to-consumer Advertising: Implications for Patient Care
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1 Direct-to to-consumer Advertising: Implications for Patient Care JAMA. 2008;300(17):1985 Biomedical Library Grand Rounds December 2, 2008
2 Today s s Presenters Ellis Rolett, MD Professor of Medicine, Active Emeritus DHMC/DMS Conflicts of interest: none Pamela Bagley, PhD, MLS Research and Education Librarian Dartmouth Biomedical Libraries Conflicts of interest: none
3 Learning Objectives Understand direct-to-consumer advertising (DTCA) as a marketing device Help your patients find authoritative sources of consumer health information
4 Direct to consumer + drugs or pharmaceuticals = 252,000 hits (10/31/2008)
5 Outline Role of FDA DTCA today Asymmetric information Sources of consumer health information
6 Outline Role of FDA DTCA today Asymmetric information Sources of consumer health information
7 Patent Medicine Advertising circa 1905
8 Federal Regulation (1) Biologics Act of 1902 First premarket control legislation. Vaccines were the focus. Pure Food and Drugs Act of 1906 Adopted U.S. Pharmacopoeia and National Formulary as official standards for strength, quality and purity of drugs. Federal Bureau of Chemistry assumed regulatory authority act included provision against false and misleading labeling, which did not cover advertising.
9 Federal Regulation (2) Food, Drug and Cosmetic Act of 1938 Expanded definition of misbranding and false advertising. Required a doctor s prescription for specified drugs. Expanded FDA powers over medical devices. Prescription Drug User Fee Act (PDUFA) of 1992 Designed to speed up new drug approvals by requiring a fee payment used to hire additional FDA employees.
10 FDA Center for Drug Evaluation and Research Funding Sources
11 FDA Structure FDA Commissioner Center for Drug Evaluation and Research (CDER) Office of New Drugs Office of Surveillance and Epidemiology
12 FDA Resources on Drugs and Devices Drug and Device Information from the US Food and Drug Administration CDER - Center for Drug Evaluation and Research CDRH - Center for Devices and Radiological Health CBER - Center for Biologics Evaluation and Research
13 FDA Resources on Drugs and Devices Drug Action Packages - drug products approved by CDER Approved Biologics - drug products approved by CBER Licensed Product Approvals - products approved by CBER
14 FDA Resources on Drugs and Devices Drug and Device Safety Information MedWatch - safety information and adverse event reporting program Public Health Advisories - drug-related warning statements Drug Safety Initiative - information about drug safety issues Medical Device Safety - device recalls, alerts, and other safety information Device Public Health Notifications - risks associated with the use of medical devices Biologics Safety Information - safety notifications by CBER
15 Outline Role of FDA DTCA today Asymmetric information Sources of consumer health information
16 DTCA of Prescription Drugs A First Amendment issue. FDA sanctioned DTCA in Guidance on Consumer-Directed Broadcast Advertisements issued in Permitted only by U.S. and New Zealand. Ads reviewed by Division of Drug Marketing, Advertising and Communications
17 FDA Guidance on DTCA Cannot omit material facts. Must present a fair balance between benefit and risk information. Most significant risks must be disclosed. Ads either contain a summary of side effects and contraindications or make adequate provision for dissemination of the product s FDA-approved label. Drug advertisements are reviewed by FDA only after they have appeared.
