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Blue Cross Blue Shield Minnesota - RetroDUR
Statistics
How to avoid being one
Blue Cross Blue Shield Minnesota - RetroDUR
Would you fly if two 727s crashed daily?
Would you take a pill if 268 people died daily?
Blue Cross Blue Shield Minnesota - RetroDUR
Adverse Drug Reactions
 A leading (4th-6th) cause of death in American
hospitals
 A leading cause of admissions (6.6 per 100) in
American hospital->1,000,000 annually
 Current estimates (Bootman) up to
$100,000,000,000 annually
 Outpatient/retail unknown, FDA MedWatch
Blue Cross Blue Shield Minnesota - RetroDUR
The FDA
 1-7-02; Joaly Enterprise Company
announces recall of gel candies due to
potential choking hazard
 1-8-02; Awrey Bakeries issues allergy
alert on undeclared egg in 2 ounce
biscuits
 1-9-02; FDA and Bristol-Myers Squibb
strengthen warnings for antidepressant
drug Serzone
Blue Cross Blue Shield Minnesota - RetroDUR
Adverse Drug Reactions
 FDA MedWatch
Estes LL, Fuhs DW, Heaton AH, and Butwinick CS.
Gastric Ulcer Perforation Associated with the use
of Injectable Ketorolac. Ann Pharmacother. 1993;
27:42-43.
Blue Cross Blue Shield Minnesota - RetroDUR
The FDA
 Recent actions
 Vioxx
 9/30/04 FDA.gov
Blue Cross Blue Shield Minnesota - RetroDUR
Chronic Vioxx 50mg
Product labeling - “Chronic use of Vioxx 50 mg
daily is not recommended.”
 risk of HTN x 2
 severe edema 15% increase
 renal insufficiency x 2
Identified chronic Vioxx 50mg use was a problem in
2Q2003
 4,722 patients with a 50mg claim
 3,338 (70.7%) were chronic users (> 30 tablets and
>30 days supply)
Blue Cross Blue Shield Minnesota - RetroDUR
Results - Vioxx 50mg Persistence
% Patients Remaining on
Rofecoxib 50mg
100%
90%
80%
p<0.001
70%
60%
50%
40%
30%
Control
Intervention
20%
10%
0%
0
30
60
Days
90
120
150 162
Blue Cross Blue Shield Minnesota - RetroDUR
What have Vioxx Members Switched to?
 On the day of Vioxx market withdrawal, 9,753
members had a supply of Vioxx available.
 In the 15 days post withdrawal:
 3,877 (39.8%) had filled a Rx for a COX-2 or nonselective NSAID
 142 (3.7%) Mobic
 900 (23.2%) Bextra
 2,123 (54.8%) Celebrex
 712 (18.3%) non-selective NSAID
Blue Cross Blue Shield Minnesota - RetroDUR
Bextra RetroDUR Potential
 Bextra is similar to Vioxx with dose-related increase
risk of HTN and edema.
 Pfizer recently sent a “Dear Doctor” notifying
prescribers of an increased risk of cardiovascular
(CV) thromboembolic events among patients
receiving Bextra post CABG.
 As with Vioxx, no increased CV events in studies up
to a year (Vioxx risk appeared after 18 months).
Blue Cross Blue Shield Minnesota - RetroDUR
Bextra RetroDUR Potential
 5,687 members with Bextra claim (Sep 1 – Oct
22)
 Medical claims analysis looking for CV disease
(ICD claims 410-414, 428, 429.2, or 429.9)
 422 (7.4%) of members with recently filled
Bextra have CVD indicators
Blue Cross Blue Shield Minnesota - RetroDUR
Celebrex
 FDA 12/17/04, NCI polyp study
“Patients in the clinical trial taking 400mg of
Celebrex twice daily had a 3.4 TIMES (emph)
greater risk of CV events compared to placebo.
For patients in the trial taking 200mg of Celebrex
twice daily, the risk was 2.5 TIMES (emph)
greater. The average duration of treatment in
the trial was 33 months.”
Blue Cross Blue Shield Minnesota - RetroDUR
Tysabri for MS
 Approved for marketing 11/23/04
 Withdrawn from market 2/28/05
 <3000 patients exposed in clinical trails over
two years
 >5000 patients exposed in practice in less than
3 months
Blue Cross Blue Shield Minnesota - RetroDUR
Al’s Rules
 Don’t ask for the new drug; think pregnancy *
 Generic , generic, generic *
 Label; on/off?
 Alcohol or aspirin OK?
 Drug demographics-you betcha ya
 Percentages: absolute, relative (gain:pain)*
Blue Cross Blue Shield Minnesota - RetroDUR
Drug Development
In vitro
Studies
Animal
Testing
Clinical Testing
Phase 1
Marketing
Is it safe,
pharmacokinetics?
Biologic
Products
Generics
become
available
Phase 2
Lead
Compound
Efficacy
selectivity
mechanism
Does it work in
patients?
Phase 3
Does it work,
double blind
Phase 4
Chemical
synthesis
Postmarketing
surveillance
Drug metabolism, safety assessment
0
Years
(average)
2
4
8–9
IND
(investigational
new drug)
NDA
(New drug
application)
20
(Patent expires 20 years
following registration
with the USPTO office)
Blue Cross Blue Shield Minnesota - RetroDUR
Al’s Rules
 Drug efficacy v. placebo
 25% RRR
 Drug safety v. placebo
 7% increase in ADR
 Efficacy: Drug 54/100 v. placebo 43/100
 11% increase
 Safety: Drug 8/100 v. placebo 1/100
 700% RRI
 Gain: pain?
Blue Cross Blue Shield Minnesota - RetroDUR
Al’s Rules
 Lies
 Damned lies
 Statistics
Worstpills.org