IV. INVENTORY (*=restricted files)

SERIES VII. PEDIATRIC RHEUMATOLOGY COLLABORATIVE STUDY GROUP (PRCSG - Dr. Brewer founded and chaired 1973- ).

Box 1 - PRCSG

Folders 1 - 4

By-laws (undated copy) and general correspondence, including FDA guidelines revision, (1973-1993).

Folders 5 - 15

Individual correspondence files for Drs. John Baum (1973-1978), Bram Bernstein (1989), James Cassidy (1975-1977), Chester Fink (1973-1977), Virgil Hanson (19731977), Jerry Jacobs (1976-1977, 1984), Joseph Levinson (1973-1978), Daniel Lovell (1988-1991), Anna-Lisa Makela (1977-1983), Jane Schaller (1973-1978), Diane Turkin (1981-1984).

Folders 16 - 23

Agenda and meeting minutes (Oct. 1977), in Europe (1981-1982), article "Methodology & Studies of Children with Juvenile Rheumatoid Arthritis" (Brewer, et al., 1982), participant CV file (1983-1984), lyme arthritis information (Dr. Avron Ross, 1984

1985), mailing addresses of members (1984-1985), mailing lists (ca. 1989), AMEXCO Gold Card year-end summaries of PRCSG expenses (1987, 1988, 1990).

Folders 24 - 27

Advisory Committee consensus conference (1987), Advisory Council correspondence, meetings, minutes, reports, study protocols, and other information (19881989).

Box 2 - PRCSG

Folders 28 - 31

Advisory Council correspondence and meetings (1990), meeting Feb. 27-29, 1992.

Folders 32 - 34

Summary Sheet of Drug Studies (1980?), Upjohn Company "INFLO News of Inflammation Research and Therapy" (1977-1978), Syntex "Rheumatology News" (1979).

Folders 35 - 41

NIH Advisory Board - early studies, correspondence, protocols, reports, meeting minutes including adult cooperative studies (1977-1981).

Folders 42 - 48

FDA - guidelines for clinical evaluation of anti-inflammatory drugs (1977-1979); Advisory Committee meetings Oct. 1978 (includes draft of proposed guidelines for evaluation of SAARDs) and Feb. 1979; new drugs information (1982); orphan products development (1982-1989); meeting in Washington, D.C. (May 1983); DMARD guidelines meeting and correspondence (1984); meeting regarding alternative medicine (Dec. 1990).

Box 3 - PRCSG

Folders 49 - 51

Cooperative Trial of Therapy of JRA, Vol. II - Database, data collection instruments, protocol, sample size tables (1984).

Folders 52 - 59

Patient medication information forms (1985), Dr. Brewer's slide script from a presentation to the AAP regarding collaborative research and the PRCSG, Syntex Laboratories correspondence and 24 color slides entitled "Biomechanics II" (1985-1987), DMARDs guidelines (1985-1986), undated TS "Recommendations for Guidelines: Clinical Testing of Non-Steroidal Anti-Inflammatory Agents in Pediatric Patients", undated Brewer notes and articles regarding NSAIDs, guidelines for the evaluation of drugs in children, "Anti-Rheumatic Drug Guidelines" by Dr. Kent Johnson (1989).

Folders 60 - 62

Adult study, sodium meclofenamate (Oct. 1973), statistics regarding delayed approval of Meclomen (1978), report "Meclomen: Overall Summary of Safety and Efficiency" (Oct. 30, 1978).

Folders 63 - 68

Methotrexate (MTX) study - MTX in severe JRA, preliminary report (Sept. 1986); correspondence, articles, clinical protocol, meetings, forms, patient assessment schedule (1982-1984).

Box 4 - PRCSG

Folders 69 - 74

MTX in severe JRA - original proposal with clinical protocol (April 1984); transcript of MTX treatment of rheumatoid arthritis symposium in Tarrytown, NY (April 26-29, 1984); meeting with Lederle Labs. in Houston (Nov. 1984); MTX funding, reports, correspondence (1984-1986).

