drug advertising tactics by @pharmed_out

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Drug Adver*sing Tac*cs ©PharmedOut 2013 Georgetown University Medical Center Part of the Drug Ads Exercise Presenta5on Series

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About misleading claims, indirect marketing, and disease mongering by @Pharmed_Out 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. * All our posts about Big Phatma: http://desdaughter.wordpress.com/tag/big-pharma/

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Page 1: Drug Advertising Tactics by @Pharmed_Out

Drug  Adver*sing  Tac*cs  ©PharmedOut  2013  

Georgetown  University  Medical  Center  Part  of  the  Drug  Ads  Exercise  Presenta5on  Series  

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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.  

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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

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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  

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Medical  Journals    

AdverCsements  in  medical  journals  reinforce  markeCng  messages.  

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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  

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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.  

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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.  

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Consumer  AdverCsement  

Medical  Journal  AdverCsement  

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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  

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Example:  Numeric  DistorCon  

*Note  the  range  of  the  y-­‐axis  {0-­‐2}  

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Time    (months)  

Percen

t  (%)  o

f  Pa*

ents  

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

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When  evaluaCng    medical  literature,  there  are    two  important  concepts    Absolute  Risk  vs.  RelaCve  Risk  

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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.  

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Absolute  Risk  and  RelaCve  Risk  

Absolute  Risk  (AR)  

describes  the  incidence  of  a  condiCon  in  a  populaCon.  

Rela0ve  Risk  (RR)  compares  the  probability  of  an  event  occurring  in  the  exposed  group  vs.  the  non-­‐exposed  group.  

 

RR= Exposed

Non-Exposed

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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     Placebo  

Heart  asacks   3/100   6/100  

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•  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%.  

RelaCve  Risk  and  Absolute  Risk  

RR for MI= 36

=0.50

AR for MI= 6%-3%= 3%

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Unfortunately,  several  people  in  the  study  develop  lung  cancer.  

Drug     Placebo  

Lung  Cancer   3/100   1/100  

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•  We  could  also  say  that  lung  cancer  risk  increases  by  2%.    

•  We  could  say  that  the  lung  cancer  risk  increases  by  200%.    

RelaCve  Risk  and  Absolute  Risk  

RR for Lung Cancer

= 31 = 3

AR for Lung Cancer= 3%-1% = 2%

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RelaCve  Risk  and  Absolute  Risk  

RelaCve  risk  makes  risks  or  benefits  look  BIGGER.  

Absolute  risk  makes  risks  or  benefits  look  smaller.  

 

 

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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   Placebo  Heart  Asacks   3   6  Lung  Cancer   3   1  

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The  Wrong  Way    To  Present  The  Data:  

•  Using  RR  for  benefit  and  AR  for  risk:  This  drug  reduces  heart  asacks  50%  while  increasing  lung  cancer  2%.  

•  A  may  use  AR  for  benefit  and  RR  for  risk:  This  drug  reduces  heart  asacks  3%  while  increasing  lung  cancer  200%.  

Drug   Placebo  Heart  Asacks   3   6  Lung  Cancer   3   1  

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Surrogate  Markers  vs.    Clinical  Endpoints  

Clinical  Endpoints    

are  events  such  as  death,  hospitalizaCon,  heart  asack,  or  cancer  diagnosis.  

 

Surrogate  Markers  

are  stand-­‐ins  or  subsCtutes,  such  as  cholesterol,  CRP  (C-­‐reacCve  protein),  and  PSA  (prostate-­‐specific  anCgen),  for  clinical  endpoints.  

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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  

 

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“Data  on  File”  CitaCons  

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“Data  on  File”  CitaCons  

Data  on  file  are  unpublished  internal  company  documents  

•  Companies  are  not  obligated  to  share  these  documents.  

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“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    

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Misleading  Ads  

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Natrecor  is  ONLY  indicated  for  the  symptomaCc  relief  of  dyspnea  in  paCents  with  acutely  decompensated  CHF.    

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PaCent  Mortality  

This  figure  appears  to  demonstrate  a  decreased  30-­‐day  mortality  for  Natrecor  (nesiriCde).  

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Using  the  complete  data  set  of  seven  clinical  trials,  30-­‐day  mortality  was  actually  higher  for  paCents  on  Natrecor.      

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References  

†BMJ  1994;  308:1692.  

•  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.  

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Summary  

•  Natrecor  is  indicated  for  symptomaCc  relief,  NOT  reducCon  of  mortality.    

•  Moreover,  the  evidence  indicates  increased  mortality.      

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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.  

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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.  

 

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Indirect  MarkeCng  

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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  

 

 

 

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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.  

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EducaConal  IniCaCves    Awer  a  Drug  is  Available  

Educa0onal  ini0a0ves  may  posiCon  a  drug  as  advantageous  in  terms  of      

•  FormulaCon  

•  Mechanism  of  acCon      

•  Adverse  effects    

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Pain  Balance  is  an  educaConal  iniCaCve  that  emphasizes  gastrointesCnal  complicaCons  caused  by  oral  NSAIDs.    

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PainBalance.org  is  Sponsored  by  ALPHARMA  

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Pain  Balance  serves  to  market  Flector  Patch,  a  transdermal  NSAID  purported  to  have  a  more  favorable  side  effect  profile  due  to  limited  systemic  absorpCon.    

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Indirect  MarkeCng  of  Gardasil  (an  HPV  vaccine)    

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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.  

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Disease  Mongering/  Disease  Awareness  

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Disease  Mongering:    “The  selling  of  sickness    that  widens  the  boundaries  of  illness  and  grows  the  markets  for  those  who  sell  and  deliver  treatments.” †  

 -­‐  Ray  Moynihan  

 

Disease  Awareness:    Industry  term  for  disease  mongering  

†Moynihan,  PLoS  Med  2006;  3:e191  

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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.  

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Mechanism  Mongering  

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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.  

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This  ad  urges  physicians  to  probe  for  BPH  symptoms,  rather  than  relying  on  paCents  to  express  complaints.    

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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.  

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