Presentation is loading. Please wait.

Presentation is loading. Please wait.

James M. Moss Lecture Virginia Chapter American College of Physicians Jeffery P. Harris MD, MACP March 1, 2013.

Similar presentations


Presentation on theme: "James M. Moss Lecture Virginia Chapter American College of Physicians Jeffery P. Harris MD, MACP March 1, 2013."— Presentation transcript:

1 James M. Moss Lecture Virginia Chapter American College of Physicians Jeffery P. Harris MD, MACP March 1, 2013

2 1)Does DTCA provide a net positive for US health care? 2) 1 st Amendment of the Constitution –do individuals and corporations have the same 1 st amendment rights? –is the freedom to speak, the freedom to hear?

3 3) Government’s regulatory role? 4)Where is the proper balance between: everyone’s eagerness to have the best drug therapy for self and family vs societal concern about the nation’s aggregate prescription drug cost

4 Greene and Herzberg. Am J of Public Health 2010 May; 100 (5):

5 1906 Voluntary pledge of the “Ethical Houses” codified by Pure Food and Drug Act –Creates the Food and Drug Administration (FDA) –To ensure: labeling reflects strength, quality, and purity standards 1912 Sherley Amendment –prohibits fraudulent claims in drug labels 1914 Federal Trade Commission (FTC) created –to regulate interstate advertising Greene and Herzberg. Am J of Public Health 2010 May; 100 (5)

6 FTC no jurisdiction over ads in medical journals –Deference to physician expertise Council of Pharmacy and Chemistry of AMA –arbiter of ethical marketing to physicians –“Seal of Acceptance” on ads in JAMA and other journals Greene and Herzberg. Am J of Public Health 2010 May; 100 (5)

7 Until 1920 advertising restricted to medical and pharmaceutical professionals E. A. Squibb & Sons and Parke, Davis & Company Place ads in Saturday Evening Post and Ladies Home Journal –No mention of a product or indication –Tout: High standards of modern pharmaceuticals Physicians as heroic

8 Greene and Herzberg. Am J of Public Health 2010 May;100 (5)

9 Greene and Hertzberg. Am J of Public Health 2010 May;100 (5)

10 Greene and Herzberg. Am J of Public Health 2010 May; 100 (5)

11 Post WWII sees increases in: –Synthetic drugs for market –Brand names…Pharmaceutical profitability –Pressure to advertise…profitability for journals 1955 AMA discontinues its “Seal of Acceptance”

12 Greene and Herzberg. Am J of Public Health 2010 May; 100 (5) Nature of the drug advertisements change – Earlier, drug names never mentioned…but in the mid 1950’s brand names appear in ads 1953 Major Pharma companies establish public relation firm: Health News Institute Chet Shaw, Director (former Executive Editor/Newsweek)

13 Greene and Herzberg. Am J of Public Health 2010 May; 100 (5) Health News Institute and Medical and Pharmaceutical Information Bureau –clinical studies as press releases –favored science writers got early access –“short shorts” small boxes of text provided at no charge to newspapers as fillers between stories –“featurettes” small broadcasts free to radio stations to fill dead air time –“backgrounder” seemingly unbiased stories on “miracle drugs” by science writers

14 Greene and Herzberg. Am J of Public Health 2010 May; 100 (5) Science writers Lawrence Galton and Donald Cooley each wrote more that 100 Pharma-favorable pieces Galton stories in: –Family Circle –Cosmopolitan –Successful Farming

15 Greene and Herzberg. Am J of Public Health 2010 May; 100 (5) Galton “Aureomycin: It Fights Germs Penicillin Won’t” “…available right now on you doctor’s prescription, a powerful new drug promises to play a heroic role in the health of your family.”

16 Greene and Herzberg. Am J of Public Health 2010 May; 100 (5) Cooley in Cosmopolitan Miltown helped “…frigid woman who abhorred marital relations respond more readily to their husbands advances.”

