1994-1995 School Year
Alexander M. Walker, M.D., Dr.P.H.
Professor of
Epidemiology and Director of the Program
September 1995
Contents
We are using our funds to train top flight practitioners who have expertise in
the special problems posed by drugs, vaccines, and medical devices, and who are
as comfortable working in industry and regulatory agencies as they are in
academia.
Doctoral students this year pursued substantive and methodological research on
drug effects on the epidemiology of diseases that are new candidates for drug
therapy. These are the current doctoral candidates:
- Peter Choo, M.D., is an internist who has been investigating the
epidemiology and complications of varicella infections at the Harvard Community
Health Plan. His work has taken on special importance with the advent of
varicella vaccines and antiviral therapies that are effective in varicella. His
findings enter directly into the global cost and benefit analysis. His studies
of herpes zoster are focusing on the incidence of the condition, predisposing
factors, and the occurrence of post herpetic neuralgia.
- Mei-Sheng Duh, M.P.H., arrived at Harvard with a pharmacy degree
from the National Taiwan University, and high recommendations from Yale, where
she had taken her M.P.H. She is combining an aptitude for data analysis with
her substantive background in using innovative techniques for analysis of HMO
administrative data. Her current work involves the application of neural
networks, which are advanced pattern recognition programs, for efficient
identification of disease states.
- Philip Wang, M.D., came to the program after finishing up as Chief
Resident in Psychiatry at Beth Israel Hospital in Boston. In conjunction with
Jerry Avorn at Harvard Medical School, he has undertaken to link New Jersey
Medicare and Medicaid data with the New Jersey state cancer registry. He will
use the resulting exposure and outcome information to test the hypotheses, based
on animal experiments, that fluoxetine and amytriptylline are cancer promoting
agents in humans.
- Rhonda Bohn, M.P.H., moved from industry into research with Jerry
Avorn's group, and is pursuing her doctorate on a part time basis. For her
thesis, she is developing a program for evaluating compliance with and safety of
glaucoma medication regimens.
Beginning last year, we decided to add an emphasis on the training of Master's
degree candidates to the program. One student was admitted last year, and two
are entering this fall. Last year Master's degree recipient, Vera Mastey
is a Canadian with a PharmD who wanted to branch into outcomes research. She
has gone on to join Pfizer, where she is working in international outcomes
research. This year's students are Miriam Sturkenboom, a Dutch
researcher who has been studying population determinants of acitretin
metabolism, pregnancy outcomes in acitretin users, and other effects associated
with drug. She has come for a year of in depth formal training. Chris
Kahler is an American hospital pharmacist who is here because he wants to
enter industry with a pharmacoepidemiologic background. Christoph Maier
is a Swiss clinical pharmacologist who has specialized in drug information
systems for physicians will pursue a part-time course while working with Hershel
Jick at the Boston Collaborative Drug Surveillance Program.
A number of students who are not formally part of the pharmacoepidemiology
program have taken advantage of the training we offer to prepare themselves for
pharmaceutical careers. Paul Coplan, graduated in June from the
psychiatric epidemiology program and went on to join Harry Guess's epidemiology
and safety group at Merck. Current doctoral students Loren Lipworth and
Edmond Shenassa are working closely with a manufacturer in the analysis
of observational data in support of licensing applications for a vaccine. As
such they have the opportunity to work closely with industry colleagues, and to
see the workings of the FDA at close range. Christine Huttin is a
French economist who spent the year in Harvard's Takemi Program in International
Health. In collaboration with Jerry Avorn and with assistance from me she has
been improving her epidemiologic skills, and has developed an empirical test of
a cost model for hypertension, using French reimbursement data. Marshall
Joffe is a post-doctoral student who has begun to apply mathematical
techniques that tease out the cycle of disease manifestation predicting drug
use, which affects disease manifestation. He and I will be working closely
together in the 1995-1996 school year.
Harvard faculty members contributing to the research program and to the
supervision of students this past year included Richard Platt of Harvard
Community Health Plan, Jerry Avorn at Harvard Medical School, and Malcolm
Maclure, who shares his time between HSPH and the Province of British
Columbia. Hershel Jick and Susan Jick of the Boston
Collaborative Drug Surveillance Program (Boston University) offer ongoing
collaborations to a number of students.
