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VIOXX

What is Vioxx?<= /b>

Vioxx was a scienti= fic breakthrough

C17H14O4S

HOW DOES VIOXX WORK= ?

HOW TO USE THIS MEDICATION?

History and Timelin= e of Vioxx

History and Timelin= e of Vioxx

History and Timelin= e of Vioxx

History and Timelin= e of Vioxx

History and Timelin= e of Vioxx

History and Timelin= e of Vioxx

History and Timelin= e of Vioxx

History and Timelin= e of Vioxx

History and Timelin= e of Vioxx

History and Timelin= e of Vioxx

History and Timelin= e of Vioxx

Questionable Reacti= ons

Ignoring the Facts<= /a>

"Epidemiologic= al studies"

Action by the FDA

Procedures for New = Drugs

Procedure Cond.=

FDA Improvements

Suggested Improveme= nts

Changes in Legislat= ion

Currently

Slide 28

Celebrex, Bextra and FenPhen
Oh My!

Are Deadly Medicati= ons the
New Trend?

Bibliography

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VIOXX
The Ethical Dilemma=

What is Vioxx?<= /b>
Vioxx is a non-ster= oidal anti-inflammatory drug.
Relieves:
Arthritis=
Acute pain in adu= lts
Painful menstrual= cycles
Tendonitis=
3 strengths availab= le:
12.5, 25, or 50 m= g

Vioxx was a scienti= fic breakthrough
Chemical Name rofec= oxib
Other trade name Ce= oxx®
First medication to= only inhibit the COX-2 enzyme.
Previous NSAIDs inh= ibited both COX-1 and COX-2.

C17H14O4S
Vioxx belonged to t= he group of NSAIDs known as coxibs (cyclooxygenase inhibitors).
Like other coxibs, = including celebrex, and bextra.  It was considered a COX-2 inhibitor
acting specifically= one form of the cyclooxygenase enzyme, This specificity allowed Vioxx and other inhibitors to reduce discomfort.
Minimal undesired gastrointestinal effects such as stomach ulcers.

HOW DOES VIOXX WORK= ?
In vivo, two enzyme= s known as COX-1 and COX-2.
COX-1 helps regulat= e normal cell function in the stomach and blood.
COX-2 plays a role = in causing arthritic pain and inflammation by increasing cytokines levels in the blo= od.
Cytokines are com= pounds that lead to pain and inflammation of joint tissue.

HOW TO USE THIS MEDICATION?
Take Vioxx as presc= ribed even when you are feeling better.
Vioxx can be taken = with or without food.
Application
In Osteoarthritis, the once a day recommended dose 25 to 50 mg.
In analgesia and dysmenorrhea, the once a day recommended dose 25 to = 50 mg.

History and Timelin= e of Vioxx
1993: Studies publi= shed in which indobufen and the     non-selective NSAID flurbiprofen are shown to     reduce cardiovascular (cv) events.=
1998:
      (April)
Results of FitzGe= rald study first presented.
Results expressed= COX-2 specific inhibitors reduced urinary excretion of metabolites. Hypothesis suggested that COX-2 inhibitors alter the balance between prostacyclin = and thromboxane.
Increase the risk= of cv events.
Trial of VIOXX ve= rsus placebo in the prevention of Alzheimer’s in patients with Mild Cognitive Impair= ment (MCI) begins.

History and Timelin= e of Vioxx
            (Nov)
         New Drug Application submitted= to the FDA. Application included data on approximately
         5,400 osteoarthritis patients = who participated in 8 double-blind, placebo-controlled and active -
         comparator studies.
         Investigator-reports of thromb= otic cardiovascular adverse events were seen with VIOXX, placebo, and compar= ator NSAIDs (ibuprofen, diclofenac, or nabumetone).
1999:
      (Jan)
         VIOXX Gastrointestinal Outcomes Research1 (VIGOR) trial initiated.

