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.
and the Federation of State Medical Boards Research and Education Foundation.
CME Information
Program Speaker/Author: Dean Haxby, PharmD Course Director: 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
Program Directors:
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
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
BMS
Eli Lilly
9%
17%
Amgen
Schering
21%
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
$30,000
Detailing
DTC
Expenditure ($ millions)
$25,000
Professional Advertising
Samples
DTC
$0
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
Year
Source: N Engl J Med 2007;357:673-81.
2005 Dollars
Rx Drugs
16% 15%
11% 9% 9% 6% 7% 7%
9%
5% 5% 5% 5% 5% 6%
9% 8% 8%
Health
2002
2004
2006
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
Skeptical clinician
High prescribers
Thought leaders
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
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
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
University/Medical School Role as a preceptor Developer of clinical guidelines Cardiology specialty (of the six specialties studied)
Rationalization
Its educational Patients need samples
Denial
It doesnt influence me I take it with a grain of salt
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
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
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
The US and New Zealand are the only developed countries to allow DTC advertising for Rx drugs
$ Billions
Direct-to-Consumer Expenditures
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
Improves compliance Physicians are in control, thus it wont lead to inappropriate prescribing
%Rx % Rx Paxil
53% 76% 31% 55% 19% 5% 52% 3% 13% 67% 26% 0%
Adjustment Disorder
Asked about Paxil Asked about antidep No med inquiry
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
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.
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 FDAs power is limited Impossible to regulate what reps say
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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