17 Morgan. Open Medicine, Vol 1, No 1 (2007) 1962 Kefauver-Harris Amendment to the Congressional Food and Drug Act (1938,1951): FDA (not FTC) to regulate prescription drug ads Package inserts must include: “Brief Summary” of side effects, contraindications, warnings, indications “Fair Balance” of risk/benefit

18 st DTCA in the US appears Readers Digest and Washington Post –Oraflex (benoxaprofen) –Pneumovax (pneumococcal vaccine) –Zovirax (acyclovir) Morgan. Open Medicine, Vol 1, No 1 (2007)

19 Green. Am J of Public Health 2010 May; 100 (5): FDA/ Federal Register : –“Brief Summary” and “Fair Balance” must apply to DTCA …but limited space in print publications and cost of broadcast air time made it impossible for Pharma to meet the threshold…so early DTCA highlighted diseases without mention of the drug

20 Major Statement + 4 sources for information –Toll free telephone service –Concurrently running print ads or brochures –The consumer’s health care provider –Website Morgan. Open Medicine, Vol 1, No 1 (2007)

21 Print Media DCTA Print Media DCTA $35 million1987 -$35 million By mid-1990’s DTCA moved to TV By mid-1990’s DTCA moved to TV $380 million $380 million $790 million $790 million Morgan. Open Medicine, Vol 1, No 1 (2007)

22 After ’97 guidelines defined the boundaries, DTCA grew rapidly: –By 2005 DTCA spending in US $4.24 billion annually Morgan. Open Medicine, Vol 1, No 1 (2007)

23 Every $1 spent on DTCA increases sales of the advertised drug by an estimated $2.20 to $4.20 Ventola. Pharmacy and Therapeutics. Oct 2011; v.36 (10)

24 Mintzes. Annu Rev. Public Health :

25 Beyond simply satisfying FDA’s requirement to make providers a source of info for patients, Pharma wanted health professionals to be prepared for DTCA-induced patient visits. Morgan. Open Medicine, Vol 1, No 1 (2007)

26 DTCA – 408% Sales Reps - 144% Samples - 229% …so competitors’ products do not benefit significantly from DTCA-induced demand Morgan. Open Medicine, Vol 1, No 1 (2007)

27 On the 100 th anniversary of the Pure Food and Drug Act of 1906 IOM study commissioned by the FDA organization, methods and performance

28 Center for Drug Evaluation and Research (CDER) undertook : Study of the “Brief summary”: how patients use it/content/graphics, layout, and font Research into distraction in broadcast television: collective role of the audio, textual and visual portions Research on print page advertisements: “…which manipulations bring consumers closer or farther way from an independent physician assessment….” CDER Update 2007

29 FDA Amendment Act ) Gave FDA authority to: Require DTCA material be submitted for review before ad is aired Seek civil monetary penalties against companies for false or misleading ad 2) Statement of risk in broadcast must be in a “clear, conspicuous, and neutral manner” 3) Print ads must contain explanation of how to report adverse reactions 4) User fee (since 1992) paid by manufacturer toward cost of reviewing new drug continue for 5 more years. 25% of the FDA’s budget in 2011 CDER Update 2007, 2011

30 IOM recommendations not implemented 2 year moratorium on DTCA after new drug approval - voluntary delay averages 15 months “Black Triangle” ( as in UK ) on new drugs, new combinations of active substances, and new delivery systems - 2 years - FDA may shorten or extend on case-by-case basis Bacui, et al editors. IOM. National Academies Press 2007

31 FDA Drug Approvals new drugs 2 biologics 8 OTC new approvals or new uses 188 generic drug tentatively approved CDER Update FDA 2007

32 Staff of 35 Division of Drug Marketing and Communication 53,000 pieces of promotional material to review in 2005 Up from 36,700 in 2002 Bacui, et al Eds. IOM. National Academies Press 2007

33 Percentage of Ads Reviewed Before Being Aired: % 32% Donohue et al NEJM 357;7 August 16, 2007

34

35 Scope and funding of FDA’s regulatory authority HHS Congressional Oversight Constitutionality of the law Supreme Court

36 Abortion legal in New York /illegal in Virginia Commonwealth of Virginia could not band newspaper ads for the procedure freedom of “commercial speech” Shuchman. NEJM 365;22 May 31, 2007