Folders 75 - 83

MTX - Arthritis Advisory Committee/Lederle Labs meeting (May 1986); MTX in severe JRA clinical protocol and grant extension request (1986); video "Study of MTX in the Treatment of Severe JRA" by Lee Martin Productions for Lederle Labs featuring Drs. Earl Brewer, Chairman, PRCSG at THCBCM in Houston and Ed Giannini, TCH Rheumatologist and Co-Principal Investigator and Senior Scientist of PRCSG who monitors the study, discussing JRA and the relatively low-dose MTX treatment, and patients and MTX study participants Melinda White and Stephanie Hernandez (2 copies of this video, 30 mins., mid 1980s); MTX in severe JRA quarterly progress reports to FDA (1987); MTX study, findings, spreadsheets, check requests (1987-1990); meeting at Lederle Labs in NY (July 1988); meeting with Symedco/Lederle in LaCosta, CA, and Dr. Brewer's presentation regarding MTX vs. SAARDs including 10 slides (Jan. 18-20, 1989).

Box 5 - PRCSG

Folders 84 - 85

Tolectin (Tolmetin)- HEW/FDA forms (1974); collaborative adult study (19751985).

*Folder 86

Tolectin - study for FDA approval, protocols, grant application, including a list of patients involved (1976).

Folders 87 - 89

Tolectin - protocols (1977); 32 slides: 18 regarding Tolmetin/Tolmetin II, 14 regarding Indocin/Phenylbutazone/Salicylates/polyarteritis (197?); forms and correspondence with McNeil Pharmaceuticals (1985).

Folders 90 - 92

Penicillamine - collaborative adult study correspondence, reports, articles (19741979); Merck, Sharp & Dohme's "A New Indication for Cuprimine - Penicillamine/MSD (1978); D-Penicillamine Program Schedule (1981).

Folders 93 - 96

Piroxicam (Feldene) protocol and investigators manual (1976); 20 slides regarding Indomethacin (1976); Indocin study NDA-16-0549 with Merck, first 2 of 4 folders (Oct. 1976).

Box 6 - PRCSG

Folders 97 - 98

Last 2 of 4 folders, Indocin study NDA- 16-0549 with Merck.

*Folder 99

Patient data regarding Indocin study.

Folders 100 - 101

Merck's Indocin study - presentation to FDA Advisory Committee (Apr. 1977) and bibliography regarding Indocin Suspension (1980).

Folders 102 - 105

Nalfon (fenoprofen calcium) study with Lily Research Labs - clinical information brochure (Mar. 1976); blood sample instructions (1977); correspondence (1979); raw data . for statistical report regarding Nalfon and aspirin in JRA (1981).

Folder 106

Oxaprozin (Daypro - diphenyl-2-oxazole propionic acid) study with Wyeth Labs - Investigator's Confidential Brochure (May 1977).

*Folder 107

Oxaprozin study, efficacy assessment data by patient (Aug. 1981).

Folder 108

Oxaprozin study, Investigator's Confidential Brochure and protocol (Jan. 1980).

Folders 109 - 113

Ibuprofen (Motrin) study with Boots Pharmaceuticals -journal articles (19781979); correspondence and brochures (1982-1989); Investigational Brochure (Mar. 1983); clinical protocol (1985); liquid ibuprofen paper and correspondence (1989).

Folders 114 - 115

Voltaren (diclofenac sodium) study with Ciba-Geigy Pharmaceuticals including correspondence (1982-1989); 50-minute VHS video tape produced by 20th Century Fox Studio, World of Arthritis, featuring Dr. Brewer and staff regarding Ciba-Geigy's Voltaren study (1985).

Box 7 - PRCSG

Folders 116 - 123

Voltaren study - 60 color slides by Ciba-Geigy photographer Nancy Ori of Dr. Brewer and his staff with various JRA patients (1988); correspondence, brochures, reports, articles, two 5" x 7" B/W photos and a biographical sketch of Voltaren patient Mickey Mantle, one 5" x 7" B/W photo of Voltaren researcher Dr. Sanford H. Roth of Phoenix, AZ, one 5" x 7" B/W photo of the Voltaren product regarding the Voltaren launch meeting in Los Angeles (Aug. 28-31, 1988), The American Journal of Medicine: Proceedings of a Symposium, Inflammatory Disease and the Role of Voltaren (Dioclofenac Sodium) reprinted from April 1986; protocols, study correspondence, reports, and information on meeting with Ciba-Geigy in Summit, NJ (1989); draft of Diclofenac report (Mar. 1990); reports on Diclofenac at PRCSG Advisory Council meeting, Rockville, MD (Apr. 5-6, 1990).

