTAL P.03 FEB-27-1998 17:16 DHHS REGION II 212 264 4600 P.01 HUMAN SERVICES USA & U.S. Department of Health and Human Services Office of the Regional Director HEALTH 26 Federal Plaza, Room 3835 Of New York, New York 10278 DEPARTMENT FAX TRANSMISSION NOTICE DATE: 2/27/98 TO: MeLanne Verveer FAX Number: (202) 456-6244 office of First Lady ORGANIZATION: FROM: Alison E. Greene, Regional Director (212) 264-4600 (phone) (212) 264-3620 (fax) NUMBER OF PAGES (including this cover) : 2 Please notify us immediately if not received properly. Thank You. MESSAGE: This is exactly what I was concerned about last December Alison TO: Hillary Rodham Clinton FROM: Jennifer Klein DATE: 11/5/97 RE: The Vice President's Question on Study Linking Increased Asthma and Antibiotic Use You had asked for information about a study that the Vice President mentioned linking increased asthma and antibiotic use. I have attached two articles discussing a recent study done in Japan that found that increased rates of childhood asthma are related to decreased rates of infectious diseases, such as measles and tuberculosis. The study does not make a direct link between antibiotics and asthma. Instead, it posits that, with better living standards and immunization programs, children have fewer respiratory infections. Childhood respiratory infections stimulate a response in the developing immune system that may protect against asthma. With fewer infections, therefore, children are at greater risk of suffering from asthma. Experts from the National Institutes of Health, the American Lung Association, and the Asthma and Allergy Foundation of America caution that there are questions about this study. Most research finds that the rise in asthma is related to changes in the environment and to genetic predisposition. Jen- This note is from VP Gone THE WHITE HOUSE WASHINGTON Please follow up + time study increased the office time d child antibiotic use? The theses is this: tree / and biotic use in childre that life throath and often controlled) De systems ities for "Fraining and development and "fine thing." remiting poly trained immune systems regard + that Actions. TO: Jennifer Klein FROM: Jon Poling DATE: November 5, 1997 RE: Relationship Between the Immune System and Atopy (Allergic Response) or Asthma in Children The following studies suggest that increased rates of childhood asthma are related, in some degree, higher immunization rates and antibiotics use, the diminished exposure to infections and a less independent immune system. Attached are three articles for your review: The Inverse Association Between Tuberculin Responses and Atopic Disorder The study discusses how the increased rates of childhood asthma are related to the deceased rates of Tuberculosis and other infections. I believe that this is the study that we have been looking for and seems to deal with the issue that Vice President Gore had mentioned. Asthma: An Epidemic in the Absence of Infection The article is a complementary piece to the previous study. It summarizes the findings of the previous study and offers an overview with less medical jargon. New Clues to Asthma Therapies The article discusses asthma therapies, but there is another article within this one entitled Why the Rise in Asthma Cases, that discusses the relationship between a decrease in infections and an increase in atopy. Experts who I have talked to from the National Institutes of Health, the American Lung Association, the Asthma and Allergy Foundation of America and other offices all say that this study is very new and has not been thoroughly researched. Furthermore, they tell me that this, if true, is certianly not the only cause for the increase of Asthma cases in developed countries like the United States. Other articles and studies have been written on the increase of Asthma cases being related to genetic and environmental reasons. I have highlighted specific portions of the text that I think you may want to look over. If you want to read a complete article, I would suggest reading the Asthma: An Epidemic in the Absence of Infection or Why the Rise in Asthma Cases. RESEARCH NEWS project world's New Clues to Asthma Therapies Monju has Identification of major players in the inflammatory cascade that damages the lungs in asthma uterial offers targets that may produce better treatments for the disease The thor- its in- non. A rising pollen count means itchy eyes, Each crisis causes an immediate difficulty in the inflammatory cascade are a few years away anging scratchy throats, and stopped-up sinuses for breathing, and repeated crises over time lead from patients' medicine cabinets, two have Had- many allergy sufferers, but for those whose to permanent lung changes that may make already made it to the shelves. Both drugs, that allergies trigger asthma, this means more the next attack even worse. which were approved late last year by the U.S. alying than just discomfort. For them, exposure to Current asthma treatments are aimed at Food and Drug Administration (FDA), got iplan- usually harmless pollen or other allergens the end result. Bronchodilators open the air- ahead of the crowd for the simple reason that can set off a life-threatening attack in which ways, and antihistamines and steroids reduce their targets, the leukotrienes, were impli- Na- the airways leading to the lungs close up- inflammation. But by dissecting the chain cated in the cascade nearly 50 years ago. had making the sufferers feel, they say, as if they of command that leads to an attack, re- Released by activated eosinophils and gnext are trying to breathe with a full-grown per- searchers have identified a whole new set other immune-system soldiers recruited to of son standing on their chest. These frighten- asthmatic lungs, the leukotrienes have rule ing attacks are becoming more and more Allergen several effects that contribute to the common. Since 1980, the prevalence of Antigen presenting States. Today, it afflicts more than 14 mil- lion people in this country alone, and costs ILLUSTRATION: BUTLIFF airway constriction and inflammation asthma has almost doubled in the United degdritic cell of asthma. They recruit other inflam- matory cells, for example. But they stails are particularly effective in contract- scon- almost 5000 lives each year-with no signs ing the smooth muscle of the bronchi, na- fleveling off. the tubes carrying air from the trachea now Researchers don't have a clear idea of into the lungs. Molecule for molecule, what is causing this increase (see sidebar). says pulmonologist Jeffrey Drazen of Nor have they worked out what predisposes H-4 II-5 Brigham and Women's Hospital in some people to asthma in the first place. But and others and others Boston, the leukotrienes are the most on one front, they are making real headway. potent bronchoconstrictors ever de- They are beginning to pinpoint many of the scribed-a fact, he adds, "that was not key biological players that take part in asthma lost on the drug companies," which attacks. And that in turn is providing re- set out to develop inhibitors. searchers with openings for new ways to treat The two approved last year are Zi- asthma, some of which are just entering clini- IgE leuton, which blocks a vital enzyme II-4 II-5 cal use. "There is a story that's coming out," needed for leukotriene synthesis and is says Yale pulmonologist Jack Elias. "It's be- marketed by Abbott Laboratories in ginning to hang together." Chicago, and Zafirleukast, which blocks The main theme of the story is inflamma- the lipid's receptors on smooth muscle tion. Doctors have known for years that and other cells and is produced by Zeneca asthma attacks are often triggered by aller- Pharmaceuticals, based in the United gens, such as cockroaches, dust-mite feces, Kingdom. Two more receptor blockers, Histamines pollen, or animal hair. Now, researchers are Leukotrienes from Merck and from SmithKline Beech- working out the exact cascade of events that am, are awaiting FDA approval. these allergens-and other nonallergen trig- The drugs have worked miracles in gers such as cold air, viral infections, and some hard-to-treat patients, Drazen exercise-set in motion in the lungs. At the says. "In some patients it's like manna top of the cascade is a particular type of im- from heaven. We treated a veterinar- mune cell called the T lymphocyte, which Overzealous warriors. The T lymphocyte helps ian allergic to dogs and cats who was responds to the noxious substances by send- command the immune cells-including mast cells and eosinophils-that react to pollen, cold, exercise, just miserable. On this treatment, he is ing out more than a dozen chemical signals: and other stimuli to trigger an asthma attack. a normal person again." But for reasons so-called cytokines, which attract inflamma- that are currently unclear, only about tory cells to the airways of the lungs. of promising targets for asthma drugs. "The half of all patients respond to the drugs; in These warriors, in particular those called therapy is moving back closer and closer to the other half, there is almost no change, the eosinophils, release chemical weapons the beginning of the inflammation cascade," says Sally Wenzel of National Jewish, who of their own. This second wave of signals, says Harold Nelson, an allergist and immu- helped conduct several of the preapproval including histamine and small, fatty mol- nologist at the National Jewish Medical and clinical trials. ecules called leukotrienes, causes blood ves- Research Center in Denver. The hope is that sels to leak and lung tissues to swell, con- these therapies, because of their improved Stopping inflammation early tracts the smooth muscles of the airways- specificity, will be more effective and less Patients who receive no relief from the cutting off the air supply like squeezing a liable to cause dangerous side effects than leukotriene inhibitors still have reason to hose-and encourages mucus production, current treatments. hope, however. While the leukotrienes act further clogging already constricted airways. Although most of the treatments aimed at late in the inflammatory cascade, other ef- www.sciencemag.org SCIENCE VOL 276 13 JUNE 1997 1643 forts are aimed at interrupting it before it gets itself that would bind to the cytokine's re- no indication of any side effects," Jardieu established. One development propelling that ceptor on eosinophils without triggering the says. Results from a second round of trials, research is the recognition that a particular cells, while also preventing the native mol- which tested the antibody's ability to protect subset of T lymphocytes seems to be a major ecule from binding. 400 asthma patients from natural exposures culprit in asthma and other allergic diseases, Perhaps closer to pharmacy shelves is an to allergens, should be published later this responding with undue vigor to apparently antibody that blocks IgE itself. After TH2 summer, says Jardieu, and she expects phase harmless invaders. signals trigger B-cell production of an IgE III trials-testing anti-IgE against the best In work done nearly a decade ago, re- with a particular specificity, the antibody available treatment-to begin this fall. searchers working with T cells from mice attaches to mast cells, and when it encoun- found they could divide the cells into two ters a protein it recognizes as threatening, it Tipping the balance against asthma groups based on the cytokines they produce. triggers the mast cells to unleash their weap- Another therapeutic strategy currently be- Members of one set, which they called TH1 ons, including leukotrienes and histamine. If ing investigated aims to short-circuit mis- cells, produce a set of signals that orches- there were some way to block the IgE trigger, placed TH2 attacks. TH1 and TH2 activities trate attacks on unfamiliar cells, protecting researchers reasoned, the whole battle could are mutually suppressive: Signals from one the body against bacteria be avoided. cell type inhibit the activity of the other. So and tumor cells. Those in But disarming IgE several researchers are attempting to take the other set-the TH2 has proved to be a advantage of certain bacteria that induce cells-produce inflamma- tricky business. When vigorous TH1 responses, causing the im- tory signals normally di- researchers tried to mune system to pump out messengers, such rected against parasitic in- as interleukin-12 and interferon-y, vaders. They also encour- that inhibit TH2 cell activity. age the antibody-producing B cells to secrete IgE anti- STEVE KAGAN Some, including Steven Holgate of Southampton University in the bodies, the hallmark of al- United Kingdom, Julian Hopkin lergies, which help trigger of Oxford University, and Gra- the inflammatory responses. ham Rook of University College, As researchers learned more about these NPN London, are working with whole activity patterns, it became clear that TH2 bacteria. They have just begun a overactivity is a major factor in asthma. High series of studies in which they will levels of IgE, for example, are common in Terrible trio. House dust mite (top attempt to protect allergic volun- asthma patients. And one of the key TH2 left), Alternaria mold (center), and teers from the perils of allergy sea- cytokines, called interleukin-5 (II-5 for short), birch pollen (left) are all common son by injecting them with a harm- helps trigger the eosinophils that can wreak triggers of asthma attacks. less bacterium of the Mycobacte- havoc in asthmatic lungs. Although the dis- rium genus, which-like many bac- tinction between TH1 and TH2 cells is not as inactivate it with antibodies, some of their teria-is a strong TH1 inducer. The hope. cut-and-dried as many might like-many hu- efforts turned out to have just the opposite says Holgate, is that "if we give this to man T cells seem to produce both TH1 and effect, even triggering fatal allergic reac- asthmatic subjects, maybe it can switch off TH2 signals-Yale's Elias says the concept tions. "I've accidentally killed animals with the allergies." "has opened doors in thinking about asthma" [the wrong kind of] anti-IgE," says Paula Immunologists found a few years ago that it and about potential new therapies. Jardieu of Genentech, who has led her com- is particular sequences in the bacterial DNA Some of those efforts are aimed directly at pany's efforts to develop the therapy. The that induce such a strong TH1 response. Those thwarting the effects of TH2 cytokines. For problem was that these antibodies attached sequences play a key role in a therapy under example, II-5 appears to be a good target. If to the same part of IgE that binds the aller- development by immunologists Eyal Raz and the cytokine's action in mice is blocked, ei- gen, thus triggering, rather than blocking, Dennis Carson and allergist David Broide of ther by inactivating the gene that codes for IgE's effects on mast cells. the University of California, San Diego. The the protein or by giving the animal antibod- Recently, however, researchers have iden- team is attempting to devise a more effec- ies that prevent II-5 from binding to and ac- tified the specific region of IgE that binds to tive means of desensitizing people to their tivating eosinophils, the animal's airways do the mast cell receptor, enabling them to allergies, which currently involves repeat- not react to allergens, says immunologist produce antibodies that block only that edly injecting them with small amounts of David Huston at Baylor College of Medicine site. Buoyed by promising results in mice, the allergen, often for years. To bolster this in Houston. This suggests several possible ap- they went on to build a human version of effect, the researchers have designed a small proaches to asthma treatments. the mouse antibody. Through DNA ma- circular piece of DNA, called a plasmid, that Two pharmaceutical companies, Schering- nipulation, they were able to transplant includes both the DNA encoding any of sev- Plough and SmithKline Beecham, have been the IgE-binding region of the mouse mol- eral common allergen proteins and fragments working on the development of human ver- ecule onto the base of a human antibody. of bacterial DNA. sions of mouse anti-II-5 antibodies, and have They tested the resulting "humanized" an- In early tests, the team injected the been getting promising results in trials with tibody by giving it to monkeys allergic to plasmids into mice, whose skin cells took animals-including primates. In the animal ragweed and found that it prevented the up the DNA. There the plasmid started pro- trials, the anti-II-5 antibodies have pre- typical skin sensitivity to the pollen. ducing the antigen protein. "It's like immu- vented both eosinophil inflammation and Initial trials, designed to test the safety of notherapy," says Raz, "but instead of having airway constriction. Human trials "are immi- this antibody in humans, have been very to give it repeatedly, you give it only twice or nent," Huston says. positive, says Jardieu. The 40 patients who three times and it is there permanently." At In addition, Huston and his colleagues, as received doses of the antibody suffered only the same time, the researchers hoped, the well as a number of industry groups, are work- mild reactions when the research team blew bacterial DNA in the plasmids would crank ing to engineer an inactive version of II-5 allergens into their lungs, with "absolutely up the suppressive effects of the treatment by 1644 SCIENCE VOL. 276 13 JUNE 1997 www.sciencemag.org RESEARCH NEWS Why the Rise in Asthma Cases? Asthma is a disease of the industrialized 20th century. First of Immunology and Allergy in Rome and his colleagues found. described in the mid-1800s, it may have existed before that time, that soldiers who tested positive for antibodies to hepatitis A but was very rare. It is still rare in developing countries. But in the virus-a sign of more childhood infections in general, say the developed world in the last 2 decades, asthma rates have skyrock- authors-had significantly fewer allergies. (The results appeared eted-doubling in the United States since 1980. "Asthma and in the April British Medical Journal:) allergies have become representative of the westernization of our Researchers have also turned up other hints that early im- society," says William Busse, an allergist at the University of munological experience can affect a child's chances of devel- Wisconsin, Madison. oping asthma-very early experience, if Jill Warner at the Researchers do not yet know why. They have come a long way University at Southampton in the United Kingdom is right. in dissecting the sequence of events that leads to individual When she and her colleagues studied immune cells from pre- asthma attacks: the activation by an allergen or other trigger of mature and terminated fetuses, they found that cells from fe- certain immune cells, which in turn marshal other cells that tuses as young as 22 weeks could multiply when exposed to mount inflammatory attacks on the lungs (see main text). But house dust mites and birch pollen-suggesting that they recog- why some people are predisposed to such attacks-and why their nized the allergens from a previous exposure. Warner is cur- numbers are now increasing-remain mysteries, although re- rently studying whether limiting a mother's exposure to com- searchers have some clues. mon allergens can protect her unborn child from later develop- Increased exposure to environ- ing allergies and asthma. 16 mental allergens and immune sys- Still, environmental influences tem changes due to fewer child- 14 can't be the full answer, because hood infections may play a role, say asthma susceptibility is well known 12 some. And geneticists are closing in to run in families. A number of all- on a host of genes that have been urgent, says Busse, because it might Asthma prevalence 10 out hunts are now under way for linked to increased asthma suscep- tibility. The search for a cause is (in millions) 8 BOURCE: AMERICAN LUNG ASSOCIATION asthma-susceptibility genes, which might be interacting with environ- 6 mental factors to drive the rising point to ways of preventing chil- 4 incidence. So far, only one team— dren from developing the disease in at Sequana Therapeutics Inc. in San the first place. For the moment, he 2 Diego-says it has pinpointed a says, "we are treating the conse- 0 gene, and team members are keep- quences of the disease, not prevent- '82 '83 '84 '85 '86 '87 '88 89 '90 '91 '92 '93 '94 ing details of their find under wraps ing it from occurring." (Science, 30 May 1997, p. 1327). But Asthma ascending. Researchers are struggling to explain One of the most popular theories asthma's dramatic increase. several more public searches are clos- holds that asthma has increased partly ing in on genes. because of greater exposure to aller- A team led by Carol Ober, a ge- gens such as house dust mites or cockroaches. Allergist Thomas neticist at the University of Chicago, reported at the recent Platts-Mills of the University of Virginia notes that nowadays American Thoracic Society meeting that its work with the South children spend more time indoors in front of the television in Dakota Hutterites, a religious group of 5000 descended from 64 close contact with carpets and upholstered furniture crawling 18th-century ancestors, has linked asthma or asthmalike condi- with dust mites. Still, Platts-Mills says, this "Annette Funicello" tions to specific regions on chromosomes 2, 13, and 21. And in a effect, as he calls it, "can't explain the rise by itself." The asthma wider study of the general population, the multicenter Collabora- increase is just too great and has occurred even in dry regions tive Study on the Genetics of Asthma reported in the April issue where the dust mite is uncommon. of Nature Genetics that its researchers have linked asthma in Another feature of modern life might also be contributing: various ethnic groups to a half-dozen different chromosome re- the fall in childhood infections. Early infections, say proponents gions. Other studies have found linkages to regions on chromo- of this idea, may stimulate a kind of immune response that somes 11 and 12 containing genes known to code for important suppresses later allergic reactions. Earlier this year, Oxford players in the inflammation that is part of asthma pathology. pulmonologist Julian Hopkin and colleagues at the Wakayama The linkages, like all the other clues, are a long way from Medical Center in Wakayama, Japan, found that children who solving the asthma riddle, but they are a start. "Everyone knew onded strongly to a skin test indicating that they had been [the gene search] was a black hole," says Susan Banks-Schlagel, exposed to tuberculosis are less likely to suffer from asthma or manager of asthma research at the National Heart, Lung, and other allergic diseases (Science, 3 January, p. 77). Similarly, in a Blood Institute. "They said, 'Oh, you'll never find anything.' But study of 1600 Italian soldiers, Paolo Matricardi of the Laboratory some interesting things are starting to happen." -G.V. eliciting production of interferon-ya other stance to which they were allergic. Raz and But the TH2 model that has inspired these TH2 suppressors. his colleagues have formed a company, new treatments may not be a complete an- Again, initial results are promising. Mice called Dynavax, and plan to begin human swer to the asthma puzzle. Viral infections, receiving the novel immunotherapy have trials in collaboration with researchers at for example, have been blamed for 80% of IgE in their blood, fewer eosinophils in Johns Hopkins University as soon as they severe asthma attacks, says Daniel Rotrosen their lungs, and less evidence of TH2-type receive FDA approval-expected "within the of the National Institute of Allergy and In- cytokines when they are exposed to the sub- year," says Raz. fectious Diseases. But viruses have usually www.sciencemag.org SCIENCE VOL. 276 13 JUNE 1997 1645 been considered a trigger of a TH1-type Those unanswered questions might ex- many suspect is the case: Asthma is not a response. Some researchers believe that vi- plain why new treatments such as the leu- single disease. Like pneumonia or anemia, ruses are not the immediate trigger, but kotriene inhibitors will not work for every- Brigham and Women's Drazen says, asthma contribute to asthma susceptibility by at- one. But the fact that the drugs don't help is a set of symptoms that has varied causes. tacking the lining of the lungs, leaving the some patients may be as important as the The new treatments, by getting closer to inner layers more exposed to environmen- help they do give some people: "That is those causes, may help doctors divide pa- tal allergens or other traditional asthma where it gets really interesting," Drazen says. tients into subgroups based on how they triggers-which would then activate TH2 "Up until now, we have graded asthma as respond to treatments, he adds. That, in cells and the other responses they orches- mild, moderate or severe," which is only of turn, will help researchers determine how to trate. Others believe the viruses may have limited help to physicians trying to deter- treat each patient most effectively-a de- an inside role, activating certain genes in mine the best course of treatment. velopment, certainly, that will help mil- the nucleus chat exacerbate or trigger the Patients' different responses to the vari- lions breathe easier. inflammatory cascade. ous drugs may help doctors sort out what -Gretchen Vogel IMMUNOLOGY. New Lead to Safer Marrow Transplants looked promising: Lymphocytes engineered with the gene for the enzyme thymidine ki- Bone-marrow transplants have become a the top bone-marrow transplant centers, par- nase died when he doused them with the mainstay of medicine's battle against blood- ticularly in patients who relapsed and re- antiviral drug ganciclovir, which the enzyme cell cancers, such as leukemias and lym- quired infusions of donor lymphocytes. Mar- converts to a deadly poison. phomas, as well as against certain noncan- row transplants are needed because the high After showing that ganciclovir also kills cerous blood diseases. But in at least half of doses of chemotherapeutic drugs and radia- the suicide gene-bearing lymphocytes in mice, all patients, the donor immune cells turn tion given to leukemia and lymphoma pa- Bordignon and colleagues began their pilot against the recipient's own tissues, triggering tients in an effort to rid them of all cancer study in humans. In 1993, they infused donor a deadly ailment called graft-versus-host dis- cells also destroy the patients' bone marrow, lymphocytes bearing the thymidine kinase or ease (GVHD). Now a team of doctors led by the vital source of both the red cells and the suicide gene into 12 patients who, after re- hematologist Claudio Bordignon at the San infection-fighting white cells of the blood. ceiving bone-marrow transplants, had suf- Raffaele Scientific Institute in Milan, Italy, But unless the donor is an identical twin, fered complications such as cancer relapse or may have found a solution to this problem. the transplant may turn on a patient, caus- virus-induced lymphomas. The lymphocytes On page 1719, the group reports the first ing GVHD, as the foreign white blood cells survived in the patients for up to a year, bat- successful human test of a gene therapy tling the tumors to achieve complete or par- designed to halt the attack of the tial remissions in five of the eight patients for donated cells on the recipient's tis- whom results are available. sues. The researchers genetically en- Of the three patients who developed RCH CENTER gineered the transplanted cells with