15th International Conference on Pharmacoepidemiology Program Schedule

August 26th-29th, 1999
Westin Copley Place
Boston, MA


Program Schedule


15:00 - 20:00 Long Range Planning Committee Meeting


08:30 - 11:00 Finance Committee Meeting
11:00 - 17:30 Board of Directors Meeting
(All members are invited to attend)
18:00 - 20:30 Board of Directors Dinner


08:30 -10:15 Committee Meetings:
Membership/Public Relations
Data Privacy
10:30 - 12:30 Committee Meetings:
Public Policy/Ethics
Data Privacy
14:00 - 17:30 Introduction to Pharmacoepidemiology Seminar Session
Moderator: Newell McElwee, PharmD, MSPH
14:05 - 15:15 Keynote - Alec Walker, MD, DRPH
15:15 - 15:30 Break
15:30 - 16:25 Workshops (Session I)
Ongoing Cohort Study with nested case-control: Inhaled steroids and cataracts
Case Control
Association of inhaled corticosteroid use with cataract extraction in elderly patients.
Economic Evaluation
International economic analysis of primary prevention of cardiovascular disease with pravastatin in WOSCOPS, west of Scotland Coronoary Prevention Study
Compliance Workshop
Persistence of use of lipid-lowering medications: a cross-national study.
16:25 - 16:35 Break
16:35 - 17:30 Workshops ( Session II)
Repeat of Session I
10:30 - 21:00 Registration
Exhibits Open


7:30 - 8:00 Poster Set Up
Exhibits Open
8:00 - 10:00 Opening Session
Chair: Samuel M Lesko

Presidential Address: Keith Beard
We're all in this together!
Keynote Address: Dr. Stephen Spielberg
Pharmacogenetics/pharmacogenomics: Implications For Pharmacoepidemiology and 21st Century Drug Development
ACPE# 748-999-99-015-L04 (0.1 CEU)
10:00 - 10:30 Break / Exhibits
10:30 - 12:00 Symposium : Genomics and Drug Safety
Chairs: Keith Beard and Stephen Spielberg
ACPE# 748-999-99-016-L04 (0.15 CEU)
Aravinda Chakravarti, PhD
James H Jewell Professor of Genetics Professor of Medicine, Case Western Reserve University
John Keller, MD, PhD
VP and Director, Alliance & Technology Group SmithKline & Beecham PLC
Penny Manasco, MD
VP Clinical Genetics, Glaxo-Wellcome Inc.
Ray Woosley, MD, PhD
Professor and Chair, Clinical Pharmacology, Georgetown University
10:30 - 12:00 Pharmacovigilance/Regulatory Affairs
15 Minute Oral Abstract Presentations
Moderator: David Goldsmith

The impact of the 1995 "Pill Scare" in the United Kingdom [280]
R. Farmer (UK)
Impact of the Quebec cost sharing drug plan on Asthmatic patients receiving social assistance [67]
L. Blais, A.M. Castilloux, J. Couture, J. LeLorier, (Canada)
Reasons and timing for withdrawal of drugs and medical devices from the worldwide pharmaceutical markets [72]
M. Fung, A. Thornton, K. Mybeck, K. Hornbuckle, E. Muniz (USA)
Risk-benefit monitoring for a poorly effective drug: Tacrine as a case study [24]
M. Patel, R. Levin, R. Bohn, J. Avorn (USA)
Assessing the risk of cardiac death with sertindole I: data from clinical trials; comparison with risperidone and olanzapine [165]
N. Moore, R. Lagnaoui, B. Bégaud (France)
Infant immunization with acellular pertussis vaccines in the US: assessment of the first two years' data from the Vaccine Adverse Event Reporting System (VAERS) [267]
M. Braun, G. Mootrey, M. Salive, R. Chen, S. Ellenberg (USA)
12:00 - 14:00 LUNCH - POSTER SESSION A
Moderators: Bert Leufkens, Brian Strom, Ulf Bergman, Bram Hartzema
14:00 - 16:00 Symposium : Antibiotic Resistance
Chair: Peter Davey
ACPE# 748-999-99-017-L04 (0.2 CEU)
Stuart B. Levy, MD
Director, Center for Adaptation Genetics and Drug Resistance, Tufts University School of Medicine
Flemming Bager, DVM
Senior Reseach Epidemiologist, Danish Zoonosis Centre
Peter Davey, MD, MRCP(UK), FRCP(E)
Professor of Pharmacoeconomics, University of Dundee, Head of Pharmacoeconomics, MEMD
14:00 - 16:00 Symposium : Safety Surveillance for Biological Production Lots
Chairs: Edward A.Bortnichak, Robert P. Wise Moderator: Hugh Tilson
A presentation of academic, industrial, and governmental views on past incidents and present procedures to minimize the probability that a problem might occur and to assure the earliest possible detection of potentially important lot-specific patterns.
Moderator: Hugh Tilson

