Transcript Pharmaceutical Industry Marketing and Influence

Pharmaceutical Industry
Marketing and Influence
Dean Haxby, Pharm.D.
Associate Professor of Pharmacy
Oregon State University, College of
Pharmacy
To receive 1.5 AMA PRA Category 1 Credits™,
you must review this progam and pass the CME
quiz at the end.
Release Date: January 2009 Expiration Date: January 2012
Attachments
• The attachments tab contains documents that
supplement the presentation.
• The slides are available as an attachment to print
out to use as a handout for the presentation.
• “Show Me the Evidence” has a list of additional
resources on evidence-based drug information and
industry marketing.
Program Funding
This work was made possible by a grant from the
state Attorney General Consumer and Prescriber
Education Program which is funded by the multi-state
settlement of consumer fraud claims regarding the
marketing of the prescription drug Neurontin.
Continuing Education Sponsors
Continuing Medical Education for the following
activity titled “Pharmaceutical Industry Marketing
and Influence”, is jointly sponsored by The
University of Texas Southwestern Medical Center
and the Federation of State Medical Board’s
Research and Education Foundation.
CME Information
Program Speaker/Author: Dean Haxby, PharmD
Course Director:
Program Directors:
Barbara S. Schneidman, MD, MPH
Federation of State Medical Boards Research and Education Foundation, Secretary
Federation of State Medical Boards, Interim President and Chief Executive Officer
David Pass, MD
Director, Health Resources Commission, Oregon Office for Health Policy and Research
Dean Haxby, PharmD
Associate Professor of Pharmacy Practice, Oregon State University College of Pharmacy
Daniel Hartung, PharmD, MPH
Assistant Professor of Pharmacy Practice, Oregon State University College of Pharmacy
Target Audience: This educational activity is intended for health care professionals who are involved with
medication prescribing.
Educational Objectives: Upon completion of this activity, the participants should be able to: describe the
purpose and expenditures for various marketing strategies and the impact on prescribing; outline techniques
pharmaceutical representatives use to influence clinicians; identify strategies clinicians can use to reduce impact
of marketing; describe the role of samples in marketing and the impact of samples on prescribing; identify drug
sample regulatory requirements and options to improve sample use; summarize research findings on the impact
of direct-to-consumer advertising of prescription drugs; identify potential conflicts of interest.
CME Policies
Accreditation: This activity has been planned and implemented in accordance with the
Essential Areas & Policies of the Accreditation Council for Continuing Medical
Education through the joint sponsorship of The University of Texas Southwestern
Medical Center and the Federation of State Medical Boards Research and Education
Foundation. The University of Texas Southwestern Medical Center is accredited by the
ACCME to provide continuing medical education for physicians.
Credit Designation: The University of Texas Southwestern Medical Center designates
this educational activity for a maximum of 1.5 AMA PRA Category 1 Credits™.
Physicians should only claim credit commensurate with the extent of their participation
in the activity.
Conflict of Interest: It is the policy of UT Southwestern Medical Center that
participants in CME activities should be made aware of any affiliation or financial
interest that may affect the authors presentation. Each author has completed and signed a
conflict of interest statement. The faculty members’ relationships will be disclosed in
the course material.
Discussion of Off-Label Use: Because this course is meant to educate physicians with
what is currently in use and what may be available in the future, “off-label” use may be
discussed. Authors have been requested to inform the audience when off-label use is
discussed.
DISCLOSURE TO PARTICIPANTS
It is the policy of the CME Office at The University of Texas Southwestern Medical Center to ensure
balance, independence, objectivity, and scientific rigor in all directly or jointly sponsored educational
activities.
Program directors and authors have completed and signed a conflict of interest statement disclosing a
financial or other relationship with a commercial interest related directly or indirectly to the program.
Information and opinion offered by the authors represent their viewpoints. Conclusions drawn by the
audience should be derived from careful consideration of all available scientific information. Products may
be discussed in treatment outside current approved labeling.
FINANCIAL RELATIONSHIP DISCLOSURE
Faculty
David Pass, M.D.