GVHD, ganciclovir totally shut down the a self-destruct button that enables immune attack in two; in the third, the disease doctors to kill them selectively with was attenuated. The success may have been a drug if they turn mutinous. This limited in the third patient, Greenberg specu- allowed the team to wipe out GVHD lates, because some of the infused lympho- in two of the three patients who de- cytes may not have borne the suicide gene. veloped it, and partially eliminate it Still, if the new gene-therapy procedure in the third-without using immuno- helps two out of every three patients, it will be suppressive drugs. an improvement. Researchers caution, how- That success is a boost for the strug- Under attack. Multiple lymphocytes are invading the ever, that tests in many more patients will be GEORGE SALE/FRED CANCER gling field of genetic therapy, says im- epidermis of human skin with graft-versus-host disease. needed to determine just how effective the munologist Drew Pardoll of the Johns therapy is. Toward this end, Bordignon is or- Hopkins University School of Medicine in attack essential organs such as the liver, ganizing a multicenter European trial that he Baltimore, who calls the work "one of a very gut, and skin. Clinicians have sought to hopes will start by the end of 1997. But even small cohort of examples in which gene avoid this attack by sifting out all of the that may not settle the question, says Pardoll, therapy has been shown to have clinical util- mature T lymphocytes from the foreign mar- because transporting the Italian group's tech- ity." Indeed, if further studies bear out the row before infusing it. Those are the cells that nique to other centers may be difficult: "I can early promise of the technique, it could make trigger GVHD, but their removal leaves the count on one hand, with a couple of fingers bone-marrow transplants much safer and patient more vulnerable to infections or can- missing, the number of groups that could do more effective. Doctors might even start cer relapse. If infection or cancer does de- this [gene-transfer procedure] with high effi- using such transplants more broadly, in pa- velop, the patient can be infused with the do- ciency." He adds, however, that developing tients with less advanced disease. The tech- nor T cells-again running the risk of GVHD. simple, reproducible protocols for the proce- nique is "very exciting," says immunologist Bordignon, a doctor trained in gene dure could boost that number. Philip Greenberg of the Fred Hutchinson therapy, recalls that he asked himself, "How One thing is certain. The therapy has al- Cancer Research Center in Seattle. "It has the might one take advantage of gene-transfer ready shown sufficient promise, says Richard potential to improve substantially the out- technology to control this problem?" He set O'Reilly, a marrow-transplant pioneer at come of [bone-marrow] transplantation." out in early 1992 to test whether he could New York City's Memorial Sloan-Kettering The strategy's seeds were planted in 1990, introduce a "suicide gene" into these cells, Cancer Center, to ensure that it "will be when Bordignon first heard about the prob- then use the gene to kill the cells if they looked at by many people." lems with GVHD were cropping up in triggered GVHD. Results with cultured cells -Ingrid Wickelgren 1 SCIENCE VOL. 276 13 JUNE 1997 www.sciencemag.org RESEARCH NEWS project world's New Clues to Asthma Therapies Monju ich has Identification of major players in the inflammatory cascade that damages the lungs in asthma naterial offers targets that may produce better treatments for the disease The thor- ists in- non. A rising pollen count means itchy eyes, Each crisis causes an immediate difficulty in the inflammatory cascade are a few years away anging scratchy throats, and stopped-up sinuses for breathing, and repeated crises over time lead from patients' medicine cabinets, two have Had- many allergy sufferers, but for those whose to permanent lung changes that may make already made it to the shelves. Both drugs, that allergies trigger asthma, this means more the next attack even worse. which were approved late last year by the U.S. adying than just discomfort. For them, exposure to Current asthma treatments are aimed at Food and Drug Administration (FDA), got iplan- usually harmless pollen or other allergens the end result. Bronchodilators open the air- ahead of the crowd for the simple reason that trator can set off a life-threatening attack in which ways, and antihistamines and steroids reduce their targets, the leukotrienes, were impli- Na- the airways leading to the lungs close up- inflammation. But by dissecting the chain cated in the cascade nearly 50 years ago. had making the sufferers feel, they say, as if they of command that leads to an attack, re- Released by activated eosinophils and enext are trying to breathe with a full-grown per- searchers have identified a whole new set other immune-system soldiers recruited to gal of son standing on their chest. These frighten- asthmatic lungs, the leukotrienes have retule ing attacks are becoming more and more Allergen several effects that contribute to the common. Since 1980, the prevalence of Antigen presenting Japan asthma has almost doubled in the United lion people in this country alone, and costs ILLUSTRATION: SUTLIFF airway constriction and inflammation dendritic cell of asthma. They recruit other inflam- States. Today, it afflicts more than 14 mil- matory cells, for example. But they inails are particularly effective in contract- con- almost 5000 lives each year-with no signs ing the smooth muscle of the bronchi, na- of leveling off. the tubes carrying air from the trachea now Researchers don't have a clear idea of into the lungs. Molecule for molecule, hugh what is causing this increase (see sidebar). says pulmonologist Jeffrey Drazen of Nor have they worked out what predisposes II-4 II-5 Brigham and Women's Hospital in port some people to asthma in the first place. But and others and others Boston, the leukotrienes are the most on one front, they are making real headway. potent bronchoconstrictors ever de- They are beginning to pinpoint many of the scribed-a fact, he adds, "that was not key biological players that take part in asthma lost on the drug companies," which attacks. And that in turn is providing re- set out to develop inhibitors. searchers with openings for new ways to treat The two approved last year are Zi- for asthma, some of which are just entering clini- IgE leuton, which blocks a vital enzyme II-4 II-5 cal use. "There is a story that's coming out," needed for leukotriene synthesis and is says Yale pulmonologist Jack Elias. "It's be- marketed by Abbott Laboratories in of ginning to hang together." Chicago, and Zafirleukast, which blocks The main theme of the story is inflamma- the lipid's receptors on smooth muscle tion. Doctors have known for years that and other cells and is produced by Zeneca asthma attacks are often triggered by aller- Pharmaceuticals, based in the United gens, such as cockroaches, dust-mite feces, Kingdom. Two more receptor blockers, Histamines pollen, or animal hair. Now, researchers are Leukotrienes from Merck and from SmithKline Beech- working out the exact cascade of events that am, are awaiting FDA approval. these allergens-and other nonallergen trig- The drugs have worked miracles in gers such as cold air, viral infections, and some hard-to-treat patients, Drazen exercise-set in motion in the lungs. At the says. "In some patients it's like manna top of the cascade is a particular type of im- from heaven. We treated a veterinar- mune cell called the T lymphocyte, which Overzealous warriors. The T lymphocyte helps ian allergic to dogs and cats who was responds to the noxious substances by send- command the immune cells-including mast cells and eosinophils-that react to pollen, cold, exercise, just miserable. On this treatment, he is ing out more than a dozen chemical signals: and other stimuli to trigger an asthma attack. a normal person again." But for reasons so-called cytokines, which attract inflamma- that are currently unclear, only about tory cells to the airways of the lungs. of promising targets for asthma drugs. "The half of all patients respond to the drugs; in These warriors, in particular those called therapy is moving back closer and closer to the other half, there is almost no change, the eosinophils, release chemical weapons the beginning of the inflammation cascade," says Sally Wenzel of National Jewish, who of their own. This second wave of signals, says Harold Nelson, an allergist and immu- helped conduct several of the preapproval including histamine and small, fatty mol- nologist at the National Jewish Medical and clinical trials. ecules called leukotrienes, causes blood ves- Research Center in Denver. The hope is that sels to leak and lung tissues to swell, con- these therapies, because of their improved Stopping inflammation early tracts the smooth muscles of the airways- specificity, will be more effective and less Patients who receive no relief from the cutting off the air supply like squeezing a liable to cause dangerous side effects than leukotriene inhibitors still have reason to hose-and encourages mucus production, current treatments. hope, however. While the leukotrienes act further clogging already constricted airways. Although most of the treatments aimed at late in the inflammatory cascade, other ef- www.sciencemag.org SCIENCE VOL. 276 13 JUNE 1997 1643 forts are aimed at interrupting it before it gets itself that would bind to the cytokine's re- no indication of any side effects," Jardieu established. One development propelling that ceptor on eosinophils-without triggering the says. Results from a second round of trials, research is the recognition that a particular cells, while also preventing the native mol- which tested the antibody's ability to protect subset of T lymphocytes seems to be a major ecule from binding. 400 asthma patients from natural exposures culprit in asthma and other allergic diseases, Perhaps closer to pharmacy shelves is an to allergens, should be published later this responding with undue vigor to apparently antibody that blocks lgE itself. After TH2 summer, says Jardieu, and she expects phase harmless invaders. signals trigger B-cell production of an IgE III trials-testing anti-IgE against the best In work done nearly a decade ago, re- with a particular specificity, the antibody available treatment-to begin this fall. searchers working with T cells from mice attaches to mast cells, and when it encoun- found they could divide the cells into two ters a protein it recognizes as threatening, it Tipping the balance against asthma groups based on the cytokines they produce. triggers the mast cells to unleash their weap- Another therapeutic strategy currently be- Members of one set, which they called TH1 ons, including leukotrienes and histamine. If ing investigated aims to short-circuit mis- cells, produce a set of signals that orches- there were some way to block the IgE trigger, placed TH2 attacks. TH1 and TH2 activities trate attacks on unfamiliar cells, protecting researchers reasoned, the whole battle could are mutually suppressive: Signals from one the body against bacteria EFA be avoided. cell type inhibit the activity of the other. So and tumor cells. Those in But disarming IgE several researchers are attempting to take the other set-the TH2 has proved to be a advantage of certain bacteria that induce cells-produce inflamma- tricky business. When vigorous TH1 responses, causing the im- tory signals normally di- researchers tried to mune system to pump out messengers, such rected against parasitic in- as interleukin-12 and interferon-y. vaders. They also encour- that inhibit TH2 cell activity. age the antibody-producing B cells to secrete IgE anti- STEVE KAGAN Some, including Steven Holgate of Southampton University in the bodies, the hallmark of al- United Kingdom, Julian Hopkin lergies, which help trigger of Oxford University, and Gra- the inflammatory responses. ham Rook of University College, As researchers learned more about these NPN London, are working with whole activity patterns, it became clear that TH2 bacteria. They have just begun a overactivity is a major factor in asthma. High series of studies in which they will levels of IgE, for example, are common in Terrible trio. House dust mite (top attempt to protect allergic volun- asthma patients. And one of the key TH2 left), Alternaria mold (center), and teers from the perils of allergy sea- cytokines, called interleukin-5 (II-5 for short), birch pollen (left) are all common son by injecting them with a harm- helps trigger the eosinophils that can wreak triggers of asthma attacks. less bacterium of the Mycobacte- havoc in asthmatic lungs. Although the dis- rium genus, which-like many bac- tinction between TH1 and TH2 cells is not as inactivate it with antibodies, some of their teria-is a strong TH1 inducer. The hope, cut-and-dried as many might like-many hu- efforts turned out to have just the opposite says Holgate, is that "if we give this to man T cells seem to produce both TH1 and effect, even triggering fatal allergic reac- asthmatic subjects, maybe it can switch off TH2 signals-Yale's Elias says the concept tions. "I've accidentally killed animals with the allergies." "has opened doors in thinking about asthma" [the wrong kind of] anti-IgE," says Paula Immunologists found a few years ago that it and about potential new therapies. Jardieu of Genentech, who has led her com- is particular sequences in the bacterial DNA Some of those efforts are aimed directly at pany's efforts to develop the therapy. The that induce such a strong TH1 response. Those thwarting the effects of TH2 cytokines. For problem was that these antibodies attached sequences play a key role in a therapy under example, II-5 appears to be a good target. If to the same part of IgE that binds the aller- development by immunologists Eyal Raz and the cytokine's action in mice is blocked, ei- gen, thus triggering, rather than blocking, Dennis Carson and allergist David Broide of ther by inactivating the gene that codes for IgE's effects on mast cells. the University of California, San Diego. The the protein or by giving the animal antibod- Recently, however, researchers have iden- team is attempting to devise a more effec- ies that prevent II-5 from binding to and ac- tified the specific region of IgE that binds to tive means of desensitizing people to their tivating eosinophils, the animal's airways do the mast cell receptor, enabling them to allergies, which currently involves repeat- not react to allergens, says immunologist produce antibodies that block only that edly injecting them with small amounts of David Huston at Baylor College of Medicine site. Buoyed by promising results in mice, the allergen, often for years. To bolster this in Houston. This suggests several possible ap- they went on to build a human version of effect, the researchers have designed a small proaches to asthma treatments. the mouse antibody. Through DNA ma- circular piece of DNA, called a plasmid, that Two pharmaceutical companies, Schering- nipulation, they were able to transplant includes both the DNA encoding any of sev- Plough and SmithKline Beecham, have been the IgE-binding region of the mouse mol- eral common allergen proteins and fragments working on the development of human ver- ecule onto the base of a human antibody. of bacterial DNA. sions of mouse anti-l1-5 antibodies, and have They tested the resulting "humanized" an- In early tests, the team injected the been getting promising results in trials with tibody by giving it to monkeys allergic to plasmids into mice, whose skin cells took animals-including primates. In the animal ragweed and found that it prevented the up the DNA. There the plasmid started pro- trials, the anti-II-5 antibodies have pre- typical skin sensitivity to the pollen. ducing the antigen protein. "It's like immu- vented both eosinophil inflammation and Initial trials, designed to test the safety of notherapy," says Raz, "but instead of having airway constriction. Human trials "are immi- this antibody in humans, have been very to give it repeatedly, you give it only twice or nent," Huston says. positive, says Jardieu. The 40 patients who three times and it is there permanently." At In addition, Huston and his colleagues, as received doses of the antibody suffered only the same time, the researchers hoped, the well as a number of industry groups, are work- mild reactions when the research team blew bacterial DNA in the plasmids would crank ing to engineer an inactive version of II-5 allergens into their lungs, with "absolutely up the suppressive effects of the treatment by 1644 SCIENCE VOL. 276 13 JUNE 1997 www.sciencemag.org RESEARCH NEWS Why the Rise in Asthma Cases? Asthma is a disease of the industrialized 20th century. First of Immunology and Allergy in Rome and his colleagues found described in the mid-1800s, it may have existed before that time, that soldiers who tested positive for antibodies to hepatitis A but was very rare. It is still rare in developing countries. But in the virus-a sign of more childhood infections in general, say the developed world in the last 2 decades, asthma rates have skyrock- authors-had significantly fewer allergies. (The results appeared eted-doubling in the United States since 1980. "Asthma and in the April British Medical Journal.) allergies have become representative of the westernization of our Researchers have also turned up other hints that early im- society," says William Busse, an allergist at the University of munological experience can affect a child's chances of devel- Wisconsin, Madison. oping asthma-very early experience, if Jill Warner at the Researchers do not yet know why. They have come a long way University at Southampton in the United Kingdom is right. in dissecting the sequence of events that leads to individual When she and her colleagues studied immune cells from pre- asthma attacks: the activation by an allergen or other trigger of mature and terminated fetuses, they found that cells from fe- certain immune cells, which in turn marshal other cells that tuses as young as 22 weeks could multiply when exposed to mount inflammatory attacks on the lungs (see main text). But house dust mites and birch pollen-suggesting that they recog- why some people are predisposed to such attacks-and why their nized the allergens from a previous exposure. Warner is cur- numbers are now increasing-remain mysteries, although re- rently studying whether limiting a mother's exposure to com- searchers have some clues. mon allergens can protect her unborn child from later develop- Increased exposure to environ- ing allergies and asthma. 16 mental allergens and immune sys- Still, environmental influences tem changes due to fewer child- 14 can't be the full answer, because hood infections may play a role, say asthma susceptibility is well known 12 some. And geneticists are closing in to run in families. A number of all- on a host of genes that have been urgent, says Busse, because it might Asthma prevalence 10 out hunts are now under way for linked to increased asthma suscep- tibility. The search for a cause is (in millions) 8 SOURCE: AMERICAN LUNG ASSOCIATION asthma-susceptibility genes, which might be interacting with environ- 6 mental factors to drive the rising point to ways of preventing chil- 4 incidence. So far, only one team- dren from developing the disease in at Sequana Therapeutics Inc. in San the first place. For the moment, he 2 Diego-says it has pinpointed a says, "we are treating the conse- 0 gene, and team members are keep- quences of the disease, not prevent- '82 '83 '84 '85 '86 '87 '88 89 '90 91 '92 '93 94 ing details of their find under wraps ing it from occurring." Asthma ascending. Researchers are struggling to explain (Science, 30 May 1997, p. 1327). But One of the most popular theories asthma's dramatic increase. several more public searches are clos- holds that asthma has increased partly. ing in on genes. because of greater exposure to aller- A team led by Carol Ober, a ge- gens such as house dust mites or cockroaches. Allergist Thomas neticist at the University of Chicago, reported at the recent Platts-Mills of the University of Virginia notes that nowadays American Thoracic Society meeting that its work with the South children spend more time indoors in front of the television in Dakota Hutterites, a religious group of 5000 descended from 64 close contact with carpets and upholstered furniture crawling 18th-century ancestors, has linked asthma or asthmalike condi- with dust mites. Still, Platts-Mills says, this "Annette Funicello" tions to specific regions on chromosomes 2, 13, and 21. And in a effect, as he calls it, "can't explain the rise by itself." The asthma wider study of the general population, the multicenter Collabora- increase is just too great and has occurred even in dry regions tive Study on the Genetics of Asthma reported in the April issue where the dust mite is uncommon. of Nature Genetics that its researchers have linked asthma in Another feature of modern life might also be contributing: various ethnic groups to a half-dozen different chromosome re- the fall in childhood infections. Early infections, say proponents gions. Other studies have found linkages to regions on chromo- of this idea, may stimulate a kind of immune response that somes 11 and 12 containing genes known to code for important suppresses later allergic reactions. Earlier this year, Oxford players in the inflammation that is part of asthma pathology. pulmonologist Julian Hopkin and colleagues at the Wakayama The linkages, like all the other clues, are a long way from Medical Center in Wakayama, Japan, found that children who solving the asthma riddle, but they:are a start. "Everyone knew responded strongly to a skin test indicating that they had been [the gene search] was a black hole," says Susan Banks-Schlagel, exposed to tuberculosis are less likely to suffer from asthma or manager of asthma research at the National Heart, Lung, and other allergic diseases (Science, 3 January, p. 77). Similarly, in a Blood Institute. "They said, 'Oh, you'll never find anything.' But study of 1600 Italian soldiers, Paolo Matricardi of the Laboratory some interesting things are starting to happen." -G.V. eliciting production of interferon-yand other stance to which they were allergic. Raz and But the TH2 model that has inspired these TH2 suppressors. his colleagues have formed a company, new treatments may not be a complete an- Again, initial results are promising. Mice called Dynavax, and plan to begin human swer to the asthma puzzle. Viral infections, receiving the novel immunotherapy have trials in collaboration with researchers at for example, have been blamed for 80% of less IgE in their blood, fewer eosinophils in Johns Hopkins University as soon as they severe asthma attacks, says Daniel Rotrosen their lungs, and less evidence of TH2-type receive FDA approval-expected "within the of the National Institute of Allergy and In- cytokines when they are exposed to the sub- year," says Raz. fectious Diseases. But viruses have usually www.sciencemag.org SCIENCE VOL. 276 13 JUNE 1997 1645 been considered a trigger of a TH1-type Those unanswered questions might ex- many suspect is the case: Asthma is not a response. Some researchers believe that vi- plain why new treatments such as the leu- single disease. Like pneumonia or anemia, ruses are not the immediate trigger, but kotriene inhibitors will not work for every- Brigham and Women's Drazen says, asthma contribute to asthma susceptibility by at- one. But the fact that the drugs don't help is a set of symptoms that has varied causes. tacking the lining of the lungs, leaving the some patients may be as important as the The new treatments, by getting closer to inner layers more exposed to environmen- help they do give some people: "That is those causes, may help doctors divide pa- tal allergens or other traditional asthma where it gets really interesting," Drazen says. tients into subgroups based on how they triggers-which would then activate TH2 "Up until now, we have graded asthma as respond to treatments, he adds. That, in cells and the other responses they orches- mild, moderate or severe," which is only of turn, will help researchers determine how to trate. Others believe the viruses may have limited help to physicians trying to deter- treat each patient most effectively-a de- an inside role, activating certain genes in mine the best course of treatment. velopment, certainly, that will help mil- the nucleus that exacerbate or trigger the Patients' different responses to the vari- lions breathe easier. inflammatory cascade. ous drugs may help doctors sort out what -Gretchen Vogel IMMUNOLOGY New Lead to Safer Marrow Transplants looked promising: Lymphocytes engineered with the gene for the enzyme thymidine ki- Bone-marrow transplants have become a the top bone-marrow transplant centers, par- nase died when he doused them with the mainstay of medicine's battle against blood- ticularly in patients who relapsed and re- antiviral drug ganciclovir, which the enzyme cell cancers, such as leukemias and lym- quired infusions of donor lymphocytes. Mar- converts to a deadly poison. phomas, as well as against certain noncan- row transplants are needed because the high After showing that ganciclovir also kills cerous blood diseases. But in at least half of doses of chemotherapeutic drugs and radia- the suicide gene-bearing lymphocytes in mice, all patients, the donor immune cells turn tion given to leukemia and lymphoma pa- Bordignon and colleagues began their pilot against the recipient's own tissues, triggering tients in an effort to rid them of all cancer study in humans. In 1993, they infused donor a deadly ailment called graft-versus-host dis- cells also destroy the patients' bone marrow, lymphocytes bearing the thymidine kinase or ease (GVHD). Now a team of doctors led by the vital source of both the red cells and the suicide gene into 12 patients who, after re- hematologist Claudio Bordignon at the San infection-fighting white cells of the blood. ceiving bone-marrow transplants, had suf- Raffaele Scientific Institute in Milan, Italy, But unless the donor is an identical twin, fered complications such as cancer relapse or may have found a solution to this problem. the transplant may turn on a patient, caus- virus-induced lymphomas. The lymphocytes On page 1719, the group reports the first ing GVHD, as the foreign white blood cells survived in the patients for up to a year, bat- successful human test of a gene therapy tling the tumors to achieve complete or par- designed to halt the attack of the tial remissions in five of the eight patients for donated cells on the recipient's tis- whom results are available. sues. The researchers genetically en- Of the three patients who developed gineered the transplanted cells with GVHD, ganciclovir totally shut down the a self-destruct button that enables immune attack in two; in the third, the disease doctors to kill them selectively with was attenuated. The success may have been a drug if they turn mutinous. This limited in the third patient, Greenberg specu- allowed the team to wipe out GVHD lates, because some of the infused lympho- in two of the three patients who de- cytes may not have borne the suicide gene. veloped it, and partially eliminate it Still, if the new gene-therapy procedure in the third-without using immuno- helps two out of every three patients, it will be suppressive drugs. an improvement. Researchers caution, how- GEORGE SALE/FRED HUTCHINSON CANCER RESEARCH CENTER That success is a boost for the strug- Under attack. Multiple lymphocytes are invading the ever, that tests in many more patients will be gling field of genetic therapy, says im- epidermis of human skin with graft-versus-host disease. needed to determine just how effective the munologist Drew Pardoll of the Johns therapy is. Toward this end, Bordignon is or- Hopkins University School of Medicine in attack essential organs such as the liver, ganizing a multicenter European trial that he Baltimore, who calls the work "one of a very gut, and skin. Clinicians have sought to hopes will start by the end of 1997. But even small cohort of examples in which gene avoid this attack by sifting out all of the that may not settle the question, says Pardoll, therapy has been shown to have clinical util- mature T lymphocytes from the foreign mar- because transporting the Italian group's tech- ity." Indeed, if further studies bear out the row before infusing it. Those are the cells that nique to other centers may be difficult: "I can early promise of the rechnique, it could make trigger GVHD, but their removal leaves the count on one hand, with a couple of fingers bone-marrow transplants much safer and patient more vulnerable to infections or can- missing, the number of groups that could do more effective. Doctors might even start cer relapse. If infection or cancer does de- this [gene-transfer procedure] with high effi- using such transplants more broadly, in pa- velop, the patient can be infused with the do- ciency." He adds, however, that developing tients with less advanced disease. The tech- nor T cells-again running the risk of GVHD. simple, reproducible protocols for the proce- nique is "very exciting," says immunologist Bordignon, a doctor trained in gene dure could boost that number. Philip Greenberg of the Fred Hutchinson therapy, recalls that he asked himself, "How One thing is certain. The therapy has al- Cancer Research Center in Seattle. "It has the might one take advantage of gene-transfer ready shown sufficient promise, says Richard potential to improve substantially the out- technology to control this problem?" He set O'Reilly, a marrow-transplant pioneer at come of [bone-marrow] transplantation." out in early 1992 to test whether he could New York City's Memorial Sloan-Kettering The strategy's seeds were planted in 1990, introduce a "suicide gene" into these cells, Cancer Center, to ensure that it "will be when Bordignon first heard about the prob- then use the gene to kill the cells if they looked at by many people." lems with GVHD that were cropping up in triggered GVHD. Results with cultured cells -Ingrid Wickelgren 1646 SCIENCE VOL. 276 13 JUNE 1997 www.sciencemag.org PERSPECTIVES ing the November 1995 assault on Jaffna. poration of the rebels into the national army continue the development of tasks and tools Cease-fires have been declared in Sudan for in El Salvador and, recently, in the Philip- that can serve as instruments of peace. both polio and dracunculiasis eradication, ex- pines provides evidence that days of tran- panding health truces beyond immunization. quillity can be the first of many steps toward References Days of tranquillity permit warring parties a lasting peace. Polio eradication activities 1. W. Morris, Ed., The American Heritage Dictionary to disengage and provide a glimpse of peace, must be conducted amidst current and future of the English Language (Houghton-Mifflin, Bos- but also give both sides a common goal to conflicts around the world. We are confident ton, 1978), p. 833. serve as a starting point for future negotia- that there will be more truces and polio will 2. K. J. Bart et al., WHO 74, 35 (1996). 