separating the wheat from the chaff obtaining useful information from pharmaceutical representatives...
TRANSCRIPT
Separating the Wheatfrom 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 CelebrexTM?
• 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 LipitorTM coffee mug?
If you answered yes to 2 or more of the above, you may be drug company dependent.
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)
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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
160.8146
125
78.2
0
50
100
150
200
Vioxx Budweiser Pepsi Nike
Million Dollars
Mukherjee D, Topol EJ. Am Heart J 2003;146:563-4.
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 physician-
pitchmen 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;323:1481-4.
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”
CorrectInformation
CorrectCorrectReasoningReasoning++
CorrectConclusion
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
• Appeal to authority
• Bandwagon effect
• Red herring
• Appeal to pity
• Appeal to curiosity
• Error of omission66
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
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Other Techniques
• Testimonial
• Relationship building
– “Face-time” is crucial
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Other Techniques
• Testimonial• Relationship building• Reinforcement
– Message comes in “under the radar”– Pens, pads, trinkets– Office survey for reinforcersShaughnessy AF. JAMA 1988;260:926.
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Other Techniques
• Testimonial
• Relationship building
• Reinforcement
• Cognitive dissonance– Creating
– Relieving66
Other Techniques
• Testimonial
• Relationship building
• Reinforcement
• Cognitive dissonance
• Food– More receptive to messages while eatingJanis I. J Pers Soc Psychol 1965;1:181-6.
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Other Techniques
• Testimonial
• Relationship building
• Reinforcement
• Cognitive dissonance
• Food
• Gifts66
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 awareZiegler MG. JAMA 1995;273:1296-8.
Taking the right “STEPS” when evaluating new information
S = SafetyT = Tolerability
look for “pooled drop-out rates”
E = Effectiveness -- Studies showing that the new drug is better than your current choiceexamples: aspirin vs tPA in acute stroke, adequate vitamin D dose to prevent fractures.
P = PriceS = Simplicity of usePreskorn 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
• Take responsibility for validity • Take active approach, teach PR your needs
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Pharm Rep Curriculum: The Process
R epresenta tive Lea ves,R esidents C om plete Eva lua tion
PR Presents Inform a tion D uring1st ha lf o f Lunch C onference
PR G iven Appointm entEva lua tion Process Expla ined
The Process (continued)
Feedback G ivento Representative
Conclusions Draw n
D iscussion focusing on ProcessDubious Info. questioned
Sales T echniques IdentifiedFallacies Pinpointed