Transcript At Issue… - American College of Physicians

James M. Moss Lecture
Virginia Chapter American College of Physicians
Jeffery P. Harris MD, MACP
March 1, 2013
1) Does DTCA provide a net positive
for US health care?
2) 1st Amendment of the Constitution
– do individuals and corporations have the same
1st amendment rights?
– is the freedom to speak, the freedom to hear?
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
• NA and European drug firms decry the
hucksterism of patent medicine ads
• As “Ethical Houses” pledge:
a) US Pharmacopoeia standards for their
products
b) Marketing only to physicians (as per AMA
Code of Ethics)
Greene and Herzberg. Am J of Public Health 2010 May; 100 (5): 793-803
• 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)
• 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)
• 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
Greene and Herzberg. Am J of Public Health 2010 May; 100 (5)
Greene and Herzberg. Am J of Public Health
2010 May;100 (5)
Greene and Hertzberg. Am J of Public
Health 2010 May;100 (5)
Greene and Herzberg. Am J of Public Health 2010 May; 100 (5)
• 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”
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)
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
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
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.”
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.”
Greene and Herzberg. Am J of Public Health 2010 May; 100 (5)
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
Morgan. Open Medicine, Vol 1, No 1 (2007)
1982-83 1st 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)
1985 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
Green. Am J of Public Health 2010 May; 100 (5): 793-803
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)
Print Media DCTA
• 1987
-$35 million
By mid-1990’s DTCA moved to TV
- $380 million
1996 - $790 million
• 1995
•
Morgan. Open Medicine, Vol 1, No 1 (2007)
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)
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)
Mintzes. Annu Rev. Public Health 2012 33: 259-277.
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)
• 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)
• On the 100th anniversary of the Pure
Food and Drug Act of 1906
IOM study commissioned by the FDA
organization, methods and performance
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
• FDA Amendment Act 2007
1) 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
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
FDA Drug Approvals 2007
76 new drugs
2 biologics
8 OTC new approvals or new
uses
188 generic drug tentatively
approved
CDER Update FDA 2007
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
Percentage of Ads Reviewed Before
Being Aired:
1996
2004
64%
32%
Donohue et al NEJM 357;7 August 16, 2007
Donohue et al NEJM 357;7 August 16, 2007
• Scope and funding of FDA’s regulatory
authority
HHS
Congressional Oversight
• Constitutionality of the law
Supreme Court
• 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
• 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
• 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
• 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
A predictable need for new FDA
guidelines and new judicial opinions
Greene and Herzberg. Am J of Public Health 2010 May; 100 (5)
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. 2011. July-Sept: 13(3): e64
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. 2011. July-Sept: 13(3): e64
Mintzes. Annu Rev. Public Health 2012 33: 259-277.
Mintzes. Annu Rev. Public Health 2012 33: 259-277.
Of Top 10 DCTA drugs
• 9/10 - dedicated website
• 7/10 - Facebook page
• 9/10 - health communicationsrelated 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. 2011. July-Sept: 13(3): e64
18/20 - were subject
to black box warning, recall,
or other safety notification
Liang and MacKay. J Med Internet Res. 2011. July-Sept: 13(3): e64
eDTCA
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 2011. July-Sept: 13 (3): e64
Informed and Empowered
or
Naive and Mislead
…opinions are widely varied
1. Misinforms patients
– eg only 25% of ads mentioning prevalence of risks
exceed 8th 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)
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)
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)
8) “Medicalization” of natural conditions, cosmetic issues, or
trivial ailments
9) Promotes new drugs before safety profiles fully known
– Rofecoxib (Vioox, Merck)
• 1996-2004 - $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)
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)
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)
1) Does DTCA provide a net positive for US
healthcare?
Very mixed opinions
2) 1st Amendment of the Constitution
– do individuals and corporations have the same
1st amendment rights?
– is the freedom to speak, the freedom to hear
Supreme Court clear on “commercial speech”
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
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. 2006
Donohue, J M, et al. A Decade of Direct-to-Consumer Advertising
of Prescription Drugs. NEJM 357;7 August 16, 2007: 673-681
Greene, J. A and Herzberg, D. Hidden in Plain Sight Marketing
Prescription Drugs to Consumers in the Twentieth Century. Am J
of Public Health. 2010 May; 100 (5): 793-803
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. 2007
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.
2011. 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. 2012.
33;259-77
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
Shuchman, M. Drug Risks and Free Speech – Can Congress Ban
Consumer Drug Ads? NEJM 356;22. May 31, 2007: 2236-2239
Ventola, C.L. Direct-to-Consumer Pharmaceutical Advertising. Pharmacy &
Therapeutics. October, 2011; v.36 (10): 669-674, 681-684
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): 669-674,
681-684
James M. Moss Lecture
Virginia Chapter American College of Physicians
Jeffery P. Harris MD, MACP
March 1, 2013