3. Anonymous, Wkly Epidemiol. Rec. 71, 189 (1995). tions. The resolution of conflict with incor- be eradicated. The challenge for science is to 4. H. F. Hull et al., Lancet 343, 1331 (1994). IMMUNOLOGY Asthma: An Epidemic in the den and polluted Poland show the same phe- nomenon (5). The German investigators also Absence of Infection? found that the prevalence of asthma was lower in the youngest children of large families than in children high in the birth order (6). These results suggest that asthma preva- William O. C. M. Cookson and Miriam F. Moffatt lence has increased because of something lack- ing in the modern environment, rather than through the positive actions of some toxic fac- 7. tor. Respiratory and other infections are much Asthma is a chronic and debilitating disease, Pollution n more common in polluted and crowded East- 3- causing swollen and inflamed airways that are crowding. em block countries than in the West, and prone to constrict suddenly and violently. Poor sanitation younger children get more infections from Asthmatics have attacks of shortness of breath their siblings than single or older children. 7. and wheezing that can be life-threatening or Childhood infections may, therefore, para- even fatal. The prevalence of asthma in West- TB Viral Helminth doxically protect against asthma. The study ernized societies has risen steadily this century, infection infection infection by Shirakawa et al. on children in Japan doubling in the last 20 years (1). Asthma now focuses on tuberculosis as a key in- affects one child in seven in Great Britain, and Polyclonal IgE fection influencing asth- in the United States it causes one-third of pedi- ma prevalence (3). -ve atric emergency-room visits. Asthma is famil- Aero allergens Inflammation is mod- house dust mite ial, and genome-wide searches by our group and pollens ulated by helper T (TH) others have shown that many genetic loci pre- animal danders lymphocytes. T lympho- dispose to the disease (2). It is unlikely, how- cytes may be classified ever, that the genetic makeup of stable popula- Delayed cutaneous Atopy into TH1 and TH2 types, according to the pat- tions can change significantly within one cen- hypersensitivity (asthma, eczema, tern of their cytokine production (7). TH1 cells tury, so the probable cause of the epidemic must to tuberculin and rhinitis) secrete interferon-y interleukin-2 (IL- lie in the environment. In this issue of Science, 2), and lymphotoxin, whereas TH2 cells secrete Shirakawa and his colleagues (p. 77) present Genes IL-4, IL-5, IL-6, IL-10, and IL-13. TH1 cells evidence for a novel environmental cause of An advantage of Infection. Atopy (asthma and enhance cellular immune responses, and TH2 asthma (3). other allergic diseases) is reciprocally related to cells favor the humoral response. Although the Asthmatic airway inflammation is initi- immunity to tuberculosis (as measured by de- TH1/TH2 classification is an oversimplifica- ated by immunoglobulin E (IgE)-mediated layed cutaneous hypersensitivity to tuberculin) tion, cells exhibiting the TH2 phenotype up- allergy ("atopy") to airborne proteins ("aller- (3). If an individual has predominantly TH2 T regulate IgE production and are prominent in ion gens"). For asthmatics, the most important cells, the TH2 phenotype interacts with environ- mental allergens to produce atopic disease. In- the pathogenesis of airway inflammation and oto source of allergens is the house dust mite. fections may alter the balance between TH1 and asthma. These mites thrive in warm, moist condi- TH2 phenotypes. The clean living conditions of As in other modern societies, infection tions and are ubiquitous in human bedding. Western society, by reducing the incidence of with Mycobacterium tuberculosis (Mtb) has for There is a dose-response relation between infection, may tip the balance toward the TH2 declined steadily in Japan during this cen- exposure to mite antigens and asthma, and a phenotype and predispose to asthma. nly tury. This is in part due to a comprehensive The plausible but unproven case can be made for program of inoculation with attenuated bo- increasing levels of mite in modern heated elsewhere in the United States. This suggests vine tuberculosis vaccine bacillus Calmette- nu- for homes (1). In Japan, asthma has increased that the innate ability to become allergic can Guérin (BCG), which is administered at 3 ran- just as the population has moved away from readily find alternative antigens. months of age. Children are tested for de- dor the traditional bare and well-ventilated house Air pollution may aggravate existing layed hypersensitivity to tuberculin (DHT) inst to Western-style buildings. In Arizona, how- asthma but is not responsible for the asthma at 6 and 7 years of age and are re-inoculated 93, ever, the dry heat means that mite allergy is epidemic (1). Comparisons have been made with BCG if the skin test is negative. Final ally rare, yet asthma is as common in Tucson as between the prevalence of asthma and al- skin testing is carried out on all children vac- lergy in highly polluted Leipzig in East Ger- when they are 12. Shirakawa et al. studied uces many and clean Munich in the West (4). 867 children after the age of 12 and showed a The authors are at the University of Oxford, Nuffield De- kan Surprisingly, the prevalence of asthma and clear negative relation between DHT re- partment of Medicine, John Radcliffe Hospital, Oxford with OX3 9DU, UK. E-mail: william.cookson@clinical- skin tests to common allergens was lower in sponses and two parameters-the presence dur- medicine.ox.ac.uk the East. Similar comparisons between Swe- of asthma and the serum IgE concentration. SCIENCE VOL. 275 3 JANUARY 1997 41 Children with positive DHT responses to mans with filariasis, who show TH2-biased hood tuberculosis infection in Japan is causal tuberculin had serum cytokine concentra- cytokine profiles, the ability to respond to Mtb in the recent asthma epidemic. However, the tions suggestive of predominant TH1 re- proteins is not lost (11). Children with eczema, incidence of other infections may also be sponses, in contrast to the TH2 profiles seen another atopic condition, occasionally un- declining, so the case for tuberculosis re- in children with negative DHTs. dergo spontaneous remission after severe bac- quires further study. Nevertheless, the new These results are an important extension terial or viral infections (12), although usually results emphasize the complexity of the envi- of observations in the 1960s and 1970s that temporarily. Both of these observations suggest ronmental contribution to asthma and re- there is a reciprocal relation between inflam- that alterations in the TH2/TH1 balance may mind us that identification of the relevant matory and humoral responses to vaccination become important only in the presence of con- factors may ultimately resolve this epidemic. regimes (7, 8). This reciprocal relation has tinued overwhelming infection. also been attributed to preferential activation Also confusing the TH1/TH2 theory of References of TH1 or TH2 subsets of T cells and is consis- asthma are the findings that helminth and 1. A. Seaton et al. Thorax 49, 171 (1994). tent with the genetic predisposition to TH1 or other parasite infection may protect against 2. S. E. Daniels and S. Bhattacharyya et al., Nature TH2 responses of different strains of mice. allergic diseases, despite up-regulation of 383, 247 (1996). Central to the relevance of the results is the TH2 responses. This type of infestation is 3. T. Shirakawa, T. Enomoto, S. Shimazu, J. M. Hopkin, Science 275, 77 (1996). hypothesis that the immune system can be invoked to explain the low prevalence of 4. E. von Mutius et al., Br. Med. J. 305, 1395 (1992). manipulated to manifest a persistent TH1 or asthma in rural Africa and the Venezuelan 5. L. Bröböck et al., Clin. Exp. Allergy 24, 826 (1994). TH2 response. If this is the case, vaccination to slums (13, 14). Helminth infection produces 6. E. von Mutius et al., Br. Med. J. 308, 692 (1994). 7. A. Kelso, Immunol. Today 16, 374 (1995). induce TH1 responses may be effective against high levels of polyclonal IgE that, possibly by 8. C. R. Parish, Transplant. Rev. 13. 35 (1972). asthma and other allergic disorders (9). In saturating the number of binding sites for IgE 9. P.G. Holt, Lancet 344, 456 (1994). mice, overwhelming Schistosoma mansoni in- on mast and other effector cells of allergy, 10. J. K. Actor et al., Proc. Natl. Acad. Sci. U.S.A. 90, 948 (1993). fection induces TH2 responses. The infection prevent activation of these cells by the rela- 11. E. Sartono et al., Eur. J. Immunol. 26, 501 (1996). concomitantly down-regulates the TH1 re- tively trivial exposures to allergens. 12. M. Lacour, Dermatology 188, 255 (1994). sponse to other antigens and delays the clear- Thus, the results of Shirakawa et al. invite 13. R. C. Godfrey, Clin. Allergy 5, 201 (1975). 14. N.R. Lynch et al., J. Allergy Clin. Immunol. 92. 404 ance of vaccinia virus (10). However, in hu- the speculation that the decline in child- (1993). SIGNAL TRANSDUCTION (4). But how signaling through GBy is termi- There Are GAPS and There Are GAPS nated has not been as clear. A report in Cell by Gilman and co-workers (5) and two oth- ers in Nature (6) identifying two members of Ravi lyengar the RGS family, GAIP and RGS4, as GAPs for members of the Gα, family and other recent papers shed light on this issue. Members of the RGS family have been Although their main function is to regulate and By subunits that exist as a single com- identified in yeast, Caenorhabditis elegans, other proteins, guanine nucleotide-binding plex. Both Gα and GBy can independently and mammals (7). Sst2p in yeast and EGL-10 proteins (G proteins) are also guanosine tri- transmit signals (3). Signal termination for in C. elegans, homologs of RGS, suppress phosphatases (GTPases), cleaving guanosine both Gα and GBy subunits likely occurs signal transmission by acting on the G pro- triphosphate (GTP) to form guanosine through GTP hydrolysis. How the GTPase tein-α subunit (8). Mammalian RGS can diphosphate (GDP). Because of this activity, terminates signaling through Gα subunits is substitute for yeast Sst2p in regulating phero- they oscillate between GTP- and GDP-bound easily understood given the observation that mone signaling (9), which is transmitted states, and thus regulate diverse processes such GDP-Gα subunits have much lower affini- through GBy subunits (10). Taken together, as protein synthesis, cytoskeleton assembly, ties for effectors than do GTP-Gα complexes these data suggest that RGS can regulate vesicle transport, and signal transduction. signaling through GBy subunits by modulat- The superfamily comprises both small mono- Activated GTP ing the activity of the GTPase of the α meric and large multimeric G proteins, but for receptor subunit. How would such regulation all members, the release of bound GDP and work? The positive cooperativity the binding of GTP are highly regulated pro- GDP between GBy and GDP inter- cesses (1). The GTPase activity of small G action with Gα subunits proteins, such as EF-Tu and Ras, is stimu- GDP lated by associated proteins called GAPs By RGS (GAP) α GTPase By (GTPase activating proteins) (2). But GAPs + E E Heterotrimeric Activating for most large G proteins had not been de- G protein Protein + GTP Effector scribed until recent work identified members GDP of the regulators of G protein-signaling (RGS) family as GAPs for this subfamily. The large heterotrimeric G proteins in- volved in signal transduction have α sub- A four-component heterotrimeric G protein-signaling system. The resting G protein is an aßy units, which are related to small G proteins, heterotrimer with GDP bound to it. Activated receptor promotes the release of GDP, the binding of GTP, and dissociation of GTP-Gα from the GBy complex. GTP-Gα and GBy can now interact with their effec- tors and propagate the signal. RGS stimulates (+) the GTPase activity of the Ga subunit, resulting in the The author is in the Department of Pharmacology, accumulation of GDP-Gα, which re-forms the stable heterotrimer. Free GBy leads to dissociation of GBy Mount Sinai School of Medicine, New York, NY 10029, from effector, thus terminating signal propagation. R, receptor; E, effector; αßy, the heterotrimeric G USA. E-mail: iyengar@msvax. mssm.edu protein; and RGS (GAP), stimulator of the GTPase of the Gα subunit. 42 SCIENCE VOL. 275 3 JANUARY 1997 REPORTS si- 4. M. Itoh et al., J. Cell Biol. 121, 491 (1993); E. Willott et The Inverse Association Between Tuberculin he al., Proc. Natl. Acad. Sci. U.S.A. 90, 7834 (1993). 5. C. P. Ponting and C. Phillips, Trends Biochem. Sci. nd 20, 102 (1995). Responses and Atopic Disorder 6. H. C. Kornau, L. T. Schenker, M. B. Kennedy, P. H. at Seeburg, Science 269, 1737 (1995). Taro Shirakawa, Tadao Enomoto, Shin-ichiro Shimazu, 7. E. Kim, M. Niethammer, A. Rothschild, Y. N. Jan, M. in Sheng, Nature 378, 85 (1995). Julian M. Hopkin* si- 8. J. H. M. Cabral et al., ibid. 382, 649 (1996). -2 9. D. A. Doyle et al., Cell 85, 1067 (1996). Human immune responses are heterogeneous and may involve antagonism between T x- 10. Z. Songyang et al., ibid. 72, 767 (1993). helper (TH) lymphocyte subsets and their cytokines. Atopy is characterized by immediate 11. A primary peptide library, KNXXXXXXX-COOH, es- where X indicates all amino acids except Cys and immunoglobulin E (IgE)-mediated hypersensitivity to agents such as dust mites and in Trp, was first used to screen peptides that bind spe- pollen, and it underlies the increasingly prevalent disorder asthma. Among Japanese ni- cifically to the glutathione-S-transferase (GST)-PDZ schoolchildren, there was a strong inverse association between delayed hypersensitivity domains. All the peptides in the library end with free se carboxylate, therefore orienting all binding pockets. to Mycobacterium tuberculosis and atopy. Positive tuberculin responses predicted a he The peptides that bound were sequenced as a mix- lower incidence of asthma, lower serum IgE levels, and cytokine profiles biased toward lg- ture, and the selectivities for amino acids at a given TH1 type. Exposure and response to M. tuberculosis may, by modification of immune in position were determined by comparison to the se- quence of control experiments with GST alone (10). profiles, inhibit atopic disorder. or Arg was not included in the calculation because of at buffer contamination during sequencing. A second- he ary library, KNXXXXXX(S,T,Y)XX-COOH, where the -2 position was fixed with Ser, Thr, and Tyr, was P used to further define the preference of some PDZ Atopy is a state of allergic response, me- according to sibship size and birth order domains. diated by IgE, to largely innocuous, com- (9) also support the possibility that dimin- he 12. Peptide library synthesis was as described (10). mon environmental antigens (allergens) ished exposure to infection might, in some Individual PDZ domains were expressed and puri- th fied as GST fusion proteins: murine hDlg PDZ-1 such as those derived from house dust way, promote atopic responses. Childhood le (186-282), PDZ-2 (281-377), PDZ-3 (428-518), mites and plant pollens (1); it underlies respiratory infections that might strongly lo- and PDZ-1/2 (281-518); murine PTPbas PDZ-3 the clinical diseases of asthma, hay fever, modify the developing immune system, (1351-1445) and PDZ-5 (1758-1848); murine n- Tiam-1 PDZ; human LIN-2 PDZ (422-507): human and eczema (2). Atopy can be recognized both systemically and within the lung, nt erythroid p55 PDZ (1-164); and human AF-6 PDZ by allergen-specific IgE in serum or by include measles, whooping cough, and tu- di- (983-1102). Glutathione beads (50 to 60 µl) satu- immediate-type hypersensitivity reactions berculosis. Some of these infections culti- rated with GST-PDZ proteins were mixed with the to peptide library (1 mg) in 300 µl of TSN buffer [40 to allergens upon intradermal skin testing. vate a TH1 immunological environment :C- mM triethylamine (pH 7.6), 150 mM NaCI, and Heterogeneous genetic and environmental with IL-12, interferon-y (IFN-γ), and tu- nt 0.01% NP-40] containing bovine serum albumin factors interact in the development of ato- mor necrosis factor (TNF) as predominant (BSA, 1 mg/ml) and 1 mM dithiothreitol (DT T). After ast 45 min of constant shaking at 4°C, the beads were py (3); a set of cytokines-interleukin-4 cytokines (10); because these cytokines o- washed with TSN buffer. The peptides retained (IL-4), IL-10, and IL-13 derived from the inhibit TH2 cytokine functions (11), the at were eluted with 30% acetic acid, tyophilized, re- TH2 subset of T lymphocytes-is central absence of such infections might release 1. suspended in distilled water, and sequenced on a Bio-Applied 477A sequencer. in mediating IgE production and the de- TH2 immune mechanisms and thus pro- is 13. Z. Songyang and L. C. Cantley, unpublished data. velopment of immediate hypersensitivity mote atopic disorder. ne 14. T. Sato, S. Irie, S. Kitada, J. C. Reed, Science 268, (4). In the case of tuberculosis, an important n- 411 (1995). In recent decades there has been an marker of TH1-mediated acquired immunity lg, 15. P. Ruff, D. W. Speicher, A. Husain-Chishti, Proc. Natl. Acad. Sci. U.S.A. 88, 6595 (1991). increase in severity, and probably in prev- (not synonymous with protection) is the th 16. R. Hoskins, A. F. Hajnal, S. A. Harp, S. K. Kim, alence, of atopic disorders in developed development of delayed-type hypersensitiv- IO- Development 122, 97 (1996); A. Brecher et al., in countries (5). Studies on migrants from ity. This can be tested by observing the 2). preparation. developing to developed countries support reaction, after 48 hours, to the intradermal 17. G. G. Habets et al., Cell 77, 537 (1994). ns 18. R. Prasad et al., Cancer Res. 53, 5624 (1993). the importance of etiological environmen- injection of tuberculin protein (12). There ng 19. G. Payne, S.E. Shoelson, G. D. Gish, T. Pawson, C. tal changes associated with "Westerniza- is likely a "J-shaped" relation between the ns T. Walsh, Proc. Natl. Acad. Sci. U.S.A. 90, 4902 tion" (6). The nature of these environ- degree of delayed hypersensitivity and the In (1993). 20. H. T. Yu et al., Cell 76, 933 (1994). mental changes is obscure, but speculation risk of tuberculous disease, in which people H- 21. z. Songyang et al., data not shown. has focused on increased air pollution or with moderate hypersensitivity are at least an 22. J.S. Simske, S. M. Kaech, S. A. Harp, S. K. Kim, Cell other toxins in the environment, in- risk (13). he 85, 195 (1996). creased indoor exposure to dust mite an- To test for clinical evidence of antag- 23. S. M. Marfatia et al., J. Biol. Chem., in press. to 24. V. Hata, S. Butz, T. Sudhof, J. Neurosci. 16, 2488 tigens in less ventilated modern homes, onism between delayed hypersensitivity to lo- (1996). and dietary changes (7). One factor tem- tuberculin and immediate atopic respons- ifs 25. J.E. Brenman et al., Cell 84, 757 (1996). porally associated with the rise of atopy is es, we conducted an epidemiologic survey dr- 26. B. Lipinska, M. Zylicz, C. Georgopoulos, J. Bacteriol. the decline of many infectious diseases in in a county of the Wakayama prefecture in 172, 1791 (1990). m- 27. S. V. Shestakov et al., J. Biol. Chem. 269, 19354 developed countries as the result of im- southern Honshu, Japan, where there has ey (1994). proved living standards and immunization been a long-established program of tuber- ti- 28. We thank M. Berne for peptide synthesis and se- programs (8). Data on the risk of atopy culin testing and immunization with at- quencing, R. Mackinnon for structural coordinates of tenuated bovine M. tuberculosis vaccine PSD-95-3, W. Boll and A. Nguyen for technical as- sistance, A. Couvillon for antibodies to GST, M. Oishi T. Shirakawa and J. M. Hopkin, Lung Research Labora- [bacillus Calmette-Guérin (BCG)] after and T. Woodford-Thomas for the PTPbas cDNA, tory, Osler Chest Unit, Churchill Hospital, Oxford OX3 7LJ, UK. birth and at 6 and 12 years of age (14). and A. Brecher for human LIN-2 PDZ. C.F. is a Lucille T. Enomoto, Department of Otolaryngology, Japanese From a population of approximately 1000 237 Markey Fellow. Supported by grants from American Cancer Society and Lucille P. Markey Charitable Red Cross Society, Wakayama Medical Center, 12- to 13-year-old schoolchildren attend- 91); Trust (L.C.C.), NIH grants CA66263 and DK34989 Wakayama, Japan. S. Shimazu, Department of Pediatrics, National Waka- ing the 18 junior high schools of the coun- (J.M.A. and A.S.F), Pew Scholars Program (A.C.C.), 29 yama Hospital, Wakayama, Japan. ty in 1995, we studied 867 children with and NIH grant CA66263 (A.H.C. and S.M.M.). 20, *To whom correspondence should be addressed. E-mail: complete retrospective records of their tu- 22 July 1996; accepted 23 October 1996 [email protected] berculin responses. We administered a SCIENCE VOL. 275 3 JANUARY 1997 77 questionnaire documenting atopic symp- strong inverse association was found be- were one-half to one-third as likely in toms and social and environmental vari- tween positive tuberculin responses at positive tuberculin responders as in nega- ables, and we also measured IgE serum both 6 and 12 years of age and a range of tive responders (Table 2). Moreover, re- levels and TH1 and TH2 cytokine profiles atopic characteristics, including symptoms mission of atopic symptoms between 7 and (15); these data were analyzed in relation at any age and IgE levels and TH2 cyto- 12 years of age was six to nine times as to the record of tuberculin responses. kine profiles assayed at 12 years of age likely in positive tuberculin responders. There was a bimodal distribution of (Fig. 1B and Tables 1 and 2). In positive Serum IgE levels, both total and allergen- delayed-type hypersensitivity responses to tuberculin responders, the rate of current specific, were also lower in the positive tuberculin upon skin testing (Fig. 1A). atopic symptoms was one-third the rate in tuberculin responders. The geometric Positive tuberculin tests (>10 mm skin negative responders. Asthmatic symptoms mean for total serum IgE level was 112 induration) correspond to response to M. tuberculosis; negative tests include fully negative reactions as well as intermediate Table 1. History of infectious diseases, atopic symptoms, IgE levels, and cytokine profiles in subjects grouped by tuberculin reactivity. ASE, allergen-specific IgE; UD, undetectable. reactions (5 to 9 mm) that generally re- flect responses to nontuberculous environ- Group 1 Group 2 Group 3 Group 4 mental mycobacteria or to BCG (16). Pos- Measurement (n = 290) (n = 289) (n = 213) Total (n = 867) (n = 75) itive tuberculin responses were recorded in 3% of the children at 3 months of age, in Tuberculin response 33.2% at 6 years, and in 58.0% at 12 years. At 6 years - - + + In many children, the tuberculin status At 12 years - + + - Positive antiviral immunity (%) changed, to either positive or negative, Measles (history + vaccine) 83.4 87.2 84.5 81.3 84.3 between the ages of 6 and 12 years (Table Chicken pox (history + vaccine) 86.9 82.3 82.2 82.7 83.9 1, groups 2 and 4). None of the children Mumps (history + vaccine) 62.8 60.9 60.1 57.3 61.0 suffered clinical tuberculous disease at any Number with IgE to Ascaris 2 2 2 1 7 stage, including 24 with florid tuberculin Symptoms (%) responses (>40 mm skin induration) who Atopy (past + present) 46.8 33.9# 25.8## 38.7 36.6 Atopy (present) 32.1 7.9## 9.8## 30.7 18.5 underwent full clinical and radiographic Asthma (past + present) 13.4 4.1# 3.7# 6.8 7.4 assessment for the disease. Rhinitis (past + present) 16.2 4.8# 8.6 14.6 10.4 Of all the children studied, 36% man- Eczema (past + present) 22.7 12.8## 12.2# 16.0 16.2 ifested atopic symptoms at some time. A Geometric mean IgE (IU/ml) 208 149** 98*** 178 154 Positive ASE (%) 55.8 43.9# 41.8# 53.3 48.2 Atopic (high IgE or positive 65.5 54.0# 49.2# 61.3 57.3 A 15 ASE) (%) Median cytokine level (pg/ml) IL-4 1.88 0.96t 0.92t 1.66 1.22 (10.2-UD)§ IL-13 18.3 10.2ttt 7.8ttt 19.1 14.2 (45.6-UD) Frequency (%) 10 IL-10 5.9 3.1tt 2.9tt 5.9 3.9 (10.2-UD) IL-12 UD UD UD UD UD IFN-γ 7.8 11.0tt 13.2+t 6.4 10.5 (23.2-UD) 5 Positive family history within 54.1 49.8 49.8 48.0 51.0 three generations (%) Mean BMI 21.1 22.0 21.9 21.2 21.6 0 "P < 0.01, ***P < 0.001 on the basis of Student's test. tp < 0.05, ttp < 0.01, tttp < 0.001 on the basis of a 10 20 30 median test. #P < 0.05, # < 0.01, ##P < 0.001 on the basis of x² against group 1, respectively. Maximum- minimum values. DHT (mm) B 4 Table 2. Odds ratios for atopy and for occurrence and remission of atopic symptoms in positive versus negative tuberculin responders by age. Multiple logistic analysis was conducted with the SPSSX package, version 2.2. In all models, allowance was made for dichotomized variables including 3 o sex, life-style, nutritional status, environmental factors, and family history. Only significant values are serum IgE) shown. 