About misleading claims, indirect marketing, and disease mongering
PharmedOut http://www.pharmedout.org/index.htm is a Georgetown University Medical Center project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices.
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2. Disclaimer:
Intellectual
Property
In
this
presentaCon,
you
will
noCce
that
we
use
images
of
many
registered
trademarks,
many
branded
drug
trade
names,
and
many
copyrighted
adverCsements
-‐-‐
from
many
different
business
concerns
-‐-‐
including
drug
companies,
markeCng
consultants
and
medical
journals.
All
of
the
intellectual
property
contained
therein
is,
and
remains,
the
exclusive
intellectual
property
of
the
respecCve
owners.
Each
images
is
used
for
the
purpose
of
educaConal,
and
criCcal,
analysis.
No
endorsement
of
any
posiCon
arCculated
in
this
presentaCon
should
be
inferred
from
the
appearance
of
any
brand,
trademark,
trade
name
or
ad
copy
herein.
This
presentaCon
has
been
designed
with
the
intent
to
qualify
for
the
doctrine
of
"fair
use"
-‐-‐
as
to
these
pieces
of
intellectual
property
-‐-‐
under
the
law
of
the
United
States.
3. We
Think
That
We
Don’t
Look
at
Ads,
But…
We
do.
• In
2011,
pharmaceuCcal
companies
spent
$322
million
on
journal
adverCsing.†
• Ads
return
$2.43
to
$4.00
in
prescripCons
for
every
dollar
spent.
†IMS
Health
StaCsCcs
2011
4. Ads
Affect
Us
• “Medical
journals
are
the
leading
source
of
medical
informaCon
for
76%
of
physicians.”
• “As
many
as
65%
[of
physicians]
will
correctly
associate
the
ad’s
messages
with
its
product.”
• “Message
retenCon
correlates
with
increased
sales.Ӡ
†Marshall,
MMM
2006
6. AdverCsing
in
Medical
Journals
• Most
medical
journals policies
limit
adverCsing
to
drugs.
• AdverCsing,
sponsored
subscripCons,
and
reprint
sales
are
major
sources
of
revenue
for
medical
journals.
• Therefore,
journals
shy
away
from
publishing
arCcles
criCcal
of
industry.†
†Fugh-‐Berman,
PLoS
Med
2006;
3:e130
7. Physicians
Receive
Different
Ads
• AdverCsing
is
targeted
to
physicians
by:
• Specialty
• Geographic
locaCon
• Prescribing
behavior
• Different
subscribers
to
the
same
journal
will
receive
different
ads.
8. The
Importance
of
Ads
in
Medical
Journals
Ads
in
medical
journals
are
important
because
they
• Are
an
important
part
of
promoConal
campaigns.
• Reinforce
markeCng
messages
conveyed
by
drug
reps,
direct
mail,
and
speaker
programs.
• Provide
reminders
that
retain
drug
names
in
our
subconscious.
• Reinforce
direct-‐to-‐consumer-‐adverCsing
(DTCA)
via
coordinaCon
of
product
logos,
colors,
and
symbols.
See
example
on
next
slide.
10. InformaCon
in
Ads
is
Not
Accurate
Studies
have
found
that:
• One-‐third
of
pharmaceuCcal
ads
are
scienCfically
inaccurate.1
• Graphs
can
be
misleading.2
• 36%
of
graphs
had
numeric
distorCon.
• One-‐third
contained
design
features
that
distorted
the
data
depicted.
• Only
58%
presented
an
outcome
relevant
to
the
drug’s
indicaCon.
• Only
4%
contained
confidence
intervals.
1
Wilkes,
Ann
Intern
Med
1992;
116:912
2
Cooper,
JGIM
2003;
18:294
12. Percent
(%)
of
Pa*ents
Compare
with
the
same
results
on
a
100-‐point
scale
Time
(months)
13. When
evaluaCng
medical
literature,
there
are
two
important
concepts
Absolute
Risk
vs.
RelaCve
Risk
14. Absolute
Risk
and
RelaCve
Risk
PresenCng
benefits
in
rela5ve
terms
and
risks
in
absolute
terms
is
a
classic
way
to
exaggerate
benefits
and
minimize
risks.
15. Absolute
Risk
and
RelaCve
Risk
Absolute
Risk
(AR)
Rela0ve
Risk
(RR)
describes
the
incidence
of
a
condiCon
in
a
populaCon.
compares
the
probability
of
an
event
occurring
in
the
exposed
group
vs.
the
non-‐exposed
group.
Exposed
RR=
Non-Exposed
16. Let’s
Look
At
An
Example…
A
placebo-‐controlled
trial
of
a
lipid-‐lowering
drug
is
performed
in
200
people
(100
treated
with
the
drug
and
100
treated
with
placebo).
