Scribe - International Society for Pharmacoepidemiology

Transcription

1st Quarter 2006
Volume 9
Number 1
INTERNATIONAL SOCIETY FOR
PHARMACOEPIDEMIOLOGY
THE INTERNATIONAL SOCIETY
Highlights
Scribbles
page 2
APHA Award
page 3
UNC CERT
page 4
New England Regional
ISPE Meeting
page 5
Obituaries
page 6
ICPE 2006
page 8
Personnel Changes
page 9
Meetings of interest
page 10
Scribeline
page 11
Book Review
page 13
Pharmacoepi
Career Center
page 15
Courses
page 16
ISPE Meetings
page 18
FOR
President’s Column
By Sean Hennessy, PharmD, PhD, FISPE
Register the Research; Post the Protocol; Distribute
the Data: An Ethical Imperative for Human
Subjects Research
The public needs to be able to place
greater confidence in biomedical research.
For example, the Journal of the American Medical Association recently began
requiring independent analysis of industryconducted studies. (ISPE’s response to this
policy is posted on ISPE’s website.) Further,
as recent discoveries of research misconduct
at Seoul National University (and past
episodes at other academic institutions)
show, the for-profit sector does not hold a
monopoly on reasons for public mistrust.
In this column, I argue that the biomedical research industry (including sponsors,
investigators, journals, and research ethics
boards) should refine its standards of practice to increase the transparency and hence
the credibility of biomedical research. The
proposed changes are only modestly incremental to current standards, and are easily
justified based on obligations to human subjects, and on grounds of advancing science
and improving population health.
Register the Research
DEADLINE FOR
Second Quarter 2006 ISSUE:
Apri 28, 2006
Since 2004, journal editors who are
members of the International Committee
of Medical Journal Editors have required
registration of clinical trials as a pre-condition of publication. This requirement
was enacted to reduce selective reporting
of results. Given the important role that
observational studies play in assessing the
effects of therapeutic interventions, biomedical journals should extend this mandate
to observational studies as well.
Post the Protocol
The World Medical Association’s
Declaration of Helsinki states in plain
English that the “design of all studies should
be publicly available.” Standard definitions
of human subjects research encompass all
non-experimental studies that use identifiable private information, and thereby most
pharmacoepidemiologic research. Given the
Declaration of Helsinki’s mandate, and the
protection from bias that can be conferred
by comparing the research report with the
study protocol, research ethics boards, journals, and sponsors should require investigators to publicly post their protocols, at least
after the study is over. As a beneficial side
effect, posting research protocols should also
promote better science by providing investigators with additional incentive to produce
thoughtful and well-documented proposals,
and by facilitating more timely dissemination of advances in research methods.
continued on page 12
Welcome to ISPE
Double Click
for list of new members
The International Society for Pharmacoepidemiology
Scribe •
Scribbles
“What Stimulates Regulatory Action?”
By Syed Rizwanuddin Ahmad
Dear All,
When a new drug is approved
for marketing by drug regulatory
agencies not much is known about
the safety of the product other than
what is submitted in the clinical
trial dossier in support of the drug.
The full safety profile of a drug may
be evident only after several years of
marketing of the drug.
Data from spontaneous reports,
postmarketing clinical trials and/or
pharmacoepidemiology studies
Editor
Syed Rizwanuddin Ahmad, MD MPH
“Participating on his personal time and
the views expressed do not necessarily
represent the views of the FDA or the
U.S. government.”
Medical Epidemiologist
Center for Drug Evaluation & Research
US Food & Drug Administration
[email protected]
Managing Editor
Mark H. Epstein, ScD
ISPE International Office
5272 River Road, Suite 630
Bethesda, MD 20816 USA
[email protected]
Website: www.pharmacoepi.org
All statements of opinion and supported fact are
published on the authority of the writer under whose
name they might appear and are not to be regarded
as the views of ISPE, unless such statements have
been adopted by the Society
add to the evidence on the safety or
efficacy of a drug. Different regulatory
agencies may take different actions
based on same or similar body
of evidence. It must be realized
that regulatory actions cannot be
simply right or wrong and cannot
be based just on the balance of risk
and benefit but have to take social
realities into consideration including
availability of suitable alternatives.
Regulatory decisions can change over
time as more data is accumulated.
Regulations in some countries
allow drug regulatory agencies to
take temporary action to suspend
a product from the market until
more convincing data is available.
Evidence-based scientific data should
always be the basis of any labeling
changes and in the presence of
insufficient data additional studies
should be done.
Spontaneous reporting systems
are the most common method used
in pharmacovigilance to generate
signals on new or rare adverse events.
However, because of the limitations
of underreporting and incomplete
information, the value of data
obtained via spontaneous reporting
systems is always questioned. In
scientific circles there is always
a debate about the value of data
obtained from spontaneous adverse
event reporting systems. Questions
pertaining to factors which stimulate
regulatory action are many: How
many reports make a signal and when
should action be taken? What is the
threshold for regulatory action?
What are the reasons for differing
regulatory decisions by different drug
regulatory agencies? Do differing
actions by different regulators have a
measurable or potentially measurable
difference in protecting public
health? What role does pressure
from the Congress/Parliament,
media, litigation, consumer advocacy
or patient support groups play in
stimulating regulatory action? What
are the problems and obstacles
in coordinating and harmonizing
decisions made by drug regulatory
agencies? It would be interesting
to discuss this topic in appropriate
scientific forum.
This issue of Scribe carries the
obituaries of two great figures in the
field of pharmacoepidemiology and
drug safety - Bill Inman and Harry
Guess who died recently. May God
give strength and courage to their
family and well wishers and keep us
focused in what we do since death
is a reminder for all of us and is
inevitable.
With peace,
Rizwan*
[email protected]
*Participating on his personal time and
the views expressed do not necessarily
represent the views of the FDA or the
U.S. government.
2
Scribe •
2005 APHA Award For Excellence Winner
David J. Graham, MD, MPH,
received the 2005 APHA (American
Public Health Association) Award
for Excellence for his scientific work
aimed at improving community
health through greater medication
safety.
David J. Graham
MD, MPH
Currently the associate director
for science and medicine at the U.S.