History and Timelin= e of Vioxx
   (Feb)
        First trial of VIOXX versus pla= cebo for the treatment
        of Alzheimer’s disease begins.<= /font>
   (April)
         Public meeting of FDA Advisory Committee on
     VIOXX NDA.
   (May)
         VIOXX approved by the FDA.
   (Oct)
         Adenomatous Polyp Prevention On VIOXX2
     (APPROVe) trial protocol finalized= .

History and Timelin= e of Vioxx
2000:
       (Feb)
  APPROVe trial enrollment begins.
       (March)
        Preliminary results from VIGOR = become available     to Merck.
         Preliminary VIGOR results submitted to the     FDA.
  Safety data shows no difference in cardiovascular   event rates bet= ween Vioxx and placebo.
       (April)
  Second trial of Vioxx versus placebo = for the     treatment of Alzheimer’s begins .

History and Timelin= e of Vioxx
  (June)
  Final VIGOR data submitted to FDA in = a
  Supplemental New Drug Application wit= h
  administration directions.
  (Nov)
      First Vioxx versus placebo trial = in the treatment of
  Alzheimer’s disease ends.
  Second interim analysis of safety data conducted, again
  showing no difference in cv event rat= es between
      placebo and Vioxx patients.

History and Timelin= e of Vioxx
2001:
       (Feb) Public meeting of FDA Advi= sory Committee on   VIGOR.
       (May)
  Second trial of safety data stopped.<= /font>
       (Oct)
  Analysis of cv data from Phase II/III= =09 studies   published in Circulati= on.
  Analysis demonstrated that Vioxx was = not
       associated with excess cv events compared with   either placebo or non-naproxen NSAIDs= .
       (Nov)
  APPROVe enrollment completed.<= /td>

History and Timelin= e of Vioxx
2002:
       (Jan)
  Merck tells FDA that other safety fin= dings shouldn’t   be as prominent as t= he conclusion that Vioxx is   safer= on stomach.
       (April)
  U.S. Prescribing Information for Vioxx updated   with VIGOR information= and data from two
  placebo-controlled studies.
  First patient is enrolled in VICTOR t= rial.
       (June)
  Pooled analysis of Vioxx and placebo indicated   serious cv events.

History and Timelin= e of Vioxx
2003
       (March)
  Vioxx in Prostate cancer (ViP) protoc= ol finalized.
       (April)
  Trial of Vioxx versus placebo in MCI = ends.
       (June)
  ViP trial enrollment begins.
  Updated pooled analysis presented at = EULAR.
        The cv event rate in patients t= aking Vioxx (25 mg)   continued to be similar to the rate in patients     taking placebo.
  Mean duration of treatment was 1.2 ye= ars in     Vioxx group and 1.3 years in placebo group .
       (Oct)
  Updated pooled analysis demonstrated = that Vioxx
  was not associated with excess cv eve= nts.

History and Timelin= e of Vioxx
2004:
       (Aug)
  FDA drug safety official David Graham states that   higher-dose of VIO= XX shouldn’t be prescribed   because studies cast serious doubt on safety of   Vioxx at doses greater than 25 mg a day.
  The same day John Jenkins, director of office of   FDA’s new drugs, wri= tes that Graham’s conclusion   is “p= retty strong language” since agency wasn’t   considering such a warning for Vioxx label.
        Jenkins suggested a change in wording.
        Graham ends up not including Je= nkins suggested   changes in poster presentation.

History and Timelin= e of Vioxx
   (Sept)
    APPROVe External Data Safety Monito= ring Board
    notifies Merck of its recommendatio= n to end APPROVe
    trial.
    Study showed risks of cv events, pa= tients on 18
    mo. trial period faced double the r= isk compared to
    the placebo.
    APPROVe, ViP and VICTOR trials term= inated early.
       Merck voluntarily withdraws Viox= x from the market.