Three
people
on
the
drug
and
six
people
on
placebo
have
heart
asacks.
Drug
Heart
asacks
Placebo
3/100
6/100
17. RelaCve
Risk
and
Absolute
Risk
RR for MI
3
=
6
= 0.50
AR for MI
= 6%-3%
= 3%
•
•
We
might
say
that
Drug
A
reduces
heart
asack
risk
by
50%
or
cuts
heart
asack
rate
in
half.
We
could
also
say
that
the
heart
asack
risk
is
reduced
by
3%.
19. RelaCve
Risk
and
Absolute
Risk
RR for Lung Cancer
•
3
= =3
1
AR for Lung Cancer
= 3%-1% = 2%
•
We
could
say
that
the
lung
cancer
risk
increases
by
200%.
We
could
also
say
that
lung
cancer
risk
increases
by
2%.
20. RelaCve
Risk
and
Absolute
Risk
RelaCve
risk
makes
risks
or
benefits
look
BIGGER.
Absolute
risk
makes
risks
or
benefits
look
smaller.
21. To
be
fair,
both
harms
and
benefits
should
be
presented
in
either
RR
or
AR
• RelaCve
Risk:
This
drug
reduces
heart
asacks
50%
while
increasing
lung
cancer
200%.
• Absolute
Risk:
This
drug
reduces
heart
asacks
3%
while
increasing
lung
cancer
2%.
Drug
Heart
Asacks
Lung
Cancer
Placebo
3
6
3
1
22. The
Wrong
Way
To
Present
The
Data:
• Using
RR
for
benefit
and
AR
for
risk:
This
drug
reduces
heart
asacks
Drug
50%
while
increasing
lung
Heart
3
cancer
2%.
Asacks
• A
may
use
AR
for
benefit
and
RR
for
risk:
This
drug
reduces
heart
asacks
3%
while
increasing
lung
cancer
200%.
Lung
Cancer
3
Placebo
6
1
23. Surrogate
Markers
vs.
Clinical
Endpoints
Clinical
Endpoints
Surrogate
Markers
are
events
such
as
death,
hospitalizaCon,
heart
asack,
or
cancer
diagnosis.
are
stand-‐ins
or
subsCtutes,
such
as
cholesterol,
CRP
(C-‐
reacCve
protein),
and
PSA
(prostate-‐specific
anCgen),
for
clinical
endpoints.
24. CitaCons
Used
in
Ads
May
Not
Be
Reliable
Unreliable
cita0ons
include:
• Conference
abstracts
or
posters
• Unpublished,
non-‐peer-‐reviewed,
usually
incomplete
data
• Supplements
to
journals
• Non-‐peer-‐reviewed,
paid
special
issues,
usually
industry-‐sponsored
• Studies
that
do
NOT
support
claims
in
ad
• Poorly
designed
or
poorly
implemented
studies
• Data
on
file
26. “Data
on
File”
CitaCons
Data
on
file
are
unpublished
internal
company
documents
• Companies
are
not
obligated
to
share
these
documents.
27. “Data
on
File”
CitaCons
Researchers
have
found
it
difficult
to
obtain
data
on
file.
Examples
of
study
results:
• Only
40%
of
“data
on
file”
references
requested
were
returned.1
• Among
125
referenced
promoConal
claims,
23
could
not
be
retrieved.
Eleven
of
these
were
irretrievable
“data
on
file”.2
• Only
20%
of
“data
on
file”
references
requested
were
returned.3
1Lexchin,
CMAJ
1994;
151:47
2Villanueva,
Lancet
2003;
361:27
3Cooper,
CMAJ
2005;
172:487
30. Natrecor
is
ONLY
indicated
for
the
symptomaCc
relief
of
dyspnea
in
paCents
with
acutely
decompensated
CHF.
31.
32. PaCent
Mortality
This
figure
appears
to
demonstrate
a
decreased
30-‐day
mortality
for
Natrecor
(nesiriCde).
33. Using
the
complete
data
set
of
seven
clinical
trials,
30-‐day
mortality
was
actually
higher
for
paCents
on
Natrecor.
34. References
• Journal
Supplements
are
non-‐peer
reviewed
collecCons
of
papers
that
are
published
as
separate
issues
of
the
journal.
Supplements
are
typically
funded
by
pharmaceuCcal
companies.†
• MeeCng
abstracts
are
not
peer
reviewed.
†BMJ
1994;
308:1692.
35. Summary
• Natrecor
is
indicated
for
symptomaCc
relief,
NOT
reducCon
of
mortality.
• Moreover,
the
evidence
indicates
increased
mortality.
36.
37. Geodon
Ad
This
ad
campaign
for
Geodon
touts
comparable
efficacy
to
other
an5psycho5cs,
“without
compromising
metabolic
parameters.”
• This
claim
is
misleading.