37 Commonwealth of Virginia could not stop pharmacists from posting drug prices… ”the free flow of commercial information is indispensable.” (Justice Harry Blackburn for the majority) Shuchman. NEJM 365;22 May 31, 2007

38 Supreme Court said the justification for prohibiting an ad must address three things: –Is the ad misleading –Does banning the ad advance a substantial government interest (eg public health) –Could government’s interest be advanced through less restrictive means (eg adding special labeling) The court used similar “tests” in overruling prohibitions on advertising of alcohol and tobacco Shuchman. NEJM 365;22 May 31, 2007

39 Federal law prevented pharmacists from advertising compounded drugs as “protection of the public’s health” Supreme Court held that the law was unconstitutional –“…if the government could achieve its interest in awareness that does not restrict speech, that restricts less speech, the government must do so.” (5-4 majority) Shuchman. NEJM 365;22 May 31, 2007

40 A predictable need for new FDA guidelines and new judicial opinions

41 Greene and Herzberg. Am J of Public Health 2010 May; 100 (5)

42 No FDA guidelines for eDTCA 2.0 Facebook – 500 million users Twitter – 100 million (most in the US) Friendster – 100 million (mainly Asia) Liang and MacKay. J Med Internet Res July-Sept: 13(3): e64

43 Of Top Ten Global Pharmaceutical Companies… 10/10 have presence on Facebook Twitter/Friendster Sponsored blogs Really simple syndication (RSS) feeds 8/10 - dedicated YouTube channel 8/10 - developed health care communications-related mobile apps Liang and MacKay. J Med Internet Res July-Sept: 13(3): e64

44 Mintzes. Annu Rev. Public Health :

45

46 Of Top 10 DCTA drugs 9/10 - dedicated website 7/10 - Facebook page 9/10 - health communications- related Twitter & Friendster traffic 8/10 - television ads on YouTube 9/10 – non-corporate eDTCA for purchase without prescriptions/illegal online pharmacies Liang and MacKay. J Med Internet Res July-Sept: 13(3): e64

47 18/20 - were subject to black box warning, recall, or other safety notification Liang and MacKay. J Med Internet Res July-Sept: 13(3): e64

48 a) block foreign internet protocol (IP) addresses b) all ads and testimonials transparent re funding c) “fair balance” of safety data must appear with all promotional materials d) social media (eg Facebook, Twitter) must police illicit pharmacies Liang and Mackay. J Med Internet Res July-Sept: 13 (3): e64 eDTCA

49 Informed and Empowered or Naive and Mislead …opinions are widely varied

50 1.Misinforms patients –eg only 25% of ads mentioning prevalence of risks exceed 8 th grade education level 2.Promoted unwarranted trusts –50% respondents thought ads approved by the government –43% thought drugs had to be completely safe to be advertised –22% thought if drugs had serious side effects they could not be advertised Ventola. Pharmacy & Therapeutics 2011 October; 36(10)

51 3) Could promote underutilization –paradoxically, litany of risks can promote unreasonable fears of drug 4) Benefits v risks not “fair balance” –84% FDA citations of manufacturers were for exaggerating benefits or minimizing risks –Mismatch of visual images/verbal message eg scene of patient taking lovely walk as drug risks outlined –FDA: allows drug company to present risks in any order they choose at discretion of company whether to include placebo comparative data does not address qualifying language – ads may use “mild”, “usually”, “short time”, “if” and “may” Ventola. Pharmacy & Therapeutics 2011 October; 36(10)

52 5) Strains relationship with health care provider –15% of patients whose request is denied consider switching physicians 6) Inadequate regulation –“pre-clearance” of DTCA not required –even if required…2008 only 35% of broadcasts ads reviewed due to FDA staff shortage 7) Increase costs of “me-too” or “copycat” drugs –eg rosiglitazone (Avandia, GlaxoSmithKline) and prioglitazone (Actos, Takeda) no more effective or safer than older, less expensive meds Ventola. Pharmacy & Therapeutics 2011 October; 36(10)