History and Timelin= e of Vioxx
  (Oct)
       FDA projects that widespread use= of Vioxx led to over 27,000 serious cv events.
      (Nov)
APPROVe trial sc= heduled to end.
       Multiple lawsuits against Merc= k Inc. for the health complications and death of patients.
2005:
       (Aug)
         ViP trial enrollment scheduled= to be completed.
2011:
       (Aug)
             ViP trial scheduled to end= .

Questionable Reacti= ons
Vioxx was on the ma= rket for five years, before it was pulled off.
The Drug was rushed= to the market in six months
Until the voluntary= withdraw of the drug Merck averaged more then 100 million per year on direct to consu= mer advertising
Commercials, ads,= drug reps
Why didn’t the FD= A limit the companies advertising?
There had been no t= ests on the long term effects

Ignoring the Facts<= /a>
Epidemiologic studi= es showed reason for concern.
   These results were ignored by the FD= A, and attacked by Merck
   Press release on May 22, 2001 “Merck Reconfirms Favorable Cardiovascular Safety of Vioxx”
The trials conducte= d by Merck that led to approval did not get published until more then a year after V= ioxx was released.

"Epidemiologic= al studies"
Epidemiological stu= dies
   Showed affect on large populations
Graph from Colon Po= lyp study
   3.5% of patients on vioxx had myocar= dial infraction or a stroke
Many other studies = TARGET, VIGOR… showed reason to be concerned.

Action by the FDA
The FDA waited two = years to review Vioxx
There was only one = major study sponsored by the FDA.
Had no influence on= the recall.

Procedures for New = Drugs
Preclinical Testing=
   -  Investigational New Drug Application (IND).  Includes:
     1. Results of Previous Experimen= ts
     2. How, where and by whom studies were           =    conducted by
     3. How chemical works in the bod= y?
     4. Toxic effects found in animal= test
Phase I Clinical Tr= ial
    -  20 to 80 healthy volunteers
Phase II Clinical T= rials
    -  100 to 300 patients with disease the drug is intended for

Procedure Cond.=
Phase III Clinical = Trials
    -  1,000 to 3,000 patients in clinics and hospitals
New Drug Applicatio= n (NDA)
     -  Contains all gather data to date about drug (Usually about 100,000 pages)
     -  Takes and average of 30 months for drug to be approved    for sale
Phase IV Studies
      -  Data from patients who are currently taking the drug

FDA Improvements
FDA is within the D= epartment of Health and Human Services
   Consists of 8 offices: Center for Dr= ug Evaluation and Research
   Dr. Lester Crawford, November 2004
1. Sponsor Institut= e of Medicine Study of the Drug Safety System
- emphasize post-m= arket phase
2. Program to Adjud= icate differences in Professional Opinion
3. Appoint Director= of Office of Drug Safety (Responsible for post-market safety)
4. Drug Safety/Risk= Management Consultations
5. Publish Risk Man= agement Guidances
-Help pharmaceutic= al agencies with management and minimization of risks

Suggested Improveme= nts
Tighten Regulations=
   -1992 “fast track” for vital med. to treat life-threatening diseases
     -1997 loosened restrictions on direct-to-consumer advertising prescription medications- glossed over ris= ks
Pay attention to al= l patients in drug study, no just healthy subjects
Force drug companie= s to publish all clinical data

Changes in Legislat= ion
Led by Iowa Sen. Ch= uck Grassley
- Taxes make up ma= jority of budget for FDA, drug companies pay              hundreds of millions
Feb. 2005
- Bill for clinica= l trial results to be publicly available to researchers, doctors and consumers
April 2005
- Bill for Indepen= dent Drug Safety Agency- free of drug company influence
800 scientists hand= le drug approval in Office of New Drugs, 14 handle post-approval scrutiny in Offi= ce of Drug Safety
 FDA has no authority to require post-approval studies