Folder 124

Barsan (Proquazone) study - report and 7 slides of statistical charts.

Folders 125 - 132

Ketoprofen (Orudis) and JRA study (ca. 1986); Sandoglobulin in polyarticular JRA study (1989); trial of Gammagard (gamma globulin) in treatment of systemic JRA (1989); 40 color slides - 16 regarding gout, 4 regarding osteoarthritis, 4 regarding psoriatic arthritis, and 16 with charts and information on Naprosyn in the treatment of JRA (197?); booklet "Clinoril (Sulindac/MSD)" by Merck Sharp & Dohme (Aug. 1978); packet regarding Tagamet, postmarket surveillance program (1979); press release concerning dimethyl sulfoxide, or DMSO (Mar. 1980); questionnaire, articles, brochures regarding Reye's Syndrome and salicylates (1982-1983).

Folders 133 - 138

International collaborative studies, USA/USSR (see Photograph Collection for photos from many of the joint meetings and the signing of the original agreements)includes three (3) Russian pins, one silver, one goldtone and dark blue, one goldtone and dark green; original "AGREEMENT BETWEEN THE GOVERNMENT OF THE UNITED STATES OF AMERICA AND THE GOVERNMENT OF THE UNION OF SOVIET SOCIALIST REPUBLICS ON COOPERATION IN THE FIELD OF MEDICAL SCIENCE AND PUBLIC HEALTH" (May 23,1972); address list of USA/USSR cooperative study members; correspondence proposing joint research and forms (1974-1975); correspondence, agenda, TS "Evaluation of Drugs in Children," study criteria from 1976 PRCSG trip to USSR; a meeting program with photos of the U. S. participants; 129 color slides of Drs. Brewer, John Mill, Paul Phillips, Ralph Williams, Morris Ziff, A. Matulis (Lithuania), Fred Steinberg, Ray Jaffe, Lawrence Shulman, John Decker, Jerry Rodnan, A. Speransky (USSR), A. Dolgopolova (USSR), M. Ivanova (USSR), V. A. Nossonova (USSR), Paul Plotz, A. A. Yakovleva (USSR), Charles Christian, and others from 1976 trip to Moscow, Leningrad, Sochi, Vilnius, etc.

Box 8 - PRCSG - USA/USSR

Folders 139 - 142

Russian journals, articles, business cards, receipts, travel catalogs and information, Moscow city map, brochures and post cards from Sochi and Vilnius, Russian-language programs, newspaper, and other items from trips 1976-1980.

Folders 143 - 144

Early JRA diagnostic criteria and protocols.

Folders 145 - 148

4th joint work meeting in San Francisco, CA, June 23-24, 1977; study meetings; Leningrad city map; 76 color slides with Drs. A. Matulis, M. Ivanova, L. S. Alekseev, A. Dolgopolova, E. R. Agababova, N. I. Melikhova, Andrew Kang, Paul Plotz, John Baum, Manuel Rudd, Paul Phillips, John Decker, Tom Metsger, Carl Leventhal, A. Speransky, Morris Ziff, I. Y. Shakhbazyan, among others, in Leningrad (Pediatric Hospital, scientists, hotel, circus, Poly Clinic, train, Russian cruiser that signaled start of 1917 Revolution), in Moscow (Tomb of Unknown Soldier, Parfumeria, Gum Dept. Store), Pushkin Palace, Pavlov's Lab and other sites during Oct. 1978 trip to the USSR.

Folders 149 - 150

Memorabilia from Dr. Brewer's Oct. 1978 stopover in Spain including postcards, booklets, receipts, score sheets from Dr. Brewer's hunt with the Duke of Alba, and 32 color slides of the hunt and of Javier Goizuetta, his wife, children, and home.

Folders 151 - 153

March 1981 joint Rheumatology Research Conference in USSR (see Photograph Collection), official memorandum regarding the working meeting results, and 27 color slides of Dr. and Mrs. L. S. Alekseev, Drs. A. V. Dolgopolova, Brewer, I. Y. Shakhbazyan, M. Ivanova, L. A. Isayeva, N. Kuzmina, Giannini, a Russian puppet show, various views of urban and rural landscapes, and two slides of a shipment of dpenicillamine/hydroxychloroquine to be used for a drug study (an empty bottle from this drug shipment is in Box 10, Folder 200).

