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`ow  to  think  about  prescription  drugs.
`
`en  years  ago,  the  multinational  pharmaceutical
`company  AstraZeneca  launched  what  was
`known  inside  the  company  as  the  Shark  Fin  Project.
`The  team  for  the  project  was  composed  of  lawyers,
`marketers,  and  scientists,  and  its  focus  was  a
`prescription  drug  known  as  Prilosec,  a  heartburn
`medication  that,  in  one  five-­year  stretch  of  its
`extraordinary  history,  earned  AstraZeneca  twenty-­six
`billion  dollars.  The  patent  on  the  drug  was  due  to
`expire  in  April  of  2001.  The  name  Shark  Fin  was  a
`reference  to  what  Prilosec  sales—and  AstraZeneca’s
`profits—would  look  like  if  nothing  was  done  to  fend
`off  the  ensuing  low-­priced  generic  competition.
`The  Shark  Fin  team  drew  up  a  list  of  fifty  options.
`One  idea  was  to  devise  a  Prilosec  2.0—a  version  that
`worked  faster  or  longer,  or  was  more  effective.
`Another  idea  was  to  combine  it  with  a  different
`heartburn  remedy,  or  to  change  the  formulation,  so
`that  it  came  in  a  liquid  gel  or  in  an  extended-­release
`form.  In  the  end,  AstraZeneca  decided  on  a  subtle  piece  of  chemical  reëngineering.  Prilosec,
`like  many  drugs,  is  composed  of  two  “isomers”—a  left-­hand  and  a  right-­hand  version  of  the
`molecule.  In  some  cases,  removing  one  of  the  isomers  can  reduce  side  effects  or  make  a  drug
`work  a  little  bit  better,  and  in  all  cases  the  Patent  Office  recognizes  something  with  one  isomer
`as  a  separate  invention  from  something  with  two.  So  AstraZeneca  cut  Prilosec  in  half.
`AstraZeneca  then  had  to  prove  that  the  single-­isomer  version  of  the  drug  was  better  than
`regular  Prilosec.  It  chose  as  its  target  something  called  erosive  esophagitis,  a  condition  in  which
`stomach  acid  begins  to  bubble  up  and  harm  the  lining  of  the  esophagus.  In  one  study,  half  the
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`patients  took  Prilosec,  and  half  took  Son  of  Prilosec.  After  one  month,  the  two  drugs  were  dead
`even.  But  after  two  months,  to  the  delight  of  the  Shark  Fin  team,  the  single-­isomer  version
`edged  ahead—with  a  ninety-­per-­cent  healing  rate  versus  Prilosec’s  eighty-­seven  per  cent.  The
`new  drug  was  called  Nexium.  A  patent  was  filed,  the  F.D.A.  gave  its  blessing,  and,  in  March  of
`2001,  Nexium  hit  the  pharmacy  shelves  priced  at  a  hundred  and  twenty  dollars  for  a  month’s
`worth  of  pills.  To  keep  cheaper  generics  at  bay,  and  persuade  patients  and  doctors  to  think  of
`Nexium  as  state  of  the  art,  AstraZeneca  spent  half  a  billion  dollars  in  marketing  and  advertising
`in  the  year  following  the  launch.  It  is  now  one  of  the  half-­dozen  top-­selling  drugs  in  America.
`In  the  political  uproar  over  prescription-­drug  costs,  Nexium  has  become  a  symbol  of
`everything  that  is  wrong  with  the  pharmaceutical  industry.  The  big  drug  companies  justify  the
`high  prices  they  charge—and  the  extraordinary  profits  they  enjoy—by  arguing  that  the  search
`for  innovative,  life-­saving  medicines  is  risky  and  expensive.  But  Nexium  is  little  more  than  a
`repackaged  version  of  an  old  medicine.  And  the  hundred  and  twenty  dollars  a  month  that
`AstraZeneca  charges  isn’t  to  recoup  the  costs  of  risky  research  and  development;;  the  costs  were
`for  a  series  of  clinical  trials  that  told  us  nothing  we  needed  to  know,  and  a  half-­billion-­dollar
`marketing  campaign  selling  the  solution  to  a  problem  we’d  already  solved.  “The  Prilosec
`pattern,  repeated  across  the  pharmaceutical  industry,  goes  a  long  way  to  explain  why  the
`nation’s  prescription  drug  bill  is  rising  an  estimated  17  %  a  year  even  as  general  inflation  is
`quiescent,”  the  Wall  Street  Journal  concluded,  in  a  front-­page  article  that  first  revealed  the
`Shark  Fin  Project.