Vaccine Safety: Historical Lessons
Neal A. Halsey, MD Dept. of International Health, Johns Hopkins School of Hygiene and Public Health
Manufacturer Monitoring of Spontaneous Safety Reports for Biologic Products
Michael Blum, MD Wyeth Labs
Lot-Specific Safety Surveillance of Biological Products
Marcel E. Salive, MD , MPH Center for Biologics Evaluation and Research, FDA
Vaccine Lot Safety, the CDC Perspective
Robert T. Chen, MD, MA Vaccine Safety and Development Activity, CDC
Bar-Code Labeled Vaccines in a Childhood Immunisation Program
Harald Heijbel, MD, MPH Swedish Institute for Infectious Disease Control
14:00 - 16:00 Methodology/Biostatistics
15 Minute Oral Abstract Presentations
Moderator: Thomas MacDonald
Adjusting for cohort effects in case-control studies: the problem of "survivors" of past exposures [176]
M Lewis, K MacRae, D Kühl-Habich, L Heinemann (Germany), W Spitzer (Canada)
Improving precision for case-control studies with time-dependent exposures [194]
S Suissa, M Edwardes (Canada), C Martinez, S Rietbrock (USA)
The case-crossover design with database studies: an efficient rate ratio estimator based on prescription times [193] " Stanley Edlavitch Award "
B Cai, S Suissa (Canada)
Estimation of the hazard function and cumulative incidence in diseases with insidious onset [264]
S Rietbrock (Germany), C Martinez, BE Wiholm (USA)
A comparison of two designs for verifying disease outcome status in large cohorts with rare exposures and low disease rates [92]
W Bilker, J Berlin, M Gail, B Strom (USA)
Artificial neural networks in pharmacoepidemiology:a case study on targeting patients for influenza vaccination [181]
B Suijkerbuijk, M Weeber, CS de Vries, LTW de Jong-van den Berg (The Netherlands)
Verification of the diagnosis of venous thrombo-embolism in a database study using the GPRD [145]
R Lawrenson, JC Todd, TJ Williams, RDT Farmer (UK)
A new approach to the use of automated data for vaccine safety surveillance [111]
RL Davis, D Rubanowice, RS Thompson, F DeStefano, R Chen (USA)
16:00 - 17:30 Council Meetings
Industry Council
Government Council
Academic Council
17:00 - 18:00 New Members/Scholarship Recipient Reception
17:00 - 18:00 Duck Boat Tours
See Boston from the land and by sea. A limited number of tours of Boston are available to attendees. Please sign up on the registration form or notify the registration office that you wish to attend. Tickets are available on a "first come first served" basis. Duck Boats leave from the Boylston Street exit of the Prudential Towers. You must be there 15 minutes prior to the time on your ticket. Tours have 2 departure times - 5 PM and 6 PM.


7:00 - 8:30 Exhibits Open
Scientific Program Committee Breakfast
Poster Set-Up
8:30 - 10:00 Cardiovascular
15 Minute Oral Abstract Presentations
Moderator: Michael Lewis
Beneficial effect of hormone replacement therapy on the incidence of acute myocardial infarction: a population-based case-control study. [54]
C Varas-Lorenzo, LA Garcia-Rodriguez, S Perez-Gutthann, A Duque-Oliart (Spain)
Are users of oral contraceptives with a Factor-V-Leiden mutation at extreme risk of venous thromboembolism? [192]
M Spannagl, E Garbe, LAJ Heinemann, W Schramm (Germany)
Excess stroke among hypertensive men and women attributable to undertreatment of hypertension [251]
OH Klungel, BHCh Stricker, AHP Paes, JC Seidell, A Bakker, V Zoltán, MM Breteler, A de Boer (The Netherlands)
Risk of serious hypoglycaemia and use of antihypertensive drugs in a cohort of diabetic patients treated with insulin [257]
K Mantey, A Bauerfeind, E Garbe (Germany), S Suissa (Canada)
Using a clinical database to evaluate the effectiveness of platelet releasate for the treatment of neuropathic diabetic foot ulcer [21]
DJ Margolis, J Santanna, BL Strom, JA Berlin (USA) Hmg-Coa
Reductase Inhibitors and the risk of Cancer [69]
L Blais, A Desgagné, J LeLorier (Canada)
8:30 - 10:00 Workshops: Decision Analysis in Relation To Antibiotic Resistance
Moderator: Peter Davey
8:30 - 10:00 Workshop T : Evaluating Effects of Drug
Insurance Policy Changes
Chair: Malcolm Maclure