Folders 154 - 157

Oct. 1982 USSR trip correspondence, brochures, documentation, reports, the official Russian-language memorandum in its original presentation folder reporting on the meeting, Dr. Brewer's handwritten meeting notes.

Folders 158 - 159

June 1983 meeting in Philadelphia with Smith Kline & French representatives; advance program and correspondence regarding the 10th European Congress of Rheumatology meeting in Moscow June 26-July 1 (Dr. Brewer did not attend).

Box 9 - PRCSG - USA/USSR

Folders 160 - 164

Sept. 1983 USSR trip correspondence, notes, expenses, 6 B/W passport photo contact prints of Dr. Brewer on an 8" x 10" sheet; and report by Dr. Brewer; undated slide sheets plus 7 slides regarding various cooperative drug study results; Jan. 1984 PRCSG meeting report; correspondence and information regarding possible June 1984 USSR trip; correspondence, expenses reports, protocol of meeting in Moscow Dec. 1015, 1984.

Folders 165 - 168

VHS video of June 7, 1985, 3-1/2-minute CNN broadcast from ARA annual meeting in Anaheim, CA, regarding "SOVIET AND AMERICAN EFFORT FOR CHILDREN'S ARTHRITIS DRUGS"; correspondence and report regarding Dr. Brewer's Sept. 1985 visit to Vilnius and Suzdal; permits and correspondence regarding July 1987 USSR trip and Russian translation of labels for JRA study (MTX); correspondence, schedules, visa applications, reports, and Russian rubles from Dr. Brewer's Oct. 1989 trip to the USSR with Drs. Giannini and Lovell.

Folders 169 - 176

Correspondence and report "ASPON-D System for Preconsultative Children's Screening Inspections" (1989-1990); correspondence and visa application for Drs. Lovell and Brewer's Oct. 1990 trip to the USSR; Dr. Brewer's invitation to the All-Union Congress of Rheumatologists in Minsk from Oct. 9-11, 3/8" x 1" red/white/blue/goldtone pin with U. S. Flag to left and USSR flag to right, report on Drs. Fink and Lovell's trip; USA/USSR general correspondence and articles (1977-1993); Russian telex file (19811987).

Folders 177 - 183

Kashin-Beck Disease as a possible study topic (1984); Winter 1976-1977 TCH Watch Magazine plus TS and reprint of Dr. Brewer's article "Soviet/U. S. Scientific Exchange Program Studies Rheumatology"; reprint of Dr. Brewer, et al., article "Juvenile Rheumatoid Arthritis: A Comparison of Patients from the USSR and USA" (Arthritis and Rheumatism, Vol. 23, No. 9, Sept. 1980, pp 977-984) regarding the first cooperative study; five Russian-language article reprints inscribed to Dr. Brewer (1982); reprint of article "Change of heart signaled in Soviet-US health agreements" (Nature, Vol. 326, March 19, 1987, p 234); TS of Dr. Brewer's "Experiences and Observations of Changes in the USSR from 1975-78 to 1988" (this article currently is being revised by Dr. Brewer for possible publication - another clean copy and an edited copy of this TS is in Series IX, Box 4, Folder 49); TS "Dr. Brewer and the USA-USSR Scientific Cooperation" by Wandy Brewer (April 1991).

Box 10 - PRCSG - USA/USSR

Folders 184 - 190

Individual correspondence files for Drs. James Cassidy (1982-1993), John Decker (1976-1978), Alexei Grom of Leningrad (1985-1996), John Klippel (1981-1990), Valentina A. Nassonova of Moscow (1981-1991); article reprints, CV, general information regarding Dr. A. K. Poznanski, radiologist (1981-1986); information regarding other candidates for PRCSG radiologist (1981-1982).

Folders 191 - 194

Publicity appearing in newspapers, magazines, brochures, newsletters, magazines and often featuring Dr. Brewer (1983, 1985, 1986); letter regarding Dr. Brewer's Oct. 1982 Radio Moscow interview by Irwina Simonova (see Photograph Collection).

Folders 195 - 200

US and USSR evaluation forms regarding hand study (1982); correspondence, draft, and final report regarding NIH contract 1-AM-02211 (1981-1984); final report "Cooperative Trial of Therapy of JRA" (1984); correspondence regarding d-pen/hydroxy drug study (1978-1980); penicillamine bottle from first drug study - label in both English and Russian (see Box 8, Folder 153 for 2 color slides of a shipment received).

