Separating the Wheat
from the Chaff
Obtaining Useful Information from
Pharmaceutical Representatives
Based on: Shaughnessy AF, Slawson DC, Bennett JH. Separating the wheat from
the chaff: identifying fallacies in pharmaceutical promotion. J Gen Intern Med
1994;9:563-8.
The CAGE Questionnaire
for Drug Company Dependence
• Have you ever prescribed Celebrex ?
TM
• Do you get Annoyed by people who complain about drug lunches
and free gifts?
• Is there a medication loGo on the pen you're using right now?
• Do you drink your morning Eye-opener out of a Lipitor coffee
mug?
If you answered yes to 2 or more of the above, you may be drug
company dependent.
TM
Source: www.NoFreeLunch.org
Drug
Rep
Bashing
Pharmaceutical Advertising
“The best defense the physician can muster
against (misleading) advertising is a healthy
skepticism and a willingness . . . to do his
(sic) homework. He must cultivate a flair for
spotting the logical loophole, the invalid
clinical trial . . . and the unlikely claim.
Above all, he must develop greater
resistance to the lure of the fashionable and
the new”
P.R. Garai, 1964
Drug Advertising
• “Promoting drugs to doctors these days is
much like selling soap to customers. It’s all in
the marketing”
– Former CEO of Pfizer, in the Wall Street Journal
• Advertising is an unabashed attempt to get
someone to buy something.
– F. Ingelfinger, former editor of NEJM
• Advertising is “the science of arresting the
human intelligence long enough to get money
from it.”
– S. Leacock. The Garden of Folly. ©1924.
Drug Advertising
• The goal of advertising is to inform,
remind, or persuade the target audience
• The difference? A select group (clinicians)
controls consumption for millions
(patients)
3
Drug Advertising
• Information alone rarely changes behavior
• Provides information, but has to generate
an emotional response to work
– Pride, fear, anger, ego gratification – all work
• Target audience considers themselves
rational and critical, requiring special
techniques
Pharmaceutical Representatives
• Education experts
• Extremely effective at changing behavior
• Advertising budget exceeds entire cost of
medical education for USA
– a large proportion of this budget is spent on PRs
Wolfe SM. J Gen Intern Med 1996;11:637-9.
Other Sales Forces: Patients
200
160.8
146
150
125
100
78.2
50
0
Vioxx
Budweiser
Pepsi
Nike
Mukherjee D, Topol EJ. Am Heart J 2003;146:563-4.
Million Dollars
Other Sales Forces: Patients
• Goal of DTC advertising: create a sales
force of patients
• Effective: 40% of patients get
prescriptions for the drugs they ask for!
Other Sales Forces: Colleagues
• Wall Street Journal: “At small meetings, these physicianpitchmen tell their peers about diseases and the drugs to
treat them, often pocketing $750 or more from the sponsor.”
• 2004; 237,000 physician-led meetings
• Speaker training – the new sales method
• Trusted colleagues = good sales
– Merck: Return on investment twice as high with MD-led
discussion groups
Hensley S, Martinez B. Wall Street Journal, July 15, 2005
The Evidence
• Increased prescribing with increased contact
– more costly prescribing
– more nonrational prescribing
– new drug prescribing
– decreased use of generic drugs
• More requests for formulary additions
– “dose-related” increase with sponsored meals
Wazana A. JAMA 2000;283:373-80.
The Evidence
• Company-sponsored speakers:
– increased residents’ inappropriate treatment
decisions
– occurred even in residents who could not
remember the speakers’ affiliations (“under
the radar”)
• CME: increases prescribing of sponsors’
drugs
Wazana A. JAMA 2000;283:373-80.
Pharmaceutical Representatives
• Excellent source for “Patient-Oriented
Evidence that Matters,” especially with an
active approach
• Experts on drugs they sell – sdf indications,
dose, side effects, pharmacokinetics
• Cannot provide information on when or for
whom
Usefulness Score
• Validity: Moderate
• Relevance: Moderate. Much irrelevant
info.