8 2 o Odds ratio 8° 8 Tuberculin response Atopic symptoms 1 Atopy 8 Occurrence Remission 00 0 Conversion to 0.50 Asthma: 0.31 Asthma: 8.2 0 20 40 60 60 positive up to 6 (0.29 to 0.83)* (0.22 to 0.45)* (6.0 to 9.8)** years of age Eczema: 0.50 Eczema: 1.6 DHT (mm) (0.33 to 0.91)* (1.0 to 2.2)* Fig. 1. Delayed hypersensitivity to tuberculin Conversion to 0.43 Asthma: 0.42 Asthma: 6.0 (DHT, in millimeters) and relation to serum IgE. (A) positive between (0.25 to 0.83)** (0.24 to 0.56)* (2.8 to 10.3)' Histogram showing bimodal distribution of re- 6 and 12 years of age Eczema: 6.7 sponses to tuberculin, assayed as DHT at 12 (4.8 to 11.4)* years of age in 867 Japanese schoolchildren. (B) Rhinitis: 9.0 Plot of log(total serum IgE) versus DHT in the same (6.2 to 14.2)* children (r = -0.492, P < 0.001). *P < 0.05, **P < 0.01, ""P 0.005. 78 SCIENCE VOL. 275 3 JANUARY 1997 REPORTS IU/ml for children who had a positive in the rate of positive atopic skin tests ration after 48 hours), intermediate (5 to 9 mm), or tuberculin response at any time, whereas it (20). In our study, we found no relation negative. At each of these ages, negative respond- ers were immunized with 10⁶ colony-forming units was 194 IU/ml for children whose respons- between a history of measles infection and (CFU) of attenuated bovine M. tuberculosis (BCG, es were always negative. A plot of the atopy. However, there are important pop- Tokyo 172 strain, Japan BCG Laboratory). At 3 logarithm of total serum IgE against the ulation and environmental differences be- months of age, 97 to 98% of the children (groups 1 to 4 in Table 1) were tuberculin-negative and received diameter of tuberculin response shows an tween Wakayama and Guinea-Bissau; BCG. inverse linear relation, T = -0.492 (Fig. also, the Wakayama region has had an 15. T. Shirakawa and K. Morimoto, Allergy 48, 177 1B). Positive tuberculin responders had established program of measles immuniza- (1993); T. Shirakawa et al., Eur. J. Epidemiol., in significantly lower levels of TH2 cytokines tion, with an uptake of 60% or more, and press. The sample consisted of 867 12- to 13-year- old students (454 boys and 413 girls) at the 18 (IL-4, IL-10, and IL-13) and higher levels there had been no measles epidemic rele- junior high schools in the southern county of of the TH1 cytokine IFN-γ. vant to our study. It is likely that a set of Wakayama prefecture who responded to a ques- In tests for confounding variables (15), specific infections that strongly promote tionnaire and donated blood for serology. The questionnaire included details on personal and fa- we found no differences in life-style, en- TH1 immunity has the potential to inhibit milial atopic disorders, life-style and environmental vironmental factors, or nutritional status atopic disorder by the repression of TH2 characteristics, weight and height, and history of between the positive and negative tuber- immunity. We believe that the role of public health immunizations. Nutritional status was assessed as BMI (body mass index), calculated by culin responders; estimated allergen expo- such an infection in repressing atopy de- weight and height. Concentrations of nitrogen di- sure was similar among the groups with pends on a number of factors, including its oxide and sulfur dioxide in ambient air have been respect to pet animal exposure, character timing, anatomical site, dose, and pro- <0.02 parts per million for the last 30 years in this district. Personal records for skin test responses to and ventilation of homes, and residence in tractedness; exposure to other infections; tuberculin and BCG inoculation, documented by a rural area. Exposure to helminths, which and host characteristics such as genetic school doctors, were available from each school's can promote high IgE levels, was minimal variables and nutritional status (21). Pro- filed records. Diagnoses of asthma, eczema, and rhinitis were made by school doctors on the basis in the population; only 7 of the 867 chil- spective and experimental studies are of international criteria. Specific IgE to five airborne dren showed IgE to Ascaris lumbricoides. needed to investigate the action of M. allergens and total serum IgE were assayed by Similar numbers of positive and negative tuberculosis and other microorganisms, Lumiward immunoassay (Shinogi); IgE to Ascaris tuberculin responders reported atopy in through natural infection or immunization lumbricoides was assayed (Arastat; DPC, Tokyo, Japan). A positive altergen-specific IgE was >0.35 any sib, parent, or grandparent (~50%) or schedules, in deviating immunity away IU/liter. An elevated total serum IgE was taken to be had chest radiograph reports of tuberculo- from atopy. >1 SD above the geometric mean (200 IU/liter). sis in the same relatives at any time Atopy was defined as one or more positive aller- gen-specific IgE, a raised total IgE, or both. Serum (~13%). REFERENCES AND NOTES cytokine levels were immunoassayed in the Mit- Several lines of evidence suggest that a subishi Kagaku BCL laboratories (Tokyo) by means causal link between tuberculin response 1. R. Ishizaka, Clin. Allergy 1, 9 (1971). of commercial kits; the minimum detectable levels and atopy is more likely than fixed deter- 2. B. Burrows, F. D. Martinez, M. Halonen, R. A. Bar- were 0.50 pg/ml for IL-4 and IL-10, 3.1 pg/ml for bee, M. G. Cline, N. Engl. J. Med. 320, 271 (1989). IL-13, 5 pg/ml for IFN-γ, and 7.8 pg/ml for IL-12 mination of both atopy and diminished 3. J. M. Hopkin, Pediatr. Allergy Immunol. 6, 139 heterodimer. Serum IgE levels were correlated with tuberculin responses by a genetic factor or (1995). TH2 cytokine levels (IL-4, correlation coefficient r = 0.356; IL-13, r = 0.565; IL-10, r = 0.558; P < factors. Our data show that tuberculin 4. I. Aebischer and B. M. Stadler, Adv. Immunol. 61, 0.001) and were inversely correlated with levels of responses change, from positive to nega- 341 (1996); J. M. Carballido, N. Carballido-Perrig, G. Terres, C. H. Heusser, K. Blaser, Eur. J. Immunol. the TH1 cytokine IFN-y V = -0.567; P = 0.001). tive and vice versa, in many children be- 22, 1357 (1992). 16. N. S. Galbraith, A. Hanson, R. Shoulman, D. W. tween 6 and 12 years of age (groups 2 and 5. I. N. Bruce, R. W. Harland, N. A. McBride, J. Mac- Andres, D. B. Lee, Br. Med. J. 1, 647 (1972); T. Mahon, Q. J. Med. 86, 425 (1993); F. Schultz- Oettinger, A. Holm, I. M. Mtoni, A. B. Andersen, K. 4 in Table 1). A marked decline in the Larsen, Monogr. Allergy 31, 9 (1993); E. von Mutius, Hasloov, Infect. Immun. 63, 4613 (1995). As a rule, incidence of positive tuberculin responses C. Fritsch, S. K. Weiland, G. Roell, H. Magnussen, positive tuberculin responses are caused by infec- in the Wakayama region over a very short tion with M. tuberculosis, whereas intermediate re- Br. Med. J. 305, 1395 (1992). sponses are caused by exposure to nontuberculous genetic interval-95% in 1965, 85% in 6. D. A. Waite, E. F. Eyles, S. L. Tonkin, T. V. O'Donnell, mycobacteria or immunization with BCG. We cannot 1975, 60% in 1985, and 58% in our Clin. Allergy 10, 71 (1980); J. Morrison-Smith and S. exclude the possibility that some of the conversions Cooper, Postgrad. Med. J. 57, 774 (1981). survey-was accompanied by a decline to tuberculin positivity after 6 years of age might be 7. H. E. Wickmann, Clin. Exp. Allergy 26, 621 (1996). attributable to a second immunization with BCG, in infectious clinical cases of tuberculosis 8. V. H. Springett, J. H. Darbyshire, A. J. Nunn; I. Suth- especially because the Tokyo 172 BCG used is from 154.4 per 100,000 in 1974 to 52.1 per erland, J. Epidemiol. Community Health 42, 370 strongly immunogenic, having retained the gene for (1988); R. Doll, Am. J. Public Health 82, 933 (1992); 100,000 in 1994 (17). Experimental ani- the major antigen, MPT 64; nor do we know what M. Burnet and D. O. White, Natural History of Infec- role environmental mycobacteria may have played in mal data show antigen-independent, re- tious Disease (Cambridge Univ. Press, Cambridge, this semirural environment. ciprocal inhibition of either TH1 or TH2 1972). 17. Japanese Ministry of Health and Welfare, Trends of immunity by infectious agents that strong- 9. E. von Mutius et al., Br. Med. J. 308, 692 (1994). Health and Welfare in Japan, 1994 (Ministry of Health 10. D. T. Fearon and R. M. Locksley, Science 272, 50 ly promote TH1 responses [such as myco- and Welfare, Tokyo, 1995). (1996); S. H. E. Kaufmann, Annu. Rev. Immunol. 11, 18. G. B. Mackaness, P. H. Lagrange, T. Ishibashi, J. bacteria (18)] or TH2 responses [such as 129 (1993). Exp. Med. 139, 1540 (1974). schistosomes (19)]. The data support the 11. A. M. Cooper et al., Immunology 84, 423 (1995); V. 19. E. J. Pearce, P. Caspar, J.-M. Grzych, F.A. Lewis, A. Donckier et al., J. Immunol. 153, 2361 (1994); L. Xu hypothesis that a decline in infection, in Sher, ibid. 173, 159 (1991). and P. Rothman, Int. Immunol. 6, 515 (1994). this instance tuberculosis, is a factor 20. S. O. Shaheen et al., Lancet 347, 1792 (1996). 12. G. P. Youmans, Am. Rev. Respir. Dis. 111, 109 21. R. W. Baker, A. Zumla, G. A. W. Rook, Q. J. Med. 89, underlying the rising severity and preva- (1975). 387 (1996); J. M. Grange, ibid., p. 323; P. G. Holt, lence of atopic disorders in recent decades 13. P.E. Fine, J. A. Steme, J. M. Ponnighaus, R. J. Rees, Toxicol. Lett. 86, 205 (1996). Lancet 344, 1245 (1994). in developed countries. These data are 22. We thank the school doctors of Hidaka Medical As- 14. The regimen in Japan for prevention of tuberculosis also consistent with the idea that atopic sociation for help with sample collections, and T. to 12 years of age by the Ministry of Health and Yamashita and F. Kurimoto (Mitsubishi), T. Onishi responses are limited by TH1 immune Welfare was administered as follows. Mantoux skin (Shinogi), and K. Kato (DPC Japan) for help with testing-after single-needle intradermal injection of mechanisms. purified protein derivative (2.5 tuberculin units) of M. serological assays. We thank the students for partic- Epidemiological data from Guinea-Bis- ipating and their teachers and school nurses for their tuberculosis (Aoyama B strain, Japan BCG Labora- assistance. Supported in part by Mitsubishi Chemi- sau show that a history of childhood mea- tory, Tokyo)-was performed in all children within 3 cal Company (Tokyo). sles infection around the time of an epi- months of birth, at 6 years of age, and at 12 years of age. Delayed hypersensitivity to tuberculin was cat- demic was associated with a 50% decrease egorized as positive mm diameter of skin indu- 23 August 1996; accepted 21 October 1996 SCIENCE VOL. 275 3 JANUARY 1997 79 TO: Jennifer Klein FROM: Jon Poling DATE: 10-9-97 RE: Wall Street Journal Article on EPA and Asthma Inhalers As of 1996, the Clean Air Act banned all production of CFCs (chlorofluorocarbons ) in accordance with the Montreal Protocol, an international agreement to protect the ozone layer. However, the United States successfully argued for an "essential use exemption" that allows for enough domestic production of CFCs to meet the needs of American asthmatics. These exemptions last until 1999 and cover all Metered Dose Inhalers (MDIs) that are CFC based. There is one CFC-free inhaler on the market, but it is not an adequate substitute for the CFC based inhalers. The International Pharmaceutical Aerosol Consortium estimates that 11 new CFC-free inhalers will be on the market by the year 2000. Until that time, the EPA will keep the CFC based inhalers exempt from the Montreal Protocol Ban. Jon' see Check If this to happened info Gather on what EPA to Asthmatic Kids: Hold Your Breath are doing we to fight By ROBERT M. GOLDBERG gies and Infectious Diseases found in emitting fire extinguishers even though Today, the Clinton administration will 1995 that failure to comply with treat- the EPA found some alternatives are ai- asthma. issue a proposal that could take away ment explains the 300% increase in ready on the market and in use. The asthma inhalers from inner-city children asthma-related deaths among children EPA's Ms. Browner apparently believes Jen to protect the Earth's ozone layer. between 1980 and 1993. that preservation sprays and coaxial ca- This is not a sick joke. or the product of -Why would the EPA want to hasten the ble are more important than medicine for an overheated conservative imagination. elimination of a medicine that's essential asthmatic children. Rather. the Environmental Protection to keeping kids alive? The Montreal proto- This is what we have come to expect Agency wants to announce a ban on chlo- col doesn't require it. And a large number from the Clinton administration: Chil- rofluorocarbon-powered inhalers in Mon- of member countries are opposed to such a dren are shamelessly invoked as a justi- treal at the international meeting on ozone quick phase-out. fication, even for policies that hurt chil- protection as a shining symbol of Amer- Yet the EPA wants America to be the dren. When it comes to their inhalers- ica's international environmental stew- first country to develop a solution for the well, what's a few innocent lives, partic- ardship. Never mind that such a ban would elimination of CFC-powered inhalers. So, ularly of children in the inner city, increase the cost and difficulty of treating despite resistance from doctors, the EPA compared to President Clinton's goal of childhood asthma. and that inner-city chil- has pushed the Food and Drug Adminis- showing international leadership on envi- dren are already six times more likely tration for tougher regulations. Under the ronmental protection? If children lose ac. than other children to the because of mad proposed new FDA rules, If one CRC-free COSS to inhalers, they'll just have to hold equate asthma care. Even though such in- inhaler hits the market. any CFC-powered their breath until the ozone layer is re- halers account for less than 1.5% of total inhaler delivering the same medicine paired. CFC emissions world-wide, the EPA is would have to go. In this way, all those who likely to get its wish. use CFC inhalers-about 95% of asthma in- Mr. Goldberg is a senior research fellow Under the Montreal protocol on ozone- haler users-will be deprived of the oppor- at the Center for Neuroscience, Medical depleting substances. 155 countries have tunity to use the inhaler that works best for Progress and Society, George Washington agreed to phase out production of CFCs them. University. me other ozone-depleting substances. An Dozens of medical groups and him- amendment to the protocol introduced by dreds of allergists have urged the FDA not the U.S. in 1990 accelerated the interna- to go ahead with its planned termination. tional phase-out. However, that amend- pleading that a change in medicine will ment left one important feature of the pro- compromise children's health. The Joint tocol intact. It still allows each member Council of Allergy. Asthma and Immunol- country to exempt from the ban certain ogy has told both the FDA and the EPA CFC-containing products deemed "essen- that their proposal will unfairly punish tial." Since the treaty was ratified. asthma poor children and the elderly. who have inhalers have been exempt because of the highest risk of asthma-related sick- their public health importance. And each ness and death. Even the FDA panel that year, the EPA nominates other products made this proposal expressed concerns for exemption. This time around. however, about the impact on such children of wip- the EPA wants to tell the world it will no ing out a whole class of CFC-powered in- longer ask to exempt inhalers. halers. EPA Administrator Carol Browner says The question is why the EPA is willing that the goal of the ban. like her many to invite those consequences. In a letter to other environmental initiatives. is to en- the FDA. the EPA claimed that the U.S. is sure that U.S. children are protected from forced under the terms of the Montreal environmental health risks. Ms. Browner protocol to limit exemptions to cases claims that more environmental regula- where no non-CFC substitutes are avail- tions will protect asthmatic children most able. Since CFC-free devices do exist. the of all. since they are among the most vul- EPA argues. the ban must apply. The EPA nerable to environmental threats. Hence, objects to the FDA's intention to weigh the taking asthma inhalers away from chil- benefits of reducing CFC emissions com- dren is being done in the name of chil- pared to the negative effects for asthmat- dren's health. ics. Incredibly. the EPA wrote to the FDA It's true that non-CFC asthma prod- that domestic assessments of impact can- ucts do exist, and that some work better not be considered in the FDA's decisions if than those containing CFCs. But differ- they conflict with U.S. treaty obligations. ent patients' asthma symptoms respond In other words, the FDA cannot consider differently to each of the available med the health impact of a ban on CM powered iemes, and specialists are opposed to ru- inhalers on U.S. children because it is at ducing that range of products simply for odds with the EPA's desire to demonstrate the sake of environmental correctness. America's commitment to environmental In addition, poorer children are espe- vigilance. cially reliant on generic inhalers with Worse, even as the EPA is hell-bent on CFC propellants. which can cost one- snatching asthma inhalers away from eighth the price of newer brand-name children and the elderly. it had no prob- THE WALL STREET JOURNAL FRIDAY, SEPTEMBER 19, 1997 products without CFCs. Ultimately. these lem exempting other products that have two factors contribute to the fact that nothing to do with children's health. only half of all children are following the Among the other CFC-laden products the inhalation schedule necessary to keep EPA has decided not to ban: document- their asthma under control. An expert preservation sprays and foam insulation panel of the National Institute for Aller- for coaxial câble. It has also spared CFC- Background on the Montreal Protocol Ban on CFCs Metered Dose Inhalers (MDIs) are medical devices used to treat asthma. Most MDIs now use chlorofluorocarbons (CFCs) to propel the medication in the inhaler. In 1996, the Clean Air Act banned production of CFCs, pursuant to the Montreal Protocol, an international agreement to protect the ozone layer. EPA did not announce a ban on CFC-based MDIs at the Meeting of the Parties to the Montreal Protocol held September 8 -19 1997. By contrast, the U.S. successfully argued for "essential use exemptions" from the ban in 1996, 1997, 1998 and 1999, in order to allow for domestic production of enough CFCs to meet the needs of American asthmatics. While a CFC-free inhaler is currently on the market, it does not adequately substitute for the many different types MDIs now in use. The International Pharmaceutical Aerosol Consortium estimates that 11 new CFC-free inhalers will be available by the year 2000, and as many as 35 by 2005. EPA will continue to ask for necessary exemptions from the Montreal Protocol ban on CFC production until a transition from CFC-based to CFC-free inhalers occurs in the U.S. Progress in protecting the ozone layer will not come at the expense of other important public health concerns, like asthma. EPA has worked closely with the FDA to craft a transition process that ensures health protection of all MDI users. Over time, the availability of substitutes will provide several options for American asthmatics while protecting public health and the ozone layer. EPA Actions to Fight Asthma in Children In July 1997, EPA Administrator Carol M. Browner signed updated air quality standards for ozone and particulate matter to better protect American children from the harmful effects of air pollution These new standards will provide new health protections to 35 million children, by helping to prevent 15,000 premature deaths, about 350,000 cases of aggravated asthma and nearly a million cases of decreased lung function. Working in partnership with the National Parent Teachers Association, the National Education Association, the American Federation of Teachers and the American Lung Association, EPA has developed the Indoor Air Quality Tools for Schools Action Kir, an easy-to-use guide which describes simple, low-cost methods for schools to improve their indoor air quality and, thereby, reduce environmental asthma risks to children. By integrating the American Lung Association's "Open Airways" children's asthma management curricula and EPA's Indoor Air Quality Tools for Schools program, the "Open Airways for Schools" program focuses on developing asthma management skills for high- risk, inner city minority children who have a higher than average asthma death rate. 2/2 PAGE ID:202 260 3684 OCT-09-97 16:43 FROM OF ADMIN /OCEPA and 163! THE Children's Health FUND A decade of caring for kids 1987 1997 THE NEW YORK CHILDHOOD ASTHMA INITIATIVE Revised Preliminary Scope of Work This city wide initiative is designed to address a growing health crisis with respect to childhood asthma. Organized as a partnership between the office of Councilman Ken Fisher and The Children's Health Fund (CHF), with strong collaboration with the New York City Department of Health, the program will have the following goals and program components. I. GOALS 1. Increase in public awareness and knowledge of pediatric asthma 2. Development of innovative primary care programs with a special asthma focus 3. Development of a broad, system-based model that integrates community, medical, educational and other interventions to address the childhood asthma epidemic 4. Development of sustainable public policies and programs that will contribute to the ongoing reduction of childhood asthma morbidity and the elimination of childhood deaths due to asthma II. PROGRAM DEVELOPMENT PROCESS The program will be developed through a process that will a) give program attention to specific communities with high asthma prevalence and to special populations with high asthma prevalence, and b) ensure coordination with and be complementary to current asthma-related activities of the NYC DOH, as well as asthma-related activities of other institutions, agencies and organizations, and c) consult and collaborate with community organizations in targeted, high prevalence communities on program development, implementation and potential for sustainability. An initial collaborative planning meeting will be scheduled with representatives from Councilman Fisher's office, the Children's Health Fund and the NYC DOH, chaired by Councilman Fisher and Irwin Redlener, MD, to discuss program design, implementation and potential community linkages. Specific topics will include a) the development of criteria for the identification of high prevalence communities / special populations as well as the site selection process, and b) the coordination of New York Childhood Asthma Initiative program components with current DOH activities, especially those in the Hunts Point area. The discussion of overall program design for the Childhood Asthma Initiative will also include contributions of the experience of the NYC DOH in Hunts Point, as well as the experience of other asthma programs and population-based models, both in NYC and elsewhere. NYCAI: Goals and Program Components: Draft 8/1/97 1 The Children's Health Fund 317 East 64th Street New York NY 10021 Telephone (212) 535-9400 Fax (212) 535-7488 III. PROGRAM COMPONENTS A. Establishment of a Childhood Asthma Task Force Co-chaired by Councilman Fisher and CHF President Irwin Redlener, MD, the task force will be composed of representatives of NYC agencies, organizations, unions, and individuals with relevant experience in a wide range of service sectors. The Task Force may appoint subcommittees as needed. Potential Tasks: 1. Participation in the development of a major asthma awareness campaign focused on the epidemic of childhood asthma in NYC 2. Development of appropriate public policy responses to the epidemic of childhood asthma B. Childhood Asthma Awareness Campaign This campaign is designed to call significant public attention to the new crisis in pediatric asthma. Its purpose will be to inform the public, provide essential information to parents of children with asthma, educate children with asthma about their disease and offer state-of-the-art information on asthma diagnosis and treatment to primary care providers who deal with this condition. It will be designed to develop effective asthma educational models to train a wide range of service providers, agencies and community organizations that interact with children. An important anticipated outcome of the Childhood Asthma Initiative will be the development of successful models of health education around asthma that may also be applied to other health conditions. Possible Campaign Components: 1. Public Information Initiative: This component will include the development of asthma awareness and knowledge surveys, the development of an ad campaign, public service announcements, the development of media coverage and appropriate materials for general distribution. These materials might include Asthma Information Kits for children and parents, community organizations such as churches and other religious institutions, tenants associations, block associations, local businesses and community service organizations; Asthma Fact Sheets for distribution at health fairs, local businesses and community events as well as other asthma information materials. The targeted audience for the public information initiative would include parents and caretakers of children with asthma, children and adolescents with asthma, community organizations, residents of high-risk communities, special populations with high asthma prevalence rates such as homeless children, and the general population. The public campaign would also NYCAI: Goals and Program Components: Draft 8/4/97 2 The Children's Health Fund 317 East 64th Street - New York NY 10021 Telephone (212) 535-9400 Fax (212) 535-7488 publicize the "asthma information hotline" and other aspects of this program. Development of the public information initiative will be in coordination with the health promotion activities of the NYC DOH and other asthma education efforts in the NYC area. 2. Asthma Information Hotline: This component will be directed at provision of state- of-the-art information on asthma for parents, teachers, community organizations, agencies and others as well as enhancing the participation of parents in the management of asthma for their children. Information will be linguistically and culturally appropriate. The hotline will have an 800 number available 5-7 days a week. It will offer general information about asthma, prevention of asthma attacks and advice on how and where to secure a primary care provider with appropriate expertise in asthma management. 