Asymmetries in Access to Data, Evidence Thresholds, and the Ability to Convey Information
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1 Asymmetries in Access to Data, Evidence Thresholds, and the Ability to Convey Information Robert W. Dubois, MD, PhD, Chief Science Officer
2 CER Will Impact Voice Patient FDA Manufacturer Plans Provider PAST: Manufacturers define the value proposition Quality Orgs ECRI NIH Patient FDA Manufacturer CMS Plans AHRQ Provider BCBS TEC DERP PRESENT: Public private, third parties define value proposition Federal CER Quality Orgs ECRI NIH Patient FDA Manufacturer CMS Plans AHRQ Provider BCBS TEC DERP FUTURE: Many more players involved Time DERP: Drug Effectiveness Review Project AHRQ: Agency for Healthcare Research and Quality BCBS TEC: Blue Cross Blue Shield Technology Evaluation Center Adapted from Avalere
3 A Thought to Ponder Is good for the gander Asymmetry of: Access to data Voice Risk and benefit evidentiary thresholds 3
4 A Thought To Ponder What s good for the goose Asymmetry of: Access to data Voice Risk and benefit evidentiary thresholds Is good for the gander 4
5 Questions to Ponder Is the public s right to know the highest consideration? Is it more important to inform or not mis inform? What if a drug appears to help some patients for off label use, how are others to know? Should communication policies be set at a National, State, or local level? What if a trusted 3 rd party vetted the information first?
6 Resolving Asymmetry Has Potential Pitfalls What s good for the goose Increase restrictions on other players Reduce restrictions on industry Is good for the gander Be careful what you ask for you just might get it
7 Asymmetry in Access to Data Asymmetry in access to data arises when one stakeholder group has preferential access to a source of research information compared with another group of stakeholders For example, government database to which access is limited to academic researchers and not available to commercial product companies
8 There is Asymmetric Access to Data TODAY TOMORROW 8
9 Asymmetry of Evidence Thresholds Asymmetry in evidence thresholds involves the application of different evidence standards to data developed by different stakeholder groups or data used for different purposes
10 FDA Evidentiary Standards Vary Among Decision Makers for drugs: substantial evidence for devices: reasonable assurance for promotion: substantial clinical experience CMS: reasonable and necessary FTC: Competent and reliable scientific evidence
11 Asymmetry of Voice/ Ability to Convey Information Asymmetry of voice arises when there are constraints on one stakeholder group in terms of the scope of information that may be disseminated by that group relative to other groups For example, promotional detailing by industry vs. academic detailing
12 There is Asymmetric Ability to Speak About CER TODAY TOMORROW 12
13 Oddity: FDA versus NIH NIH website recently commented on an antidepressant study, observing it was unlikely for any future similar studies to be run it was too expensive, and this was as good as it gets when it comes to studies Lilly cited the study, and then received a letter from the FDA chastising it for making claims based on the study Slide from Tevi Troy, Hudson Institute
14 The Industry Has More Restrictions Than Others Pharmaceutical companies need multiple clinical trials to support assertions All other organizations the payer, the government, FDA critics can compare without two trials
15 As of 9/24/11 Existing & Upcoming AHRQ Reviews Brain & Nerve Antiepileptic Medications for Seizure Control (Upcoming draft 7/11) Acute Migraine Treatment in Emergency Settings (Upcoming) Preventive Pharmacological Treatments for Migraine (Upcoming) Effectiveness of Treatments for Restless Legs Syndrome (Upcoming) Comparison of Characteristics of Nursing Homes and Other Residential Long Term Care Settings for Persons with Dementia (Upcoming) Breathing Conditions Allergen Specific Immunotherapy for the Treatment of Allergic Rhinoconjunctivitis and/or Asthma (Upcoming) Cancer Report Clinician Patients Recombinant Human Growth Hormone in the Treatment of Cystic Fibrosis 10/10 4/11 4/11 Epoetin & Darboepoetin for Managing Anemia During Cancer (Upcoming Draft 6/10) Policy Maker Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer Comparative Effectiveness of Hematopoietic Stem Cell Transplants in the Pediatric Population (Upcoming Draft 6/10) 5/10 11/10 11/10 Therapies for Clinically Localized Prostate 2/08 7/08 7/08 Medications to Reduce the Risk of Primary Breast Cancer in Women 9/09 1/10 1/10