• Work: Low
If validity or relevance is zero,
usefulness is zero
Coming to a Theater Near You
The Drug Rep Always Rings Twice
A 1-act, 6
scene play
Based on: Somerset M, et al. Dramaturgical study of meetings between general
practitioners and representatives of pharmaceutical companies. BMJ 2001;323:14814.
The Plot
• Scene 1: The exchange of status
– Drug rep acknowledges subordinate status
and then proceeds to take a superior role by
giving of a present
– “Here you go . . . A desk calendar to use. . .”
• Scene 2: Introduction of the conflict
– Find out what they know. Let them know they
are entirely correct but have the potential to
do better
– “Are you aware of . . . “
The Plot
• Scene 3: Bring in the dragon killer
– Cite the benefits of the drug, using research evidence
and always by mentioning an expert.
– “Dr. __ at the university – he’s certainly switching
over patients”
• Scene 4: Doc takes center stage
– The doc brings out his/her own armor to fight off the
new information
– “Yes, but . . .”
The Plot
• Scene 5: All glory, laud, and honor
– Having created conflict, the drug rep re-establishes
empathy with compliments and sympathy
– “I know cost is an issue . . . you’re getting a lot of
pressure . . .”
• Scene 6: The rep sets the hook
– Bring out more gifts, try to squeeze out more
indebtedness
– “Before I go I have something else for you . . .”
The “Appeals Process”
Correct
Correct
+
Information
Reasoning
Correct
Conclusion
See: Johnson RH, Blair JA. Logical Self-Defense. 2nd ed. Toronto:
McGraw-Hill Ryerson Limited. 1991.
Appeals – Rational/Non Rational
• Rational: All relevant information,
true facts, sound reasoning
connecting facts to conclusion
• Non-rational: Fallacy of Logic
Non-Rational Appeal
• “Cefawhatzitcalled” is effective against
98% of bacteria causing sinusitis
• “Cefawhatzitcalled” is the best drug for
treating sinusitis
• You should use my drug for
your patient
Fallacies of Logic
•
•
•
•
•
•
6
Appeal to authority
Bandwagon effect
Red herring
Appeal to pity
Appeal to curiosity
Error of omission
Appeal to Authority
• “Dr. ____ from ____ University uses this
drug”
• The fallacy: basing a decision on an
authority’s decision, not on the authority’s
reason for making the decision
Bandwagon Effect
• “This is the most prescribed ____ in the U.S.”
• The fallacy:
– A derivative of the appeal to authority
– Not knowing reasons why the drug is the most
prescribed
– The Ford Escort is the best selling car in the world . . .
Red Herring
• This drug:
– Has a unique carboxyl group on the terminal chain
– Is safer in the event the patient also overdoses on
acetaminophen (Tylenol)
– Penetrates the bacterial cell wall better
• The fallacy: interesting (or not) but irrelevant
information
Appeal to Pity
• “Can’t you help me out by trying . . .”
• “Doesn’t every patient deserve a trial . . .”
• The fallacy: Basing a decision on
emotions (pity, wishful thinking), rather
than evidence
Appeal to Curiosity
• “Let me show you this brief
demonstration of how our drug works”
• “Our antibiotic is a zwitterion . . .”
• The fallacy: Similar to the red herring
appeal, the demonstration or highlighting
of a non-clinical uniqueness captivates
the mind
Error of Omission
• “I’m glad you asked me that question. . .”
• The fallacy: Omitting information
necessary for making a totally informed
decision
– STEPS: Safety, Tolerability, Effectiveness,
Price, Simplicity
Other Techniques
• Testimonial
– Experts
– Self-testimonial
6
Other Techniques
• Testimonial
• Relationship building
– “Face-time” is crucial
6
Other Techniques
• Testimonial
• Relationship building
• Reinforcement
– Message comes in “under the radar”
– Pens, pads, trinkets
– Office survey for reinforcers
Shaughnessy AF. JAMA 1988;260:926.
6
Other Techniques
• Testimonial
• Relationship building
• Reinforcement
• Cognitive dissonance
– Creating
– Relieving
6
Other Techniques
• Testimonial
• Relationship building
• Reinforcement
• Cognitive dissonance
• Food
– More receptive to messages while eating
Janis I. J Pers Soc Psychol 1965;1:181-6.