Food and Drug Administration’s
Office of Drug Safety, Dr. Graham’s
20-year career in drug safety has
contributed to the withdrawal of 10
marketed drugs. He has also shown
that most FDA risk management
programs have had little or no effect
in improving the safety profile of
problem drugs.
Within FDA, Dr. Graham is
the only medical officer ever to be
promoted to the rank of master
medical reviewer. In August 2004,
Dr. Graham completed a study
linking myocardial infarction risk
with the drug refecoxib, marketed
under the brand name Vioxx. He
estimated that 88,000 to 141,000
Americans had experienced
myocardial infarction because of
rofecoxib use, and 61,000 of them
had died. He testified before the
Senate Finance Committee in
November 2004 and described
structural, cultural and scientific
biases within FDA that he said
leads to the approval and continued
marketing of unsafe medicines.
is standing between the American
public and the use of marketed
medications with potentially serious
risks that, in many instances, are not
warranted or are seriously delayed in
public awareness of such risks,” wrote
APHA and ISPE member Julie M.
Zito, PhD, in a letter nominating
Dr. Graham for the Award for
Excellence. “His work demonstrates
an ability to identify questions of
great consequence, to help engage the
resources to design and conduct the
studies to assess the question and to
be fearless in bringing interpretation
to the policy level.”
Dr. Graham’s many awards and
honors include the Cliff Robertson
Sentinel Award from the Association
for Certified Fraud Examiners, the
FDA Outstanding Service Award
for identification, evaluation and
acquisition of new data resources,
and the FDA Commendable Service
Award for market withdrawal of
troglitazone.
“In many ways, it is not an
exaggeration to say that David
Graham’s leadership and courage
3
Scribe •
The University of North Carolina at Chapel Hill Center for
Education and Research on Therapeutics (CERTs)
By Sue Tolleson-Rinehart PhD and Alan D. Stiles MD
The mission of the UNC CERTs
is to improve the use of drugs, devices,
and biologics used to treat the pediatric population. Children are not small
adults, and pediatric therapeutic use
is not merely a variation on the adult
case. One of the biggest differences
in the worlds of pediatric and adult
therapeutics research is the sheer difference in volume of research. For both
ethical and economic reasons, comparatively few drugs and devices have
been studied in pediatric populations.
One of the clinical consequences of the
relative paucity of pediatric therapeutics research is that 50 to 75% of
pharmaceutical use in this population is
off-label use.
atric therapeutics use by evaluating
the implementation of a new error
reporting system at UNC Hospitals,
before and after adoption of a computerized order entry system. The CERTs,
working with our partner, the US
Pharmacopeia, has explored the types
and severity of pediatric adverse events
reported to MedMARx, a national voluntary reporting system, and determining whether standard ICD9-CM and
codes for external causes of injuries,
poisonings and adverse effects of drugs
(the “E codes”) recorded in emergency
department administrative databases
are sufficiently accurate and detailed
to become reliable sentinels of adverse
drug events.
Recent legislation, such as the Best
Pharmaceuticals for Children Act and
the Pediatric Research Equity Act, has
stimulated new clinical trials of drugs
in children, and the use of devices in
children is also receiving new attention. The reality, however, is that it
will take decades for pediatric therapeutics research to accumulate the kind
of knowledge base available to pharmacoepidemiologists studying adult
therapeutic uses. Whether the subject
matter is safety, quality, or effectiveness
of pediatric therapeutic use, we have
much work to do. The UNC CERTs
has been meeting that challenge for
the last six years by assembling a broad
team of public and private partners to
pursue a varied portfolio of projects addressing the entire spectrum of pediatric therapeutics.
Quality. The UNC CERTs is
Safety. The UNC CERTs has ap-
Effectiveness. The UNC CERTs
proached questions of safety in pedi-
contributing to better pediatric quality
of care with projects that emphasize pediatric patient reported outcomes and
providers’ need for tools to help them
do their jobs better. For example, we
worked with our partners, the American Academy of Pediatrics and others,
to develop a new ADHD Toolkit to
help providers understand ADHD from
the standpoint of patients and parents.
We are using surveillance of and education to prevent community-acquired
antibiotic resistance, a systematic
review of the quality of instruments
used to measure young children’s
pain, and projects to improve asthma
management. A new CERTs project is
identifying the most likely sources of
improvement in the quality of care for
cystic fibrosis patients at the end of life.
has conducted a randomized, con-
trolled trial of the effectiveness of
subcutaneous continuous glucose
monitoring systems aimed at preventing hypoglycemic incidents in children with Type I diabetes. The UNC
CERTs, with its partner, the Cincinnati
Children’s Hospital Medical Center,
has conducted an evaluation of the appropriate use of therapeutic drug monitoring for patients on aminoglycosides.
A new CERTs project is identifying
the most effective strategies for improving the transitions of adolescents with
serious chronic illness to adulthood and
adult health care, including strategies to
help young adults manage their complicated medication regimens.
Public policy. The UNC CERTs
played a major role in identifying an
alarming return of cases of vitamin Ddeficient Rickets and, working with the
American Academy of Pediatrics, has
contributed to new guidelines recommending vitamin D supplementation
for breastfed infants. The CERTs is
continuing to evaluate the most effective strategies for assuring that pediatricians and family practitioners prevent
Rickets by encouraging supplementation. The CERTs has cooperated with
the Institute of Medicine, the National
Institute of Child Health and Human
Development, and others, to strengthen
policies to improve pediatric therapeutic use across the board.
With so much in the world of
pediatric therapeutics left to learn,
the UNC CERTs looks forward to a
continuing menu of projects to improve
the use of drugs, biologics, and devices
to treat children.
4
Scribe •
Our Experience with a Regional ISPE
Meeting: A Success!
By Rhonda L. Bohn, Jerry Avorn, and Joanna Haas
The first New England
Regional ISPE Meeting was
held on November 9th, 2005 at
Genzyme Center in Cambridge,
Massachusetts. The event was
co-sponsored by Genzyme
Corporation and the Division
of Pharmacoepidemiology and
Pharmacoeconomics, Brigham
and Women’s Hospital, Harvard
Medical School. One hundred and
seven invitations were sent out for
the event and included members
from all New England States. Of the
46 members that responded to the
invitation and stated that they were
planning to attend the meeting, 38
members (or potential members)
attended the event. Members from
as far as Connecticut came to the
meeting in Cambridge despite the
weather, which was rainy and quite
windy.