Dean Haxby, Pharm.D
Daniel Hartung, Pharm.D., MPH
Barbara S. Schneidman, MD, MPH
Type of Relationship/Name of Commercial Interest(s)
None
Employment/CareOregon
None
None
Learning Objectives
1. Describe the purpose and expenditures for various
marketing strategies and the impact on prescribing
2. Outline techniques pharmaceutical representatives use
to influence clinicians
3. Identify strategies clinicians can use to reduce impact of
marketing
4. Describe the role of samples in marketing and the
impact of samples on prescribing
5. Identify drug sample regulatory requirements and
options to improve sample use
6. Summarize research findings on the impact of direct-toconsumer advertising of prescription drugs
7. Identify potential conflicts of interest
Important Contributions by the
Pharmaceutical Industry
• Development of new treatments that
improve health and well-being
• Make substantial contributions to
educational, health care and professional
organizations
• Provide indigent care programs
Pharmaceutical Manufacturers
• Are for-profit companies
• Primary mission is to increase share holder
value
• This is accomplished by:
– developing new products
– successfully marketing those products
– having an effective lobby to protect and
advance their interests
2007 Fortune 500 Profits
J &J
21%
Pfizer
37%
Merck
20%
Abbott
8%
Wyeth
21%
BMS
9%
Eli Lilly
17%
Amgen
21%
Schering
11%
Pharmaceutical Industry
• One of the most profitable industries in the
US
• Industry advocates argue these profits are
justified because:
– Required to support R & D
– Tremendous value of medications
– High risk of the industry
• A report by Tufts University says it costs
$802 million to bring a drug to market
Industry Critics
• Profits are excessive
• Drug development cost figures grossly inflated
– exclude tax deductions/credits, include capital
opportunity cost (1/2 of total), skewed sample of drugs,
industry figures not verifiable
• Government funds much of critical research on
new drugs
• Uninsured cannot afford medications
Public Citizen
Pharmaceutical Industry
Marketing
•
•
•
•
A key to industry profitability
Highly effective
Very sophisticated
Multi-pronged campaigns targeting
clinicians and patients
Pharmaceutical Industry
Promotion & Marketing
$35,000
Samples
Expenditure ($ millions)
$30,000
Detailing
DTC
$25,000
Professional Advertising
Samples
$20,000
$15,000
$10,000
Detailing
Professional
Advertising
$5,000
DTC
$0
2005
2004
2003
2002
2001
2000
1999
1998
1997
1996
Year
Source: N Engl J Med 2007;357:673-81.
2005 Dollars
Annual Increase in US Prescription
Drug & Total Health Expenditures
Annual % Change
Rx Drugs
20%
17% 17%
18%
16% 15%
16%
13%
14% 13%
12%
10%
11%
11%
12%
11%
11%
8%
6%
10% 9%
6% 7%
7%
4%
6%
8%
12%
9%
5% 5% 5% 5% 5% 6%
9%
9%
8% 8%
6%
7% 7%
9%
Health
2%
0%
1990
1992
1994
1996
1998
2000
2002
2004
2006
Expenditures by Type of
Marketing 2004 ($ Billions)
Samples
Detailing
DTCA
IMS
15.9
7.3
4
CAM
6.3
20.4
4
Total
15.9
20.4
4
Percent
28%
36%
7%
Meetings
E-promo.