16 As of 9/24/11 Existing & Upcoming AHRQ Reviews Cardiovascular Conditions Report Clinician Patient Policy Maker Management of Atherosclerotic Renal Artery Stenosis 11/07 6/07 6/07 Radiofrequency Catheter Ablation for Atrial Fibrillation 8/08 11/09 11/09 Lipid Modifying Agents for Treating Cholesterol 9/09 11/09 11/09 Adding ACEIs and/or ARBs to Standard Therapy for Stable Ischemic Heart Disease 10/09 7/10 7/10 Off label uses of Recombinant Factor VIIa 6/10 10/10 ACEIs, ARBS, & DRIs for Hypertension update 6/11 Neurothrombectomy Devices for Treatment of Acute Ischemic Stroke 8/11 Adjunctive Devices to Remove Thrombus and/or Protect from Distal Embolization in Acute Coronary Syndrome Patients Undergoing PCI (Upcoming) Stroke Prevention and Atrial Fibrillation (Upcoming) Testing of CYP2C19 Variants and Platelet Reactivity for Guiding Antiplatelet Treatment (Upcoming) Treatments for Women with CAD (Upcoming) DVT Prophylaxis for Special Populations: LMWH vs. Unfractionated Heparin (Upcoming) VTE Prophylaxis in Orthopedic Surgery (Upcoming)
17 As of 9/24/11 Existing & Upcoming AHRQ Reviews Development Delays, ADHD, Autism Therapies for Children with Autism Spectrum Disorders (Upcoming) 4/2011 ADHD Treatment in Preschoolers and All Ages (Upcoming) Therapies for Adolescents/Young Adults with Autism Spectrum Disorders (Upcoming) Diabetes Report Clinician Patient Policy Maker Premixed Insulin Analogues for Adults with T2DM 9/08 3/09 3/09 Oral Meds for Adults with T2DM 3/11 6/11 6/11 Insulin Delivery & Glucose Monitoring Methods for DM (Upcoming) Digestive System Management of GERD 9/11 9/11 9/11 Therapies for Crohn s Disease (Upcoming Draft 9/11) Treatment for Phenylketonuria (Upcoming Draft 9/11) Endocrine and Metabolism Treatment of Subclinical Hypo or Hyperthyroidism (Upcoming Draft 3/10) Functional Limitations Multidisciplinary Pain Programs for Chronic Non Cancer Pain 6/10 Pressure Ulcer Risk Assessment and Prevention 7/10 Pressure Ulcer Treatment Strategies (Upcoming)
18 Existing & Upcoming AHRQ Reviews Genitourinary Conditions Preventive Medical Therapy for Recurrent Nephrolithiasis in Adults (Upcoming) Screening & Treatment of Early Chronic Kidney Disease (Upcoming) Treatments for Urinary Incontinence in Women (Upcoming) Primary Care Management of Abnormal Uterine Bleeding (Upcoming) Gynecology Treatments for Chronic Pelvic Pain in Women (Upcoming Draft 10/10) Menopausal Symptoms: Comparative Effectiveness of Therapies (Upcoming) Infectious Disease & HIV/AIDS Screening & Treatments of C. Difficile infections (Upcoming) 5/10 Adherence to Hepatitis C Treatment Interventions (Upcoming) Comparative Effectiveness of Treatment for Hepatitis C in Adults (Upcoming) Screening for Hepatitis C Virus Infection in Adults (Upcoming) Comparative Effectiveness of Procalcitonin Guided Decisions for the Diagnosis and Management of Sepsis (Upcoming) Report Clinician Patient Policy Maker As of 9/24/11
19 As of 9/24/11 Existing & Upcoming AHRQ Reviews Mental Health Report Clinician Patient Policy Maker Off label Use of Atypical Antipsychotics 5/10 7/07 2nd Generation Antidepressants for Adults 1/07 8/07 8/07 Traumatic Brain Injury and Depression 4/11 4/11 4/11 1st and 2nd Generation Antipsychotics in Adults (Upcoming) Treatment for Depression after Unsatisfactory Response to SSRIs (Upcoming) 1st and 2nd Generation Antipsychotics in Children and Young Adults (Upcoming) Non Pharmacologic Interventions for Treatment resistant Depression in Adults 9/11 Effectiveness of Interventions Addressing Concomitant Mental Health and Chronic Medical Conditions in the Primary Care Setting (Upcoming) CER of Psychological Treatments and Pharmacologic Treatments for Adults with PTSD (Upcoming) Management Comparative Effectiveness of Medication Adherence Interventions End of Life and Hospice Care (Upcoming) Effects of Bundled Payment Strategies on Health Care Spending and Quality of Care (Upcoming)
