Drug Advertising Tactics by @Pharmed_Out
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About misleading claims, indirect marketing, and disease mongering ...

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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Drug Advertising Tactics by @Pharmed_Out Presentation Transcript

  • 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    
  • 28. Misleading  Ads  
  • 29. Natrecor  is  ONLY   indicated  for  the   symptomaCc  relief  of   dyspnea  in  paCents   with  acutely   decompensated  CHF.    
  • 30. PaCent  Mortality   This  figure  appears  to   demonstrate  a   decreased  30-­‐day   mortality  for  Natrecor   (nesiriCde).  
  • 31. Using  the  complete   data  set  of  seven   clinical  trials,  30-­‐day   mortality  was  actually   higher  for  paCents  on   Natrecor.    
  • 32. 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.  
  • 33. Summary   •  Natrecor  is  indicated  for  symptomaCc  relief,  NOT  reducCon  of   mortality.     •  Moreover,  the  evidence  indicates  increased  mortality.      
  • 34. 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.  
  • 35. 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.    
  • 36. Indirect  MarkeCng  
  • 37. 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  
  • 38. 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.  
  • 39. EducaConal  IniCaCves     Awer  a  Drug  is  Available   Educa0onal  ini0a0ves  may  posiCon  a  drug  as   advantageous  in  terms  of       •  FormulaCon   •  Mechanism  of  acCon       •  Adverse  effects    
  • 40. Pain  Balance  is  an   educaConal  iniCaCve   that  emphasizes   gastrointesCnal   complicaCons   caused  by  oral   NSAIDs.    
  • 41. PainBalance.org  is  Sponsored  by   ALPHARMA  
  • 42. Pain  Balance  serves  to   market  Flector  Patch,   a  transdermal  NSAID   purported  to  have  a   more  favorable  side   effect  profile  due  to   limited  systemic   absorpCon.    
  • 43. Indirect  MarkeCng   of  Gardasil  (an  HPV   vaccine)    
  • 44. 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.  
  • 45. Disease  Mongering/   Disease  Awareness  
  • 46. 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  
  • 47. 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.  
  • 48. Mechanism  Mongering  
  • 49. 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.  
  • 50. This  ad  urges   physicians  to  probe   for  BPH  symptoms,   rather  than  relying   on  paCents  to   express  complaints.    
  • 51. 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.  
  • 52. •  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