`In  “The  Truth  About  the  Drug  Companies:  How  They  Deceive  Us  and  What  to  Do  About  It”
`(Random  House;;  $24.95),  Marcia  Angell  offers  an  even  harsher  assessment.  Angell  used  to  be
`the  editor-­in-­chief  of  The  New  England  Journal  of  Medicine,  which  is  among  the  most  powerful
`positions  in  American  medicine,  and  in  her  view  drug  companies  are  troubled  and  corrupt.  She
`thinks  that  they  charge  too  much,  engage  in  deceptive  research,  produce  inferior  products,
`borrow  their  best  ideas  from  government-­funded  scientists,  and  buy  the  affections  of  physicians
`with  trips  and  gifts.  To  her,  the  story  of  Nexium  and  drugs  like  it  is  proof  that  the
`pharmaceutical  industry  is  “now  primarily  a  marketing  machine  to  sell  drugs  of  dubious
`benefit.”
`Of  course,  it  is  also  the  case  that  Nexium  is  a  prescription  drug:  every  person  who  takes
`Nexium  was  given  the  drug  with  the  approval  of  a  doctor—and  doctors  are  professionals  who
`ought  to  know  that  there  are  many  cheaper  ways  to  treat  heartburn.  If  the  patient  was  coming  in
`for  the  first  time,  the  doctor  could  have  prescribed  what’s  known  as  an  H2  antagonist,  such  as  a
`generic  version  of  Tagamet  (cimetidine),  which  works  perfectly  well  for  many  people  and  costs
`only  about  twenty-­eight  dollars  a  month.  If  the  patient  wasn’t  responding  to  Tagamet,  the
`doctor  could  have  put  him  on  the  cheaper,  generic  form  of  Prilosec,  omeprazole.
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`The  patient’s  insurance  company  could  easily  have  stepped  in  as  well.  It  could  have  picked
`up  the  tab  for  Nexium  only  if  the  patient  had  first  tried  generic  Tagamet.  Or  it  could  have
`discouraged  Nexium  use,  by  requiring  anyone  who  wanted  the  drug  to  pay  the  difference
`between  it  and  generic  omeprazole.  Both  the  physician  and  the  insurance  company,  meanwhile,
`could  have  sent  the  patient  to  any  drugstore  in  America,  where  he  or  she  would  have  found,
`next  to  the  Maalox  and  the  Pepcid,  a  package  of  over-­the-­counter  Prilosec.  O.T.C.  Prilosec  is
`identical  to  prescription  Prilosec  and  effectively  equivalent  to  prescription  Nexium,  and  it  costs
`only  twenty  dollars  a  month.
`Throughout  the  current  debate  over  prescription-­drug  costs—as  seniors  have  gone  on  drug-­
`buying  bus  trips  to  Canada,  as  state  Medicaid  programs  and  employers  have  become
`increasingly  angry  over  rising  health-­care  costs,  and  as  John  Kerry  has  made  reining  in  the
`pharmaceutical  industry  a  central  theme  of  his  Presidential  campaign—the  common  assumption
`has  been  that  the  rise  of  drugs  like  Nexium  is  entirely  the  fault  of  the  pharmaceutical  industry.
`Is  it?  If  doctors  routinely  prescribe  drugs  like  Nexium  and  insurers  routinely  pay  for  them,  after
`all,  there  is  surely  more  than  one  culprit  in  the  prescription-­drug  mess.