Journals
No data
No data
0.5
2
0.3
0.5
2
0.3
0.5
3%
0%
1%
Unmonitored
Total
No data
27.7
14.4
47.9
14.4
$57.5
25%
Gagnon MA, Lexchin J. PLoS
Medicine 2008;5:1-5
Pharmaceutical Representatives
• Still the major focus of pharmaceutical marketing
• Approximately 100,000 reps in 2005 vs 38,000 in
1995
• 1 rep per 6 MDs in US and 1 rep per 2.5 targeted
MDs
• 6 million detail visits annually
• Cost estimate $12 - $13 thousand per MD on
detailing (IMS data)
• PhRMA:”serves an essential function in the health
care delivery system”
Characteristics of
Representatives
•
•
•
•
Presentability/appearance
Outgoing personality
Excellent interpersonnal skills
Assertive
Representative Training
• How to be observant and assess clinician
personalities
• How to adjust approach based on reactions
and profile information
• How to gather and use personal information
to establish a connection
• How to monitor impact of various
marketing strategies on prescribing
Plos Medicine 2007;4(4):0621-25
How Representative Can Tailor
Approach
• Friendly clinician
• Frame interactions as
gesture of friendship
• Skeptical clinician
• Use literature, humility,
appeal to their “high
intellect”
• High prescribers
• Make best effort to
establish personal
connection, best gifts
Plos Medicine 2007;4(4):0621-25
How Representaive Can Tailor
Approach
• Clinician prefers
competing product
• Find out why, try to
capture a niche
• Refuses to see reps
• Try to work through office
staff, can get useful
information
• Thought leaders
• Friendly thought leaders
groomed for speaking
circuit. Monitor impact of
local talks and their
allegience
Plos Medicine 2007;4(4):0621-25
Targeted Clinicians
• High volume prescribers
• Specialists: scripts they initiate can continue
for years by PCPs
• Opinion leaders
• Low volume, non-influential clinicians
receive much less attention
Physician Rating of Rep
Information Usefulness
60%
50%
40%
30%
20%
10%
0%
Very
Somewhat
Not Very Not at All No Answer
Useful
Kaiser Family Foundation Report
March, 2002
Physician Rating of Accuracy of
Representative Information
80%
70%
60%
50%
40%
30%
20%
10%
0%
Very
Somewhat
Not Very
Not at All
Kaiser Family Foundation March,
2002
No Answer
Stages of Rep/Provider
Interactions
• Acknowledgement of relative status
– Valuable time, opinion leader
• Find out what is known
• Outline benefits of product
– Expert name drop
• Provider resistance
• Reinforcement of role
– Compliments, sympathy
• Closure: ensure opportunity for return, gifts,
obligation
BMJ 2001;323:1481-84
Benefits to Provider
• Pleasant respite from workday demands
• Someone who is “impressed” with their “superior
knowledge”
• Can be object of flattery and sympathy
– Psychological benefits
• Receipt of gifts
• Can present themselves as skeptic
– Questions information, doesn’t agree to prescribe
• Can feel like they were in control
BMJ 2001;323:1481-84
Representative Goals
•
•
•
•
•
Develop positive relationship
Opportunity for future contact
Create a sense of obligation
Control agenda
Promoting product appears secondary in
many interactions
Influence on Prescribing
• Studies show that prescribing is influenced by
industry representatives
• Higher cost, less rational prescribing is associated
with:
– Frequency of use of representatives as an information
source
– Perceived credibility of representative
• Even a few minutes of contact can impact
prescribing
Arch Fam Med 1996;5:237
Soc Sci Med 1988;26:1183
Perceived Influence of
Pharmaceutical Reps
70%
60%
50%
40%
None
A Little
A Lot
30%
20%
10%
0%
You
Other MDs
Am J Med 2001;110:551
Physician/Drug Representative
Meetings
Specialty
Family Physicians
Internal Medicine
Cardiology
Pediatrics
Surgeons
Anesthesiology
Meetings/Month
16
10
9
8
4
2
N Engl J Med 2007;356:1742-50
Physician Industry Relationships
Benefits
Samples
Gifts
Travel/CME funding
Payments
Any Relationship
% Reporting
78%
83%
35%
28%
95%
N Engl J Med 2007;356:1742-50
Physician Factors Associated
With Receipt of Payments
• Practice with < 25% Medicaid/uninsured
• Private practice
– Less likely in hospital/HMO setting
•
•
•
•
University/Medical School
Role as a preceptor
Developer of clinical guidelines
Cardiology specialty (of the six specialties
studied)
N Engl J Med 2007;356:1742-50
Physician Interactions With
Detailers
• Physicians are aware of potential conflicts
• Interactions are welcomed
• Reps described as:
– Pleasant
– Friendly
– Helpful
J Gen Intern Med 2007;22:184-90
Methods to Deal With Potential
Conflict of Interest
• Eliminate the conflict
– Can be difficult and painful
• Rationalization
– “Its educational”
– “Patients need samples”
• Denial
– “It doesn’t influence me”
– “I take it with a grain of salt”
J Gen Int Med 2007;22:184-90
Clinician Marketing Data
• One of best market research systems in the
world
• Manufacturers have extensive data
• Collect information from pharmacies,
PBM’s, AMA and Government
• Can track impact of different strategies
• Profiles help target efforts
Ann Intern Med 2007;146:742-8
AMA Master File
• Has been sold to industry for decades
• Contains physician identifier data that can be
linked to other prescribing data
• Generated 16% of AMA revenue in 2005
• Due to member concerns, a new “opt out” option
allows individual physicians to request that
companies not share their individual data with
representatives
• Most doctors do not know about the program and
few have signed up (<1%)
Ann Intern Med 2007;146:751-2
How to “Opt-out”
• Physicians can enroll by going to the following
website:
– www.ama-assn.org/go/prescribingdata
• Purchasers of the data must agree to restrict
prescriber profiling by reps for those who have
opted out
• Must be renewed every three years and
manufacturers have 90 days to comply after
requesting the opt-out
Ann Intern Med 2007;146:742-48
Conclusions on Representative
Marketing
• Industry invests billions on detailing
• Most prescribers meet with representatives
• Representatives are skilled at developing
relationships with and influencing clinicians
• Meetings with representatives are
associated with less rational prescribing and
increased costs
• Most physicians feel they are not influenced
What Can Clinicians Do?
