Transcript Direct to Consumer Advertising

The New DTCA
Landscape
A Rose by Any Other Name,
or Lipstick on a Pig?
www.prescriptionaccess.org
Direct-to-Consumer
Advertising




$4.7 - $5 Billion to consumers in 2006
ROI: 150%-420%
Only US & NZ permit it
But what gets advertised?


Newest, most expensive, and copycats
Not necessarily what’s better, safer, or appropriate
What’s wrong with DTCA
Overemphasizes drug therapy
Ask your Doctor
If Diet and
Exercise are
Right for you…
What’s wrong with DTCA:
Overpromotes brand-name drugs
Ask your Doctor if
hydrochlorothiazide
Is right for you…
What’s wrong with DTCA
Harms Dr-Patient Relationship

Wastes scarce time
in visit

Undermines doctorpatient trust

Affects prescribing
I saw an ad
on TV for…
What drugs need promoting?
“[T]o rely on the drug companies
for unbiased evaluations of their
products makes about as much
sense as relying on beer
companies to teach us about
alcoholism…The fact is that
marketing is meant to sell drugs,
and the less important the drug,
the more marketing it takes to sell
it. Important new drugs do not
need much promotion. Me-too
drugs do.”

Marcia Angell, MD, New England
Journal of Medicine
Vioxx: DTCA’s poster child


Over 20 million people took it
Was it useful?







1-2% of patients, less gastric risk
No better than ibuprofen
Expensive!
80,000-120,000 cardiac events,
32,000-48,000 deaths (Graham)
Millions of unnecessary Rxs
Billions in unnecessary spending
Prediction of public backlash and
increased regulation of DTCA
Post-Vioxx predictions







“DTCA spending will decrease”
“DTCA will become more sober &
educational”
“Consumers will become skeptical”
“Congress will regulate DTCA”
“FDA enforcement will increase”
“Industry will self-regulate”
“DTCA will shift away from TV”
“DTCA spend will decrease”
Annual DTCA spend in billions
5.00
4.50
4.00
3.50
Vioxx withdrawal
Sept 30, 2004
3.00
2.50
2.00
2002
2003
2004
2005
2006
DTCA still “working”
Top 3 Products by Sales, 2006
Drug
Sales
Rank
2006 Sales
DTCA
spend rank
2006 DTCA
spend
Lipitor
1
$8.6 billion
9
$138.2 million
Nexium
2
$4.3 billion
4
$176.7 million
Advair
3
$3.9 billion
7
$145.6 million
Sources: IMS Health, “Top 10 Products by U.S. Sales”, and DTC Perspectives, June/July 2007
DTCA dwarfed by
promotions to physicians
25
20
15
10
5
DTCA
Physicians
(Detailing,
Journal ads
Samples)
0
19
96
19
97
19
98
20
00
20
01
20
02
20
03
20
04
20
05
Spending in billions
30
Source: “A Decade of Direct-toConsumer Advertising of Prescription
Drugs,” Donohue,Julie M.;
Cevasco,Marisa; Rosenthal,Meredith B.,
N Engl J Med, 2007, 357, 7, 673-681
DTCA will become more
sober & educational

Brief surge of “doctors
in white coats”
appearing in ads

Now a mixed bag of
“educational” ads and
over-the-top ads
What were they thinking?
“Disease Awareness ads
will increase”
Tamiflu/Happy Feet tie-in



Not particularly
effective – 1.3 day
reduction
Cost: ~$85.00
Adverse events:
delirium,
hallucinations,
abnormal behavior
“Consumers will become
more skeptical”

Level of trust with drug industry (Harris Poll, 4/07)
 Trust: 27% vs. Distrust 42%

TNS Healthcare Poll of consumers, 6/07
 60%: Ads are misleading and/or contain exaggerated
claims.
 Almost half: Broadcast ads do not contain enough
information about risks and side effects
 43%: Ads are unclear and lead patients to request
inappropriate drugs.
“Congress will regulate DTCA”

PDUFA
 Fines for deceptive ads (Senate: max
$150k, House: max $250k)
 Fees for pre-broadcast review
 No moratorium on DTCA
 No change in standards
 No guarantee of increased enforcement
“FDA Enforcement will increase”
OCC approval requirement, 1/31/02
Vioxx withdrawal, 9/30/04
3
2006
Source: GAO, “Improvements Needed in FDA’s
Oversight of Direct-to-Consumer Advertising”
1
2007 so far
(My additions for
2006 & 2007)
Who got FDA’s coveted
solitary 2007 letter?



“Rozerem would like to
remind you that it’s
back to school
season.”
Rozerem is not
approved for children
Reminder ads violate
PhRMA guidelines
FDA asks Takeda to close the barn
door after the horse is gone



When do kids go back to school? September
When was FDA letter issued? March
What did the letter ask Takeda to do?


“DDMAC requests that Takeda immediately cease
the dissemination of violative promotional
materials for Rozerem such as those described
above.”
“Stop…Or I’ll Shout Stop again!”
“Industry will self-regulate”



PhRMA “Guiding Principles on Direct to
Consumer Advertisements”
 Vague & unenforceable
 “Office of Accountability” report –
no details!
Fox Guarding The Henhouse Award
Violations aplenty
“DTCA will shift away from TV”
DTCA Spending by
Media Type, 2006
1.71%
All TV
1.00%
3.46%
Magazines
26.70%
TV
68.30%
National
Magazines
Sunday
Supplements
Internet
Other
What’s happened since Vioxx?







DTCA spending continues to go up
Ads not really more sober & educational
Consumers somewhat more skeptical, but
DTCA still works
Congress has done little to regulate
FDA enforcement has continued to go down
Industry self-regulation is a joke
DTCA continues to rely on TV, most
ineffective medium for full information
What’s needed









Increase enforcement
 Advisory Review fees would help, but only if will is there
End requirement of FDA Chief Counsel review of letters
Reduce delays in letters
Impose fines permitted by PDUFA
Require pre-dissemination broadcast
Prohibit reminder ads
Regulate disease awareness ads that connect to product ads
Prohibit coupons
Return to pre-1997 requirements – full “brief summary”
Learn more about PAL
 www.prescriptionaccess.org/blog
 www.bitterpillawards.org
 www.askpharmie.org