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`he  problem  with  the  way  we  think  about  prescription  drugs  begins  with  a  basic
`misunderstanding  about  drug  prices.  The  editorial  board  of  the  Times  has  pronounced  them
`much  too  high;;  Marcia  Angell  calls  them  “intolerable.”  The  perception  that  the  drug  industry  is
`profiteering  at  the  expense  of  the  American  consumer  has  given  pharmaceutical  firms  a
`reputation  on  a  par  with  that  of  cigarette  manufacturers.
`In  fact,  the  complaint  is  only  half  true.  The  “intolerable”  prices  that  Angell  writes  about  are
`confined  to  the  brand-­name  sector  of  the  American  drug  marketplace.  As  the  economists
`Patricia  Danzon  and  Michael  Furukawa  recently  pointed  out  in  the  journal  Health  Affairs,  drugs
`still  under  patent  protection  are  anywhere  from  twenty-­five  to  forty  per  cent  more  expensive  in
`the  United  States  than  in  places  like  England,  France,  and  Canada.  Generic  drugs  are  another
`story.  Because  there  are  so  many  companies  in  the  United  States  that  step  in  to  make  drugs  once
`their  patents  expire,  and  because  the  price  competition  among  those  firms  is  so  fierce,  generic
`drugs  here  are  among  the  cheapest  in  the  world.  And,  according  to  Danzon  and  Furukawa’s
`analysis,  when  prescription  drugs  are  converted  to  over-­the-­counter  status  no  other  country
`even  comes  close  to  having  prices  as  low  as  the  United  States.
`It  is  not  accurate  to  say,  then,  that  the  United  States  has  higher  prescription-­drug  prices  than
`other  countries.  It  is  accurate  to  say  only  that  the  United  States  has  a  different  pricing  system
`from  that  of  other  countries.  Americans  pay  more  for  drugs  when  they  first  come  out  and  less  as
`the  drugs  get  older,  while  the  rest  of  the  world  pays  less  in  the  beginning  and  more  later.  Whose
`pricing  system  is  cheaper?  It  depends.  If  you  are  taking  Mevacor  for  your  cholesterol,  the  20-­
`mg.  pill  is  two-­twenty-­five  in  America  and  less  than  two  dollars  if  you  buy  it  in  Canada.  But
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`generic  Mevacor  (lovastatin)  is  about  a  dollar  a  pill  in  Canada  and  as  low  as  sixty-­five  cents  a
`pill  in  the  United  States.  Of  course,  not  every  drug  comes  in  a  generic  version.  But  so  many
`important  drugs  have  gone  off-­patent  recently  that  the  rate  of  increase  in  drug  spending  in  the
`United  States  has  fallen  sharply  for  the  past  four  years.  And  so  many  other  drugs  are  going  to
`go  off-­patent  in  the  next  few  years—including  the  top-­selling  drug  in  this  country,  the  anti-­
`cholesterol  medication  Lipitor—that  many  Americans  who  now  pay  more  for  their  drugs  than
`their  counterparts  in  other  Western  countries  could  soon  be  paying  less.
`The  second  misconception  about  prices  has  to  do  with  their  importance  in  driving  up  over-­
`all  drug  costs.  In  one  three-­year  period  in  the  mid-­nineteen-­nineties,  for  example,  the  amount  of
`money  spent  in  the  United  States  on  asthma  medication  increased  by  almost  a  hundred  per  cent.
