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Drug	
  Adver*sing	
  Tac*cs	
  
©PharmedOut	
  2013	
  
Georgetown	
  University	
  Medical	
  Center	
  
Part	
  of	
  the	
  Drug	
  Ads	
  Exercise	
  Presenta5on	
  Series	
  
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.	
  
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
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.”†	
  
†Marshall,	
  MMM	
  2006	
  
Medical	
  Journals
AdverCsements	
  in	
  
medical	
  journals	
  
reinforce	
  markeCng	
  
messages.	
  

	
  	
  
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	
  
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.	
  
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.	
  
Consumer	
  
AdverCsement	
  

Medical	
  Journal	
  
AdverCsement	
  
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	
  
Example:	
  Numeric	
  DistorCon	
  

*Note	
  the	
  range	
  of	
  the	
  y-­‐axis	
  {0-­‐2}	
  
Percent	
  (%)	
  of	
  Pa*ents	
  

Compare	
  with	
  the	
  same	
  results	
  
on	
  a	
  100-­‐point	
  scale	
  

Time	
  	
  (months)	
  
When	
  evaluaCng	
  	
  
medical	
  literature,	
  there	
  are	
  	
  
two	
  important	
  concepts	
  	
  
Absolute	
  Risk	
  vs.	
  RelaCve	
  Risk	
  
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.	
  
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
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	
  
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%.	
  
Unfortunately,	
  several	
  people	
  in	
  the	
  study	
  
develop	
  lung	
  cancer.	
  
Drug	
  	
  
Lung	
  Cancer	
  

Placebo	
  

3/100	
  

1/100	
  
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%.	
  	
  
RelaCve	
  Risk	
  and	
  Absolute	
  Risk	
  
RelaCve	
  risk	
  makes	
  risks	
  or	
  benefits	
  look	
  
BIGGER.	
  
Absolute	
  risk	
  makes	
  risks	
  or	
  benefits	
  look	
  
smaller.	
  

	
  
	
  
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	
  
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	
  
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.	
  

	
  
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	
  
“Data	
  on	
  File”	
  CitaCons	
  
“Data	
  on	
  File”	
  CitaCons
	
  
Data	
  on	
  file	
  are	
  unpublished	
  internal	
  
company	
  documents	
  
•  Companies	
  are	
  not	
  obligated	
  to	
  share	
  these	
  
documents.	
  
“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	
  	
  
Misleading	
  Ads	
  
Natrecor	
  is	
  ONLY	
  
indicated	
  for	
  the	
  
symptomaCc	
  relief	
  of	
  
dyspnea	
  in	
  paCents	
  
with	
  acutely	
  
decompensated	
  CHF.	
  
	
  
PaCent	
  Mortality	
  
This	
  figure	
  appears	
  to	
  
demonstrate	
  a	
  
decreased	
  30-­‐day	
  
mortality	
  for	
  Natrecor	
  
(nesiriCde).	
  
Using	
  the	
  complete	
  
data	
  set	
  of	
  seven	
  
clinical	
  trials,	
  30-­‐day	
  
mortality	
  was	
  actually	
  
higher	
  for	
  paCents	
  on	
  
Natrecor.	
  
	
  
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.	
  
Summary	
  

•  Natrecor	
  is	
  indicated	
  for	
  symptomaCc	
  relief,	
  NOT	
  reducCon	
  of	
  
mortality.	
  	
  
•  Moreover,	
  the	
  evidence	
  indicates	
  increased	
  mortality.	
  	
  
	
  
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.	
  
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.	
  
	
  
Indirect	
  MarkeCng	
  
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	
  
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.	
  
EducaConal	
  IniCaCves	
  	
  
Awer	
  a	
  Drug	
  is	
  Available	
  
Educa0onal	
  ini0a0ves	
  may	
  posiCon	
  a	
  drug	
  as	
  
advantageous	
  in	
  terms	
  of	
  	
  	
  
• 

FormulaCon	
  

• 

Mechanism	
  of	
  acCon	
  	
  	
  

• 

Adverse	
  effects	
  	
  
Pain	
  Balance	
  is	
  an	
  
educaConal	
  iniCaCve	
  
that	
  emphasizes	
  
gastrointesCnal	
  
complicaCons	
  
caused	
  by	
  oral	
  
NSAIDs.	
  
	
  
PainBalance.org	
  is	
  Sponsored	
  by	
  
ALPHARMA	
  
Pain	
  Balance	
  serves	
  to	
  
market	
  Flector	
  Patch,	
  
a	
  transdermal	
  NSAID	
  
purported	
  to	
  have	
  a	
  
more	
  favorable	
  side	
  
effect	
  profile	
  due	
  to	
  
limited	
  systemic	
  
absorpCon.	
  
	
  
Indirect	
  MarkeCng	
  
of	
  Gardasil	
  (an	
  HPV	
  
vaccine)	
  
	
  
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.	
  
Disease	
  Mongering/	
  
Disease	
  Awareness	
  
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	
  
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.	
  
Mechanism	
  Mongering	
  
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.	
  
This	
  ad	
  urges	
  
physicians	
  to	
  probe	
  
for	
  BPH	
  symptoms,	
  
rather	
  than	
  relying	
  
on	
  paCents	
  to	
  
express	
  complaints.	
  
	
  
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.	
  
•  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!	
  

PharmedOut	
  is	
  supported	
  by	
  individual	
  dona*ons.	
  
Please	
  consider	
  suppor*ng	
  us!	
  
hsp://www.pharmedout.org	
  or	
  202-­‐687-­‐1191	
  
	
  
	
  
	
  

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Drug Advertising Tactics

  • 1. Drug  Adver*sing  Tac*cs   ©PharmedOut  2013   Georgetown  University  Medical  Center   Part  of  the  Drug  Ads  Exercise  Presenta5on  Series  
  • 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.”†   †Marshall,  MMM  2006  
  • 5. Medical  Journals AdverCsements  in   medical  journals   reinforce  markeCng   messages.      
  • 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.  
  • 9. Consumer   AdverCsement   Medical  Journal   AdverCsement  
  • 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  
  • 11. Example:  Numeric  DistorCon   *Note  the  range  of  the  y-­‐axis  {0-­‐2}  
  • 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%.  
  • 18. Unfortunately,  several  people  in  the  study   develop  lung  cancer.   Drug     Lung  Cancer   Placebo   3/100   1/100  
  • 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  
  • 25. “Data  on  File”  CitaCons  
  • 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    
  • 29.
  • 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.    
  • 48. PainBalance.org  is  Sponsored  by   ALPHARMA  
  • 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.    
  • 50. Indirect  MarkeCng   of  Gardasil  (an  HPV   vaccine)    
  • 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.  
  • 55.
  • 56.
  • 57.
  • 58.
  • 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!   PharmedOut  is  supported  by  individual  dona*ons.   Please  consider  suppor*ng  us!   hsp://www.pharmedout.org  or  202-­‐687-­‐1191