• Reduce or eliminate contact with industry
representatives
– “Just say no”
• Identify and use unbiased and independent sources
of prescribing information
– Medical letter, prescribers letter, cochrane data-base of
systematic reviews, Oregonrx.gov
– See the document in attachments for sources of
evidence-based drug information
• Opt-out to limit use of AMA master profile
Drug Samples
• A major marketing strategy
• An estimated $18 billion (retail value)
distributed in 2005
• Estimated use: 10-20% of patient
encounters
• Primary industry goals :
– Influence prescribing habits/get patients on med
– Representative access, a reason to visit
Trends in Retail Value of Sample
Distribution
20
18
16
14
12
10
8
6
4
2
0
Retail Value $ Billions
1996
1998
2000
2002
2004
Arguments for Samples
• A source of medications for the indigent
• Reduces cost to patient
• Provider can test effectiveness and
tolerability before committing patient to
long term use
• Prescribers can gain experience with a
product
Arguments for Samples
• Can start therapy immediately
• A way around formulary or PA
requirements
• Can assist with patient instruction
• Improves patient satisfaction
• Enhances patient-provider relationship / gift
giving
Arguments Against Samples
• Loss of pharmacist review/counseling
• Clinician unfamiliarity may increase chance
of medication errors
• Sub-optimal treatment choices may be made
• Labeling/documentation is often deficient
• Storage concerns
– Environment
– Security
Arguments Against Samples
• Estimated that only about half reach
patients
• Ethical concerns with personal use by
providers
• Only branded expensive drugs are sampled
which increases overall cost of care
• Inconsistent supplies for indigent patients
Survey of Sample Use
•
•
•
•
12% of Americans received samples
13% of patients with insurance received samples
10% of the uninsured received samples
72% of sample users were above 200% of the
federal poverty level
• 82% of sample users had health insurance the
entire year while 18% were uninsured at least part
of the year
Am J Public Health 2008;98:284-9
Sample Use in Pediatrics
• 4.9% of children received samples in 2004
• 10% of those receiving a prescription
medication received samples
• 84% went to patients with insurance the
whole year
• Over 500,000 children received drugs that
were subsequently subject of serious safety
concerns
Pediatrics 2008;122:736-42
Samples Influence on Prescribing
• Randomized 29 Internal Medicine residents
to a no sample and sample group
• No sample group was:
– Less likely to use an advertised brand drug
– Trend towards less expensive drugs
Am J Med
2005;118:881-4
Samples Influence on Prescribing
• Studied 32 family medicine resident and
faculty physicians prescribing for
hypertension before and after a ban on
samples
• Prescribing of first-line agents increased
from 38% to 61%
• Impact was greatest on residents
Fam Med 2002;34:729-31
Other Research on Sample Use
• In a physician survey of the effect of sample
availability on prescribing, it was concluded that
sample availability influences choice of drug and
can lead to suboptimal drug selection (J Gen Int
Med 2000;15:478-83)
• Samples are frequently used by clinicians or their
family members; and by office staff: in one clinic
the retail cost of samples taken was $10,000
(JAMA 1997;278:141-3)
Sample Impact on Cost and
Continuation
• Patient out-of-pocket costs increased 47%
(p<0.001)
• Total Rx costs increased 38% (p< 0.0001)
• The odds of continuing the same medication
was dramatically lower after receipt of a
sample than a prescription: OR, 0.22 (CI
0.08 – 0.65)
Medical Care 2008;46:394-402
Conclusions on Drug Samples
• Samples are a major marketing tool
– Reps gain access
• Sample use can lead to higher costs for both
patients and the health care system
• Sample use may compromise the quality of
prescribing
• Samples are less likely to go to the
uninsured
Prescription Drug Marketing Act
(PDMA)
• Due to abuse, sample regulations were
implemented in 1987 (PDMA)
• Applies to manufacturers
• Manufacturers must keep records of sample
distribution
• Requires signed requests by prescribers
• Requires appropriate storage conditions
JCAHO Sample Requirements
•
•
•
•
•
•
•