`But  none  of  that  was  due  to  an  increase  in  the  price  of  asthma  drugs.  It  was  largely  the  result  of
`an  increase  in  the  prevalence  of  usage—that  is,  in  the  number  of  people  who  were  given  a
`diagnosis  of  the  disease  and  who  then  bought  drugs  to  treat  it.  Part  of  that  hundred-­per-­cent
`increase  was  also  the  result  of  a  change  in  what’s  known  as  the  intensity  of  drug  use:  in  the  mid-­
`nineties,  doctors  were  becoming  far  more  aggressive  in  their  attempts  to  prevent  asthma  attacks,
`and  in  those  three  years  people  with  asthma  went  from  filling  about  nine  prescriptions  a  year  to
`filling  fourteen  prescriptions  a  year.  Last  year,  asthma  costs  jumped  again,  by  twenty-­six  per
`cent,  and  price  inflation  played  a  role.  But,  once  again,  the  big  factor  was  prevalence.  And  this
`time  around  there  was  also  a  change  in  what’s  called  the  therapeutic  mix;;  in  an  attempt  to  fight
`the  disease  more  effectively,  physicians  are  switching  many  of  their  patients  to  newer,  better,
`and  more  expensive  drugs,  like  Merck’s  Singulair.
`Asthma  is  not  an  isolated  case.  In  2003,  the  amount  that  Americans  spent  on  cholesterol-­
`lowering  drugs  rose  23.8  per  cent,  and  similar  increases  are  forecast  for  the  next  few  years.
`Why  the  increase?  Well,  the  baby  boomers  are  aging,  and  so  are  at  greater  risk  for  heart  attacks.
`The  incidence  of  obesity  is  increasing.  In  2002,  the  National  Institutes  of  Health  lowered  the
`thresholds  for  when  people  with  high  cholesterol  ought  to  start  taking  drugs  like  Lipitor  and
`Mevacor.  In  combination,  those  factors  are  having  an  enormous  impact  on  both  the  prevalence
`and  the  intensity  of  cholesterol  treatment.  All  told,  prescription-­drug  spending  in  the  United
`States  rose  9.1  per  cent  last  year.  Only  three  of  those  percentage  points  were  due  to  price
`increases,  however,  which  means  that  inflation  was  about  the  same  in  the  drug  sector  as  it  was
`in  the  over-­all  economy.  Angell’s  book  and  almost  every  other  account  of  the  prescription-­drug
`crisis  take  it  for  granted  that  cost  increases  are  evidence  of  how  we’ve  been  cheated  by  the
`industry.  In  fact,  drug  expenditures  are  rising  rapidly  in  the  United  States  not  so  much  because
`we’re  being  charged  more  for  prescription  drugs  but  because  more  people  are  taking  more
`medications  in  more  expensive  combinations.  It’s  not  price  that  matters;;  it’s  volume.
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`his  is  a  critical  fact,  and  it  ought  to  fundamentally  change  the  way  we  think  about  the
`problem  of  drug  costs.  Last  year,  hospital  expenditures  rose  by  the  same  amount  as  drug
`expenditures—nine  per  cent.  Yet  almost  all  of  that  (eight  percentage  points)  was  due  to
`inflation.  That’s  something  to  be  upset  about:  when  it  comes  to  hospital  services,  we’re
`spending  more  and  getting  less.  When  it  comes  to  drugs,  though,  we’re  spending  more  and
`we’re  getting  more,  and  that  makes  the  question  of  how  we  ought  to  respond  to  rising  drug  costs
`a  little  more  ambiguous.
`Take  CareSource,  a  nonprofit  group  that  administers  Medicaid  for  close  to  four  hundred
`thousand  patients  in  Ohio  and  Michigan.  CareSource  runs  a  tightly  managed  pharmacy  program
`and  substitutes  generics  for  brand-­name  drugs  whenever  possible.  Nonetheless,  the  group’s
`pharmacy  managers  are  forecasting  at  least  ten-­per-­cent  increases  in  their  prescription-­drug
`spending  in  the  upcoming  year.  The  voters  of  Ohio  and  Michigan  can  hardly  be  happy  with  that
`news.  Then  again,  it’s  not  as  if  that  money  were  being  wasted.