18 Impact of DTCA: Assertions Proponents of DTCA Provides educational information. Enhances doctor-patient relationship. Improves adherence to prescription drug regimens. Stimulates competition. Results in lower prices. Opponents of DTCA Consumers lack expertise to evaluate content of ads. Drug risks are not communicated effectively. Encourages overuse of medications. Leads to increased prices. Lyles, Ann Rev Public Health, 2002
19 Impact of DTCA: Facts. Consumers who request an advertised medicine from their doctor very often receive a prescription for that product. Lyles, Ann Rev Public Health, 2002 In 2000, every $1 spent on DTCA yielded an additional $4.20 in drug sales. Kaiser Family Foundation
20 Survey by USA Today Kaiser Family Foundation Harvard School of Public Health March 4, 2008
21 Pharmaceutical Marketing Expenditures in the United States in 2004 Gagnon MA, Lexchin J (2008) PLoS Med 5(1)
22 Promotional Spending Donohue, Cevasco, Rosenthal. NEJM (2007) 357:
23 Annual Spending on DTCA and Professional Promotion ($ M) 35,000 30,000 Direct-to-consumer advertising Professional promotion Free samples Total promotion 25,000 20,000 15,000 10,000 5, Donohue, Cevasco, Rosenthal. NEJM (2007) 357:
24 Feb 13, 2008
25 Express Scripts, Jan 2008
26 Trends in Prescription Use 2000 to 2006 Express Scripts, Jan 2008
27 Trends in Prescription Use 2000 to 2006 Antihyperlipidemics Antidepressants Express Scripts, Jan 2008
28 Trends in Prescription Use 2000 to 2006 Estrogens Express Scripts, Jan 2008
29 Number of DTC Materials Submitted to FDA, GAO-07-54, Nov 2006
30 DTCA: Internet and Podcast In late 2006 AstraZeneca launched a six-part podcast series with About.com as part of its Living with Heartburn program in support of proton pump inhibitor Nexium. The company has also created a video for the effort, which educates consumers on coping with heartburn and acid reflux disease. MM&M June 2007
31 Outline Role of FDA DTCA today Asymmetric information Sources of consumer health information
32 Asymmetric Information (Knowledge Is Power) Agents on one side of a market have much better information than those on the other side Nobel Prize in Economics Patients know their risks, insurance companies may not. Doctors understand the proper treatments, patients may not. Pharmaceutical companies know more about the benefits and risks of drugs than patients.
33 November 21, Popular Radio Host Has Drug Company Ties. Dr. Frederick Goodwin, host of NPR s The Infinite Mind program, earned at least $1.3M from drug makers for marketing lectures. October 3, Top Psychiatrist Didn t Report Drug Makers Pay. Dr. Charles Nemeroff, chair of Emory Univ Department of Psychiatry, earned $2.8M consulting for drug makers. June 8, Researchers Fail to Reveal Full Drug Pay. Dr. Joseph Biederman, child psychiatrist at Mass General Hospital, earned at least $1.6M in consulting fees from drug makers.
34 New York Times February 7, 2008, page 1
35 New York Times February 7, 2008
36 Ask your doctor if LIPITOR is right for you. The Wall Street Journal, Dec 4, 2007
37 Ask your doctor if LIPITOR is right for you. The Wall Street Journal, Dec 4, 2007
38 Ask your doctor if LIPITOR is right for you. The Wall Street Journal, Dec 4, 2007
39 Pfizer pulls Lipitor ads featuring Dr. Robert Jarvik February 26, Pfizer announced that it is withdrawing the TV commercials featuring an endorsement of Lipitor by Dr Robert Jarvik. Dr. Jarvik and Pfizer were a target of a US House Committee on Energy and Commerce investigation into celebrity endorsements in direct-to-consumer advertisements. Pfizer spent $258 million on Lipitor advertisements between January 2006 and September Heartwire,
40 Direct-to to-consumer Advertising Requip
41 Requip Ad Deconstructed Consumer Reports, November 2007
42 LIFE AS PATHOLOGY "It was so frustrating, like a mystery I couldn't solve. Night after night, strange sensations in my legs." Consumer Reports, Nov 2007
43 BUILDING CREDIBILITY "I had to get up and move when all I wanted to do was rest. I had Restless Legs Syndrome." Consumer Reports, Nov 2007
44 OMITTED FACTS "My doctor said symptoms usually get worse when it's time to relax." Consumer Reports, Nov 2007
45 TURNAROUND "And then he said something else. Requip." Consumer Reports, Nov 2007
46 HALF THE STORY "He said Requip would help relieve those RLS symptoms that were making nights so difficult." Consumer Reports, Nov 2007
47 WAKE-UP CALL "He told me what to watch for, that Requip may cause you to fall asleep or feel very sleepy during normal activities such as driving, or to faint or feel dizzy when you stand up." Consumer Reports, Nov 2007