The evening began with
hors d’oeuvres and a light dinner
as members mingled with old
colleagues and met new ones.
Jerry Avorn and Joanna Haas then
presented their perspectives on
the role of pharmacoepidemiology
in academia (Jerry) and in the
biotechnology industry (Joanna). A
question and answer period followed
as well as dessert, coffee, and further
mingling with colleagues.
As a follow-up to the Regional
Meeting, an e-mail was sent out to
all New England Regional members
requesting input on the meeting for
those that attended as well as asking
those who were not present why they
did not attend.
Twenty-eight members responded
to the post-meeting questionnaire.
Twenty respondents attended the
meeting and eight did not. Among
the eight members that did not attend
six (75%) had other commitments
and two (25%) responded with
“other” or no response. Two of the
eight respondents (25%) who did
not attend the meeting thought the
“schedule” could be more attractive
while the majority (75%) believed
the agenda was attractive and was not
the reason for non-attendance. Three
of the eight members (38%) who
could not attend the meeting thought
that location was a factor while the
remainder either did not find location
a problem or did not respond to the
question.
Among the 20 members who
responded to the questionnaire and
did attend the meeting, all found the
meeting informative. The majority of
members (90%) believed the best part
of the meeting was the collegiality
and meeting old and new friends in
the area. Four of the 20 respondents
(20%) also stated as a primary or
secondary reason that they enjoyed
the presentations the most.
would be interested in another
New England Regional Meeting, all
respondents answered positively. Of
the 23 respondents to the question of
how many times per year a regional
meeting should be held, 4 (17%)
responded once per year, 12 (52%)
responded twice per year, and 7
(30%) responded four times per
year. Seven of 20 respondents (35%)
stated they would like to sponsor a
New England Regional Meeting and
13 (65%) were uncertain.
Overall, the in-person and
questionnaire feedback was that the
first New England Regional Meeting
was a great success. Everyone was
extremely enthusiastic and was
excited about attending another
meeting. Given the responses to
the questionnaire, the majority of
members believe that the meeting
should be held twice a year, with
many groups willing to sponsor such
an event. It is our hope that the
first NE Regional ISPE meeting will
provide a “springboard” for future
meetings in other regions, both
within and outside the U.S. Given
our success, this could be a model for
other ISPE regions to replicate, since
besides its own utility it provides
ISPE with continuity and a presence
between its own rare events.
Among members that responded
to the question of whether they
5
Scribe •
Obituaries
Obituaries
Bill Inman,
FRCP FFPM
(1929-2005)
a lifetime of firsts
By Nigel S B Rawson, PhD,
Pharmacoepidemiologist,
GlaxoSmithKline,
Oakville, Ontario;
Adjunct Professor,
University of Waterloo,
Waterloo, Ontario, and
Memorial University of Newfoundland,
St John’s, Newfoundland, Canada
([email protected])
1. Richmond C. Bill Inman. BMJ 2005;331:1477.
2. Yellow cards and green forms. Uppsala Rep 2004;27:101. (www.who-umc.org/pdfs/UR27.pdf).
3. Inman WHW. Don’t tell the patient: behind the drug
safety net. Los Angeles: Highland Park Productions,
1999.
4. Inman W. 30 years in postmarketing surveillance: a
personal perspective. Pharmacoepidemiol Drug Saf
1993;2:239-58.
5. Inman WHW. Role of drug-reaction monitoring in the
investigation of thromboembolism and “the pill.” Br Med
Bull 1970;26:248-56.
6. Inman WHW, Vessey MP, Westerholm B, Engelund
A. Thromboembolic disease and the steroidal content of
oral contraceptives. BMJ 1970;2:203-9.
7. Inman WHW. Recorded release. In: Gross FH, Inman
WHW, eds. Drug monitoring. London: Academic
Press, 1977:65-78.
8. Looking back and forward. Uppsala Rep 2005;28:17.
(www.who-umc.org/pdfs/UR28.pdf).
9. Inman WHW. Post-marketing surveillance of adverse
drugs in general practice II: prescription-event
monitoring at the University of Southampton. BMJ
1981;282:1216-7.
10. Rawson NSB, Pearce GL, Inman WHW. Prescriptionevent monitoring: methodology and recent progress. J
Clin Epidemiol 1990;43:509-22.
11. Inman WHW, ed. Monitoring for drug safety. 2nd edn.
Lancaster: MTP Press, 1986.
12. Inman B. A summer plague: polio and its survivors.
BMJ 1995;310:1545.
13. Inman WHW. Attitudes to adverse drug reaction
reporting. Br J Clin Pharmacol 1996;41:434-5.
14. Edwards R, Faich G, Tilson H. Points to consider: the
roles of surveillance and epidemiology in advancing drug
safety. Pharmacoepidemiol Drug Saf 2005;14:665-7.
William (Bill) Howard
Wallace Inman, a United Kingdom
and international pioneer in
postmarketing surveillance and
pharmacoepidemiology died on
October 20, 2005.1 In his 76 years,
Bill had a lifetime of firsts.
He was the first medical student
to complete his studies entirely in
Cambridge (until the late 1970s, all
University of Cambridge medical
students pursued the clinical part of
their training at London hospitals),
which came about after he contracted
polio in 1950 during his pre-clinical
studies.2 I am sure that this was a first
he would have gladly forfeited, but
without it, Bill would probably not
have gone into drug safety.3
After finishing his training in
1959, Bill initially ran clinical trials
at ICI Pharmaceuticals. However,
in 1964, the late Sir Derrick
Dunlop recruited him as a founding
member of the permanent staff of the
Committee on Safety of Drugs (later
Committee on Safety of Medicines),
which was established in the wake
of the thalidomide tragedy. Bill was
the Committee’s Medical Assessor of
Adverse Reactions for the next 16
years. During that time, he developed
the “yellow card” postmarketing
surveillance scheme,2,4 one of the first
of its kind and arguably the best in
the world for many years.