`The  drug  that  CareSource  spends  more  money  on  than  any  other  is  Singulair,  Merck’s  new
`asthma  pill.  That’s  because  Medicaid  covers  a  lot  of  young,  lowerincome  families,  where
`asthma  is  epidemic  and  Singulair  is  a  highly  effective  drug.  Isn’t  the  point  of  having  a  Medicaid
`program  to  give  the  poor  and  the  ailing  a  chance  to  live  a  healthy  life?  This  year,  too,  the
`number  of  patients  covered  by  CareSource  who  are  either  blind  or  disabled  or  have  received  a
`diagnosis  of  aids  grew  from  fifteen  to  eighteen  per  cent.  The  treatment  of  aids  is  one  of  the
`pharmaceutical  industry’s  great  success  stories:  drugs  are  now  available  that  can  turn  what  was
`once  a  death  sentence  into  a  manageable  chronic  disease.  The  evidence  suggests,  furthermore,
`that  aggressively  treating  diseases  like  aids  and  asthma  saves  money  in  the  long  term  by
`preventing  far  more  expensive  hospital  visits.  But  there  is  no  way  to  treat  these  diseases  in  the
`short  term—and  make  sick  people  healthy—without  spending  more  on  drugs.
`The  economist  J.  D.  Klienke  points  out  that  if  all  physicians  followed  the  treatment
`guidelines  laid  down  by  the  National  Institutes  of  Health  the  number  of  Americans  being
`treated  for  hypertension  would  rise  from  twenty  million  to  forty-­three  million,  the  use  of  asthma
`medication  would  increase  somewhere  between  twofold  and  tenfold,  and  the  number  of
`Americans  on  one  of  the  so-­called  “statin”  class  of  cholesterol-­lowering  medications  would
`increase  by  at  least  a  factor  of  ten.  By  these  measures,  it  doesn’t  seem  that  we  are  spending  too
`much  on  prescription  drugs.  If  the  federal  government’s  own  medical  researchers  are  to  be
`believed,  we’re  spending  too  little.
`
`T
`
`he  fact  that  volume  matters  more  than  price  also  means  that  the  emphasis  of  the
`prescription-­drug  debate  is  all  wrong.  We’ve  been  focussed  on  the  drug  manufacturers.  But
`decisions  about  prevalence,  therapeutic  mix,  and  intensity  aren’t  made  by  the  producers  of
`drugs.  They’re  made  by  the  consumers  of  drugs.
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`This  is  why  increasing  numbers  of  employers  have  in  recent  years  made  use  of  what  are
`known  as  Pharmacy  Benefit  Managers,  or  P.B.M.s.  The  P.B.M.s  draw  up  drug  formularies—lists
`of  preferred  medications.  They  analyze  clinical-­trials  data  to  find  out  which  drugs  are  the  most
`cost-­effective.  In  a  category  in  which  there  are  many  equivalent  options,  they  bargain  with  drug
`firms,  offering  to  deliver  all  their  business  to  one  company  in  exchange  for  a  discount.  They
`build  incentives  into  prescription-­drug  plans  to  encourage  intelligent  patient  behavior.  If
`someone  wants  to  take  a  brand-­name  oral  contraceptive  and  there  is  a  generic  equivalent
`available,  for  example,  a  P.B.M.  might  require  her  to  pay  the  price  difference.  In  the  case  of
`something  like  heartburn,  the  P.B.M.  might  require  patients  to  follow  what’s  called  step  therapy
`—to  try  the  cheaper  H2  antagonists  first,  and  only  if  that  fails  to  move  to  a  proton-­pump
`inhibitor  like  omeprazole.  Employers  who  used  two  or  more  of  these  strategies  last  year  saw  a
`decrease  of  almost  five  per  cent  in  their  pharmacy  spending.
`There  is  no  mention  of  these  successes  in  “The  Truth  About  the  Drug  Companies.”  Though
`much  of  the  book  is  concerned  with  the  problem  of  such  costs,  P.B.M.s,  the  principal  tool  that
`private  health-­care  plans  use  to  control  rising  drug  costs,  are  dismissed  in  a  few  paragraphs.
