separating the wheat from the chaff obtaining useful information from pharmaceutical representatives...

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