The panelists in this workshop will present their experiences behind-the-scene with scientific evaluation of politicized policies, including:
1) Is "New Hampshire" still happening elsewhere?
2) What are the methodologic problems with doing the evaluation from the policy maker's versus the clinician's perspective?
3) What controls or instrumental variables can be used? What biases do they have?
4) How do you launch a randomized policy trial?
8:30 - 10:00 Symposium: Protection of Personal Health Information - Issues and Approaches
Chair: Don Willison
ACPE# 748-999-99-018-L04 (0.15 CEU)

Throughout the world, information systems are being developed to improve the ability to manage an increasingly complex health care system. These will aid evidence-based decision making immensely at the policy level and for health services research, providing comprehensive data on utilization outcomes, with the capability of risk adjustment of outcomes. This raises important concerns regarding who may have access to one's personal health information and under what circumstances.

This year at ICPE we will look at recent developments internationally and "best practices" with regard to protection of personal health information in the context of pharmacoepidemiologic studies. The format will be a panel session followed by a workshop and forum on political developments.
Introduction: Don Willison
Recent Legislative and Polisy Developments
John Fanning - USA
Current bills/ DHHS initiative, safe harbour discussion
Deborah Shatin - USA
Changes to Legislation in Minnesota
Annekaren Bertelsman - Europe
State of implementation of European Directive, British High Court ruling of use of anonymized information for commercial purposes, US - EU negotiations

Michael Wolfson - Canada
Tri-Council policy statement, Bill C54, Statistics Canada
10:00 - 10:30 Break
10:30 - 12:00 Workshops: Exploring the Frontier
Examples of methods, projects and systems which maximize protection of personal health information while ensuring access for research in the interest of public health
Don Willison - Introduction
Philip Steel - Overview of procedural and statistical approaches
Filip De Meyer - IMS RAMIT -"trusted third party" System
Alice White - Pregnancy registry, GlaxoWellcome
Arnold Gordon - Initiatives among pharmaceutical manufacturers
Alan Zaslavsky - a continuing education approach
Elizabeth Andrews - Reflections on "Where to from here?"
10:30 - 12:00 Invited Lecture: Donald Rubin, PhD
"Propensity scores, instrumental variables, and related methods for estimating causal effects in pharmacoepidemiologic analyses"
ACPE# 748-999-99-019-L04 (0.15 CEU)
10:30 - 12:00 Prescribing Practices
15 Minute Oral Abstract Presentations
Moderator: Corinne De Vries
Continuing medical education, individual academic detailing versus peer review group approach: Can it alter antidepressant prescribing? [252]
MEC van Eijk, AJ Porsius, A de Boer (The Netherlands), J Avorn (USA)
Preferential prescribing of type of combined oral contraceptive pill by general practitioners to teenagers with acne [93]
S Rowlands, H Devalia, R Lawrenson (UK)
General practitioners' adherence to the Dutch National Guideline: "Prophylactic Aspirin in patients with ischemic heart disease".[180]
R Fijn, AGG Stuurman-Bieze, PB Van den Berg, M Veenstra, LTW De Jong-Van den Berg (The Netherlands)
Duration of antidepressant therapy and the risk of depression relapse [239]
MCJM Sturkenboom, I Martha, K Lee, P van der Linden, J van der Lei, R Quik (The Netherlands)
Organizational factors related to the management of pain in Cancer patients living in long term care [103]
K Lapane, G Papandanotas, V Mor (USA)
Bringing Pharmacoepidemiology and Pharmacoeconomics to the bedside: Experience from a teaching hospital program [30]
J Avorn, D Solomon, M Patel, E Knight (USA)
Moderators: Anick Bérard , Judith Jones, R. Herings, Bengt-Eric Wiholm
Cochrane Methods Working Group Meeting
Stanley A. Edlavitch Award Presentation
15:00 - 15:30 Break
15:30 - 17:30 Peer Reviewed Papers
Chair: Richard Farmer
ACPE# 748-999-99-020-L04 (0.2 CEU)