Using this scheme, he
pioneered the first study that
linked oral contraceptives with
thromboembolism5 and, soon after,
was the first to show that the risk was
associated with the strength of the
hormonal dose and that, decreasing
the dose, increased safety without
reducing efficacy.6 This earned him
the title of “father of the mini-pill,”
which he found amusing due to the
discordance between “father” and
“the pill.”
Bill was the first to propose a
full-scale epidemiologic plan for
postmarketing surveillance in the
United Kingdom7,8 and, in 1980,
established the Drug Surveillance
Research Unit (DSRU), which later
became the Drug Safety Research
Unit.4,9 One of the Unit’s aims
was to develop methods based on
epidemiologic principles to monitor
the safety of newly marketed drugs
used in general practice. I joined the
DSRU in early 1981 and worked
with Bill for over 7 years on the
development of Prescription-Event
Monitoring (PEM),2,10 which became
the second national drug safety
monitoring scheme in England.
PEM continues today and has been
instituted in other countries.
For much of my time at the
DSRU, I was also working part-time
for my PhD, with Bill as one of my
supervisors.3 I was Bill’s first and only
graduate student. I do not know the
reason for this, but I like to think it
was not an adverse reaction to my
efforts.
Bill produced the first book
on drug safety monitoring in 1980
with a second edition in 1986,11
much of which remains essential
reading for all scientists involved
in identifying drug safety issues. In
1985, the University of Southampton
continued on page 7
6
Scribe •
Obituaries continued from page 6
appointed him as the world’s first
professor of pharmacoepidemiology.4
Bill continued working on PEM
until he retired in 1994 as postpolio syndrome and confinement to
a wheelchair for over 40 years led
to declining health. He remained
an active writer in retirement,3,12,13
completing an autobiography shortly
before his death.
Working with Bill, I learned
much that has benefited my career.
His central tenet that the patient
is of paramount importance in drug
safety evaluation has also become
one of my guiding principles. In
pharmacoepidemiology today, where
studies are frequently based on
large-scale health care utilization
databases, it is all too easy to
overlook this fundamental element.
Bill combined
pharmacoepidemiology, which
can be uneasy bedfellows. He
showed how voluntary reports
and more formal epidemiologic
studies could work together
synergistically. I believe Bill would
have supported efforts to draw
the pharmacoepidemiology and
pharmacovigilance communities
closer together.14
As an individual, Bill was
an intuitive, hard worker, with
a great sense of humor and a
positive outlook on life. He was a
knowledgeable and entertaining
speaker on the risk, identification
and quantification of adverse
drug reactions and, in spite of his
disability, travelled all over the
world to give presentations and
provide expert evidence. He was also
forthright, which did not always endear
him to the Establishment and may
have prevented him from receiving
some of the accolades he deserved.2
With Bill’s death, I have
lost an innovative mentor, and
pharmacoepidemiology have lost an
inimitable contributor.
Harry Guess,
MD, PhD, FISPE
(1940-2006)
Prominent ISPE member and
recipient of the 2005 ISPE Sustained
Scientific Excellence Award Harry A.
Guess, MD, PhD, died on January 1,
2006 at the age of 65 years.
Son of Harry A. Guess and Vista
Brabham Guess. Following his mother’s
death shortly after his birth, he was
adopted by his aunt Dorothy Brabham
Guess who had married his father.
After his father’s death in 1946, Dr.
Guess lived with his adoptive mother
in Bamberg, SC.
He attended Georgia Tech on a
Navy ROTC scholarship and graduated
in 1964 with both a B.S. and a M.S.
He served in the United States Navy
for five and a half years on Admiral
Rickover’s staff at the Atomic Energy
Commission, Division of Naval
Reactors.
After completing his military
service, Dr. Guess attended Stanford
University where he received a
Ph.D. in Mathematics and a M.S. in
Operational Research in 1972. After
a year of teaching, Harry spent two
years at Bell Laboratories developing
statistical models of communication
networks and went to NIH to work
on mathematical population genetics
and biostatistics. There he and
others developed what has become a
widely used method for calculating
the statistical uncertainty in cancer
risk estimates based on animal data.
This work kindled an interest in
taking a more biological approach to
understanding human health risks.
He enrolled in medical school at the
University of Miami. (M.D. 1979)
with epidemiologic research as his
career goal. He did his residency
training in pediatrics at the University
of North Carolina-Chapel Hill.
He later added board certification
in preventive medicine and public
health.
In 1985 Harry established the
Epidemiology Department at Merck
Research Laboratories and retired
as vice president from Merck in
2003, in order to become the first
director of the University of North
Carolina-GlaxoSmithKline Center of
Excellence in Pharmacoepidemiology
and Public Health at UNC, and
professor of Epidemiology, Biostatistics
and Pediatrics. Harry led the UNC
Centers for Education and Research
on Therapeutics (CERTs), which
focused on the optimal use of drugs,
medical devices and biological
products in pediatrics. He also
obtained NIH funding to lead UNC as
part of a large NIH roadmap initiative
to study the dynamic assessment
of patient-reported chronic disease
outcomes (PROMIS). Harry’s career
straddled pharmacoepidemiology
7
Scribe •
22nd International Conference on Pharmacoepidemiology
& Therapeutic Risk Management
August 24-27, 2006, Lisboa Congress Centre, Lisbon, Portugal
The Board of Directors
and members of ISPE would
like to express their sincere
appreciation to the following
individuals and organizations
that have volunteered their
considerable time and effort
to work on the ICPE 2006.
We can’t wait to experience
the charm and delights Lisboa
offers!
2006 Core Committee,
Scientific Program
Committee
Bert Leufkens, FISPE,
Chair, Miles Braun, Filipa Costa,
Mark H. Epstein, Jean-Pierre
Gregorie, Jesper Hallas, Bram
Hartzema, FISPE, Thomas
MacDonald, FISPE, Vasco
de Jesus Maria, Ana Paula
Martins, Yola Moride, FISPE,
Susana Perez-Gutthann, FISPE,
Sebastian Schneeweiss, FISPE,
Robert Vander Stichele, Alec
Walker, FISPE, and Julie Zito.