Currently
May 18, 2005- FDA a= nnounces members of Drug Safety Oversight Board (DSB)
- provide independ= ent oversight and advice to the director of the Center for Drug Evaluation and Research
Problems:
No authority to pul= l the drug from the market
Majority of DSB mem= bers are senior members of CDER- responsible for drug approvals
- 11 of 15 are CDE= R officials
- 3 of 11 are not = involved in review of new drug applications
- 2 of 3 are from = Office of New Drugs
May 20, 2005 FDA an= nounces meetings will be private

Slide 28

Celebrex, Bextra and FenPhen
Oh My!
Celebrex and Bextra= are both COX-2 inhibitors like Vioxx
  Celebrex shown to cause myriad health problems and was pulled off the market by the FDA
   Bextra was forced off the market due= to the scare of similar drugs
Fenphen, the known = diet drug, was shown to cause increases in a deadly incurable form of hypertension

Are Deadly Medicati= ons the
New Trend?
Many new ‘wonder’ d= rugs are slowly being shown to have an adverse effect on people taking them=
  Oxycontin, Zoloft, Prozac
Pharmaceutical comp= anies are regularly being taken to court over harmful medications
All of these proble= matic drugs show the need to have stricter testing and regulation policies

Bibliography
Topol, Eric J.  Failing the Public Health-Rofecoxib, = Merck, and the FDA.  The New England Jou= rnal of Medicine, 2004 351, 1707
Kweder, Sandra M.D.=   Center for Evaluation and Research, F= ood and Drug Administration 2004