Inhaled Corticosteroids and the risk of Diabetes among the elderly [68]
N Dendukuri, L Blais, J LeLorier (Canada)
A pharmacoeconomic analysis of administering preventative Tamoxifen to women at high risk of breast cancer in Canada [283]
D Logan, BP Will, JM Berthelot, W Flanagan, E Tomiak, M Fung Kee Fung, WK Evans, MC Wolfson (Canada)
15:30 - 17:30 Symposium : New Methods to enhance drug safety surveillance
Chair: Marcel Salive, MD, MPH
New methods for signal detection
Ana Szarfman, MD, PhD
Application of new methods to drug safety surveillance
Evelyn Rodriguez, MD, MPH Ralph Lillie, RPh
Application of new methods to biologics
Marcel Salive, MD, MPH Discussant - Hugh Tilson, MD, DrPH
18:00 - 20:00 Top of the Prudential Towers
Take the skywalk from the hotel to the top of the Prudential Towers. Join your colleagues for food, conversation and some entertainment.



7:00 - 8:30 Exhibits
New Board of Directors' Breakfast
Poster Set Up
8:30 - 10:00 Drug Utilization
15 Minute Oral Abstract Presentations
Moderator: Kris Bingefors
Predictors of adherence to lipid-lowering therapy [234]
CS de Vries (The Netherlands), PT Donnan, N Waugh, T MacDonald (UK)
Trends in antihypertensive medication prescribing in the United States: How much do clinical trials matter? [25]
E Knight, R Glynn, R Levin, J Avorn (USA)
Three years after the campaign folic acid use further increased in the northern Netherlands [179]
LTW de Jong-Van den Berg, HEK De Walle, MC Cornel (The Netherlands)
Computing costs and utilization with proportional rates vs. popluation-based prevalence. Does it matter? [76]
J Zito, C Mullins, D Safer, S dosReis, J Gardner (USA)
Antipsychotic drug use and hospitalisation in patients with schizophrenia [233]
CS de Vries, DIR Boyle, TM MacDonald (UK)
Clinical use patterns of the oral anti-hyperglycaemic agent Acarbose [64]
V Catalan, J Couture, J LeLorier (Canada)
8:30 - 10:00 Pharmacoeconomics/ Outcomes Research
15 Minute Oral Abstract Presentations
Moderator: Bryan Luce
Cost-effectiveness of the combination of misoprostol with diclofenac in the Tayside population [100]
SV Morant, PG Davey, TM MacDonald (UK)
Immune tolerance induction in hemophilia A patients with inhibitors: costly can be cheaper [27]
A Colowick, R Bohn, B Ewenstein, J Avorn (USA)
Coronary Artery Stenting and its effect on revascularization and cardiac outcomes in broad based clinical practice [37]
S Kimmel, R Localio, C Brensinger, C Miles, S Sherpa, J Hirshfeld, B Strom (USA)
Costs and effects of combining stenting with ReoPro®: results from the EPISTENT study [254]
JEF van Rijkom, BA van Hout (The Netherlands) AM Lincoff (USA)
Cost of gastro-protective agents attributable to nonsteroidal antiinflammatory drugs [63]
E Rahme, L Joseph, J LeLorier (Canada) S Kong, D Watson (USA)
Economic study of cephalosporins in the treatment of moderate lower respiratory tract infection [207]
HE Zhigao, J Chen (China)
8:30 - 10:00 Workshop W : Large Scale Clinical Trials
Moderator: Nicholas Moore
This workshop will address the safety and tolerance concerns involved with either frequent adverse reactions (tolerance) or on the opposite rare serious events (safety). Is extrapolated data sufficient? Are direct comparisons necessary and if so what methodology should be used and who should foot the bill?
10:00 - 10:30 Break - Sponsored by Boots Healthcare
10:30 - 12:00 Symposium : Clinical Practice Guidelines in relation to pharmacoepidemiologic research
Moderator: Hugh Tilson
ACPE# 748-999-99-021-L04 (0.15 CEU)

