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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