`Angell’s  focus,  instead,  is  on  the  behavior  of  the  pharmaceutical  industry.  An  entire  chapter,  for
`instance,  centers  on  the  fact  that  the  majority  of  drugs  produced  by  the  pharmaceutical  industry
`are  either  minor  variations  or  duplicates  of  drugs  already  on  the  market.  Merck  pioneered  the
`statin  category  with  Mevacor.  Now  we  have  Pfizer’s  Lipitor,  Bristol-­Myers  Squibb’s  Pravachol,
`Novartis’s  Lescol,  AstraZeneca’s  Crestor,  and  Merck’s  second  entrant,  Zocor—all  of  which  do
`pretty  much  the  same  thing.  Angell  thinks  that  these  “me-­too”  drugs  are  a  waste  of  time  and
`money,  and  that  the  industry  should  devote  its  resources  to  the  development  of  truly  innovative
`drugs  instead.  In  one  sense,  she’s  right:  we  need  a  cure  for  Alzheimer’s  much  more  than  we
`need  a  fourth  or  fifth  statin.  Yet  me-­too  drugs  are  what  drive  prices  down.  The  presence  of  more
`than  one  drug  in  a  given  category  gives  P.B.M.s  their  leverage  when  it  comes  time  to  bargain
`with  pharmaceutical  companies.
`With  the  passage  of  the  Medicare  prescription-­drug-­insurance  legislation,  late  last  year,  the
`competition  created  by  me-­toos  has  become  even  more  important.  The  bill  gives  responsibility
`for  managing  the  drug  benefit  to  P.B.M.s.  In  each  therapeutic  category,  Medicare  will  set
`guidelines  for  how  many  and  what  kinds  of  drugs  the  P.B.M.s  will  have  to  include,  and  then  the
`P.B.M.s  will  negotiate  directly  with  drug  companies  for  lower  prices.  Some  analysts  predict  that,
`as  long  as  Medicare  is  smart  about  how  it  defines  the  terms  of  the  benefit,  the  discounts—
`particularly  in  crowded  therapeutic  categories  like  the  statins—could  be  considerable.  Angell
`appears  to  understand  none  of  this.  “Medicare  will  have  to  pay  whatever  drug  companies
`charge,”  she  writes,  bafflingly,  “and  it  will  have  to  cover  expensive  me-­too  drugs  as  well  as
`more  cost-­effective  ones.”
`
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`The  core  problem  in  bringing  drug  spending  under  control,  in  other  words,  is  persuading  the
`
`users  and  buyers  and  prescribers  of  drugs  to  behave  rationally,  and  the  reason  we’re  in  the
`mess  we’re  in  is  that,  so  far,  we  simply  haven’t  done  a  very  good  job  of  that.  “The  sensitivity  on
`the  part  of  employers  is  turned  up  pretty  high  on  this,”  Robert  Nease,  who  heads  applied
`decision  analysis  for  one  of  the  nation’s  largest  P.B.M.s,  the  St.  Louis-­based  Express  Scripts,
`says.  “This  is  not  an  issue  about  how  to  cut  costs  without  affecting  quality.  We  know  how  to  do
`that.  We  know  that  generics  work  as  well  as  brands.  We  know  that  there  are  proven  step
`therapies.  The  problem  is  that  we  haven’t  communicated  to  members  that  we  aren’t  cheating
`them.”
`Among  the  costliest  drug  categories,  for  instance,  is  the  new  class  of  antiinflammatory
`drugs  known  as  cox-­2  inhibitors.  The  leading  brand,  Celebrex,  has  been  heavily  advertised,  and
`many  patients  suffering  from  arthritis  or  similar  conditions  ask  for  Celebrex  when  they  see  their
`physician,  believing  that  a  cox-­2  inhibitor  is  a  superior  alternative  to  the  previous  generation  of
`nonsteroidal  anti-­inflammatories  (known  as  nsaids),  such  as  ibuprofen.  (The  second  leading  cox-­2
`inhibitor,  Merck’s  Vioxx,  has  just  been  taken  off  the  market  because  of  links  to  an  elevated  risk
`of  heart  attacks  and  strokes.)  The  clinical  evidence,  however,  suggests  that  the  cox-­2s  aren’t  any
`better  at  relieving  pain  than  the  nsaids.  It’s  just  that  in  a  very  select  group  of  patients  they  have  a
`lower  risk  of  side  effects  like  ulcers  or  bleeding.