20 As of 9/24/11 Existing & Upcoming AHRQ Reviews Musculo skeletal Conditions Report Clinician Patient Policy Maker Analgesics for Osteoarthritis (update ongoing) 9/06 1/07 1/07 Treatment of Primary and Secondary Osteoarthritis of the Knee 9/07 4/09 4/09 Drug Therapies for Rheumatoid or Psoriatic Arthritis in Adults (Update in Progress) 11/07 4/08 4/08 Prevention of Fractures in Men & Women with Low Bone Density or Osteoporosis 12/08 6/08 6/08 Obesity Pain Management for Hip Fracture 5/11 5/11 5/11 DMARDs in Children with Idiopathic Arthritis (Upcoming) Effectiveness of Antinuclear Antibody, Rheumatoid Factor, and Citric Citrullinated Peptide Testing for the Evaluation of Musculoskeletal Complaints in Pediatric Populations (Upcoming) Biologic and Nonbiologic Systemic Agents and Phototherapy for the Treatment of Chronic Plaque Psoriasis (Upcoming) Bariatric Surgery & Nonsurgical Therapy for Adults with Metabolic Conditions and Obesity (Upcoming) Approaches to Weight Maintenance in Adults (Upcoming) Comparative Effectiveness of Childhood Obesity Intervention Programs (Upcoming)
21 Existing & Upcoming AHRQ Reviews Ophthalmologic Conditions Report Clinician Patient Policy Makers Treatment for Glaucoma (Upcoming) Pregnancy and Childbirth Therapeutic Management of Gestational Diabetes 3/08 8/09 9/09 Nitrous Oxide for Management of Labor Pain (Upcoming) Progestogens for Prevention of Preterm Birth (Upcoming) Terbutaline Pump for Prevention of Preterm Birth (Upcoming) Respiratory Conditions Recombinant HGH for Treatment of Cystic Fibrosis 10/10 3/11 3/11 Renal Disease Screening, Monitoring and Treatment of Early Chronic Kidney Disease in Adults (Upcoming) As of 9/24/11 21
22 Knowledge that is not put into practice is like food that is not digested Sri Sathya Sai Baba Indian Spiritual Leader 22
23 Substantial ARRA funding for Conveying Information $681 Millions USD $ Research $132 Data Infrastructure Dissemination and Adoption $19 Administrative support, inventory, evaluation Recovery.gov. Clancy CM. Comparative Effectiveness Research Symposium, Washington DC, June 15, 2010.
24 Many Vehicles to Communicate CER AHRQ s Effective Health Care Program: Integrating Comparative Effectiveness Research into Everyday Practice. October 2010.
25 Academic Detailing is Growing AHRQ funded initiative $11.7M contract to Total Therapeutic Management 1,500 sites (1,300 PCP practices, 200 health systems) 6 visits/site over 3 years Detailing AHRQ reports (pre mix insulin, oral DM agents) States also involved: VT, PA, SC, ME National Resource Center for Academic Detailing (Avorn) 25
26 Government Funds Other CER Communications
27 New Developments May Alter the Landscape Restrictions on manufacturer speech may be clarified and perhaps significantly altered. 1. Citizen Petition filed by 7 companies 2. Sorrell v IMS Health (546 US, 2011) 3. United States v Caronia (2d Circuit, 2011) Slide modified from Alan Bennett, Ropes and Gray
28 IMS v Sorrell VT law prohibits the collection or use of physician identifiable data for purposes of drug marketing or promotion This form of speaker and content based restriction unconstitutional anyone except a pharma manufacturer could collect info and speak about it state had chosen to restrict one class of individuals with a particular viewpoint from saying what anyone else could say Slide modified from Alan Bennett, Ropes and Gray
29 IMS v Sorrell (cont d) The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good. the fear that people would make bad decisions if given truthful information (does not) justify content based burdens on speech. Especially when the audience, in this case prescribing physicians, consists of sophisticated and experienced consumers. Slide modified from Alan Bennett, Ropes and Gray
30 United States v Caronia Caronia was a sales rep for Jazz Pharmaceuticals Caught in government sting operation conspiring with a company paid consultant to promote Xyrem for excessive daytime sleepiness Company had already submitted SNDA Convicted of talking about indication several weeks before it was approved Slide modified from Alan Bennett, Ropes and Gray
31 Possible Decisions in Caronia 1. Uphold conviction 2. Find a technicality and avoid Constitutional issue 3. Use commercial speech doctrine and find no basis for regulation of truthful speech once an SNDA has been filed 4. Find that Sorrell prohibits the regulation of truthful non misleading manufacturer speech Slide from Alan Bennett, Ropes and Gray
32 Questions to Ponder Is the public s right to know the highest consideration? Is it more important to inform or not mis inform? What if a drug appears to help some patients for off label use, how are others to know? Should communication policies be set at a National, State, or local level? What if a trusted 3 rd party vetted the information first?
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