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------=_NextPart_01C5911C.AECB2D70 Content-Location: file:///C:/2EC94422/EthicsPresentation_B_files/pres.xml Content-Transfer-Encoding: quoted-printable Content-Type: text/xml; charset="utf-8" ------=_NextPart_01C5911C.AECB2D70 Content-Location: file:///C:/2EC94422/EthicsPresentation_B_files/v3_slide0043.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Slide 1
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The Ethical
Dilemma
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What is Vioxx?=
<= /td> <= /td> <= /td> <= /td> <= /td> <= /td>
Ø Vi= oxx is a non-steroidal anti-inflammatory drug.
Ø Rel= ieves:
    <= /span>   Arthritis
     Acute pain in adults
     Painful menstrual cycles
     Tendonitis
Ø 3 = strengths available:
     12.5, 25, or 50 mg
------=_NextPart_01C5911C.AECB2D70 Content-Location: file:///C:/2EC94422/EthicsPresentation_B_files/v3_slide0034.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Slide 1
Vioxx was a sc= ientific breakthrough
<= /td> <= /td> <= /td> <= /td> <= /td>
Ø Ch= emical Name rofecoxib
Ø Ot= her trade name
= Ceoxx®
Ø Fi= rst medication to only
in= hibit the COX-2
enz= yme.
Ø Pr= evious NSAIDs inhibited
bo= th COX-1 and COX-2.
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C17= H14O4S
<= /td> = = <= /td> <= /td> <= /td>
Ø Vi= oxx belonged to the group of NSAIDs known
as= coxibs (cyclooxygenase inhibitors).
Ø L= ike other coxibs, including celebrex, and bextra.
It= was considered a COX-2 inhibitor
Ø ac= ting specifically one form of the
cyclooxygenase enzyme, This specificity allowed
Vi= oxx and other inhibitors to reduce discomfort.
Ø Mi= nimal undesired gastrointestinal effects such
as= stomach ulcers.
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HOW DOES VIOXX= WORK?
<= /td> <= /td> <= /td> <= /td> = <= /td> <= /td>
Ø I= n vivo, two enzymes known as COX-1 and COX-
2.<= /font>
Ø CO= X-1 helps regulate normal cell function in the
st= omach and blood.
Ø CO= X-2 plays a role in causing arthritic pain and
in= flammation by increasing cytokines levels in
the= blood.
     Cytokines are compounds that lead= to pain
   and inflammation of joint tissue.
------=_NextPart_01C5911C.AECB2D70 Content-Location: file:///C:/2EC94422/EthicsPresentation_B_files/v3_slide0032.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Slide 1
HOW TO USE THIS MEDICATION?
<= /td> <= /td> <= /td> = <= /td> <= /td>
Ø Ta= ke Vioxx as prescribed even when you are
fe= eling better.
Ø Vi= oxx can be taken with or without food.
Ø App= lication
   In Osteoarthritis, the once a day
   recommended dose 25 to 50 mg.
   In analgesia and dysmenorrhea, the = once a
   day recommended dose 25 to 50 mg.
------=_NextPart_01C5911C.AECB2D70 Content-Location: file:///C:/2EC94422/EthicsPresentation_B_files/v3_slide0026.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Slide 1
History and Ti= meline of Vioxx
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History and Ti= meline of Vioxx
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file:///C:/2EC94422/EthicsPresentation_B_files/v3_slide0036.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Slide 1
History and Ti= meline of Vioxx
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History and Ti= meline of Vioxx
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History and Ti= meline of Vioxx
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History and Ti= meline of Vioxx
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History and Ti= meline of Vioxx
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History and Ti= meline of Vioxx
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History and Ti= meline of Vioxx
<= /td> <= /td> <= /td> = <= /td> <= /td> <= /td> <= /td>
Ø = 2004:
       (Aug)
<= span style=3D'mso-tab-count:2'>       FDA drug safety official David Graham states that
     higher-dose of VIOXX shouldn’t be prescribed
     because studies cast serious doubt on safety of
     Vioxx at doses greater than 25 mg a day.
<= span style=3D'mso-tab-count:2'>       The same day John Jenkins, director of office of
<= span style=3D'mso-tab-count:1'>     FDA’s new drugs, writes that Graham’s conclusion
<= span style=3D'mso-tab-count:1'>     is “pretty strong language” since agency wasn’t
     considering such a warning for Vioxx label.
     =       Jenkins suggested a change in wording.
<= span style=3D'mso-tab-count:1'>     =       Graham ends up not including Jenkins suggested
     changes in poster presentation.
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History and Ti= meline of Vioxx
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History and Ti= meline of Vioxx
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Questionable R= eactions
<= /td> <= /td> <= /td> = <= /td> <= /td> <= /td> <= /td>
Ø V= ioxx was on the market for five years, before it
wa= s pulled off.
Ø Th= e Drug was rushed to the market in six
mon= ths
Ø U= ntil the voluntary withdraw of the drug Merck
a= veraged more then 100 million per year on
di= rect to consumer advertising
     Commercials, ads, drug reps
<= span style=3D'mso-tab-count:2'>     Why didn’t the FDA limit the comp= anies advertising?
Ø Th= ere had been no tests on the long term
eff= ects
------=_NextPart_01C5911C.AECB2D70 Content-Location: file:///C:/2EC94422/EthicsPresentation_B_files/v3_slide0006.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Slide 1
Ignoring the F= acts
<= /td> <= /td> <= /td> <= /td> = <= /td> <= /td> <= /td> <= /td>
Ø Ep= idemiologic studies showed reason for
con= cern.
   These results were ignored by the = FDA, and attacked
by = Merck
   Press release on May 22, 2001 “Mer= ck Reconfirms
Fa= vorable Cardiovascular Safety of Vioxx”
Ø Th= e trials conducted by Merck that led to
a= pproval did not get published until more then a
ye= ar after Vioxx was released.
------=_NextPart_01C5911C.AECB2D70 Content-Location: file:///C:/2EC94422/EthicsPresentation_B_files/v3_slide0007.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Slide 1
<= /td> <= /td> <= /td> <= /td> <= /td> <= /td> <= /td>
Ø Ep= idemiological studies
   Showed affect on large
populations
Ø G= raph from Colon Polyp study
   3.5% of patients on vioxx had
my= ocardial infraction or a stroke
Ø M= any other studies TARGET,
VI= GOR… showed reason to
be= concerned.
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