Applies to hospitals and health-systems
Same standards as non-sample medications
Written policies and procedures
Proper, secure storage, regular inspections
Labeled and dispensed like other meds
Documentation same as other orders
An effective recall mechanism
Strategies to Improve Sample
Use
• Apply JCAHO requirements
• Develop sample formulary
– Consider use of generic samples
• Clinics can ban samples
– No Free Lunch has developed a patient education
leaflet entitled “Why we don’t have free samples”
– It is available for download free of charge at
www.nofreelunch.org
– Helps to support clinics that choose not to accept
samples
Direct to Consumer (DTC)
Advertising
• Advertising directly targeting consumers
• In 1997, the FDA relaxed regulations
• Eliminated requirement to list all side-effects
– Allowed referral to another source of information such
as a toll free number or website
• The US and New Zealand are the only developed
countries to allow DTC advertising for Rx drugs
Trends in DTC Advertising
5
4.5
4
3.5
3
2.5
2
1.5
1
0.5
0
$ Billions
1996
1998
2000
2002
2004
2006
Type of DTC Advertising
• Print Advertising
– Magazines
– Newspapers
• Television
• Radio
• Internet
Direct-to-Consumer Expenditures
Nexium
(AstraZeneca)
$224 Million (2005)
Lunesta (Sepracor)
$214 Million (2005)
Vytorin (Merck/SP)
$155 Million (2005)
Coke Classic
$146 Million
(2004)*
Source: Donohue JM. NEJM. 2007;357:673-81; *WSJ Oct 7, 2005;
**WSJ Apr 16, 2004
Bud Light
$136 Million
(2003)**
PhRMA Position on DTC Ads
• Serves to improve public health
– Prompts people to seek care
– Promotes informed discussions
– Provides useful information to consumers
• Improves compliance
• Physicians are in control, thus it won’t lead
to inappropriate prescribing
Public Citizen Position on DTC
• Promotion not education
• Ads increase demand for newer more
expensive products, thus increase costs
• Physician gate-keepers susceptible to
marketing
• Can stimulate inappropriate use
• Can harm doctor-patient relationship
• FDA is grossly understaffed to regulate
www.publiccitizen.org
Systematic Review of DTCA
• Patients who request a drug are 16x more likely to
get it
• DTCA campaigns significantly increase trend of
Rx volume of targeted drugs
• DTCA campaigns can increase new diagnoses
• Concern about risks of treating minor conditions
• To date no studies of patient satisfaction or health
outcomes
Qual Saf Health Care 2005;14:246-50
Kaiser Family Foundation Study
• 30% of adults have talked to their doctor as
a result of seeing a drug ad
• 44% of these individuals were prescribed
the drug they asked about
• Showed TV ads for Nexium, Lipitor and
Singulair
Kaiser Family Foundation November,
2001
Kaiser DTC Study Results
• Ads prompt patients to talk with their provider
• Those with greatest health needs most likely to
take action
– 25% without condition would discus further
• Educational ability is mixed
– Patients can identify condition, drug name, and need to
see doctor; but most felt they knew little or nothing
more about the condition or drug
– Many subjects could not recall side effects or where to
get additional information
Kaiser Family Foundation November,
2001
Clinician Response to DTCA
Based Medication Requests
• Survey of PCPs comparing clinician
responses to a request for more information
based on DTC ad vs. a reference book
• Requests based on DTC adds:
– Were more likely to become annoyed
– Less likely to answer questions
– Less likely to provide written information
Arch Intern Med 2003;163:1808-12
Survey Respondents Response to
a Hypothetical Denied Request
•
•
•
•
46% thought they would be disappointed
25% would try to change prescribers mind
24% might try a different doctor
15% thought they would switch to a new
doctor
Health Affairs 2000;19(2):110-128
Influence of Patient Requests on
Antidepressant Prescribing
• 298 physician visits by standardized pts
• Patients presented with symptoms of two
conditions: major depression, adjustment
disorder
• Divided into three groups
– Asked about Paxil
– Asked about antidepressants in general
– No mention of drug therapy
JAMA 2005;293:1995-2002
Influence of Patient Requests on
Antidepressant Prescribing
• Major Depression
– Asked about Paxil
– Asked about antidep.