Additionally, more than
150 ISPE members registered to
review the more than 650 abstracts
submitted for presentation in
Lisbon. The Committee will
meet on April 23, 2006 to select
abstracts for oral presentations,
poster presentations, workshops
and symposia.
2006 Local Host
Committee, Lisboa
Ana da Costa Miranda,
António Lourenço, António
Faria Vaz, Carla Barros, Filipa
Costa, Filipa Duarte-Ramos,
Francisco Batel Marques,
Henrique Dias Pinto de Barros,
José Aranda da Silva, José
Carlos Marinho Falcão, José
Cabrita, José Aleixo Dias, Jorge
Félix, Magda Nunes de Melo,
Maria Augusta Soares, Maria
João Toscano, Paulo Carvalhas,
Rui dos Santos Ivo, Vitor
Rodrigues, and Zilda Mendes.
2006 ICPE Sponsoring Organizations
•
Associação Nacional das Farmácias
•
European Association for Clinical Pharmacology and Therapeutics
•
European Drug Utilization Research Group
•
International Society for Pharmacovigilance
•
International Society for Pharmacoepidemiology
8
Scribe •
New Prescription Drug Information Format to
Improve Patient Safety
The U.S. Food and Drug
Administration (FDA) recently
unveiled a major revision to
the format of prescription drug
information commonly called the
package insert, to give healthcare
professionals clear and concise
prescribing information. In an effort
to manage the risks of medication use
and reduce medical errors, the new
package insert will provide the most
up-to-date information in an easy-toread format.
Each year, approximately 300,000
preventable adverse events occur in
hospitals in the U.S., many as a result
of confusing medical information.
Research shows that prioritizing the
warning information has a greater
impact on reducing such events.
Revised for the first time in more than
25 years, some of the most significant
changes include (i) a Highlights
section to provide immediate access
to the most important prescribing
information about benefits and risks,
(ii) a Table of Contents for easy
reference to detailed safety and
efficacy information, (iii) the date
of initial product approval, making
it easier to determine how long a
product has been on the market, and
(iv) a toll-free number and Internet
reporting information for suspected
adverse events to encourage more
widespread reporting of suspected side
effects. For details please visit: http://
www.fda.gov/bbs/topics/news/2005/
NEW01272.html
Personnel
Changes
Personnel Changes
In early 2006, Dr. Anne
Trontell, Deputy Director of the
Office of Drug Safety in the U.S.
FDA, embarked on a 12-month detail
to the Agency for Healthcare Research and Quality (AHRQ) to serve
as a senior advisor in pharmaceutical
outcomes research in the Center for
Outcomes and Effectiveness (COE).
Dr. Trontell will foster research and
collaboration between FDA and
AHRQ on drug effectiveness and
safety. She will also participate in
effectiveness and risk communication
research and outreach conducted by
the new AHRQ Effective Health Care
Program. Authorized under Section 1013
of the Medicare Modernization Act.
More information about the program can
be found at www.effectivehealthcare.
ahrq.gov.
While at COE, Dr. Trontell will
participate in developing their pharmaceutical outcomes research agenda in
drug effectiveness and safety and cultivate research partnerships in these areas
between AHRQ, FDA, CMS, academic,
and professional organizations. Dr.
Trontell’s long-standing interests in risk
management and risk communication will
greatly contribute to her activities with the
Effective Health Care Program. One of the
Program’s missions is to improve the quality,
speed, and uptake of health care communications to consumers, clinicians, payers,
and health care policy makers by translating
findings in ways to meet the specific needs
of different stakeholders.
Effective with the start of Dr. Trontell’s
detail, Dr. Jonca Bull, current Deputy
Director of the Office of Pharmacoepidemiology and Statistical Science, is also serving
as Acting Deputy Director for ODS.
9
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Meetings of Interest
Meetings of Interest
Drug Safety and Public Health: Launch
of MHRA Commissioned Studies on Drug
Safety
The U.K. Medicines and Healthcare
products Regulatory Agency (MHRA) is
hosting a one-day meeting ‘Drug Safety
and Public Health: Launch of MHRA
Commissioned Studies on Drug Safety’ in
London, on March 27, 2006. This meeting
is to discuss some of the important current
challenges in pharmacoepidemiology and
to introduce the proposed collaborative
pharmacoepidemiology initiative between the
MHRA and academia.
Further information can be found at
www.mhra.gov.uk/conferences.
ISPE 2006 Mid-Year Meeting
The 6th Annual Meeting of the International
Society of Pharmacovigilance (ISoP) will be held
in Liege (Belgium) from October 11-13, 2006.
The general theme for the 6th Annual Meeting
chosen by the Scientific Committee is “Joining
Forces for Managing Risks”. Why ? The 6th
ISoP Annual Meeting will follow the 29th Annual
Meeting of National Centers participating in the
WHO Program for International Drug Monitoring
(October 9-11, 2006). A joint session will be held
on October 11.
Further information can be found at
www.isop2006.org.
April 24: Epidemiology and Management of
Benefit & Risk
April 25: Courses
• Advanced Topics in Pharmacoepidemiology
September 11-13,2006
Doubletree Hotel & Executive Meeting
Center, Rockville, Maryland
Second American Congress of
Epidemiology
June 21-24, 2006
Westin Seattle Hotel, Seattle, Washington
For more information,
visit www.epicongress2006.org
Building Tomorrow’s Patient-Reported
Outcome Measures:
The Inaugural PROMIS Conference
PROMIS is an interdisciplinary forum
for examining conceptual, clinical, and
methodological aspects of assessing and using
patient-reported outcomes.