Box 11 - PRCSG - USA/USSR

Folders 201 - 206

D-pen/hydroxy study correspondence, reports, Dr. Brewer's handwritten notes, expenses, Soviets' 1985 U.S. visit (see Photograph Collection), TS and slide script for a presentation during the June 1985 visit, TS and article reprint by Dr. Brewer, et al., "Penicillamine and Hydroxychloroquine in the Treatment of Severe Juvenile Rheumatoid Arthritis: Results of the U.S.A.-U.S.S.R Double-Blind Placebo-Controlled Trial" (New England Journal of Medicine, Vol. 314, No. 20, May 15, 1986, pp 1269-1328).

Folders 207 - 211

Auranofin study - early meeting (April 1981); abstracts from Worldwide Auranofm Symposium in Montreal (Oct. 1981); proceedings of Montreal meeting in The Journal of Rheumatology (Supplement No. 8, Vol. 9, July-August 1982); general information in simulated leather binder inscribed "ORAL GOLD THERAPY IN RHEUMATOID ARTHRITIS: Auranofm Symposium and Workshops, August 3 and 4, 1982, San Francisco, CA, Earl J. Brewer, Jr., M.D." (See Photograph Collection); reprint of proceedings including article "Early Experiences with Auranofm in Juvenile Rheumatoid Arthritis" by Dr. Brewer, et al. (The American Journal of Medicine, Dec. 30, 1983, pp 152-156); program and TS for Dr. Brewer's presentation ."Experience with Auranofin in JRA" at the Aug. 1982 meeting.

Folders 212 - 219

Undated TS by Ed Giannini "Auranofin in the Management of JRA"; correspondence, blinded tables, 'Ridaura' Protocol (June 1983), AU-109 study with Smith Kline & French Labs; investigators' meeting in Philadelphia (Aug. 1983); 54 slides of tables, charts, graphs, and an eye exam relating to oral gold usage; Aug. 1983 revision of 'Ridaura' Protocol; Smith Kline French contract AU 109 Ridaura (1983-1987 - terminated 1990); Smith Kline French Confidential Investigational Use Circulars (June and Nov. 1983).

Box 12 - PRCSG - USA/USSR

Folders 220 - 226

Auranofin study Smith Kline French Confidential Investigational Use Circular (May 1984); 'Ridaura' study revised (1984); correspondence (1985-1986); Mar. 31, Apr. 1, 1985, meeting in Washington, D.C.; May 1987 clinical report on protocols A-24-A and A-99-P; lab data and case report form regarding adverse experiences (1987 compilation); correspondence and reprints of articles by Dr. Brewer and others (1987-1989 - see Series IX, Box 12, VHS Tape C for an undated Cable News Network 3-1/2-minute broadcast "The Golden Girl" regarding JRA patient Lacey Livingston and Auranofin).

Folders 227 - 233

MTX study protocol; 1989 Russian case report forms; correspondence and article reprints regarding MTX in severe JRA (1985-1989); correspondence, Dr. Brewer's handwritten notes, article reprints (some in Russian, a few of those with accompanying translations), newsletters, expenses regarding Auranofin/MTX study (1986-1987).

Box 13 - PRCSG - USA/USSR

Folders 234 - 237

MTX/Auranofin study correspondence, notes, newsletters (1988-1990); Nov. 29, 1988, 4-page list of "PUBLICATIONS RESULTING FROM USA/USSR COOPERATIVE STUDY"; Dec. 4-12, 1988, USSR trip correspondence, agenda, 2 booklets and a pamphlet in Russian, and a program in English for the "ALL-UNION CONFERENCE [regarding] LOCAL THERAPY OF THE RHEUMATIC DISORDERS [and] DEDICATED TO THE 60TH ANNIVERSARY OF AUSSR AND TO THE 30TH ANNIVERSARY OF THE INSTITUTE OF RHEUMATOLOGY OF THE USSR ACADEMY OF MEDICAL SCIENCES 7-9 December 1988 Moscow"; script of Dr. Brewer's presentation on MTX and pediatric rheumatology (Dec. 9, 1988). (See Series I, Box 3 for Dr. Brewer's 1991 nomination as a foreign member of AUSSR and Series X, Box 2 for Dr. Brewer's certificate as an Honorary AUSSR Member).