6
Other Techniques
• Testimonial
• Relationship building
• Reinforcement
• Cognitive dissonance
• Food
6
• Gifts
Gifts
• Acceptance establishes relationship with
attendant obligation
• Culturally programmed to return “gift”
• Goal of advertising- “emotional response”
Chren MM, Landefeld CS, Murray TH. doctors, drug companies, and gifts.
JAMA 1989;262:3448-3451.
Sunshine Policy
“What would my patients think if
they knew they were paying for
this (Cruise on the river, dinner at
the Clifton, box seats) ?”
AMA Opinion E-8.061 Gifts to Physicians from Industry
What Can We Do?
• Identifying non-rational does not ensure
protection
• Common (mis)belief: “can receive . . . and
not be influenced”
• “. . . implies lack of judgment . . .”
• The more unaware, the more vulnerable
• Visceral response, not intellectual
FDA Commissioner
• “An enormous potential exists for misleading
advertisement to reach physicians and
influence prescribing decisions” -- David
Kessler, MD (Kessler DA. Ann Intern Med 1992;116:950-1).
• Proving information is secondary goal, primary
goal is to sell product
– 12% of statements incorrect, easily correctable
– one fourth of clinicians aware
Ziegler MG. JAMA 1995;273:1296-8.
Taking the right “STEPS” when
evaluating new information
S=
T=
Safety
Tolerability
look for “pooled drop-out rates”
E=
Effectiveness -- Studies showing that the
new drug is better than your current choice
examples: aspirin vs tPA in acute stroke, adequate vitamin D
dose to prevent fractures.
P=
S=
Price
Simplicity of use
Preskorn SH. Advances in antidepressant therapy: the pharmacologic basis. San
Antonio: Dannemiller Memorial Educational Foundation, 1994
STEPS- Clinical Example
Should ezetimibe be used to treat
hypercholesterolemia?
Safety:
• No safety issues
• No  rhabdomyolysis in comb. with statins
STEPS- Clinical Example
Tolerability:
• No particular issues
• Pooled dropout rate 5% (= placebo)
STEPS- Clinical Example
Effectiveness:
• LDL-C 18-25% when used alone
• Ezetimibe + 10 mg simvastatin: LDL-C to same
degree as higher doses of simvastatin alone
• But . . .
– No research showing its effectiveness in  death, stroke,
CV disease
– No research in patients with other illnesses
STEPS- Clinical Example
Price:
• $75/month
• Less than simvastatin, atorvastatin
• Simv. 10 mg + ezetimibe > simvastatin 40 mg (at
least now)
Simplicity
• QD
• No dosage adjustments
• Can be given with or without food
STEP- Clinical Example
Should SSRIs be the drug of first choice for the
treatment of depression?
– Anderson IM, Tomenson BM. Treatment
discontinuation with SSRIs compared with tricyclic
antidepressants: A meta-analysis. BMJ
1995;310:1433-8.
– 62 RCTs, double-blind comparing efficacy and
tolerability
Measured Outcomes
• Efficacy: Hamilton Depression Rating
scale
• Tolerability: Pooled drop-out rates
Results
• Efficacy: favored Tricyclics
• Tolerability: favored SSRIs
– drop-out rates nearly equal, 30.8% vs 33.4%
• NNT 10 vs 9
• What about safety?
– suicide rates equal
• Price: Large difference, but need to
consider total cost of care
Information Mastery
• Rely on PR for data, not decisions
• Look for “Patient-Oriented Evidence that
Matters”, the reasons to choose one drug
over another
– STEPS
4
• Take responsibility for validity
• Take active approach, teach PR your
needs
Pharm Rep Curriculum: The Process
PR Given Appointment
Evaluation Process Explained
PR Presents Information During
1st half of Lunch Conference
Representative Leaves,
Residents Complete Evaluation
The Process (continued)
Discussion focusing on Process
Dubious Info. questioned
Sales Techniques Identified
Fallacies Pinpointed
Conclusions Drawn
Feedback Given
to Representative