`“There  are  patients  at  high  risk—people  who  have  or  have  had  an  ulcer  in  the  past,  who  are
`on  blood-­thinning  medication,  or  who  are  of  an  advanced  age,”  Nease  says.  “That  specific
`group  you  would  likely  start  immediately  on  a  cox-­2.”  Anyone  else,  he  says,  should  really  be
`started  on  a  generic  nsaid  first.  “The  savings  here  are  enormous,”  he  went  on.  “The  cox-­2s  are
`between  a  hundred  and  two  hundred  dollars  a  month,  and  the  generic  nsaids  are  pennies  a  day—
`and  these  are  drugs  that  people  take  day  in,  day  out,  for  years  and  years.”  But  that  kind  of
`change  can’t  be  implemented  unilaterally:  the  health  plan  and  the  employer  have  to  explain  to
`employees  that  in  their  case  a  brand-­new,  hundreddollar  drug  may  not  be  any  better  than  an  old,
`one-­dollar  drug.
`Similarly,  a  P.B.M.  might  choose  to  favor  one  of  the  six  available  statins  on  its  formulary—
`say,  AstraZeneca’s  Crestor—because  AstraZeneca  gave  it  the  biggest  discount.  But  that
`requires,  once  again,  a  conversation  between  the  health  plan  and  the  employee:  the  person  who
`has  happily  been  taking  Pfizer’s  anti-­cholesterol  drug  Lipitor  for  several  years  has  to  be
`convinced  that  Crestor  is  just  as  good,  and  the  plan  has  to  be  very  sure  that  Crestor  is  just  as
`good.
`The  same  debates  are  going  on  right  now  in  Washington,  as  the  Medicare  program  decides
`how  to  implement  the  new  drug  benefit.  In  practice,  the  P.B.M.s  will  be  required  to  carry  a
`choice  of  drugs  in  every  therapeutic  category.  But  how  do  you  define  a  therapeutic  category?
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`Are  drugs  like  Nexium  and  Prilosec  and  Prevacid—all  technically  known  as  proton-­pump
`inhibitors—in  one  category,  and  the  H2  antagonists  in  another?  Or  are  they  all  in  one  big
`category?  The  first  approach  maximizes  the  choices  available.  The  second  approach  maximizes
`the  bargaining  power  of  P.B.M.s.  Deciding  which  option  to  take  will  have  a  big  impact  on  how
`much  we  end  up  paying  for  prescription  drugs—and  it’s  a  decision  that  has  nothing  to  do  with
`the  drug  companies.  It’s  up  to  us;;  it  requires  physicians,  insurers,  patients,  and  government
`officials  to  reach  some  kind  of  consensus  about  what  we  want  from  our  medical  system,  and
`how  much  we  are  willing  to  pay  for  it.  AstraZeneca  was  able  to  do  some  chemical  sleight  of
`hand,  spend  half  a  billion  on  advertising,  and  get  away  with  the  “reinvention”  of  its  heartburn
`drug  only  because  that  consensus  hasn’t  yet  been  reached.  For  sellers  to  behave  responsibly,
`buyers  must  first  behave  intelligently.  And  if  we  want  to  create  a  system  where  millions  of
`working  and  elderly  Americans  don’t  have  to  struggle  to  pay  for  prescription  drugs  that’s  also
`up  to  us.  We  could  find  it  in  our  hearts  to  provide  all  Americans  with  adequate  health  insurance.
`It  is  only  by  the  most  spectacular  feat  of  cynicism  that  our  political  system’s  moral  negligence
`has  become  the  fault  of  the  pharmaceutical  industry.