• Introduction to Pharmacoepidemiology
visit www.pharmacoepi.org
International Society of Pharmacovigilance
(ISoP) Annual Meeting
Gaithersburg, Maryland, USA
For more information:
http://meetings.promis.iqsolutions.com
ISPE 2007 Mid-Year Meeting
April 21-23, 2007
Amsterdam, the Netherlands
23rd International Conference on
Pharmacoepidemiology & Therapeutic Risk
Management
August 19-22, 2007
22nd International Conference on
Pharmacoepidemiology & Therapeutic
Risk Management
Quebec City Convention Centre
Quebec City (Quebec), Canada
Pharmacoepidemiology and the Public’s
Health
August 24-27, 2007
Lisboa Congress Centre, Lisbon, Portugal
visit www.epicongress2006.org
10
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Scribeline
Scribeline
Dr. David Graham
Which medical school did
you graduate from and
when?
Dr. David Graham is the
Associate Director for Science
and Medicine at the U.S. FDA’s
Office of Drug Safety. Dr. Graham
graduated from the Johns Hopkins
School of Medicine in the previous
century and trained in internal
medicine at Yale and in adult
neurology at the University of
Pennsylvania. After his clinical
training, he completed a three-year
fellowship in epidemiology with
the U.S. Public Health Service
while earning a MPH from Johns
Hopkins with concentrations in
epidemiology and biostatistics.
Dr. Graham lived with his
wife in a 12-foot wide row house in
a very dangerous neighborhood, a
few blocks from the Johns Hopkins
hospital in Baltimore,MD. They
saw first-hand the scourge of
poverty, crime, social inequality
and illegal drugs. In retrospect, he
can’t believe they lived there (his
classmate was gunned down during
his senior year), but the rent was
cheap and he could see his wife at
dinner, even when on-call as a 3rd
or 4th year student. Fortunately,
they survived that terrible lapse in
judgment.
Which patient has had most
effect on your work, and
why?
Several patients come to mind,
who together, taught me how
fragile a gift life is. From this,
I learned that I might help more
patients through epidemiology and a
population approach to health.
What is your best published
work?
I don’t know that any of it is
particularly good, let alone “the
best”. I’m most proud of our study
of physician compliance with liver
enzyme monitoring for troglitazone,
which shed light on the “fig-leaf” and
insincerity of risk management as
practiced today (this poster got the
Best Paper Award at ICPE
Barcelona).
What is the best piece of
advice you have received?
It’s from the Book of Proverbs:
“above all else guard your heart, for
there are the wellsprings of life”.
What is the best advice that
you can give to a new person
in the field?
Maintain your integrity,
question every assumption including
your own, and keep your eye on the
population effect of the drugs you
study.
What is your greatest regret?
That I didn’t savor each moment
of my life as I experienced them, the
joyful as well as the painful.
What apart from your partner
is the passion of your life?
My religious faith, my children
and hiking along various woodland
and mountain trails.
What is your greatest fear?
The emotional, spiritual or physical
death of any of my children.
What are you currently
reading?
The Fabric of the Cosmos, by
Brian Greene, and the 9th volume in
the Master and Commander series
by Patrick O’Brian.
Which is your favorite
country?
Every country has its special
beauty and I’ve enjoyed every
country I have visited, but besides
the US, France is simply wonderful!
What do you think is the
most exciting field of science
at the moment?
Molecular genetics and multistring theory, not necessarily in that
order.
What part of your work gives
you the most pleasure?
That moment of discovery,
when in analyzing your data, you see
the answer to a question you’ve been
studying for months, and the fruit of
your labor revealed.
What is your favorite
journey, and why?
My journey through “middle
earth” as I read Tolkien’s Lord of the
Rings for the first time as a teenager;
11
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President’s Column continued from page 1
Distribute the Data
Human subjects research is only
ethical if its results advance science,
which is an inherently open process.
Openness is a key distinguishing feature
between science and technology. Therefore, in order for any research study
involving human subjects to be ethical,
there needs to be a reasonable expectation that its results will be published,
regardless of their impact on the sponsor
or investigator. In this spirit, the Declaration of Helsinki states that “Negative as well as positive results should be
published or otherwise publicly available.” As a consequence, research ethics
boards should prohibit investigators
from entering into research agreements
that limit the right of investigators to
publish study results. Further, research
ethics boards should require an affirmative statement regarding the investigators’ intent to publish the study’s results
in the peer-review literature.
Space limitations in journals are the
primary historic rationale for not making
individual-level data available in their
entirety; however, with the advent of the
internet, space limitations are no longer
at issue. Certainly, the opportunity for
independent scrutiny and re-analysis of
individual-level data can only improve
the scientific process. Therefore, journals
should require investigators to make
individual-level study data publicly
available as a condition of publication.
Naturally, posted data need to be free of
identifiers that would permit linkages to
individual research participants and of
variables that could lead to deductive
disclosure of the identity of individual
subjects. “Data sharing” is already an
accepted practice among investigators
funded by the US National Institutes of
Health (NIH). In particular, NIH applicants seeking USD 500,000 or more in
in study budgets. Care is indeed needed
to prevent violating the confidentiality of
research subjects. A secondary argument
against posting study data has to do with
Arguments Against
giving away something of value. However,
if one takes the view that investigators
The principal arguments against regisand their employers do not own the data,
tration of observational studies seem to be
but rather serve as stewards of data that
technical questions surrounding the most
are owned by the subjects themselves, this
appropriate registrar, and uses of the regisargument becomes much less compelling.
try. The issue of hosting is easily addressable; an appropriate government-funded or Conclusion
otherwise independent agency would seem
to be the best choice. The registry would
There is a plain need to improve
presumably be queried primarily by public the credibility of research results. I have
advocacy groups seeking to ensure comoutlined three incremental, practical
plete reporting of study results. The main
steps that would substantially improve the
argument against posting research prototransparency, and hence the credibility of
cols seems to be that they are seen as the
biomedical research. Each step is an increintellectual property of the investigator or mental rather than radical departure from
the investigator’s employer. Clearly, howaccepted standards. Several of these steps
ever, the rights of human subjects and the are congruent with a document entitled
advancement of science and of population “Principles for Protecting Integrity in the
health outweigh any intellectual property Conduct and Reporting of Clinical Trials”
rights. Again, science is an inherently
that was published by the American Asopen process. The main arguments against sociation of Medical Colleges in January
posting individual-level study data seem
2006 (http://www.aamc.org/research/clinito be the time and expense involved in
caltrialsreporting/clinicaltrialsreporting.
posting data together with the information pdf). It is the proper role of research organeeded to understand them (e.g., the data nizations like ISPE to provide leadership
dictionary) in a way that does not violate
in advocating for approaches like these.
the confidentiality of subjects. Since postI look forward to a productive and
ing individual-level data has value, the
spirited
discussion of this proposal.
cost of posting them should be included
direct costs in any single year are expected
to include a plan for data sharing or state
why data sharing is not possible.