3. Provider Education: In New York City currently, provider knowledge with respect to asthma diagnosis and management is variable and inconsistent. The recent release of the revised Guidelines for the Diagnosis and Management of Asthma (National Asthma Education and Prevention Program, NHLBI) offers an opportunity to develop provider education strategies that reflect state-of-the-art asthma care. Under this component of the program, an effort will be undertaken to educate physicians, as well as other primary care providers such as nurses and physician assistants. Other professionals that interact regularly with asthmatic children and their parents will also be targeted, including clerks at health facilities, pharmacists and social service providers. A particular focus will be those providers who provide services in high risk communities and those serving high risk special populations. The provider education programs will be coordinated with existing efforts that target provider education under the auspices of DOH and other organizations in the city. Provider education strategies will identify effective approaches and will be designed to complement current programs, such as the Greater New York Asthma Initiative Provider Education Conference scheduled for Spring, 1998. It may also include: the organization of a city-wide conference on childhood asthma development of targeted teaching programs and educational materials for physicians a physician's newsletter the development of special training programs for nurses, pharmacists, social service workers and clerical staff The provider education programs will include information on the diagnosis of asthma, identification of asthma symptoms, identification of asthma triggers, identification of risk factors for fatal asthma, current treatment options, prevention strategies, development of patient-provider asthma management plans, and NYCAI: Goals and Program Components: Draft 8/4/97 3 The Children's Health Fund 317 East 64th Street - New York NY 10021 Telephone (212) 535-9400 Fax (212) 535-7488 appropriate use of asthma management devices such as peak flow meters and spacers. 4. Enhanced School and Day Care Programs: This component will focus on educating school-age children and adolescents with asthma about asthma triggers, asthma management, asthma medications, strategies for maximal asthma control, asthma and athletics and reduction in activity limitation due to asthma. It will also focus on educational programs for teachers, administrators and other school staff. It will build on school-based programs already existing in the city and will be targeted towards high-risk school districts. The Day Care program would provide education to both day care staff and parents in the recognition of asthma symptoms, use of asthma medications, identification of asthma triggers, general asthma management strategies and identification of primary care resources. It will also include specific early childhood development programs such as Head Start. C. Clinical Program: Primary Care and Asthma Centers Possible Program Components: 1. Establishment and/or enhancement of primary care programs with a special asthma focus: Primary Care and Asthma Centers will be organized in two communities where asthma is particularly problematic. Locations will include the Hunts Point Peninsula community where The Children's Health Fund's affiliated project, the South Bronx Children's Health Center, is already working closely with the New York City Department of Health. This program will be structured to complement existing asthma initiatives in the Hunts Point community. An additional Primary Care and Asthma Center site will be established in collaboration with institutions that currently provide primary health care services in Brooklyn. On-going development of this program component will be closely coordinated with the Department of Health and local community partners such as The Point. The Primary Care and Asthma Centers will provide needed state-of-the-art asthma care in these two high- risk communities and will also serve as demonstration sites for the development and evaluation of a range of clinical, educational and community programs and materials targeted at childhood asthma for broader implementation and dissemination. Neighborhood Asthma Specialists: A critical component of the childhood asthma initiative will be the integration of increased public awareness of asthma with the provision of enhanced clinical care. As part of this effort, nurses would be trained to become neighborhood-based specialists in asthma management and education. They would be initially based in the Primary Care and Asthma Centers described below and would provide asthma education, training and outreach across a wide range of sites within a specific geographic area, linking medical facilities to schools, NYCAI: Goals and Program Components: Draft 8/4/97 4 The Children's Health Fund 317 East 64th Street - New York NY 10021 Telephone (212) 535-9400 Fax (212) 535-7488 housing, community organizations, churches, tenant associations, day care centers, multi service centers, block associations, local social service organizations, local pharmacies, local businesses and others providing community services. The Neighborhood Asthma Specialists would thus serve a key role in integrating and linking asthma education and services within high-risk geographic locations and in developing a sustainable focus on childhood asthma within those communities. A particular component of their community education activities would be the identification and training of key neighborhood residents to become Neighborhood Asthma Educators. This program component will be initially developed as part of the Primary Care and Asthma Centers; additional Neighborhood Asthma Specialists may also be based in other high risk communities. In Hunts Point, the Neighborhood Asthma Specialists will coordinate with ongoing activities of the NYC DOH. 2. High prevalence special population emphasis: This program component will focus on special population subgroups with high asthma prevalence rates, including homeless children, children under detention, street youth, immigrant children and high-risk age groups such as infants, very young children, and teen parents. 3. Other clinical enhancement programs and asthma interventions: Interventions that could be developed and evaluated in high-risk communities, either as pilot programs or smaller-scale components of the main program, include the development of generalizable models for short-term intensive asthma interventions, the use of mobile units to supplement fixed site programs in additional sites for clinical or educational purposes and the development of interventions to reduce environmental and psychosocial risk factors for asthma attacks. IV. EVALUATION A specific evaluation plan will be developed for each program component to assess its effectiveness, generalizability, and potential for sustainability and expansion. The program -specific evaluation plans will be developed in consultation with other asthma-related programs in NYC that have similar program components to ensure effective linking of evaluation results across programs. In particular, evaluation of program components that are situated in the Hunts Point community will be coordinated with existing programs of the NYC DOH. As part of an evaluation baseline assessment, a targeted assessment of childhood asthma prevalence and incidence in NYC could be undertaken. This could include the identification of communities, age groups and special populations with high asthma prevalence rates, assessment of indicators of asthma morbidity (e.g. hospitalizations, emergency department use, primary care visits, days missed from school because of asthma), and surveillance / investigation of near-fatal asthma attacks and asthma deaths. Surveillance efforts will be coordinated with and will collaborate with other surveillance efforts, in particular those of the NYC DOH and others around emergency department asthma surveillance. The evaluation plan will also serve to identify new directions for the New York Childhood Asthma Initiative and suggest modifications of the existing program. NYCAI: Goals and Program Components: Draft 8/4/97 5 The Children's Health Fund 317 East 64th Street - New York NY 10021 Telephone (212) 535-9400 Fax (212) 535-7488 09/15/97 MON 16:36 FAX 212 535 7488 CHF 003 THE Children's DRAFT 091597 11:58 Health FUND THE PROPOSED PLAN TO ANNOUNCE THE NEW YORK CITY CHILDHOOD ASTHMA INITIATIVE WHAT: A press conference for The Children's Health Fund to announce a major public health Initiative, The New York City Childhood Asthma Initiative, and plans to develop a primary care and asthma center. This is an opportunity to unveil the program components, to talk with principals involved, and dignitaries who support the initiative as an effort to fight against the epidemic of asthma. This comprehensive plan is designed to be a model for programs that can be executed throughout the United States. WHO: An exceptional coalition of: FEDERAL INTERESTS: The White House, Ms. Hillary Rodham Clinton; LOCAL GOVERNMENT: The City Council of New York, led by Councilman Kenneth Fisher; PUBLIC HEALTH ADMINISTRATION: the New York City Department of Health, represented by Benjamin Mojica, Acting Commissioner; THE CHILDREN'S HEALTH FUND: spearheaded by Irwin Redlener, MD; ACADEMIC HEALTH CENTER: Montefiore Medical Center, represented by Spencer Forman, MD, Chief Executive Officer; WHY: The New York City Childhood Asthma Initiative addresses the epidemic proportions of asthma in New York City, where incidence of the disease is among the highest in the nation. The press conference is to advise the community, via the press, of the diverse efforts that the Initiative will introduce, and to introduce the plan as a national model. WHEN: Monday, September 22, 1997 1:00 pm Time frame: approximately 20 minutes to one-half hour; Post-conterence: visit to nearby day care center. WHERE: South Bronx Children's Health Center 911 Longwood Avenue The Bronx, New York. OTHER: 1.0 Speakers 11 Irwin Redlener, MD, President, The Children's Health Fund; 1.2 Kenneth Fisher, Councilman. Borough of Brooklyn; 1.3 Benjamin Mojica, MD, Acting Commissioner, NYC Department of Health: 1.4 Spencer Forman, MD, President, Chief Executive Officer, Montefiore Medical Center; 1.5 Hillary Rodham Clinton, Esq., First Lady of the United States. The Children's Health Fund, 317 East 64th Street, New York NY 10021, Telephone (212) 535-9400, Fax (212) 535-7488 09/15/97 MON 16:36 FAX 212 535 7488 CHF 4 004 New York City Childhood Asthma Initiative announcement, page 2. 2.0 Other invited, nonspeaking guests to be acknowledged, including New York City Council President Peter Vallone, Bronx Borough President Frederic Ferrer, U.S. Representative Jose Serrano, Bronx Assemblyman Jeffiey Klein, private sector major donation from the President of Schering Laboratories (full list to follow.) 3.0 Tentative Agenda 1:00 Scheduled start time 1:00 Irwin Redlener, MD opens the floor, introduces Mrs. Clinton, introduces other speakers, invites Ken Fisher to speak. 1:01 Kenneth Fisher discusses the genesis of the budget allocation for the New York City Childhood Asthma Initiative. 1.05 Irwin Rediener speaks of the problems of underserved children, asthma and the need for a children's agenda in New York City. 1:09 Benjamin Mojica, Acting Commissioner of Health, presents the Department's perspectives on the program. 1:13 Spencer Forman, Montefiore Medical Center, speaks of the initiative from the perspective of the incidence of asthma in the Bronx, and Montefiore's long- term commitment to children's health. 1:17 Hillary Rodham Clinton speaks. (CHF to be advised of her point of view.) 1:21 Conclusion. 1:22 Questions and answers. 20.70 uninsured 65% Medicard Call re Speakers 15070 Third party Insurance 2 perces. I Ulinical services 65% Hispanic Public Awareness 30-35070 Af- Am. 1 eligible for Many Medicard, but not enrolled CC: Sanjay Gupta was 9/22 THE WHITE HOUSE WASHINGTON ic Davids OFFICE OF THE FIRST LADY 57234 TO Patti Solis - Doyle FROM Jen FAX # 6- 5340 PHONE # # OF PAGES (including cover) COMMENTS As I said, the event could include: , A visit to the clinic in Hunt's Point ( which has the highest asthma rate in the country); and 2 4 visit to a child care center in Hunt's Point where they will be training child care providers about asthma. Irwin has all commitments ($) 187 place for this project (except for contribution from Schering- Plough which they expect soon). This event would be the launch of the initiative. Jen 100 12:10 26/60/60 THE Children's Health FUND A decade of caring for kids 1987 I997 THE NEW YORK CHILDHOOD ASTHMA INITIATIVE Revised Preliminary Scope of Work This city wide initiative is designed to address a growing health crisis with respect to childhood asthma. Organized as a partnership between the office of Councilman Ken Fisher and The Children's Health Fund (CHF), with strong collaboration with the New York City Department of Health, the program will have the following goals and program components. I. GOALS 1. Increase in public awareness and knowledge of pediatric asthma 2. Development of innovative primary care programs with a special asthma focus 3. Development of a broad, system-based model that integrates community, medical, educational and other interventions to address the childhood asthma epidemic 4. Development of sustainable public policies and programs that will contribute to the ongoing reduction of childhood asthma morbidity and the elimination of childhood deaths due to asthma II. PROGRAM DEVELOPMENT PROCESS The program will be developed through a process that will a) give program attention to specific communities with high asthma prevalence and to special populations with high asthma prevalence, and b) ensure coordination with and be complementary to current asthma-related activities of the NYC DOH, as well as asthma-related activities of other institutions, agencies and organizations, and c) consult and collaborate with community organizations in targeted, high prevalence communities on program development, implementation and potential for sustainability. An initial collaborative planning meeting will be scheduled with representatives from Councilman Fisher's office, the Children's Health Fund and the NYC DOH, chaired by Councilman Fisher and Irwin Redlener, MD, to discuss program design, implementation and potential community linkages. Specific topics will include a) the development of critcria for the identification of high prevalence communities / special populations as well as the site selection process, and b) the coordination of New York Childhood Asthma Initiative program components with current DOH activities, especially those in the Hunts Point area. The discussion of overall program design for the Childhood Asthma Initiative will also include contributions of the experience of the NYC DOH in Hunts Point, as well as the experience of other asthma programs and population-based models, both in NYC and elsewhere. NYCAI: Goals and Program Components: Draft 8/1/97 1 The Children's Health Fund . 317 East 64th Street New York NY 10021 Telephone (212) 535-9400 Fax (212) 535-7488 0222 D 12:11 26/60/60 III. PROGRAM COMPONENTS A. Establishment of a Childhood Asthma Task Force Co-chaired by Councilman Fisher and CHF President Irwin Redlener, MD, the task force will be composed of representatives of NYC agencies, organizations; unions, and individuals with relevant experience in a wide range of service sectors. The Task Force may appoint subcommittees as needed. Potential Tasks: 1. Participation in the development of a major asthma awareness campaign focused on the epidemic of childhood asthma in NYC 2. Development of appropriate public policy responses to the epidemic of childhood asthma B. Childhood Asthma Awareness Campaign This campaign is designed to call significant public attention to the new crisis in pediatric asthma. Its purpose will be to inform the public, provide essential information to parents of children with asthma, educate children with asthma about their disease and offer state-of-the-art information on asthma diagnosis and treatment to primary care providers who deal with this condition. It will be designed to develop effective asthma educational models to train a wide range of service providers, agencies and community organizations that interact with children. An important anticipated outcome of the Childhood Asthma Initiative will be the development of successful models of health education around asthma that may also be applied to other health conditions. Possible Campaign Components: 1. Public Information Initiative: This component will include the development of asthma awareness and knowledge surveys, the development of an ad campaign, public service announcements, the development of media coverage and appropriate materials for general distribution. These materials might include Asthma Information Kits for children and parents, community organizations such as churches and other religious institutions, tenants associations, block associations, local businesses and community service organizations; Asthma Fact Sheets for distribution at health fairs, local businesscs and community events as well as other asthma information materials. The targeted audience for the public information initiative would include parents and caretakers of children with asthma, children and adolescents with asthma, community organizations, residents of high-risk communities, special populations with high asthma prevalence rates such as homeless children, and the general population. The public campaign would also NYCAI: Goals and Program Components: Draft 8/4/97 2 The Children's Health Fund 317 East 64th Street - New York NY 10021 Telephone (212) 535-9400 Fax (212) 535-7488 803 11:11 26/60/60 publicize the "asthma information hotline" and other aspects of this program. Development of the public information initiative will be in coordination with the health promotion activities of the NYC DOH and other asthma education efforts in the NYC area. 2. Asthma Information Hotline: This component will be directed at provision of state- of-the-art information on asthma for parents, teachers, community organizations, agencies and others as well as enhancing the participation of parents in the management of asthma for their children. Information will be linguistically and culturally appropriate. The hotline will have an 800 number available 5-7 days a week. It will offer general information about asthma, prevention of asthma attacks and advice on how and where to secure a primary care provider with appropriate expertise in asthma management. 3. Provider Education: In New York City currently, provider knowledge with respect to asthma diagnosis and management is variable and inconsistent. The recent releasc of the revised Guidelines for the Diagnosis and Management of Asthma (National Asthma Education and Prevention Program, NHLBI) offers an opportunity to develop provider education strategies that reflect state-of-the-art asthma care. Under this component of the program, an effort will be undertaken to educate physicians, as well as other primary care providers such as nurses and physician assistants. Other professionals that interact regularly with asthmatic children and their parents will also bc targeted, including clerks at health facilities, pharmacists and social service providers. A particular focus will be those providers who provide services in high risk communities and those serving high risk special populations. The provider education programs will be coordinated with existing efforts that target provider education under the auspices of DOH and other organizations in the city. Provider education strategies will identify effective approaches and will be designed to complement current programs, such as the Greater New York Asthma Initiative Provider Education Conference scheduled for Spring, 1998. It may also include: the organization of a city-wide conference on childhood asthma development of targeted teaching programs and educational materials for physicians a physician's newsletter the development of special training programs for nurscs, pharmacists, social service workers and clerical staff The provider education programs will include information on the diagnosis of asthma, identification of asthma symptoms, identification of asthma triggers, identification of risk factors for fatal asthma, current treatment options, prevention strategies, development of patient-provider asthma management plans, and NYCAI: Goals and Program Components: Draft 8/4/97 3 The Children's Health Fund 317 East 64th Street New York NY 10021 Telephone (212) 535-9400 Fax (212) 535-7488 004 12:12 26/60/60 appropriate use of asthma management devices such as peak flow meters and spacers. 4. Enhanced School and Day Care Programs: This component will focus on educating school-age children and adolescents with asthma about asthma triggers, asthma management, asthma medications, strategies for maximal asthma control, asthma and athletics and reduction in activity limitation due to asthma. It will also focus on educational programs for teachers, administrators and other school staff. It will build on school-based programs already existing in the city and will be targeted towards high-risk school districts. The Day Care program would provide education to both day care staff and parents in the recognition of asthma symptoms, use of asthma medications, identification of asthma triggers, general asthma management strategies and identification of primary care resources. It will also include specific early childhood development programs such as Ilead Start. C. Clinical Program: Primary Care and Asthma Centers Possible Program Components: 1. Establishment and/or enhancement of primary care programs with a special asthma focus: Primary Care and Asthma Centers will be organized in two communities where asthma is particularly problematic. Locations will include the Hunts Point Peninsula community where The Children's Health Fund's affiliated project, the South Bronx Children's Health Center, is already working closely with the New York City Department of Health. This program will be structured to complement existing asthma initiatives in the Hunts Point community. An additional Primary Care and Asthma Center site will be established in collaboration with institutions that currently provide primary health care services in Brooklyn. On-going development of this program component will be closely coordinated with the Department of Health and local community partners such as The Point. The Primary Care and Asthma Centers will provide needed state-of-the-art asthma care in these two high- risk communities and will also serve as demonstration sites for the development and evaluation of a range of clinical, educational and community programs and materials targeted at childhood asthma for broader implementation and dissemination. Neighborhood Asthma Specialists: A critical component of the childhood asthma initiative will be the integration of increased public awareness of asthma with the provision of enhanced clinical care. As part of this effort, nurses would be trained to become neighborhood-based specialists in asthma management and education. They would be initially based in the Primary Care and Asthma Centers described below and would provide asthma education, training and outreach across a wide range of sites within a specific gcographic area, linking medical facilities to schools, NYCAI: Goals and Program Components: Draft 8/4/97 4 The Children's Health Fund 317 East 64th Street New York NY 10021 Telephone (212) 535-9400 Fax (212) 535-7488 900 12:13 26/60/60 housing, community organizations, churches, tenant associations, day care centers, multi service centers, block associations, local social service organizations, local pharmacies, local businesses and others providing community services. The Neighborhood Asthma Specialists would thus serve a key role in integrating and linking asthma education and services within high-risk geographic locations and in developing a sustainable focus on childhood asthma within those communities. A particular component of their community education activities would be the identification and training of key neighborhood residents to become Neighborhood Asthma Educators. This program component will be initially developed as part of the Primary Care and Asthma Centers; additional Neighborhood Asthma Specialists may also be based in other high risk communities. In Hunts Point, the Neighborhood Asthma Specialists will coordinate with ongoing activities of the NYC DOH. 2. High prevalence special population emphasis: This program component will focus on special population subgroups with high asthma prevalence rates, including homeless children, children under detention, street youth, immigrant children and high-risk age groups such as infants, very young children, and teen parents. 3. Other clinical enhancement programs and asthma interventions: Interventions that could be developed and evaluated in high-risk communities, either as pilot programs or smaller-scale components of the main program, include the development of generalizable models for short-term intensive asthma interventions, the use of mobile units to supplement fixed site programs in additional sites for clinical or educational purposes and the development of interventions to reduce environmental and psychosocial risk factors for asthma attacks. IV. EVALUATION A specific evaluation plan will be developed for each program component to assess its effectiveness, generalizability, and potential for sustainability and expansion. The program -specific evaluation plans will be developed in consultation with other asthma-related programs in NYC that have similar program components to ensure effective linking of evaluation results across programs. In particular, evaluation of program components that are situated in the Hunts Point community will be coordinated with existing programs of the NYC DOH. As part of an evaluation baseline assessment, a targeted assessment of childhood asthma prevalence and incidence in NYC could be undertaken. This could include the identification of communities, age groups and special populations with high asthma prevalence rates, assessment of indicators of asthma morbidity (e.g. hospitalizations, emergency department use, primary care visits, days missed from school because of asthma), and surveillance / investigation of near-fatal asthma attacks and asthma deaths. Surveillance efforts will be coordinated with and will collaborate with other surveillance efforts, in particular those of the NYC DOH and others around emergency department asthma surveillance. The evaluation plan will also serve to identify new directions for the New York Childhood Asthma Initiative and suggest modifications of the existing program. NYCAI: Goals and Program Components: Drall 8/4/97 5 The Children's Health Fund 317 East 64th Street New York NY 10021 Telephone (212) 535-9400 Fax (212) 535-7488 900 12:14 26/60/60 MEMORANDUM FOR THE FIRST LADY Sep 10, 1997 FROM: Domestic Policy Staff SUBJECT: Child Asthma Initiative IMPACT Asthma is a chronic inflammatory disease of the airways. In the United States, asthma affects 14 to 15 million persons. It is the most common chronic disease of childhood, affecting an estimated 4.8 million children with the direct and indirect cost estimated at $6.2 billion dollars in 1993. Over 3800 children and young adults under 25 died from asthma nationwide during the period 1980-1993. 