Geodon
increases
weight
and
cholesterol
levels,
although
less
so
than
other
anCpsychoCcs.
• Therefore,
Geodon
DOES
compromise
metabolic
parameters.
38.
39. Lipitor
Ad
• The
ad
notes
a
45%
reduc5on
in
non-‐fatal
MI
in
the
ASCOT-‐LLA
study.
• However,
the
published
ASCOT-‐LLA
study
does
not
assess
non-‐fatal
MI
alone
(there
was
a
36%
reducCon
in
nonfatal
MI
and
fatal
CHD).†
• The
reference
in
the
ad
is
NOT
to
the
ASCOT-‐LLA
study
published
in
the
Lancet.
The
reference
is
to
data
on
file.
• Furthermore,
the
study
found
that
there
was
no
significant
difference
between
groups
in
all-‐cause
mortality
or
cardiovascular
mortality.
41. Indirect
MarkeCng:
PromoCon
Without
MenConing
the
Product
Indirect
marke0ng
includes:
• Disease
Awareness
(also
called
Disease
Mongering )
• PromoCng
a
condiCon
that
a
targeted
therapy
treats
• MiCgaCng
negaCve
percepCons
of
a
product
• Disparaging
compeCng
products
42. Pre-‐launch
PromoCon
• PromoCon
of
a
drug
starts
years
before
regulatory
approval
is
expected.
• Companies
cannot
legally
promote
a
drug
“pre-‐launch”
before
approval.
• Indirect
markeCng
is
allowed.
• More
money
is
spent
on
promoCng
a
drug
in
the
three
years
prior
to
launch
than
in
the
first
year
awer
the
drug
arrives
on
the
market.
43.
44.
45.
46. EducaConal
IniCaCves
Awer
a
Drug
is
Available
Educa0onal
ini0a0ves
may
posiCon
a
drug
as
advantageous
in
terms
of
•
FormulaCon
•
Mechanism
of
acCon
•
Adverse
effects
47. Pain
Balance
is
an
educaConal
iniCaCve
that
emphasizes
gastrointesCnal
complicaCons
caused
by
oral
NSAIDs.
49. Pain
Balance
serves
to
market
Flector
Patch,
a
transdermal
NSAID
purported
to
have
a
more
favorable
side
effect
profile
due
to
limited
systemic
absorpCon.
51. Why
Does
Merck
emphasize
genital
warts,
a
cosmeCc
problem?
The
answer
lies
in
the
compeCCon:
• Merck s
Gardasil
protects
against
two
strains
of
HPV
that
cause
cervical
cancer
AND
protects
against
strains
that
cause
genital
warts.
• GlaxoSmithKline's
Cervarix
protects
against
four
types
of
HPV
that
cause
cervical
cancer
but
does
not
protect
against
any
strains
that
cause
genital
warts.
Therefore,
it
is
logical
for
Merck
to
market
using
this
dis5nc5on
by
promoCng
protecCon
against
genital
warts.
53. Disease
Mongering:
Disease
Awareness:
The
selling
of
sickness
that
widens
the
boundaries
of
illness
and
grows
the
markets
for
those
who
sell
and
deliver
treatments. †
Industry
term
for
disease
mongering
-‐
Ray
Moynihan
†Moynihan,
PLoS
Med
2006;
3:e191
54. Disease
Mongering
During
Pre-‐launch
• Example:
Modafinil
(Provigil)
was
originally
approved
for
narcolepsy.
• “Disease
awareness”
campaigns
created
new
condiCons:
• Hypersomnolence,
• excessive
sleepiness
(ES)
• shiw-‐work
syndrome
(SWS)
• See
examples
on
next
slides.
60. Increased
Screening
can
Cause
Increased
Sales
Why
wait
for
paCents
to
complain
when
you
can
elicit
symptoms
that
call
for
drug
treatment?
See
example
on
next
slide.
61. This
ad
urges
physicians
to
probe
for
BPH
symptoms,
rather
than
relying
on
paCents
to
express
complaints.
62. Conclusion
• PharmaceuCcal
adverCsements
owen
include
misleading
graphics,
figures,
and
references.
• Beware
of
benefits
being
presented
as
relaCve
risks
and
harms
being
presented
as
absolute
risks.
• Disease
awareness
and
other
indirect
markeCng
techniques
can
affect
our
percepCons
of
disease
prevalence
and
appropriate
treatments.
63. • Promotes
raConal
prescribing.
• Provides
Grand
Rounds,
seminars,
and
free,
web-‐based
CME.
• Offers
teaching
tools,
videos,
slideshows,
paCent
factsheets,
“No
Drug
Reps”
cerCficate,
and
many
other
resources.
• Internships
available!
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is
supported
by
individual
dona*ons.
Please
consider
suppor*ng
us!
hsp://www.pharmedout.org
or
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