Students and faculty associated with the program have pursued their research
activities in a wide variety of settings in the past year. These include two
staff model HMOs in Massachusetts, a general practice data base, and three
governmental units:
- Harvard Community Health Program
- Fallon Clinic
- General Practitioner Research Database (UK)
- Pharmacare (British Columbia)
- Italian regional health authorities in Friuli-Venezia-Giulia and Rome.
The pharmacoepidemiology course and the pharmacoepidemiology seminar series
provide our major activities within the larger Harvard community. The course
this year had 14 students, nearly all of them physicians or pharmacists, most
with current research interests in drug safety, drug effects or drug economics.
The seminar series, coordinated by Karin Michels, D.Sc. while she
finished her dissertation on effects of diethylstilbesterol, included speakers
from industry, the FDA, academia, and law. I have appended a list of topics and
speakers to this letter.
Outreach beyond the Harvard community has included a new venture in electronic
publishing on the World Wide Web and a major service commitment to the
International Society for Pharmacoepidemiology (ISPE). Our Web site,
the Drugs and Devices Information Line
(http://www.hsph.harvard.edu/Organizations/DDIL/ddilhpge.html) contains review
articles written by students and by me, and offers connections to other sites of
interest in drug epidemiology. I have attached a copy of the DDIL home page.
At ISPE, I have the honor of serving as President for the 1995-1996 year. The
greatest achievement of the Society has been to provide a collegial forum where
members of our profession can meet colleagues unhindered by the usual division
into academic, industry, and regulatory worlds. The recently completed annual
congress in Montréal attracted 525 registrants, and was perhaps the best
to date in terms of science and interaction. Next year's congress will be held
in Amsterdam. In the year between congresses, the Society is working on issues
vital to the field. The Public Policy and Ethics Committee is dealing with the
implications of European confidentiality guidelines for large data base
research, and members are involved in shaping national guidelines. I have
written two articles in support of this effort in the Society's journal, Pharmacoepidemiology
and Drug Safety. The Guidelines committee, consisting of members from the
FDA, Pharma, and academics within the Society (including Harvard faculty Jerry
Avorn and myself) has developed standards for the documentation and conduct of
pharmacoepidemiologic studies. The document responds to a challenge set before
the Society by the FDA's Robert Temple at our congress in Washington two years
ago. (You can find this document and other on the DDIL home page.)
We are deeply grateful for major support this past year from Berlex,
Boehringer-Ingelheim, Ciba Geigy, Hoffman La Roche, Merck, and Pfizer.
Connaught Laboratories has recently indicated that it wishes to join the group
of sponsors, and I am in discussion with several other companies.
Representatives from sponsoring companies commonly visit the School to attend or
offer seminars, and to meet with students. I am always available to sponsors to
offer advice and help where I can, and to help them arrange for longer term
consulting and research projects.
- Compliance with Medications
- Mark Monane, MD
- Harvard Medical School
- Can a Human Teratogen be Used With Relative Safety? The Case of
Accutane
- Allen Mitchell, MD
- Boston University
- A Nationwide Clinical Trial of Ibuprofen Use in Children
- Samuel Lesko, MD
- Boston University
- The Use of Adverse Drug Reaction Reports by the FDA
- Peter Barton Hutt, Esq.
- Covington & Burling
- Appropriate Use of Placebo-Controlled Studies
- Robert Temple, MD
- Food and Drug Administration
- The Evolution and Philosophy of FDA Safety Regulations: Epidemiologic
Implications
- Gerald Faich, MD, MPH
- Pharmaceutical Safety Assessment, Inc.
- Confidentiality Restrictions on the Use of Large, Linked, Data Bases
- Alec Walker
- Layered Cohort Designs for Drug Utilization Epidemiology
- Malcolm Maclure, ScD
- Harvard School of Public Health
- Desktop Manipulation of Large Health Care Databases
- Susan Andrade, DSc
- University of Rhode Island, and
- Alec Walker
- Denmark: A Sleeping Beauty for Pharmacoepidemiologists?
- David Gaist, MD
- Odense University
- The Inter-relationship of Epidemiology, Outcomes Research, Disease
Management, and Related Topics in Healthcare Research
- Bruce J.O. Wong, MD
- SmithKline Beecham
- Chan KW, Felson DT, Yood RA, Walker AM. Incidence of rheumatoid arthritis
in Central Massachusetts. Arth Rheum 1994:36:1691-1696
- Fontanet AL, Johnston BD, Walker AM, Bergqvist Y, Hellgren H, Rooney.