`There  is  a  second  book  out  this  fall  on  the  prescription-­drug  crisis,  called  “Overdosed
`America”  (HarperCollins;;  $24.95),  by  John  Abramson,  who  teaches  at  Harvard  Medical  School.
`At  one  point,  Abramson  discusses  a  study  that  he  found  in  a  medical  journal  concluding  that  the
`statin  Pravachol  lowered  the  risk  of  stroke  in  patients  with  coronary  heart  disease  by  nineteen
`per  cent.  That  sounds  like  a  significant  finding,  but,  as  Abramson  shows,  it  isn’t.  In  the  six  years
`of  the  study,  4.5  per  cent  of  those  taking  a  placebo  had  a  stroke  versus  3.7  per  cent  of  those  on
`Pravachol.  In  the  real  world,  that  means  that  for  every  thousand  people  you  put  on  Pravachol
`you  prevent  one  stroke—which,  given  how  much  the  drug  costs,  comes  to  at  least  $1.2  million
`per  stroke  prevented.  On  top  of  that,  the  study’s  participants  had  an  average  age  of  sixty-­two
`and  most  of  them  were  men.  Stroke  victims,  however,  are  more  likely  to  be  female,  and,  on
`average,  much  older—and  the  patients  older  than  seventy  in  the  study  who  were  taking
`Pravachol  had  more  strokes  than  those  who  were  on  a  placebo.
`Here  is  a  classic  case  of  the  kind  of  thing  that  bedevils  the  American  health  system—
`dubious  findings  that,  without  careful  evaluation,  have  the  potential  to  drive  up  costs.  But
`whose  fault  is  it?  It’s  hard  to  blame  Pravachol’s  manufacturer,  Bristol-­Myers  Squibb.  The
`study’s  principal  objective  was  to  look  at  Pravachol’s  effectiveness  in  fighting  heart  attacks;;
`the  company  was  simply  using  that  patient  population  to  make  a  secondary  observation  about
`strokes.  In  any  case,  Bristol-­Myers  didn’t  write  up  the  results.  A  group  of  cardiologists  from
`New  Zealand  and  Australia  did,  and  they  hardly  tried  to  hide  Pravachol’s  shortcomings  in
`women  and  older  people.  All  those  data  are  presented  in  a  large  chart  on  the  study’s  third  page.
`What’s  wrong  is  the  context  in  which  the  study’s  findings  are  presented.  The  abstract  at  the
`
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`beginning  ought  to  have  been  rewritten.  The  conclusion  needs  a  much  clearer  explanation  of
`how  the  findings  add  to  our  understanding  of  stroke  prevention.  There  is  no  accompanying
`commentary  that  points  out  the  extreme  cost-­ineffectiveness  of  Pravachol  as  a  stroke
`medication—and  all  those  are  faults  of  the  medical  journal’s  editorial  staff.  In  the  end,  the  fight
`to  keep  drug  spending  under  control  is  principally  a  matter  of  information,  of  proper
`communication  among  everyone  who  prescribes  and  pays  for  and  ultimately  uses  drugs  about
`what  works  and  what  doesn’t,  and  what  makes  economic  sense  and  what  doesn’t—and  medical
`journals  play  a  critical  role  in  this  process.  As  Abramson  writes:
`
`When  I  finished  analyzing  the  article  and  understood  that  the  title  didn’t  tell  the  whole  story,  that  the  findings  were  not  statistically
`significant,  and  that  Pravachol  appeared  to  cause  more  strokes  in  the  population  at  greater  risk,  it  felt  like  a  violation  of  the  trust  that  doctors
`(including  me)  place  in  the  research  published  in  respected  medical  journals.  
`
`The  journal  in  which  the  Pravachol  article  appeared,  incidentally,  was  The  New  England
`Journal  of  Medicine.  And  its  editor  at  the  time  the  paper  was  accepted  for  publication?  Dr.
`Marcia  Angell.  Physician,  heal  thyself.  ♦
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