– No med inquiry
%Rx % Rx Paxil
53%
76%
31%
52%
3%
13%
55%
19%
5%
67%
26%
0%
• Adjustment Disorder
– Asked about Paxil
– Asked about antidep
– No med inquiry
JAMA 2005;293:1995-2002
DTC Model
• Advertising increases awareness of
condition and treatment
• Awareness motivates patients to seek care
or treatment
• Requests lead to increased prescribing
• DTC essentially adds patients to the
manufacturers sales force
Common Patient Misperceptions
• Many think DTC ads are reviewed and
approved by the FDA before an add is
released
• Some patients think DTC advertised drugs
are completely safe and only highly
effective agents are advertised
DTC Advertising Conclusions
• DTCA works to increase sales
• There is a substantial return on investment for
manufacturers
• While DTCA can increase the rate of treatment,
research shows there is potential for increases in
both appropriate and inappropriate treatment
• Policies are needed to mitigate risks of DTCA in
the US
Common Techniques Used in
Ads
•
•
•
•
•
Drug touted as unique, new or first
Appeal to authority
Bandwagon appeal
Appeal to celebrity
Appeal to fear
Slide Courtesy of NoFreeLunch.org
Disease Mongering
• Strategies to expand markets
• Promotional campaigns change the way people think about
common ailments
– Menopause becomes hormone deficiency
– Shyness becomes social anxiety disorder
– Acid indigestion becomes gastroesophageal reflux disease
• Lowering thresholds for treating common conditions
• The US has 5% of the worlds population yet accounts for
50% of drug consumption
• For an entertaining video that provides a hypothetical
example, go to www.youtube.com and search for
motivational deficiency disorder. Click on a new epidemic.
Selling Sickness by Moynihan and
Cassels
Regulation of Marketing
• FDA responsible for oversight, not Federal
Trade Commission (FTC)
• Research suggests journal ads often do not
meet all FDA requirements
• FDA does not have adequate staff
• FDA’s power is limited
• Impossible to regulate what reps say
Industry Sponsored CE Programs
• Industry invests heavily in educational
programs as part of their overall marketing
plan
• $2.4 billon spent on CME in 2006
– 712,163 hours of education
– 61% supported by commercial sources
• It may be very difficult to critically evaluate
information provided
Assessing Bias in Commercially
Supported CME
•
•
•
•
Disclosure: Required whether COI present or not
Branding
Ideally should present levels of evidence
Favorable presentation of data, especially using
low level evidence
• Watch out for verbiage suggesting weak evidence:
“its possible”, “may be”, “in my experience”
• Unapproved use of products
– Off-label drug use must be clearly identified
Questions to Ask
• Why am I attending?
• Are there better sources of information?
• Will I be able to critically evaluate this
information?
Conclusions
• The primary mission of a pharmaceutical company
is to generate profit and increase shareholder value
• Effective marketing helps companies achieve their
mission
• Enormous amounts are expended in the marketing
of prescription drugs, primarily for detailing,
samples and DTCA
• Industry marketing is sophisticated, influential and
impacts health professionals decision making
Conclusions
• Industry marketing can lead to sub-optimal prescribing
• Current marketing practices are controversial and opinions
vary depending on ones perspective
• Clinicians can make choices to avoid undue influence
• Using unbiased and evidence-based sources of drug
information and avoiding commercial sources as much as
possible is an important step
• Consider signing up for the AMA opt-out program to
prevent detailers from using your individual prescribing
data at www.ama-assn.org/go/prescribingdata
Thank you
This work was made possible by a grant from the
state Attorney General Consumer and Prescriber
Education Program which is funded by the multi-state
settlement of consumer fraud claims regarding the
marketing of the prescription drug Neurontin.
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