342 children died from asthma in 1993 alone. Asthma is associated with the loss of 28 million activity days annually and 2.2 million pediatrician visits. It is the leading cause of school absenteeism. It has been estimated that among children 5- 17 years old, asthma accounted for approximately 10 million missed school days at a cost of $726.1 million in caretakers' time lost from work. TRENDS The burden of asthma on the US population is increasing. Through the 1980's, the prevalence of asthma increased 29%, hospitalization rates increased 6% and mortality rates increased as well. The most notable increases were for children and young adults. Hospitalization rates for children less than five years old have increased 57% since 1980. These rates increased at a time when total hospitalization rates for children decreased. Overall, the annual age-specific asthma death rate increased 118% (from 1.7 to 3.7 per million) between 1980 and 1993 for persons aged 0-24. Explanations for rising prevalence, morbidity and mortality are varied. Investigators have attributed increased hospitalization to improved diagnosis, untoward effects of treatment, environmental factors, improvements in vital statistic reporting, and increased tendencies for asthmatic patients to use hospital emergency departments as primary sources of care. VULNERABLE POPULATIONS Childhood asthma has become more prevalent and more severe in the last decade, and disproportionately affects minority populations. In 1993, among children aged 5-14 years, blacks were four times more likely than whites to die from asthma.. In the 0-4 age group, blacks were six times more likely to die from asthma than whites. Hospitalization rates are consistently highest among blacks. In 1993, among persons aged 0-24 years, blacks were 3.4 times more likely than whites to be hospitalized for asthma.. Children living in the inner city are particularly vulnerable. New York City has the highest rate of hospitalization and mortality for childhood asthma of any area in the United States. As of 1993, New York City children were hospitalized for asthma at four times the national rate. Within the city, these rates are three to five times higher for African Americans and Latinos than for the rest of the population. Areas in New York City with the highest asthma hospitalization rates include the South Bronx, Upper Manhattan, Central and North Brooklyn. Nationally, asthma rates are highest in New york, Chicago, Fresno, and Maricopa County, Arizona. The exact relationship between generally known risk factors and the increase in asthma-related morbidity and mortality among minority inner city children has not been determined. Poverty undoubtedly impacts upon the health of inner-city populations. Poverty has been linked to underdiagnosis and subsequent reduced preventive asthma care. Defined risk factors such as passive and active cigarette smoking and air pollution may be greater for minority, inner-city children. Also, infestation with pests such as roaches, mites, rodents and mosquitoes are greater problems among the poor than the more affluent. Finally, socio-economic status has been directly linked to overall compliance and medical follow-up. PATHOGENESIS AND MANAGEMENT Asthma results from complex interactions among inflammatory cells, mediators and the cells and tissues resident in the airway. Atopy, the genetic predisposition for the development of a mediated response to common aeroallergens, is the strongest identifiable predisposing factor for developing asthma. In susceptible individuals, this chronic inflammation causes recurrent episodes of wheezing, breathlessness, chest tightness 2 and cough, particularly at night and in early morning. The episodes are usually associated with widespread but variable airflow obstruction that is reversible either spontaneously or with treatment. This inflammation does cause an associated increase in the existing bronchial hyperresponsiveness to a variety of stimuli. The effective treatment of asthma is dependent on four components: 1) correct diagnosis of asthma 2) reducing factors contributing to asthma severity 3) pharmacological therapy 4) self-management education. The goals of asthma therapy are to: 1) prevent chronic and troublesome symptoms 2)maintain normal pulmonary function 3) maintain normal activity levels 4)prevent recurrent exacerbations 5) provide optimal pharmacotherapy with minimal side-effects and 6) meet patients' and families' expectations of satisfaction with asthma care. NEW YORK CHILDHOOD ASTHMA INITIATIVE This initiative is organized as a partnership between the office of Councilman Ken Fisher and The Children's Health Fund, with strong collaboration from the New York City Department of Health. The goals of the program are to increase public awareness and knowledge of pediatric asthma and develop programs, models, and policies that will serve to reduce childhood asthma morbidity and eliminate childhood deaths due to asthma. The initiative will give attention to specific communities with high asthma prevalence. The program components will include a Childhood Asthma Task Force. This task force will be representative of NYC service sector agencies and will be co-chaired by Councilman Fisher and Children's Health Fund President Irwin Redlener MD. Other program components are Childhood Asthma Awareness Campaign and Clinical Programs. These components will include a public information initiative, asthma information hotline and provider education. In addition, the establishment and/or enhancement of primary care programs with special asthma focus will be organized in two communities where asthma is particularly problematic, Hunt's Point and Brooklyn. Existing care centers will provide needed state-of-the-art asthma care in these two high risk communities and will serve as demonstration sites for a range of clinical and educational programs targeted at childhood asthma. 3 TO: Tom Freedman FROM: Neera Tanden RE: Asthma The Problem: There has been a huge increase in asthma over the last decade. It is a particular problem for children. While there has been a great deal of speculation as to the cause of the dramatic increase, no one can figure out why it is happening. The speculation runs the gamut from environmental pollution to tobacco to urban violence. Asthma is actually a problem throughout the developed world; people are suffering asthmatic reactions to a range of allergens that once caused little trouble. And basically, although scientists are learning more about asthma, the explosion is still largely a mystery. The Facts Asthma now afflicts about 14.6 million Americans.[Newsweek, 5/26/97] This is twice the number it was 25 years ago. [Life, 5/97] The number of American asthmatics grew by 6.2 million between 1984 and 1994 -- an astonishing 74% increase. [San Francisco Chronicle, 7/3/96] There are now more than 5 million children afflicted with asthma - 1 in 13 children in 1993, which is 79% more than in 1982.[LA Times, 10/27/96] Asthma costs $ 6.2 billion a year in missed work and school, in medications and hospital visits. [Life, 5/97] Asthma has become the most common chronic disease of childhood, the No. 1 cause of hospitalization and absenteeism. [Life, 5/97] Asthma is especially severe in the inner city, where rates of asthma emergency room visits and deaths can be eight times the national average. The United States has an overall asthma rate of about 5 percent. But the rate is 8.4 percent in New York City, and it can reach 25 percent among kids in the poorest urban neighborhoods. The Interest: The dramatic rise in asthma has been called an "epidemic," "pandemic," and "crisis" in recent media stories. 1. Newsweek, "The Scary Spread of Asthma" (Cover Story), 5/26/97 2. Good Morning America 3. The Today Show 4. Life Magazine, "An Epidemic of Sneezing and Wheezing," 5/97 5. Front page: LA Times, San Francisco Chronicle, NY Daily News The Tie-In Asthma is related to three policy proposals the Administration is currently pushing. Generating interest in fighting asthma will only help increase support for these proposals. 1. New EPA regulations -- We have used asthma as a major justification for our plan to increase environmental regulations. In fact, during the briefing on the new standards, Katie McGinty said: "[T]he President is strengthening current smog standards that we know seriously exacerbate asthma conditions and other lung ailments, and that particularly affect children. Asthma is one of the leading causes of children's hospitatlization and, following from that, a leading cause of children missing out on school days. So the step -- the decision the President made today advances our commitment to clean air in this country and allows ust ot take important gains on a pullutant that we konw causes premature death and other pullutants that we know dramatically exacerbate lung conditions and particularly asthma." We are and should continue to highlight the fact that we are proposing these regulations simply to lower the number of children who suffer from asthma. 2. Expanding Health Care for Children Because asthma is the number one chronic disease in children and the number one cause of hospitalization, it is a big reason why we need to insure these children whose parents are working but cannot afford health care. If asthmatic children have regular access to medical care, their asthma can be regulated and controlled, thereby lessening the number of emergency room visits. 3. Tobacco Smoking - especially by parents near their children - can cause asthma. And of course, asthmatics suffer greatly from those who smoke around them because their smoke can often trigger an attack. The Proposals 1. Researching the Causes of Asthma. We basically do not know why rates of asthma are climbing - but we should. As we did with breast cancer, we can marshall federal resources to study the causes of asthma as well as new treatments. Our funding of breast cancer research was popular with a certain constituency; in a like manner, parents may similarly support an effort to find the causes of asthma. 2. Launching a National Education Campaign on Asthma. A national education campaign would do some good here. Asthma is one disease in which educating parents about the symptoms and some of the instigators of attacks would alleviate some of the problem. In fact, New York City is already experimenting with ways to educate parents of asthmatic children by simply explaining to them that they need to get rid of rugs, stuffed animals, etc. 3. Grants to schools for medical equipment for asthma management that will be available for use in school nurses' offices. Arizona is starting such a program. 09/15/97 MON 16:36 FAX 212 535 7488 CHF 4 002 MEMO TO: Jennifer Klein THE Children's Health FUND FROM: Melissa Ziriakus DATE: September 15, 1997 SUBJECT: Children's Health Fund press event Irwin Redlener and I have been in discussions to develop and provide you with a proposed outline for the New York City Asthma Initiative press conference on September 22 involving Ms. Hillary Clinton. HRC seen this before I've attached that for your review, and invite you to call if you have any questions. 1 TV evew or couple of reporters DS to Speaking Program, HRC to tour monil unit No Q3A Fina parent of child w/ asinma what needs to be done to Uinic CC: Irwin Redlener, MD Review pieces of initiative Message 1 Asthmu epiaemic all children HHS, EPA Accomp. high risk neighborhoods Other states doing anything Sanjay to tain to Irwin ve Hunt's Point up Rate] 2. Connect to underserved children - Hes into kid's health impl. B children's health fund work on 7 $ 314 M to from Astnma Schering Plow - - Public Partnership Partnership HRC to me ntion The Children's Health Fund, 317 East 64th Street, New York NY 10021, Telephone (212) 535-9400, Fax (212) 535-7488 4 Montejiore committed to building (nildren's Health System for South Bronx Griwide program - HRC shld stress - - not just S.Bronx Sanjay Gupta 12/10/97 07:33:03 PM Record Type: Record To: Brenda B. Costello/WHO/EOP CC: Jennifer L. Klein/OPD/EOP Subject: Final points FOOD SAFETY President Clinton asked for and received 43 million dollars in FY 98 budget to fund an early-warning system for food-borne illness, increased seafood inspections and expanded food-safety research. Last year, President signed the Safe Drinking Water Act of 1996, which includes regulatory improvements to help states and water utility managers to prevent drinking-water contamination problems. Resources are provided for thr first time for drinking water infrastructure that will help hundreds of communities protect residents from harmful contaminants. done Sanjay Gupta 12/10/97 06:48:23 PM Record Type: Record To: Jennifer L. Klein/OPD/EOP CC: Brenda B. Costello/WHO/EOP Subject: Asthma ASTHMA The congressional report from HHS that I received states there are no recent bills directly addressed to asthma. I did find a few things that could be included in the briefing book for asthma. I'll try to be brief. NHLBI (National Heart Lung and Blood Institute) NIAID (National Institute of Allergy and Infectious Diseases) NAEPP(National Asthma Education and Prevention Program) 1) Childhood Asthma Management Program -- examines and compares the long-term effects of asthma on lung growth and develpment 2) National Cooperative Inner City AsthmaStudy -- supports seven centers to design, implement, and evaluate a comprehensive intervention program to reduce recurrent asthma episodes among inner-city children 3) NAEPP has convened two expert panels to prepare guidelines for the diagnosis and management of asthma. The first in 1989 and the most recent in 5-97 AHCPR( Agency for Health Care Policy and Research) 1) Pediatric Asthma Patient Outcome Research Team (PORT II) -- will test the cost-effectiveness of the NHLBI (described above) and evaluate new educational and organizational approaches to deliver pediatric asthma care in managed settings CLEAN AIR Administrator Browner signed the new standards for smog and soot on July 16, 1997. These standards will prevent approx 350,000 cases of aggravated asthma. These standards are expected to prevent 15,000 premature deaths and 1 million cases of decreased lung function In September 1996, Browner issued the National Agenda to protect Children's Health from Environmental threats. This agenda called on the EPA to address the special vulnerabilities of children - like susceptibility to air pollution ans asthma. In May, 1997, Browner created the Office of Children's Health Protection to ensure implementation of the Agency's National Agenda President Clinton signed the Executive Order on the Protection of Children from Environmental Health and Safety Risks (EO #13045) on April 21, 1997. This execuitve order stated that eachfederal agency must address environmental health threats to children in its regulations and programs. The executive order also created the Task Force on Environmental Health and Safety Risks which is chaired by Browner and Shalala. FOOD SAFETY Statement by the President Aug 3, 1996 Signed into law H.R. 1627 -- the "Food Quality Protection Act of 1996" Replaces conflicting and outdated pesticide residue standards with a single, rigorous, health-based standards for all food. All pesticides will be required to meet the new standard. It will also provide for the swift approval of safe, new pesticide alternatives for farmers. Most importantly, HR 1627 contains special new provisions to protect America's infants and children from pesticide risks. Demonstrates how Congress and the Administration can work together to help both farmers and consumers. TOXIC WASTE Administration has strengthened and improved Superfund clean-ups. In first three years, 197 sites were cleaned up. This is more than in the previous 12 years of other administartion. This administration is cleaning sites three times more a year than were done before. 12/10/97 18:16 FAX CHILDREN'S HEALTH FUND 002 CONTACT: THE CHILDREN'S HEALTH FUND SCHERING PLOUGH CORPORATION Melissa Ziriakus (212) 535-9400 William O'Donnell (973) 822-7476 COMMUNICATIONS STRATEGIES Laurie Smith (973) 635-6669 THE CHILDREN'S HEALTH FUND, SCHERING-PLOUGH CORPORATION, THE NEW YORK CITY COUNCIL, AND NYC DEPARTMENT OF HEALTH LAUNCH MAJOR INITIATIVE TO FIGHT ASTHMA BRONX, N.Y., December 11, 1997 - Tackling the urgent need to treat childhood asthma, The New York City Childhood Asthma Initiative today launched a nationwide effort to fight asthma in inner-city communities. First Lady Hillary Rodham Clinton, speaking at a press conference at the South Bronx Children's Health Center, headed adist of dignitaries praising this innovative community-based effort that teams the public and private sectors to deliver asthma prevention and treatment services to neighborhoods with the greatest need. The multi-year, multimillion dollar prograin is a partnership of The Children's Health Fund (CHF), Schering-Plough Corporation, Montefiore Medical Center, and the New York City Council. The New York City Childhood Asthma Initiative, brainchild of New York City Councilman Kenneth Fisher and CHF President Dr. Irwin Redlener, is designed to be a comprehensive treatment, prevention and education model to serve as a prototype for urban areas throughout the country. The New York City Council, under the leadership of Speaker Peter Vallone and Councilman Fisher, has provided $1.5 million in funding for the New York project. -more- 12/10/97 18:17 FAX CHILDREN'S HEALTH FUND 003 The Childhood Asthma Initiative/page 2 Schering-Plough Corporation and Schering-Plough Foundation have provided funds estimated at more than $1 million to establish a primary care and asthma center in the South Bronx. Primary medical care and asthma speciality services will be provided by Montefiore Medical Center in the Bronx. Community education and outreach will be coordinated with other special asthma programs in New York City. "Asthma is a serious illness, complicating many aspects of a child's life and becoming a chronic lifelong problem if left unmanaged," said Irwin Redlener, MD, president and co-founder of The Children's Health Fund. "Yet today, unlike just a few years ago, we know that there are ways to prevent the occurrence of asthma attacks and there are treatments available that can dramatically lessen its effccts. Every day, we see the effect of asthma on children's lives, and we are excited to be able to implement a program that can have a significant, positive impact on the health of young children." "What is sadly ironic about asthma is that so much emergency effort is spent to treat patients and we still lose too many children unnecessarily," said Richard W. Zahn, president of Schering Laboratories. "Given the many scientific advances in asthma treatment and prevention, it is unconscionable that this disease remains such as menacing problem. Children's lives can be saved and cnhanced, if proper steps are taken." An estimated 12- to 14 million Americans suffer from asthma; 5-6 million are children. These numbers are growing rapidly. Since 1980, there has been a 57 percent increase in asthma hospitalization rates for children less than 5 years old. Approximately 5,000 U.S. deaths are attributed to asthma annually. New York is particularly hard hit it has the highest rate of asthma per capita in the nation. Asthma now ranks as the No. 1 health concern in many New York City schools, mainly elementary schools in poor areas and in minority communities. -more- 12/10/97 18:17 FAX CHILDREN'S HEALTH FUND 004 The Childhood Asthma Initiative/page 3 "Asthina is at its worst in cities such as New York, where children are hospitalized for asthma at nearly twice the national rate," said Dr. Redlener. "Inner-city areas present a host of agents that can aggravate asthma, including outdoor allergens such as dust, mold and other indoor allergens including cockroach droppings and crowded conditions that can breed respiratory infections. Stress and tobacco smoke arc also contributing factors." "We have the opportunity to improve the quality of life for 120,000 children in New York. We can keep these children in schools, keep their parents at work and reduce health care costs by recognizing the tragic consequences of asthma and making it a public policy," said Fisher. "The New York City Council is proud to be part of this partnership to tackle asthma in New York," said Speaker Vallone. "All children in this city deserve the opportunity to lead healthy, productive lives, and this initiative can help make that happen." "As a nation, we must declare war on childhood asthma and allergies." said Zahn. "Today, The Children's Health Fund, Schering- Plough Corporation, Montefiore Medical Center and The New York City Council are dedicating ourselves to helping underprivileged children who suffer from these respiratory diseases." The Children's Health Fund initiates and supports pediatric programs designed to meet the complex health care needs of medically underserved, homeless and indigent children. Now in its tenth year of operation, The Children's Health Fund was established by pediatrician Redlener and singer/composer Paul Simon. -more- 12/10/97 18:17 FAX CHILDREN'S HEALTH FUND 1. 005 The Childhood Asthma Initiative/page 4 In addition to the contribution to The New York City asthma initiative, a separate contribution from the Schering-Plough Foundation will fund the purchase of a dedicated CHF mobile medical unit for use in helping children in Newark and Elizabeth, N.J. and in the surrounding Union County area. Schering-Plough Corporation is a research-based pharmaceutical and health care products company headquartered in Madison, N.J. Schering laboratories is the U.S. pharmaceutical business unit and Schering-Plough Foundation is the philanthropic arm of the parent company. Today, company scientists continue to pursue new and more effective agents to prevent or block the effects of the body's allergic and immunological responses. In the disease management area, the company has developed comprehensive intervention programs to manage the coverage, quality and costs of disease treatments in asthma, rhinitis, angina, hepatitis and prostate cancer. ### 12/10/97 WED 19:00 FAX 212 535 7488 CHF 001 FAX TRANSMITTAL THE Children's COVER SHEET Health FUND To: Jennifer Klein Via Fax #: 202 456 2878 From: Dennis Jahnson Date: 12/10 The number of pages in this fax (including this cover page): 5 If there is a problem with this fax transmission, please call (212) 535-9400 Ext. Message: Jennifer, Attached IS the correspendence about CHF / Dept. of Health agreement. Please call me if you need additional info. Dennis The Children's Health Fund 317 East 64th Street New York, New York 10021 212/535-9400 1002 12/10/97 WED 19:00 FAX 212 535 7488 CHF TEL 212-788-4920 Dec 10'97 17:08 No. 012 P.02 EHS/ADMINISTRATION THE CITY OF NEW YORK DEPARTMENT OF HEALTH OFFICE OF THE COMMISSIONER on BENJAMIN MOJICA, M.D., M.P.H. ACTING COMMISSIONER 125 WORTH STREET TEL (212) 788-5261 NEW YORK, NY 10013 FAX (212) 964-0472 December 10, 1997 Kenneth K. Fisher Council Member, 33rd District 16 Court Street - Room 1505 Brooklyn, NY 11241 Dear Council Member Fisher: I have reviewed your memo of December 9, 1997 regarding the Asthma Initiative and the development of an agreement with the Children's Health Fund. I am pleased that this memo contains many of the suggestions we recently provided to you and Dr. Redlener. There are. however, a number of issues that require further clarification. I have noted below our comments on each of the items listed in your memo: 1. Any agreement for payment must be subject to an actual registered contract not just an agreed upon scope of service. 2. This is agreeable subject to legality and a review of the reasonableness of amount sought. as well as the factors cited in your memo. As stated several times in the past, we will be as llexible as is reasonable in this reyard. 3. Agreed. 4. Agreed, but with the understanding that the partnership relationship extends to the planning and execution of all activities, including public relations activities surrounding the initiative. 5. Agreed. 6. The support is not limited to the Peninsula as the Hunts Point program extends over both zip codes 10474 and 10459. In addition, the DON would be most comfortable if the support were to be provided out of the South Bronx Children's Health Center or, in the alternative, another location in the Hunts Point program area. 003 12/10/97 WED 19:00 FAX 212 535 7488 CHF Dec 10'97 17:08 Nu. 012 P.03 EHS/ADMINISTRATION TEL 212-788-4920 Kenneth K. Fisher Council Member, 33rd District, cont. 7. Agreed. 8. Agreed. Guidelines and comments have already been provided. 9. We are unclear as to the intent of the phrase "work within" and do not feel il adds anything of substance to the discussion and may, in fact, limit collaboration. 10. Agreed. 1 trust that you will find these comments helpful in reaching a quick resolution of outstanding issues. 1 have instructed my staff to contact Dr. Redlener to schedule a meeting as soon as possible to work on the contract. Finally, concerning the press conference, 1 have been advised that it is not appropriate to hold a press conference with Dr. Redlener announcing the citywide asthma initiative until a contract is in place. Therefore, 1 regret that I will not be attending the press conference. Sincerely, Benjamin Mojica MD. MPH 12/10/97 WED 19:00 FAX 212 535 7488 CHF 004 DEC-09-1997 16:29 FROM CM KENNETH K. FISHER-33CD TO 12125357488 P.02 CHAIR LANDMARKS, PUBLIC SITING THE COUNCIL AND MARITIME USES THE CITY OF NEW YORK KENNETH K. FISHER CITY HALL COMMITTEE ASSIGNMENTS: COUNCIL MEMBER 33RD DISTRICT NEW YORK, NY 10007 ECONOMIC DEVEI SIPMENT BROOKLYN GOVERNMENT CONTRACTS LAND USE PARKS. RECREATION, CULTURAL AFFAIRS AND INTERNATIONAL INTERGROUP RELATIONS TO: Benjamin Mojica, Acting Commissioner NYC Department of Health Irwin Redlener, MD The Children's Health Fund FROM: Kenneth K. Fisher DATE: December 9, 1997 RE: Asthma Initiative CC: Andrew Goodman, MD James Capoziello Karen Redlener Dianne McLean, PhD John Talmage Mia Kozicharow I want to thank both of you for your efforts to this point. In the interest of moving forward I have memorialized the agreement as I understand it, with a further understanding that the following points will be incorporated in a formal contract. 1. The Department of Health agrees to provide The Children's Health Fund with $1.122 million dollars for the first year of the agreement, pending a mutually agreed upon scope of services. 2. The Department of Health agrees to make retroactive payments to The Children's Health Fund for expenses incurred since July 1, 1997 for the initiation, planning and development of the Initiative, assuming the expenses are relevant to the final agreement, within the scope of services, and The Department of Health has the authority to make such payments. 3. The Children's Health Fund agrees that the legal relationship between itself and The Department of Health will be that of purchaser/vendor. He The Department of Health agrees that the programmatic and public relationship between itself, The Children's Health Fund and The New York City Council will be that of partners. 5. The Children's Health Fund agrees to commit to a series of activities, including the development of a primary care and asthma center for children, a provider education program, and a mobile-based primary care and asthma program for homeless children CITY HALL: 250 BROADWAY, 22ND FLOOR NEW YORK, NY 10007 212-788-6981 FAX: 212-788-7052. DISTRICT OFFICE: 16 COURT STREET (ROOM 1505) BROOKLYN, NY 11241 718-875-5200 FAX. 718-643-0620 12/10/97 WED 19:01 FAX 212 535 7488 CHF 4. 