Falciparum malaria in eastern Thailand: a randomized trial of the efficacy of a
single dose of mefloquine. Bull WHO 1994;72:73-78
- Chan KW, Felson DT, Yood RA, Walker AM. The lag-time between onset of
symptoms and diagnosis of rheumatoid arthritis. Arth Rheum 1994;37:814-820
- Traversa G, Caracciolo B, Da Cas R, Menniti Ippolito F, Raschetti R, Walker
AM. L'uso dei farmaci antinfiammatori nonsteroidei nella popolazione di Roma.
Giornale Italiano di Farmacia Clinica 1994;8
- Gray DT, Walker AM, Fyler DC, Chalmers TC. Examination of the early "learning
curve" for transcatheter closure of patent ductus arteriosus. Circulation
1994;90[part 2]:II36 - II42
- Walker AM, Bortnichak EA, Lanza LL, Yood RL. The infrequency of liver
function testing in NSAID users. Arch Fam Med 1995;4:24-29
- Traversa G, Walker AM, Menniti Ippolito F, Caffari B, Capurso L, Dezzi A,
Koch M, Maggini M, Spila Alegiani S, Raschetti R. Gastroduodenal toxicity of
different NSAIDs: a case-control study in the Province of Rome. Epidemiology
1995;6:49-54
- Zuber PLF, Jacquier P, Hohlfeld P, Walker AM. Toxoplasma infections among
pregnant women in Switzerland: a cross-sectional evaluation of regional and
age-specific lifetime average annual incidence. Am J Epidemiol 1995;141:659-666
- Walker AM. IMBRF/ISPE conference on medical databases and privacy.
(Commentary) Pharmacoepidemiol Drug Safety 1995;4:15-16
- Andrade SE, Walker AM, Platt R, Hollenberg NK, Testa MA, Saperia GM,
Gottlieb LK. Discontinuation of antihyperlipidemic drugs: Do rates reported in
clinical trials predict rates in primary care settings? N Engl J Med
1995;332:1125-1131
- Walker AM. Low power and striking results -- A surprise but not a paradox.
(editorial) N Engl J Med 1995;332:1091-1092
- Avorn J, Bohn RL, Mogun H, Gurwitz GH, Monane M, Everitt D, Walker AM.
Neuroleptic drug exposure and treatment of parkinsonism in the elderly. Am J Med
1995;99:48-54
- Lanza LL, Walker AM, Bortnichak EA, Gause GO, Dreyer NA. Incidence of
symptomatic liver function abnormalities in a cohort of NSAID users.
Pharmacoepidemiol Drug Safety 1995;4:231-238
- Lanza LL, Dreyer NA, Schultz NJ, Walker AM. Use of insurance claims in
epidemiologic research: Identification of peptic ulcers, GI bleeding,
pancreatitis, hepatitis and renal disease. Pharmacoepidemiol Drug Safety.
1995;4:239-248
- Oliveria SA, Felson DT, Reed JI, Cirillo PA, Walker AM. The incidence of
symptomatic hand, hip and knee osteoarthritis in a health maintenance
organization. Arthritis Rheum 1995;38:1134-1141
- Lanza LL, Walker AM, Bortnichak E, Dreyer NA. Peptic ulcer and
gastrointestinal hemorrhage associated with NSAID use in patients under 65 years
of age. Arch Int Med 1995;(in press)
- Hayashi K, Walker AM. Japanese and American reports of randomized trials:
Differences in the reporting of adverse effects. Contr Clin Trials 1995; (in
press)
- Walker AM. Generic data. Pharmacoepidemiol Drug Safety. 1995;(in press)
- Andrade SE, Saperia GM, Gottlieb LK, Walker AM, Platt R. Effects of gender
and age on the discontinuation rate of antihyperlipidemic drug therapy.
(submitted)
- Andrade SE, Platt R, Gottlieb LK, Saperia GM, Walker AM. Discontinuation
of drug therapy: Assessment by means of automated data bases. (submitted)
- Oliveria SA, Felson DT, Klein RA, Reed JI, Walker AM. Estrogen replacement
therapy and the development of osteoarthritis. (submitted)
This document has been provided through the Drugs and Devices
Information Line, http://www.hsph.harvard.edu/Organizations/DDIL/ddil.html
If you have questions or comments about the DDIL, please write to: ddil@episun1.harvard.edu