53 8) “Medicalization” of natural conditions, cosmetic issues, or trivial ailments 9) Promotes new drugs before safety profiles fully known – R ofecoxib (Vioox, Merck) $100 million/year on marketing $1 billion/year in sales – Sept 30, 2004 – Merck voluntarily removed Vioox from market incidence of MIs and CVAs – Safety advisories, black box warnings, or withdrawals eg: benozaprofen (Oroflex, Eli Lilly) troglitazone (Rezulin, ParkeDavis) cisapride (Propulsid, Janssen) ceriva statin (Baycol, Bay tegaserod (Zelnorm, Norvartes) Ventola. Pharmacy & Therapeutics 2011 October; 36(10)

54 1.Inform, educate, empower patients 2.Encourage patients to contact a clinician –2004 FDA survey – exposure to DTCA prompted 27% of Americans to make appointment with clinician –53% of physicians said DTCA led to better discussions with patients 2006 GAO survey – only 2-7% of patients got script for requested drug 3.Encourages patient compliance –Harvard/MGH survey – 46% of physicians felt DTCA increase patient compliance Ventola. Pharmacy & Therapeutics 2011 October; 36(10)

55 4. Reduces misdiagnosis & undertreatment –Harvard/MGH survey – 25% of patients who visited a doctor after seeing DTCA received new diagnosis 5. Removes the stigma of certain diagnosis –finasteride (Proscar/Merck) – widely regarded as increasing awareness of BPH –1997 genital herpes drug campaign – 45% patients prompted by seeing ad –erectile dysfunction 6. encourages product competition Ventola. Pharmacy & Therapeutics 2011 October; 36(10)

56 1) Does DTCA provide a net positive for US healthcare? Very mixed opinions 2) 1 st Amendment of the Constitution –do individuals and corporations have the same 1 st amendment rights? –is the freedom to speak, the freedom to hear Supreme Court clear on “commercial speech”

57 3)Government’s regulatory role? Vagaries of politics 4)Where is the proper balance between: everyone’s eagerness to have the best drug therapy for self and family vs societal concern about the nation’s aggregate prescription drug cost Providers’ role fulfilled

58 Center for Drug Evaluation and Research Update. Improving Health through Human Drugs. FDA 2007, 2011 Direct-to-Consumer Prescription Drug Advertising. A Position Paper of the American College of Physicians Donohue, J M, et al. A Decade of Direct-to-Consumer Advertising of Prescription Drugs. NEJM 357;7 August 16, 2007: Greene, J. A and Herzberg, D. Hidden in Plain Sight Marketing Prescription Drugs to Consumers in the Twentieth Century. Am J of Public Health May; 100 (5):

59 The Future of Drug Safety: Promoting and Protecting the Health of the Public. Baciu, A, Stratton, K, and Burke, S, Editors. Institute of Medicine. National Academies Press Liang, B.A. and Mackay, T K. Prevalence and Global Health Implications of Social Media in Direct-to-Consumer Drug Advertising. J Med Internet Res July-Sept: 13 (3): e64 Mintzes B. Advertising of Prescription-Only Medicines to the Public; Does Evidence of Benefit Counterbalance Harm? Annu. Rev. Public Health ; Morgan, S G. Direct-to-Consumer Advertising and Expenditures on Prescription Drugs: A Comparison of Experiences in the United States and Canada. Open Medicine, Vol 1, No 1 (2007) e37-e45

60 Shuchman, M. Drug Risks and Free Speech – Can Congress Ban Consumer Drug Ads? NEJM 356;22. May 31, 2007: Ventola, C.L. Direct-to-Consumer Pharmaceutical Advertising. Pharmacy & Therapeutics. October, 2011; v.36 (10): , Topol, E. J. Failing the Public Health – Rofecoxib, Merck, and the FDA. NEJM 351;17 Oct 21,2004 Ventola, C.L. Direct-to-Consumer Pharmaceutical Advertising. Therapeutic or Toxic. Pharmacy & Therapeutics. October, 2011; v.36 (10): ,

61 James M. Moss Lecture Virginia Chapter American College of Physicians Jeffery P. Harris MD, MACP March 1, 2013


Download ppt "James M. Moss Lecture Virginia Chapter American College of Physicians Jeffery P. Harris MD, MACP March 1, 2013."

Similar presentations


Ads by Google