005 P.00 Memorandum December 9, 1997 page - 2- 6. The Children's Health Fund agrees to provide primary-care-based asthma education services, including an health educator, social worker, nurse asthma specialist and asthma intervention medical supplies for approximately 250 children, to the Hunts Point Peninsula community in partnership with existing Department of Health programs at that site. "These education services may operate out of The Children's Health Fund's South Bronx Children's Health Center and/or a new primary care and asthma center. 7. The Department of Health agrees that The Children's Health Fund will operate a primary care and asthma center as part of the contract which may be implemented in another South Bronx community. 8. The Children's Health Fund agrees that the contract is predicated on a mutually agreedupon scope of services of sufficient detail which The Children's Health Fund will provide to The Department of Health The Department of Health agrees to provide guidelines to and work collaboratively with The Children's Health Fund so that they can draft an appropriate scope of work. 9. The Department of Health agrees that all personnel paid for by The Children's Health Fund's portion of the funds will work within and report to The Children's Health Fund. 10. All parties agree that the remaining program will be finalized with The Department of Health within a reasonable period of time. Again, I want to thank you for your cooperation and I look forward to participating in Thursday's press conference with you and putting a contract in place as soon as possible. Georg Speech FAX COVER SHEET Thursday, December 11, 1997 09:14:31 AM To: Neera Tanden Fax #: 12024562878 From: Fax: 3 pages and a cover page. MEMORANDUM December 10, 1997 To: Ilillary Clinton From: Emily Jenkins, Tucson/Almaty HealthCare Goalition Re: Synopsis of current issues regarding asthma from the perspectives of clinical treatment, research, and community efforts in education and prevention Introduction Since our brief conversation in Almaty, I have been interviewing various experts regarding asthma as a health problem in the U.S., especially among children, and have assembled materials which I hope will be helpful to you in gaining an understanding of the problem and what has and needs to be done about it. For the sake of brevity, I will send a list of the specialists and background data under separate cover as an attachment to this document. Because of the in-migration of asthmatics to Tucson, the medical community and the University of Arizona College of Medicine have conducted long term research studies which have put Tucson in the forefront in clinical knowledge and expertise in research, especially in epidemiology, the analysis of the mechanisms of the disease, and the role of indoor air quality and environmental factors in the development of the discasc. Asthma is a significant and growing health problem, despite advances in understanding and treating the disease For a quick description of the clinical aspects of the disease and the medications used to treat it, see pages 3-4 in Tackling Asthma in Arizona. This document also summarizes the key issues regarding the impact of the disease, since asthma is the chronic condition which causes the most hospital admissions for children and accounts for the most absentccism from school. In the last 20 years, the death rate from asthma in the U.S. has increased 50 per cent. This increase has occurred in spite of advances in the clinical diagnosis and treatment of the disease and the reduction of particulates in the air in the environment. Much of the current research is aimed at these questions. For children, there are some significant areas of concern: Children of lower socio-economic groups have more severe asthma than children of higher economic groups Black and Puerto Rican children have more asthma than children of other ethnic groups, including children of Mexican-American descent The development of the disease in children is not easily understood, and prevention and treatment issues are multi-faceted Guidelines for the diagnosis and treatment of asthma have been developed by the NIH and adopted by WHO for global application In April 1997, the National Heart, Lung and Blood Institute of the National Institutes for Health issued updated Clinical Practice Guidelines for the Diagnosis and Management of Asthma (copy sent under separate cover). These NIH guidelines have been modified and adopted by WHO (Global Initiative for Asthma sent under scparate cover). Rescarch in Tucson and other places has established that adherence to the guidelines results in improved outcomes for patients. Theseaguidelines incorporate the new drugseand therapies and also the diagnostic tools available tophysicians and patients to monitor the disease. The barriers to the successful implementation of the guidelines appears to be the need to educate physicians who treat children, including pediatricians, family practice specialists, and physicians in urgent care and emergency departments. Nurses and paramedic personnel also need to be included. A model project is the Tucson Alliance for Pediatric Asthma Care, which provides cducational programs to physicians, nurscs, school nurscs, daycarc providers, athletic coaches and other persons who regularly have custodial relationships with children. The programs include families and trains health care volunteers and staff as patient and family educators. The role of the patients and the families are critical in this process. Even very young children can learn to use a peak flow meter to monitor their airway status, and parents must monitor the usc of the medication and bc ccrtain that there is continuous treatment of the disease. Parents also need to create an environment in the home which reduces triggers for the disease, such as cigarette smoke, dust mites, cockroach and rodent urine, dog and cat dander, formaldehyde-impregnated carpets and furnishings, and other regional allergens such as mold and mildew. This need for parents to be proactive may be one of the reasons why children of lower socio-economic status have more asthma and more severe disease. Parcnts of children at risk for asthma or with asthma must have access to a quality health system and seek out care early on, not only for asthma but also for respiratory infections that can lead to the development of the asthma. Seeking medical care only when the child is having a severe attack is not effective in preventing or managing the disease. The ability to change the home environment may also be beyond the capability of these parents. The Inner City Asthma Project currently being funded by NIH will study the impact of effective treatment and home environmental and patient/family education programs on populations in several regions of the country, including Tucson. This five year program should provide the data needed to support changes in services and environmental conditions by physicians, managed care plans, state and local health agencies and providers, and other organizations, such as schools, day care providers and housing authorities. Managed care plans and Medicaid providers must be convinced of the need for early intervention in diagnosis and treatment of children with asthma, including patient and family education, allergen testing, and easy access to health providers for these children. What needs to be done to prevent the development of asthma and to limit its impact on the health of children? 1. Community wide programs such as the Tucson Alliance for Pediatric Asthma need to be conducted to implement what is already known and established in the areas of clinical diagnosis and treatment, education for patients, families, and care providers, and control of indoor air quality in homes, schools, day care centers, and other places where children spend their time. 2. Managed care/plans and other insurance programs such as Mcdicaid need to provide accessible health care services to asthmatic children of children at risk for asthma, including educational programs and case management services to support the families to assure compliance. 3. Public attention needs to be directed to this problem, with special attention to primary prevention efforts, which include elimination of smoking during pregnancy, protection of infants and small children from indoor air pollutants, and early treatment of respiratory infections which can lead to the development of the disease. 4. Research needs to be continued in the areas of the development and treatment of the disease, the regional (geographic) variances in environmental factors, genetic factors, and varianccs in incidence in socio-cconomic groups. Asthma in the Elderly Population The longer people live, the more likely it is that they will develop asthma, especially if they have a history of smoking or respiratory discase or infections. As the population ages, the incidence of asthma will increase. Research indicates that children may appear to "outgrow" their asthma, but actually it smolders and often reappears in later life. When asthma occurs along with other diseases of the elderly, such as congestive heart failure, it can be difficult to diagnose and treat. An aging population will require diagnostic and treatment services, and environmental conditions in nursing homes must be addressed. Gaining a comprehensive understanding of the problem of asthma and what needs to be donc If you would like to increase your understanding of the issues surrounding asthma and what is known and can he implemented to prevent and limit the impact of the disease, I invite you to Tucson. I will organize a program which will include: 1. discussions with national and international experts in clinical and research areas 2. discussions with physicians regarding patient care issues 3. a briefing on the Inner City Asthma Project, including a tour of the El Rio Community Health Center, which will be the research site 4. briefing on the Tucson Alliance for Asthma Care which operates under the auspices of the Tucson chapter of the American Lung Association 5. meeting with families and children regarding their experiences in learning about and monitoring their asthma and the impact which it hasion their lives. 6. discussion of the present and future role of managed care plans in providing coverage and prevention programs (Arizona has a managed care alternative Medicaid program) DEC-09-1997 14:35 FROM TMC PLANNING/MARKET TO 12024562878 P.01 TUCSON/ALMATY HEALTHCARE COALITION TEL: 520-324-1784 FAX: 520-795-5689 Tucson Medical Center, Arizona Building, 2nd floor, 5301 East Grant Road, Tucson, Arizona 85712 FAX COVER SHEET: Brenda D DATE: 12/9/97 TOTAL PGS: TO: Nera Tanden Tel: Fax: FROM: Emily Jenhis Tel: Almatly Project Fax: 795-5689 RE: 202 456 2878 Good summery of issues- - Arizona +US, DEC-09-1997 14:35 FROM TMC PLANNING/MARKET TO 12024562878 P.02 Tackling Asthma in Arizona A Report by the Arizona Asthma Coalition August 1997 DEC-09-1997 14:36 FROM TMC PLANNING/MARKET TO 12024562878 P.03 ARIZONA ASTHMA COALITION The Arizona Asthma Coalition, a prevention partnership, was formed in 1996 with five objectives. OBJECTIVES Collaborate and build partnerships to improve asthma management Increase awareness of asthma management Share data and information Evaluate the effectiveness of interventions Advocate for public health priorities and activities It is our hope that appropriate legislative, administrative and medical bodies will act upon the recommendations contained in this report. The Coalition membership includes the following groups: Academy of Family Physicians, Arizona Chapter Glaxo Wellcome, Inc. Academy of Pediatrics, Arizona Chapter Health Services Advisory Group ADHS/Arizona Center for Minority Health Health Partners Health Plan ADHS/Health Planning, Evaluation & Statistics Humana Inc. ADHS/Community & Family Health Intel Corporation ADHS/Women & Children's Health Intergroup of Arizona, Inc. ADHS/Public Health Policy & Practice Kid Radio KHITS ADHS/Chronic Disease Prevention Merck and Company, Inc. ADHS/Chronic Disease Epidemiology Maricopa County Department of Health Arizona Disease Control Research Commission Maricopa Managed Care Systems Aetna US Healthcare Mercy Care Plan AHCCCS Mohave County Department of Health American Lung Association of Arizona Murphy Elementary, School District 21 Arizona Asthma and Allergy Institute PCS Health Systems Arizona Physicians, Inc. Phoenix Children's Hospital Arizona HMO Association Phoenix Pediatrics Arizona Public Health Association Samaritan Prime Care Network Asthma Information Resources Scottsdale Memorial Home Health Care BlueCross BlueShield Scottsdale Memorial Hospital North Cathy Graeff, Inc. Signature Homecare CIGNA Healthcare St. Joseph's Children's Hospital Coconino County Health Department University of AZ College of Pharmacy Faculty from the U of A, Health Sciences Center Your Family Physicians 2 DEC-09-1997 14:36 FROM TMC PLANNING/MARKET TO 12024562878 P.04 WHAT IS ASTHMA? Asthma, once thought of as a "simple" hypersensitive reaction, is now known to be a complex condition with a spectrum of causes and contributing factors, with airway inflammation as its central attribute. Asthma is a reversible obstructive lung disease, caused by an increased reaction of the airways to various stimuli. It is a chronic condition with acute exacerbations. Asthma can be a life-threatening disease if not properly managed. Asthmatics have bronchial tubes that are virtually continuously inflamed and hyperactive, sent into suffocating spasms by a broad range of provocations that may vary from one individual to another. Some of the substances and circumstances that may trigger attacks are: smoke, airborne molds, pollens, dust, animal dander, exercise, cold air, many household and industrial products, air pollutants, scents, and simple stress. An episode finds the victim gasping for breath as the airways become constricted, the passages inflamed and clogged with thick, sticky secretions. The narrowed airway is responsible for the difficulty in breathing with the familiar "wheeze." 3 DEC-09-1997 14:36 FROM TMC PLANNING/MARKET TO 12024562878 P.05 WHAT IS THE TREATMENT? Those who suffer from asthma must typically take a variety of medications, usually on a regular basis. They include bronchodilators, corticosteroids, and other reducers of inflammation. With the recent recognition of the major role played by continuing inflammation, regular use of inhaled steroids is increasingly advised. Complying with these often complex treatment regimens can prove particularly difficult for children. Two classes of medications are used to treat asthma--bronchodilators and anti-inflammatory agents. Bronchodilators act principally to dilate the airways by relaxing bronchial muscle. They include beta-adrenergic agonists, methylxanthines, and anticholinergics. Anti-inflammatory agents interrupt the development of bronchial inflammation and have a prophylactic or preventive action. They may also modulate or terminate ongoing inflammatory reactions in the airways. These agents include corticosteroids, cromolyn sodium or cromolyn-like compounds, and other anti-inflammatory compounds. 4 DEC-09-1997 14:37 FROM TMC PLANNING/MARKET TO 12024562878 P.06 ASTHMA PREVALENCE IN ARIZONA According to the Arizona Department of Health Services, an estimated 210,000 asthmatics reside in Arizona. Hospital discharge rates for pediatric asthma in Arizona are highest among African- Americans (see graph #1), approximately 4 times that of Hispanics and Whites. Hospital discharge rates for asthma in 1995 were highest in Yuma County followed by Maricopa County (see graph #2). The asthma death rate in Arizona in 1995 was 2.8 per 100,000 while the death rate in the United States was 2.1 (see graph #3). According to the Arizona Department of Health Services, Maricopa County had the third highest death rate from asthma compared with other counties in the United States. Asthma hospitalizations in 1995 were highest in the last quarter of the year, the time of year with the highest levels of airborne particulate matter in Arizona (see graph #4). 5 DEC-09-1997 14:37 FROM TMC PLANNING/MARKET TO 12024562878 P.07 ASTHMA PREVALENCE NATIONWIDE Asthma affects 14 to 15 million persons, including 4.8 million children under the age of 18. Between 1982 and 1992, the prevalence rate--the rate per thousand persons--of pediatric asthma rose from 40.1 to 63.4, an increase of 58 percent. Some of this increase in prevalence may be due to "diagnostic exchange," the tendency for physicians to label patients with asthma instead of an alternative diagnosis, but this only accounts for part of the increase in prevalence. The number of deaths attributed to asthma has increased by 98.9 percent since 1979, from 2,598 in 1979 to 5,167 in 1993. For persons under age 25, the annual age specific asthma death rate increased 118% between 1980-1993. Annual hospitalization rates among persons age 25 and under increased 28% from 1980- 1993. 6 DEC-09-1997 14:37 FROM TMC PLANNING/MARKET TO 12024562878 P.08 ASTHMA IN CHILDREN Asthma is the leading serious chronic illness among children. Most children have mild problems, and their illness can be controlled by treatment at home or in the doctor's office. For some children the illness becomes a formidable problem causing many visits to the hospital emergency room and multiple hospitalizations. Asthma accounts for 10 million lost school days annually. It is the leading cause of school absenteeism attributed to chronic conditions. Asthma is the third-ranking cause of hospitalization among children under the age of 15; it is the first-ranking cause among chronic conditions. Secondhand smoke can cause serious harm to children. An estimated 200,000 to one million asthmatic children have their condition worsened by exposure to secondhand smoke. Children are more vulnerable than adults to air pollution because they breathe more rapidly and inhale more pollutants per ratio of body weight than adults. Only about a quarter of the children with asthma outgrow the condition; for the rest, the condition is a lifelong ordeal. The condition persists in 85 percent of women and in 72 percent of men who had the disease as children. 7 DEC-09-1997 14:38 FROM TMC PLANNING/MARKET TO 12024562878 P.09 COSTS Hospital charges for treating children with asthma amounted to $12 million in Arizona in 1995. Addition uncounted costs include emergency room visits, physician costs, lost work days, and missed school. The annual direct health care cost of asthma nationwide is approximately $9.8 billion; indirect costs (e.g., lost work days) add another $2.8 billion, for a total of $12.6 billion. The largest single direct cost may be emergency room use estimated to account for 43% of the direct costs. Asthma also accounts for an estimated 10.1 million missed days from school and 200,000 hospitalizations per year in children less than 18. 8 DEC-09-1997 14:38 FROM TMC PLANNING/MARKET TO 12024562878 P.10 WHO GETS ASTHMA? Recent studies suggest that children of smokers are twice as likely to develop asthma as children of nonsmokers. Women who smoke during pregnancy have babies with abnormally narrowed airways that predispose them to asthma. Although African-Americans represent approximately 12 percent of the U.S. population, they account for 21 percent of deaths due to asthma. The reason for this discrepancy is unknown. In 1982, the prevalence rate of asthma among African-Americans was 13.3 percent higher than the rate among whites; in 1992, the rates for both races were up--but the rate among blacks was 15.4 percent higher than that for whites. 9 DEC-09-1997 14:38 FROM TMC PLANNING/MARKET TO 12024562878 P.11 COALITION RECOMMENDATIONS Based on the asthma prevalence and mortality compared to other states, the Arizona Asthma Coalition recommends: Work in conjunction with managed care organizations to implement the guidelines from the National Institutes of Health on diagnosing and managing asthma. Because over 80% of Arizonans covered by health insurance receive care through HMO's, these systems provide the most effective route to implement "best practices." Some HMO's in Arizona are already providing leadership in asthma care. Train providers such as physicians, nurse practitioners and nurses in up-to-date asthma prevention and treatment protocols. Establish a certification process for primary caregivers, especially in the area of pediatric asthma management. Provide self-care education and resources for patients and families with asthmatic children. Target improved asthma management services to communities with disproportionally high rates of hospitalization from asthma. Improve funding and equipment for school-based health care providers and ensure that each school has a full-time certified asthma care provider. Asthma is the number one cause of school absences. School-based providers can play a vital role in treating and educating children with asthma and in preventing emergency room visits from uncontrolled asthma episodes. Implement clean indoor air laws around the state, including a ban on smoking in the workplace. Research shows a link between passive smoking and increased exacerbations of asthma. Implement control measures to reduce airborne particulates in order to help us achieve the federal Environmental Protection Administration (EPA) health standard for particulate pollution. Research shows a link between poor outdoor air quality and higher morbidity rates. The relationship is most apparent with particulate pollution. By December 1997 Arizona must submit a plan to reduce particulates to EPA. 10 1995 Arizona Asthma Hospital Discharges* By Race/Ethnicity-Specifio Rates 1 Among Children Age 2-20 Race/Ethnicity DEC-09-1997 14:39 FROM Black M-305 827.6 Hispanic n=542 198.5 TMC PLANNING/MARKET White n-1,205 190.1 TO Nat Am* 51.6 (n=41) Asian 38.3 (n=6) 0 200 400 600 800 1,000 12024562878 P.12 Discharges Rate/100,000 Population Arizona hospital discharges from non-federal facilities (Does not include IHS facilities) Tote: Rate based on Arizona 1990 Census Population 1995 Asthma Hospital Discharge Rate 2 By County For Children Age 2-20 County of Residence DEC-09-1997 14:39 Yuma 323.5 Maricopa 213.7 FROM Pinal 192.2 Pima 175 Mohave 151.4 La Paz 138.2 Santa Cruz 111.1 Coconino 107.7 TMC PLANNING/MARKET Cochise 104.7 Graham 91 Yavapai 75.7 TO Navajo 62 Gila 37.7 Apache 30.8 Greenlee 30.6 O 50 100 150 200 250 300 350 Discharges/100,000 Population 12024562878 P.13 Arizona hospital discharges from non-federal facilities (Does not include IHS facilities) bie: Rate based on ADES 1995 Population Projections Asthma Death Rate* 3 Arizona and United States, 1991-1995 Arizona United States DEC-09-1997 14:40 3 n=116 FROM 2.5 n=94 n=87 CO 7791 90 2 Rate TMC PLANNING/MARKET 1.5 1 TO 0.5 0 1991 1992 1993 1994 1995 12024562878 P.14 Year Number of Deaths per 100,000 population ource: Arizona Department of Health Services; Office of Planning, Evaluation, and Statistics DEC-09-1997 14:41 FROM TMC PLANNING/MARKET TO 12024562878 P.15 Hospital Asthma Charges Among Children in Arizona During 1995 ($12,614,344)* HMO 3.84 Payor Type Care AHCCCS/Medicaid 3 AHCCCS HCG 1.96 other PPO 1.65 395 Indemity Indemity 1.17 AHCCCS Other 0.56 Self/Charity 0.45 0 1 2 3 4 5 Charges (Millions $) Other includes CHAMPUS, Child Rehab, Work Comp, IHS, Foreign Nation *All discharges from non-federal facilities among children age 2-20 Asthma Hospital Discharges* Among Children Age 2-20 4 During 1995 (2,346 Discharges) 250 * Emergency - Urgent - Elective 232 204 200 Discharges 150 112 118 126 110 131 123 100 86 74 96 63 49 50 33 35 $ 7 8 4 1 6 3 3 9 14 11 10 0 Jan Feb M3r ACT May Jun Jul Aug Sep Oct Nov Dec Month of Admission "Discharges From All Non-federal facilities asthma Page 1 MEMORANDUM TO JENNIFER KLEIN FROM SANJAY GUPTA RE PEDIATRIC ASTHMA ASTHMA IN CHILDREN KEY FACTS What is asthma? Asthma is a chronic inflammatory disorder of the airways. In susceptible individuals, this inflammation causes recurrent episodes of wheezing, breathlessness, chest tightness and coughing, particularly at night or in the early morning. These episodes, or "asthma attacks", are usually associated with airflow obstruction that is often reversible, either spontaneously or with treatment. Asthma can vary in severity and is categorized as either: mild intermittent, mild persistent, moderate persistent or severe persistent. Asthma often begins in childhood and can start as early as the first year of life: 70% of all people with asthma developed asthma before age seven. Asthma is frequently found in association with what is referred to as "atopy", the susceptibility to produce antibodies toward common allergens such as animals, cockroaches, house-dust mites, indoor molds and outdoor allergens. asthma Page 2 Other factors that can precipitate or trigger asthma attacks include: tobacco smoke, indoor/outdoor pollution, viral respiratory infections, trauma and other stressors, exercise, drugs, emotions, cold air, aspirin and sulfite sensitivity. Who has asthma? As of 1994, approximately 4.8 million children under the age of 18 have asthma, according to the National Institute for Allergy and Infectious Diseases, for a prevalence rate of 4.3%. Nationally, asthma rates are highest in New York, Chicago, Fresno, California and Maricopa County, Arizona. Asthma prevalence and mortality rates are continuing to rise nationwide. In 1994, in high risk areas of New York City the asthma prevalence rate for children reached between 8.6% and 14%. In 1996, it reached 25% for the population of homeless children cared for by The Children's Health Fund. As of 1993, New York City children were hospitalized for asthma at more than four times the national rate and the hospitalization rate is continuing to rise. Within New York City, African Americans and Latinos have three to five-and-and a- half times the hospitalization rates of whites. Among New York City children 14 and younger, those living in a zip code in the lowest 20th percentile of median income had four times the hospitalization rate of those living in the highest 20th percentile of median income. Areas in New York City with highest asthma hospitalization rates include the South Bronx, Upper Manhattan, Central and North Brooklyn. The number of children hospitalized for asthma nationwide has increased fivefold over the past 20 years. In 1993, asthma accounted for nearly 200,000 hospitalizations among people less than 25 years old. asthma Page 3 Hospitalization rates for children less than five years old have increased by 57% since 1980. Compared with white children, African American children are four to six times more likely to die from asthma and three times more likely to be hospitalized for asthma. Poor children with asthma reported 40% fewer physician visits, yet were 40% more likely to be hospitalized than children with more economic resources. What are the consequences of asthma for children? Nationwide, asthma is associated with the loss of 28 million activity days annually and 2.2 million pediatrician visits. It is the leading cause of school absenteeism. It has been estimated that among children 5-17 years old, asthma accounted for approximately 10 million missed school days, at a cost of $726.1 million in caretaker's time lost from work. Asthma can be fatal. Over 3,800 children and young adults under 25 died from asthma nationwide during the period of 1980-1993. In 1993 alone, 342 children and young adults under 25 died from asthma. What are the costs of asthma? In 1993, the total direct and indirect annual costs of asthma were estimated to be over $6.2 billion in 1990 dollars, not including the economic impact of this disease on affected patients and families. Non-monetary costs for children with asthma include decreased asthma Page 4 quality of life, mental distress for patients and families, social labeling associated with a chronic disease and complications from medication use. 12/10/97 WED 11:37 FAX 202 456 6244 0FC OF THE FIRST LADY 1 001 CLASSIFICATION AIR FORCE ONE FAX To: Jen Klein 62828 FROM: David Shepter From TO: Heckend 0'Kam 456-5709 REMARKS : Midual- Pls. sid tas 5/6 4 Jun + Sn pay Tax. D AFI FAX NUMBER : DATE-TIME GROUP : TOTAL PAGES : (TOTAL INCLUDES COVER) CLASSIFICATION 12/10/97 WED 11:37 FAX 202 456 6244 OFC OF THE FIRST LADY 4 002 DRAFT 12/9/97 FIRST LADY HILLARY RODHAM CLINTON STATEMENT FOR NEW YORK CITY CHILDREN'S ASTHMA INITIATIVE SOUTH BRONX CHILDREN'S HEALTH CENTER DECEMBER 11, 1997 I 12/10/97 WED 11:37 FAX 202 456 6244 OFC OF THE FIRST LADY 003 Acknowledgments. From advance Today we take another step in our comprehensive effort to protect the health of America's youth a step that will meet head on the most common chronic medical problem children face today: asthma. And like all important steps, it is one we are taking together: doctors, nurses, health care providers, community leaders, government, citizens, and parents. Asthma affects nearly 5 million American children. Over the past decade, it has led to more than 4000 deaths. Worse, these numbers are on the rise. In the last 20 years, the number of children hospitalized for asthma has increased five-fold; the number of deaths has more than doubled. We also know asthma hits hardest the children of our inner cities. New York City children, for example, are hospitalized at four times the national rate. Moreover, the hardest hit of the hardest hit are minorities - African Americans and Latinos. 