Scribeline continued from page 11
such wonder, adventure and
heroism.
What is your favorite saying?
It’s from Shakespeare’s Hamlet:
“This above all-to thine own self
be true. And it must follow, as the
night the day, that thou canst not
then be false to any man”.
What is the least enjoyable
job you’ve ever had?
Dishwasher at a summer camp
for naturalists run by the Audubon
Society. I smashed a lot of dishes just
for entertainment’s sake.
12
Scribe •
Book Review
Regulating pharmaceuticals in Europe: striving
for efficiency, equity and quality
Elias Mossialos, Monique Mrazek and Tom Walley (ed.)
Open University Press ISBN 0 335 21466 5, Hardback £69.99, Paperback: c£24.99
Field: Public Health; drug policy; drug regulation; drug finance; and drug prescribing.
Format: Paperback and Hardback.
Audience: Students of health policy, regulation and management, pharmacy, and for health managers
and policy makers.
Purpose: This title offers a broad perspective on institutional, political and supranational aspects of
pharmaceutical regulation.
Content: Taking a broad perspective that encompasses institutional, political and supranational aspects of
pharmaceutical regulation, this book examines the approaches used to manage pharmaceutical
expenditure through various factors across Europe and what impact these strategies have had on
efficiency, quality, equity and cost, of pharmaceutical care. The book is divided in to 21 chapters
written by leading health policy analysts who review recent evidence and experience in Europe,
describing, analysing and comparing the successes and failures of specific initiatives to regulate the
pharmaceutical market. In Chapter 1 the editors summarize the contributions of all the authors to
give an overview of the full book. Chapters 2-4 tackle specific topics related to political, legal and
public health aspects of pharmaceutical regulation at national and European Union level. Ways
to measure and monitor policy outcomes in the pharmaceutical sector are examined in Chapter 5.
Chapters 6-13 tackle specific topics relating to supply and demand-side measures (i.e., regulating
pharmaceutical prices, reimbursement of pharmaceuticals, good prescribing practice, patients and
their medicines, financial incentives for prescribing, regulating distribution and retail pharmacy,
the role of hospital pharmacies, and the impact of cost sharing). Chapters 14-18 explore how
regulations may vary in different segments of the pharmaceutical market for off-patent and overthe-counter drugs and the current and future implications of lifestyle dugs, biotechnology and
alternative medicines. Chapters 19-20 examine the regulation of pharmaceutical markets in other
countries with a very different historical and cultural background, specifically the Central and
Eastern European countries and the Commonwealth of Independent States. Chapter 21 examines
important ethical issues related to approaches to managing pharmaceutical markets.
13
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Obituaries continued from page 7
and public health, and he strove
to address practical issues facing
the industry and clinicians with an
academic and innovative approach
to complex problems. He has made
notable contributions to research
on vaccines, the natural history of
complex disease, development and
validation of clinical trial endpoints
and patient reported outcomes, and
pharmacoepidemiology, in many
cases setting the industry standard.
Harry was a Fellow of the American
Academy of Pediatrics, the American
College of Preventive Medicine,
and the American College of
Epidemiology. He co-authored more
than 150 research articles and served
on the editorial boards of Epidemiology,
Journal of Clinical Epidemiology,
and Journal of Epidemiology and
Biostatistics. He was named to Who’s
Who in Medicine and Health in
2003. He gave invited congressional
testimony on medical data privacy
in 1998. Over the years, Harry was a
mentor to numerous junior and senior
scientists at Merck, UNC, and other
institutions, guiding their development
and improving their understanding
of epidemiological concepts. His
success in academia and research was
remarkable, yet his research endeavors
were always accomplished while
pursuing one of his passions: teaching
and advising graduate students. At
UNC and elsewhere, Harry was known
as the consummate teacher and sought
after advisor for graduate students and
colleagues.
He is survived by his wife of
forty-one years Geraldine Graflund
Guess; two daughters, Carol Guess of
Seattle, Washington and Alison Guess
Fitton and her husband Bruce Howard
Fitton and one grandchild Jacob David
Fitton, and a first cousin Evelyn Moore
McGee of Charleston, SC.
Book Review continued from page 13
Highlights: The book is a welcome addition to the body of literature already published on pharmaceutical
policy and regulation. It attempts to consider the perspectives and regulatory influences on
all the actors involved in the market for pharmaceuticals. Its specific contribution is that
it offers a comprehensive analysis of all aspects of pharmaceutical regulation within the
European context, and combines theoretical outlooks with the most current empirical evidence
available.
Related reading: This title fills a gap in the book market looking at pharmaceuticals specifically and health care
more generally. Other books such as Drugs and Money (World Health Organization, 2002) or
commercial publications have overviewed current issues in pricing and reimbursement in Europe
but not in a comprehensive evaluative manner. Still other books have taken a national focus to
examining pharmaceutical markets such as that of the United States or discuss only a few of the
issues included in this book such as prescribing and drug utilization. Further, this book builds upon
other books in this series namely Regulating Entrepreneurial Behavior in the Health Care Sector
(R. Saltman, R. Busse and E. Mossialos (Eds.)). None however comprehensively examine how
countries in Europe have been regulating their pharmaceutical markets broadly across all actors. Nor
has there been any comprehensive text examining the success of these regulations in containing
pharmaceutical expenditures while improving efficiency and quality.
14
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The Exclusive Career Resource for Professionals in Pharmacoepi & Therapeutic Risk Management
N ew
http://careers.pharmacoepi.org
Pharmacoepi Career Center!