48 DON T T WORRY, BE HAPPY "Tell your doctor if you experience these problems or if you drink alcohol or are taking medicines that make you drowsy. Also tell your doctor if you experience new or increased gambling, sexual, or other intense urges while taking Requip." "Side effects may include nausea, drowsiness, vomiting, and dizziness. Thanks to Requip, the RLS mystery is not keeping me up anymore. Ask your doctor about Requip." Consumer Reports, Nov 2007
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51 Improvement in RLS Symptoms after 2 nights and 2 weeks
52 TREAT*RLS US CLINICAL TRIAL Bogen, Mayo Clin Proc 2006
53 TREAT*RLS US CLINICAL TRIAL Ropinirole in the Treatment of Patients With Restless Legs Syndrome: A US-Based Randomized, Double-Blind, Placebo-Controlled Clinical Trial RICHARD K. BOGAN, MD; JUNE M. FRY, MD, PHD; MARKUS H. SCHMIDT, MD, PHD; STANLEY W. CARSON, PHARMD; AND SALLY Y. RITCHIE, MSC; FOR THE TREAT RLS US (THERAPY WITH ROPINIROLE EFFICACY AND TOLERABILITY IN RLS US) STUDY GROUP Mayo Clin Proc. 2006;81(1):17-27 Financial support for this study came from GlaxoSmithKline Research and Development. Dr Bogan has acted as a consultant and is on the speakers bureau for GlaxoSmithKline; he does industry-funded research for GlaxoSmithKline, SCHWARZ PHARMA, Inc, and Boehringer Ingelheim. Dr Fry has research contracts with GlaxoSmithKline, Merck & Co, Inc, Boehringer Ingelheim, and Sanofi-Aventis. Dr Schmidt has research contracts with GlaxoSmithKline and is a member of GlaxoSmithKline s RLS National Advisory Board. Dr Carson and Ms Ritchie are employees of GlaxoSmithKline.
54 And what about side (adverse) effects?
55
56 Outline Role of FDA DTCA today Asymmetric information Sources of consumer health information
57 Who s s searching for health information on the web? 10 million Americans each day 80% American internet users, or some 113 million adults, have searched some time or other for info. about at least 1 of 17 health topics August 2006 survey of internet users conducted by the Pew Internet & American Life Project
58 How are they searching? Two-thirds start with an internet search engine (like Google or Yahoo) According to the August 2006 survey of internet users conducted by the Pew Internet & American Life Project
59 What s s the impact of their findings? 58% say the information they found affected a decision about how to treat an illness or condition. 55% say the information changed their overall approach to maintaining their health or the health of someone they help take care of. 54% say the information led them to ask a doctor new questions or to get a second opinion from another doctor. August 2006 survey of internet users conducted by the Pew Internet & American Life Project
60 Concerns 25% say they felt overwhelmed by the amount of information they found online 22% say they felt frustrated by a lack of information or an inability to find what they were looking for online August 2006 survey of internet users conducted by the Pew Internet & American Life Project
61 Quality of information Just 15% of health seekers say they "always" check quality indictors (e.g. source and date) an additional 10% say they do so most of the time 85 million Americans gather health advice online daily without consistently examining the quality indicators August 2006 survey of internet users conducted by the Pew Internet & American Life Project
62 How can you help? Guide your patients toward reliable sources of health information Refer them to support at DHMC Consumer Health Library in Matthews-Fuller Health Sciences Library Health Education Center (HEC) Suggest web sites MedlinePlus Biomedical Libraries Consumer Health Information site
63 Consumer Health Library
64 DHMC Health Education Center
65 Consumer Health Information Site Google: consumer health DHMC
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68 MedlinePlus
69 Use MedlinePlus to find information on Restless Leg Syndrome
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74 Use MedlinePlus to find information on Lipitor
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80 Talking with Your Doctor
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88 Drug Information Portal druginfo.nlm.nih.gov/
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94 Outline Role of FDA DTCA today Asymmetric information Sources of consumer health information
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