2 12/10/97 WED 11:37 FAX 202 456 6244 0FC OF THE FIRST LADY 004 Here in Now York, the asthma rates for African American and Latino children are three to five times higher than rates for other populations. An African American child is four to six times more likely to die from asthma than a white child. Behind these statistics, there are human stories. Children who cannot step outside the front door without a pocketful of inhalers. Children who cannot walk a block or ride a bike without grasping for air. Children who miss out on education, friendship, and community because of their condition. Asthma is the leading cause of school absenteeism. Last year, it was the cause of more than 10 million missed school days. To a parent, there are few things more frightening than sceing the look he or che is struck hv asthma To 12/10/97 WED 11:39 FAX 202 456 6244 OFC OF THE FIRST LADY 001 These resources will go toward providing health care coverage for children who are currently uninsured. Up to 10 percent of these funds can be used for on-the-ground services -- like those we see here today. Earlier this year, the President announced a plan to see to it that parents and doctors know exactly what and how much medicine to give children. Right now, the vast majority of medications -- including asthma drugs -- are not tested for kids. The President's Pediatric Labeling Initiative will change all that. No parent should have to guess how much medicine to give a sick child. During the course of his administration, my husband has taken a series of other important steps to safeguard the health of our children: from protecting and defending Medicaid to signing cutting-edge legislation like the Family and Medical Leave and Kennedy-Kassebaum Acts to shielding our young people from tobacco and drugs to seeing to it that our children get the immunizations they necd. 5 12/10/97 WED 11:39 FAX 202 456 6244 OFC OF THE FIRST LADY 002 He has also made a special effort to see to it that the air our children breathe, the water they drink, and the 1000 шсу cal public health standards for smog and soot that will prevent 350,000 cases of aggravated asthma. He has cleaned up a record number of toxic waste sites and expanded community right to know laws SO that families know exactly what substances are being released into the world around them. Under this administration, we have strengthened and revolutionized food safety laws for meat, seafood, and poultry for the first time in a generation -- and we have toughened regulations to keep harmful pesticides off our children's food. All these efforts work toward a single dream: Better health and safer lives for our children. With today's initiative -- and with your work and commitment -- we are one step closer toward making that dream a reality. Thank you. 6 DAVID SHIPLEY 12/09/97 01:51:38 PM Record Type: Record To: Jennifer L. Klein/OPD/EOP, Sanjay Gupta/WHO/EOP, OMARY_M @ A1 @ CD @ LNGTWY CC: Subject: edit of asthma speech. as you can see, there are some questions. thanks, di DRAFT 12/9/97 FIRST LADY HILLARY RODHAM CLINTON STATEMENT FOR NEW YORK CITY CHILDREN'S ASTHMA INITIATIVE SOUTH BRONX CHILDREN'S HEALTH CENTER DECEMBER 11, 1997 Acknowledgments. From advance Today we take another step in our comprehensive effort to protect the health of America's youth -- a step that will meet head on the most common chronic medical problem children face today: asthma. And like all important steps, it is one we are taking together: doctors, nurses, health care providers, community leaders, government, citizens, and parents. Asthma affects nearly 5 million American children. Over the past decade, it has led to more than 4000 deaths. Worse, these numbers are on the rise. In the last 20 years, the number of children hospitalized for asthma has increased five-fold; the number of deaths has more than doubled. We also know asthma hits hardest the children of our inner cities. New York City children, for example, are hospitalized at four times the national rate. Moreover, the hardest hit of the hardest hit are minorities -- African Americans and Latinos. Here in New York, the asthma rates for African American and Latino children are three to five times higher than rates for other populations. An African American child is four to six times more likely to die from asthma than a white child. Behind these statistics, there are human stories. Children who cannot step outside the front door without a pocketful of inhalers. Children who cannot walk a block or ride a bike without grasping for air. Children who miss out on education, friendship, and community because of their condition. Asthma is the leading cause of school absenteeism. Last year, it was the cause of more than 10 million missed school days. To a parent, there are few things more frightening than seeing the look of confusion and then fear on your child's face as he or she is struck by asthma. To a child, I cannot imagine anything more terrifying than not being able to breathe -- no matter how hard you try. That is why I am so gratified by the action you are taking today. The Children's Health Fund, the Montefiore [Monta-fee-or] Medical Center, and [what level of govt? Are we involved?] have come together to create an innovative public-private partnership to lower the UNITED is 3 rates of childhood asthma. This initiative will increase public awareness of pediatric asthma through programs, models and policies [can we be more specific about this? Will teach parents to take their kids for checkups? Get away from cockroaches? What?]. Mobile medical units and primary care centers will provide treatment to homeless children and those at particular dvan risk. [need one more specific here. What does it do for real people?] If there is any disease that illustrates that an ounce of prevention is worth a pound of intensive care, asthma is it. care and teachersion prof. This is part of the President's [are we involved? Is there govt support? If so, say above wrt people coming in pub-priv partnership. If not, trans should be, "what you are doing here fits with the president's efforts to build a ] overall commitment to building a strong foundation for the health of all our children. This summer, the President signed into law a balanced budget that will help extend health insurance to up to 5 million children. During the course of his administration, my husband has taken a series of important steps to safeguard the health of our children: from protecting and defending Medicaid to signing cutting-edge legislation like the Family and Medical Leave and Kennedy-Kassebaum Acts to shielding our young people from tobacco and drugs to seeing to it that our children get the immunizations they need. He has made a special effort to see to it that the air our children breathe, the water they drink, and the food they eat are safe. The President issued tough new public health standards for smog and soot that will prevent 350,000 cases of aggravated asthma. He has cleaned up a record number of toxic waste sites and expanded community right to know laws so that families know exactly what substances are being released into the world around them. Under this administration, we have strengthened and revolutionized food safety laws for meat, seafood, and poultry for the first time in a generation -- and we have toughened regulations to keep harmful pesticides off our children's food. All these efforts work toward a single dream: Better health for our children. With today's initiative -- and with your help and commitment -- we are one step closer toward making that dream a reality. Thank you. 12/02/97 18:07 FAX CHILDREN'S HEALTH FUND 001 THE Children's Health FUND FAX TRANSMITTAL COVER SHEET To: Jennifer Klein Via Fax #: (202) 456-2878 From: Melissa Ziriakus Date: September 16, 1997 The number of pages in this fax (including this cover page): 6 If there is a problem with this fax transmission, please call (212) 535-9400 Proposed outline for December 11, 1997 Children's Health Fund press event. I look forward to speaking with you about details and can be reached at (212) 535-9400, ext. 280. 12/02/97 18:07 FAX CHILDREN'S HEALTH FUND 002 THE Children's Health FUND Memo to: Jcnnifer Klein From: Melissa Ziriakus Date: December 2, 1997 Subject: Children's Health Fund press event Irwin Redlener and I have been in discussions to develop and provide you with a proposed outline for the New York City Asthma Initiative press conference on December 11 at 11:00 AM involving Ms. Hillary Clinton. I've attached that for your review, and invite you to call if you have any questions. Separately, I also sent to Sanjay Gupta, via FedEx today for tomorrow morning delivery, a copy of the childhood Asthma Briefing Book, along with some other program orientation pieces. CC: Irwin Redlener, MD The Children's Health Fund . 317 East 64th Street New York NY 10021 Telephone (212) 535-9400 . Fax (212) 535-7488 12/02/97 18:07 FAX CHILDREN'S HEALTH FUND 120297 15:20 DRAFT DRAFT DRAFT DRAFT The Proposed Plan to Announce The New York City Childhood Asthma Initiative WHAT: A press conference for The Children's Health Fund to announce a major public health initiative, The New York City Childhood Asthma Initiative, and plans to develop a primary care and asthma center, This is an opportunity to unveil the program components, to talk with principals involved, and dignitaries who support the initiative as an effort to fight against the epidemic of asthma. This comprehensive plan is designed to be a model for programs that can be executed throughout the United States. WHO: An exceptional coalition of: FEDERAL INTERESTS: The White House, Ms. Hillary Rodham Clinton; LOCAL GOVERNMENT: The City Council of New York, led by Councilman Kenneth Fisher; PUBLIC HEALTH ADMINISTRATION: the New York City Department of Health, represented by Benjamin Mojica, Acting Commissioner; THE CHILDREN'S HEALTH FUND and MONTEFIORE MEDICAL CENTER: spearheaded by Irwin Redlener, MD: PRIVATE SECTOR: Schering Laboratories, represented by Richard W. Zahn, president. WHAT: The New York City Childhood Asthma Initiative addresses the epidemic proportions of asthma in New York City, where incidence of the disease is among the highest in the nation. The press conference is to advise the community, via the press, of the diverse efforts that the Initiative will introduce, and to introduce the plan as a national model. WHEN: Thursday, December 11, 1997 11:00 am Time frame: approximately 20 minutes to one-half hour; WHERE: South Bronx Children's Health Center 911 Longwood Avenue The Bronx, New York. OTHER: Speakers Irwin Redlener, MD, President. The Children's Health Fund; Vice President for the Children's Medical Center. Montefiore Medical Center; Kenneth Fisher, Councilman, Borough of Brooklyn; Benjamin Mojica, MD, Acting Commissioner, NYC Department of Health; Richard W. Zahn, President, Schering Laboratories; Hillary Rodham Clinton, Esq., First Lady of the United States. Other invited, nonspeaking guests to be acknowledged, include New York City Council President Peter Vallone, Bronx Borough President Frederic Ferrer, U.S. Representative Jose Serrano, Bronx Assemblyman Jeffrey Klein. 12/02/97 18:08 FAX CHILDREN`S HEALTH FUND 4. 004 New York Childhood Asthma Initiative Announcement, page 2. Tentative Agenda 11:00 Scheduled start time 11:00 Irwin Rediener, MD opens the floor, introduces Mrs. Clinton, introduces other speakers, invites Ken Fisher to speak. 11:01 Kenneth Fisher discusses the genesis of the budget allocation for the New York City Childhood Asthma Initiative. 11:05 Irwin Redlener speaks of the problems of underserved children, asthma and the need for a children's agenda in New York City. 11:09 Benjamin Mojica, Acting Commissioner of Health, presents the Department's perspectives on the program. 11:13 Richard Zahn, president of Schering Laboratories, speaks of the initiative from the perspective of the advances in asthma treatment, and the need to deliver these treatments. 11:16 Irwin Redlener speaks of bringing the effort to the attention of Hillary Rodham Clinton, and her interest in it. 11:17 Hillary Rodham Clinton speaks. (CHF to be advised of her point of view.) 11:21 Conclusion. 11:22 Questions and answers. ### 12/02/97 18:08 FAX CHILDREN'S HEALTH FUND 005 New York Childhood Asthma Inititive Announcement, page 3. Other considerations 1. Will there be limitations to the number of persons allowed within the restricted area? If so, how many people? 2. How far in advance do you need lists of invitees? Do you need both date of birth and social security number? Separate from invitees, presumably employees of the South Bronx Children's Health Center will also need to be cleared, correct? (The Center will be used as an indoor holding station before the event.) What about the days' patients? 3. Who takes care of street permits (the street will need to be blocked off), WE or The White House? 4. What is the general size of a restricted area? (See below) 5. We are intending to set up a large enclosed heated tent for the press conference since it will be outside in the Bronx and it will likely be cold. May we do so re security? The size tent we have in mind is 20 x 60 (to fit approx 100 people and including a stage as shown in att. drawing.) 6. Are credentials issued at the time of the event? 7. What is the protocol for inviting local politicians? Is that done by The White House or by The Children's Health Fund? 006 D ASTHMA MOBILE MEDICAL UNIT 16*12*12 H HEWITT PLACE 20x80 STAGE TENT- APARTMENT WITH CLEAR BLDGS. SIDES CHILDREN`S HEALTH FUND SEATING APARTMENT BUILDING SIDEWALK STANDING (PROJECTS) ROOM SIDEWALK SOUTH PRESS BRONX TABLE - CHILDREN'S HEALTH CENTER # Receipt A OPEN-ENDED ROAD BLACKS LONGWOOD AVENUE 12/02/97 18:08 FAX LAYOUT (PROPOSED) FOR 12.11.97 (11:00 AM) PRESS CONFERENCE MEMORANDUM FOR THE FIRST LADY Nov 25, 1997 FROM: Domestic Policy Staff SUBJECT: Child Asthma Initiative IMPACT Asthma is a chronic inflammatory disease of the airways. In the United States, asthma affects 14 to 15 million persons. It is the most common chronic disease of childhood, affecting an estimated 4.8 million children with the direct and indirect cost estimated at $6.2 billion dollars in 1993. Over 3800 children and young adults under 25 died from asthma nationwide during the period 1980-1993. 342 children died from asthma in 1993 alone. Asthma is associated with the loss of 28 million activity days annually and 2.2 million pediatrician visits. It is the leading cause of school absenteeism. It has been estimated that among children 5-17 years old, asthma accounted for approximately 10 million missed school days at a cost of $726.1 million in caretakers' time lost from work. TRENDS The burden of asthma on the US population is increasing. Through the 1980's, the prevalence of asthma increased 29%, hospitalization rates increased 6% and mortality rates increased as well. The most notable increases were for children and young adults. Hospitalization rates for children less than five years old have increased 57% since 1980. These rates increased at a time when total hospitalization rates for children decreased. Overall, the annual age-specific asthma death rate increased 118% (from 1.7 to 3.7 per million) between 1980 and 1993 for persons aged 0-24. Explanations for rising prevalence, morbidity and mortality are varied. Investigators have attributed increased hospitalization to improved diagnosis, untoward effects of treatment, environmental factors, improvements in vital statistic reporting, and increased tendencies for asthmatic patients to use hospital emergency departments as primary sources of care. VULNERABLE POPULATIONS Childhood asthma has become more prevalent and more severe in the last decade, and disproportionately affects minority populations. In 1993, among children aged 5-14 years, blacks were four times more likely than whites to die from asthma.. In the 0-4 age group, blacks were six times more likely to die from asthma than whites. Hospitalization rates are consistently highest among blacks. In 1993, among persons aged 0-24 years, blacks were 3.4 times more likely than whites to be hospitalized for asthma.. Children living in the inner city are particularly vulnerable. New York City has the highest rate of hospitalization and mortality for childhood asthma of any area in the United States. As of 1993, New York City children were hospitalized for asthma at four times the national rate. Within the city, these rates are three to five times higher for African Americans and Latinos than for the rest of the population. Areas in New York City with the highest asthma hospitalization rates include the South Bronx, Upper Manhattan, Central and North Brooklyn. Nationally, asthma rates are highest in New york, Chicago, Fresno, and Maricopa County, Arizona. The exact relationship between generally known risk factors and the increase in asthma-related morbidity and mortality among minority inner city children has not been determined. Poverty undoubtedly impacts upon the health of inner-city populations. Poverty has been linked to underdiagnosis and subsequent reduced preventive asthma care. Defined risk factors such as passive and active cigarette smoking and air pollution may be greater for minority, inner-city children. Also, infestation with pests such as roaches, mites, rodents and mosquitoes are greater problems among the poor than the more affluent. Finally, socio-economic status has been directly linked to overall compliance and medical follow-up. PATHOGENESIS AND MANAGEMENT Asthma results from complex interactions among inflammatory cells, mediators and the cells and tissues resident in the airway. Atopy, the genetic predisposition for the development of a mediated response to common aeroallergens, is the strongest identifiable predisposing factor for developing asthma. In 2 susceptible individuals, this chronic inflammation causes recurrent episodes of wheezing, breathlessness, chest tightness and cough, particularly at night and in early morning. The episodes are usually associated with widespread but variable airflow obstruction that is reversible either spontaneously or with treatment. This inflammation does cause an associated increase in the existing bronchial hyperresponsiveness to a variety of stimuli. The effective treatment of asthma is dependent on four components: 1) correct diagnosis of asthma 2) reducing factors contributing to asthma severity 3) pharmacological therapy 4) self-management education. The goals of asthma therapy are to: 1) prevent chronic and troublesome symptoms 2)maintain normal pulmonary function 3) maintain normal activity levels 4)prevent recurrent exacerbations 5) provide optimal pharmacotherapy with minimal side-effects and 6) meet patients' and families' expectations of satisfaction with asthma care. NEW YORK CHILDHOOD ASTHMA INITIATIVE This initiative is organized as a partnership between the office of Councilman Ken Fisher and The Children's Health Fund, with strong collaboration from the New York City Department of Health. The goals of the program are to increase public awareness and knowledge of pediatric asthma and develop programs, models, and policies that will serve to reduce childhood asthma morbidity and eliminate childhood deaths due to asthma. The initiative will give attention to specific communities with high asthma prevalence. The program components will include a Childhood Asthma Task Force. This task force will be representative of NYC service sector agencies and will be co-chaired by Councilman Fisher and Children's Health Fund President Irwin Redlener MD. Other program components are Childhood Asthma Awareness Campaign and Clinical Programs. These components will include a public information initiative, asthma information hotline and provider education. In addition, the establishment and/or enhancement of primary care programs with special asthma focus will be organized in two communities where asthma is particularly problematic, Hunt's Point and Brooklyn. Existing care centers will provide 3 needed state-of-the-art asthma care in these two high risk communities and will serve as demonstration sites for a range of clinical and educational programs targeted at childhood asthma. 4 DEC-04-1997 12:56 FROM TMC PLANNING/MARKET TO 12024562878 P.01 TUCSON/ALMATY HEALTHCARE COALITION 520-324-1784 FAX 520-795-5689 Tucson Medical Center, Arizona Bldg, 2nd floor, 5301 East Grant Road, Tucson, Arizona 85712 FAX COVER SHEET: Date: 12/4/97 Number of Pages: To: Jennifer Klein 202-456-2878 Assistant to the First Lady From: Emily Jenkins, Project Director 520-795-5689 Re: Asthma Information and Invitation to Speak at Greater Issues Series Jennifer: Thank you for your call. Attached is a copy of Dr. Thorpe's invitation to Mrs. Clinton to speak at the Greater Issues Series. We would like to combine this visit with an informational program for Mrs. Clinton on asthma from clinical, research and community perspectives. I will FedEx a package of information to you next week regarding asthma as a health problem in the U.S., with information on these different areas of the problem. Emily Jenkins DEC-04-1997 12:56 FROM TMC PLANNING/MARKET TO 12024562878 P.02 TMC HealthCare December 3. 1997 Mrs. Hillary Rodham Clinton 1600 Pennsylvania Avenue Washington, DC 20500-0001 Dear Mrs. Clinton: As an influential advocate for a better world, we ask that you consider sharing your views on social reform - both nationally and globally - in our widely acclaimed speakers program held annually in Tucson, Arizona. Our program, which is sponsored by the TMC Foundation, is 14 years old. Known as the Greater Issues Series (GIS), the program features prominent national and international figures. Tucson Medical Center (TMC), a community hospital, is the largest medical facility in Southern Arizona. Through relationships with health care providers throughout Southern Arizona and Northern Mexico, we strive to improve the quality of life within our sphere of influence. TMC has a large pediatrics department. More than 4,500 babies are born each year in TMC's Labor & Delivery department. We do extensive work in the area of respiratory ailments, especially pediatric asthma. We excel in a wide range of health care services, and assure that our services are provided to all, including the uninsured and underinsured. One of TMC's primary missions is to help create a healthier community, and that includes relationships beyond Tucson - and even Mexico. TMC is the lead hospital in the Almaty, Kazakhstan, health care program, which you visited recently. Almaty Program Director Emily Jenkins is housed in our TMC facilities and is a member of our Communications Team. We want to thank you for your kind remarks about Tucson during media interviews, and for the interest you expressed to Emily about our asthma projects in Tucson. The University of Arizona has one of the leading programs in respiratory disease. We would arrange a briefing for you regarding the research being done in the respiratory program as part of a GIS visit. Currently, we are developing an early learning and elder care program for employees and the community, with specific attention being given to welfare-to-work participants. The State of Arizona considers this a model program for other Arizona organizations to emulate. We are hopeful that TMC's work in this area can impact some of the family needs you address in your book It Takes a Village. Communications Team 5301 E. Grant Road Tucson, AZ 85712 (520) 324-2018 Fax: (520) 324-2127 DEC-04-1997 12:56 FROM TMC PLANNING/MARKET TO 12024562878 P.03 Mrs. Hillary Rodham Clinton December 3, 1997 Page 2 The TMC Foundation, which has sponsored GIS since 1983, has attracted distinguished speakers who have had an impact on our community. We would greatly appreciate the opportunity to include your name in that register of eminent speakers: James (Scotty) Reston, Helmut Schmidt, Edward Heath, Henry Kissinger, Jeanne Kirkpatrick, Abba Eban, Peter Ueberroth, Tip O'Neill, Casper Weinberger, Eric Sevareid, Mario Cuomo, George Will, Carl Sagan, Zbigniew Brzezinski, Peter Arnett, William Bennett, Richard Cheney, Elizabeth Dole, Richard Lamm and Shimon Peres. The GIS format focuses on a single guest speaker, who addresses an audience of approximately 2,000. Before and after the speech, there are receptions/discussions with smaller groups. There also is a brief meeting with the media. Normally, we set ground rules for the media so that the focus of questions is on the topics addressed during the GIS program. Given your prominence and the news coverage that would be generated by your appearance in Tucson, we would work with your press secretary to manage the media briefing. GIS speakers who were in office or a spouse of someone in office when they spoke in our program include: Mario Cuomo, governor of New York at the time; Zbigniew Brzezinski, who was a member of the President's Foreign Intelligence Advisory Board; and Elizabeth Dole, whose husband, Bob, was in Senate leadership. Enclosed is our recent report to the community, which provides a brief overview of the work we do at TMC. If you need more information, please have someone on your staff contact us. If you decide to participate in our GIS program, we would hope that it could be during the first quarter of 1998. We are more than willing to work around your schedule and help with any special arrangements that you need. We look forward to hearing from you. Sincerely, Danece P Thoye Darrell P. Thorpe, M.D. President and Chief Executive Officer TMC HealthCare CC: Patti Solis-Doyle, Director of Scheduling Mona Pasqael, Western Political Director Emily Jenkins, Almaty Program Director Enclosures Communications Team 5301 E. Grant Road Tucson, AZ 85712 (520) 324-2018 Fax: (520) 324-2127