Debate format including the following:
Jerry Avorn, MD
Brigham & Womens Hospital Harvard University Medical School
Nancy Mattison, PhD
The Mattison Group
Kathy Lohr, PhD
University of North Carolina School of Public Health
10:30 - 12:00 Cohort and Case-Control Studies of Drug Safety
15 Minute Oral Abstract Presentations
Moderator: Susanne Perez-Gutthann
Neural tube defects in relation to pregnancy use of folic acid antagonists [6]
S Hernández-Díaz, MM Werler, AA Mitchell (USA)
Ovulation-inducing drugs: a cohort study of side effects in the newborn [232]
CS de Vries (UK), WM Meijer (The Netherlands), C Olesen, H Toft Sørensen (Denmark), LTW de Jong-van den Berg (The Netherlands)
Infant vaccinations and risk of asthma in childhood [59]
F DeStefano, D Gu, P Kramarz (USA)
The risk of acute pancreatitis associated with acid-suppressing drugs [168]
IA Eland, BHCh. Stricker (The Netherlands), C Huerto, LA Garcia Rodriguez (Spain)
Teratogenicity of neuroleptics: cohort studies in two population-based databases [230]
CS deVries, T MacDonald (UK), AVC Vleer, LTW de Jong-van den Berg (The Netherlands), H Toft Sørensen (Denmark)
Non steroidal anti-inflammatory drugs and systolic cardiac function [154]
J Feenstra, A Mosterd, DE Grobbee, BHCh Stricker (The Netherlands)
10:30 - 12:00 Workshop X: Calcium Channel Blockers and the risk of cancer.
Moderator: Jacques LeLorier

In 1996 a paper published in the American Journal of Hypertension claimed that "CCB therapy may increase the risk of cancer." This contention gave rise to much debate, and to untold anxiety and confusion among patients using CCBs. The study was shown to be severely flawed, but doubts concerning the potential carcinogenicity of CCBs have not yet been dissipated completely.

Discussion of the following areas:
1. Why do such errors occur?
2. What repercussions do they have?
3. How can they be prevented?
4. Which principles should guide responsible evaluation and dissemination of knowledge?
5. How can these be implemented?
Moderators: Sean Hennessy, LTW De Jong Van den Berg, Yola Morida, Alec Walker
14:00 - 16:00 Symposium: Data Quality for drug risk assessment
Moderator: R. Nelson
ACPE# 748-999-99-022-L04 (0.2 CEU)

The pharmaceutical industry focuses its postmarketing safety resources primarily on spontaneous reporting systems. This is partly due to the emphasis by national regulatory authorities on such systems and their data. While there is definite value in spontaneous reporting schemes as early warning systems, they by themselves cannot confirm, validate, and quantify risks.

Without the ability to measure adverse reaction risks that are common as well as those that are rare, events considered clinically serious and those not thought to be serious, true benefit-to-risk determinations cannot be made at either the public health or individual patient care levels. The recent Council for International Organizations of Medical Sciences report, or CIOMS IV , expertly highlights these issues facing regulatory authorities.

Drug product labeling is the legal basis for most product advertising and information communicated to the health practitioner. However, prescription drug labeling is of increasingly diminished value once a drug is in clinical use, since safety data are no longer systematically collected. Risks associated with drug use in clinical practice are largely undetermined, so the professionals who prescribe pharmacotherapy may have no firm basis on which to make safety decisions.

Introduction of the Problem ISPE Ad Hoc Committee Progress
R.C. Nelson, PhD, RCN Associates
Data quality situation in Europe Use of dedicated drug safety data
Saad Shakir, MD, FRCP Director, Drug Safety Research Unit Southampton, UK
Management of Drug Risks at FDA Special report to the Commissioner
Ralph Lillie, MPH FDA
Data on using drugs safely Information needed by clinicians
Brian Strom, MD, MPH University of Pennsylvania
Unsafe at any speed? Lesson learned from the auto industry
Dave Pederson Booz-Allen Hamilton
Systems approach and megatrends Wrap-up and continued challenges
Robert C. Nelson, PhD RCN Associates
16:00 - 16:30 Closing Remarks
Keith Beard, Elizabeth Andrews
Abstract and Young Investigator Awards