ISPE has launched the Pharmacoepi Career Center as the premiere online employment resource for the pharmacoepidemiology
and therapeutic risk management industry. From the ISPE website, the Pharmacoepi Career Center will offer the community
the opportunity to list employment openings and allow job seekers to post resumes for review, respond to announcements
with a click of the mouse, or search listings by field. Thi s exclusive online career networking resource will connect academia,
government, pharmaceutical firms, CROs, and service providers with the most highly skilled professionals in the industry
worldwide.
FIND jobs
Job Seekers - The Pharmacoepi Career
Center is a free resource providing you
with timely access to the best employers,
student internships and job opportunities
in pharmacoepidemiology, therapeutic risk
management, drug safety, and more, plus:
Advanced job searching options
• Control over your career advancement
• Increased exposure for your résumé
• Optional email alerts of new jobs
POST jobs
E m p l o y e r s – I S PE ’s i n te r n at i o nal
membership represents more than 45
countries from the pharmaceutical industry,
health care providers, academic institutions,
government agencies, consulting firms
and other interested organizations. The
Pharmacoepi Career Center will offer
the most targeted advertising for your
pharmacoepidemiology and therapeutic
risk management job openings and student
internships, plus:
• Quick and easy job posting
• Quality candidates
• Online reports provide you with job
activity statistics
• Simple pricing options
• Special introductory offer
Free Job Seeker Benefits
>
>
>
>
>
EASY SEARCHING: multiple search criteria, keyword
searching.
AUTOMATIC NOTIFICATION (ISPE Member Benefit):
create automated weekly email notification of new job
listings that match your desired criteria.
SECURE ACCOUNT: stores your resume (plus 2
additional documents) and tracks your application
history.
RESUME POSTING (ISPE Member Benef it):
confidential contact information (optional); trackable
resume “hits”
CLEAN INTERFACE: easy to read, no pop-ups, email
listings to a friend (or yourself).
Employer Benefits
>
>
>
>
ACCOUNT MANAGEMENT: sign-on for easy access to
your company account; site forms will guide you to build
a professional classified ad; enhanced detail screen
list all of your job postings for greater exposure.
ACTIVITY REPORTS: track the number of candidates
viewing your job, the number applying online, and the
times your ad was emailed to a friend or sent to job
seekers in our new “job search agent.”
RESUME DATABASE: our new resume database
allows you to proactively search for candidates with the
appropriate package purchase. You can even create
daily automatic email notification of new resumes that
match your specified criteria.
POSTING PACKAGES: choose the options to suit
your organization. Competitively priced packages offer
more cost-effective recruiting than major commercial
job boards, newspapers, or other services.
15
ISPETrainingCourse
Scribe •
ISPE TRAINING COURSE
AT YOUR LOCATION
Planning and Evaluating
the Effectiveness of Risk
Management Programs. An
intensive, interactive half-day
or full-day workshop.
Introduction to
Therapeutic
Risk Management
This course was initially presented as a half-day course prior to ISPE annual meetings, and
was evaluated by participants as an extremely useful training program. Now it is available
at your location and can be customized to meet your needs.
COURSE
DESCRIPTION
The course is designed to meet the following objectives:
• Provide an overview of therapeutic risk management tailored to professionals in
pharmacoepidemiology, pharmacovigilance, regulatory, and risk communication;
• Present requirements of risk management plans, with emphasis on systematic assessments
of risk and the effectiveness of risk minimization interventions;
• Demonstrate methods of program evaluation, including Failure Mode and Effect
Analysis;
• Afford an opportunity to explore risk management planning in more depth through a
problem-solving workshop tailored to meet the needs of the on-site organization.
The program is taught by internationally distinguished pharmacoepidemiologists who have
extensive relevant experience with risk management programs – most of whom are Fellows
of the International Society of Pharmacoepidemiology (FISPE).
WHO SHOULD
ATTEND
WHERE CAN
THE COURSE BE
OFFERED
FOR INFORMATION
CONTACT
Anyone working in the fields of pharmacoepidemiology, pharmacovigilance, drug utilization
review, regulatory affairs, outcomes research and risk communication and who are likely to
be involved in products under special scrutiny due to safety concerns. Work settings include
pharmaceutical companies, government, academia, contract research organizations, legal
firms, and media/public relations firms.
At a location of your choice -- corporate conference room, conference center, hotel, or
university. ISPE faculty are available to teach this course worldwide.
Mark Epstein, ScD
ISPE Executive Secretary
301-718-6500 or [email protected]
ISPE provides an international forum for the open exchange of scientific information among academia, government, and industry and for the development of policy; provides scientific education; and advocates for the fields of pharmacoepidemiology and therapeutic risk management.
16
ISPETrainingCourse
Scribe •
An intensive, interactive,
one-day workshop
on common methodologies
& techniques used in
pharmacoepidemiological
research.
ISPE TRAINING COURSE
AT YOUR LOCATION
Introduction to
Pharmacoepidemiology
& Drug Safety
This widely acclaimed introductory course is a proven, efficient way to
instruct your staff at your convenience.
COURSE
DESCRIPTION
WHO SHOULD
ATTEND
WHERE CAN
THE COURSE BE
OFFERED
FOR INFORMATION
CONTACT
Specifically designed for persons who are new to
pharmacoepidemiology, therapeutic risk management and
drug safety. A proven, practical introduction to this important
discipline. Participants will work in teams on case studies and will
present the results to other participants. Taught by senior-level
pharmacoepidemiologists – most of whom are Fellows of the
International Society of Pharmacoepidemiology (FISPE).
Anyone new to the field who is involved with the interpretation, critical
appraisal and dissemination of pharmacoepidemiological studies and
research findings. Work settings include pharmaceutical companies,
government, academia, contract research organizations, legal firms,
and media/public relations firms.
At a location of your choice -- conference center, university, hotel, or
corporate conference room. ISPE faculty are available to teach this
course in North America, Europe and Asia/Pacific Rim.
Mark Epstein, ScD
ISPE Executive Secretary
301-718-6500 or [email protected]
ISPE provides an international forum for the open exchange of scientific information among academia, government, and industry and for the development
of policy; provides scientific education; and advocates for the fields of pharmacoepidemiology and therapeutic risk management.
17
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Visit ISPE website
www.pharmacoepi.org
for more meeting
information.
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Scribe - International Society for Pharmacoepidemiology

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