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The CAGE Questionnaire for Drug Company Dependence. Have you ever prescribed C elebrex TM ? Do you get A nnoyed by people who complain about drug lunches and free gifts? Is there a medication lo G o on the pen you're using right now?

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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.


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Case

You are an overworked, under-appreciated physician in a large hospital-based practice and while going through the mail find an invitation to a lecture on a new diabetes drug. The lecture, sponsored by the manufacturer, takes place in a restaurant at New York City’s Madison Square Garden, and is preceded by dinner. Following the lecture, the invitation reads, you will be escorted to your seat to watch a basketball game between the Knicks and the Raptors. “A free Knick game sounds pretty good,” you think to yourself, “and that lecture doesn’t sound half-bad either.”

Would you accept the invitation?


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American Medical AssociationCouncil on Ethical & judicial Affairs(JAMA, Jan 23/30, 1991)

  • “Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value.”

  • “Subsidies from industry should not be accepted directly or indirectly to pay for the costs of travel, lodging, or personal expenses of the physicians who are attending the conferences and meetings . . .”

  • “No gifts should be accepted if there are strings attached.”


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American College of PhysiciansPhysicians and the Pharmaceutical IndustryPosition Statement (Ann Int Med, April 15, 1990)

“Gifts, hospitality, or subsidies offered to physicians by the pharmaceutical industry ought not to be accepted if acceptance might influence or appear to others to influence the objectivity of clinical judgement. A useful criterion in determining acceptable activities and relationships is: Would you be willing to have these arrangements generally known?”


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Canadian Medical Association Policy SummaryPhysicians and the Pharmaceutical Industry(CMAJ, Feb 1, 1992)

  • “Practicing physicians should not accept personal gifts from the pharmaceutical industry or similar bodies”

  • “Practicing physicians may accept patient-teaching aids appropriate to their area of practice provided these aids carry only the logo of the donor company and do not refer to specific therapeutic agents.”


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The Royal College of PhysiciansThe Relationship between physicians and the pharmaceutical industry(J Royal Coll Phys London, October 1986)

  • “A physician should not accept inordinate or excessive hospitality from any pharmaceutical company. The borderline of acceptability is not easy to define. The provision of modest refreshment at a conference should be construed as reasonable; a lavish private dinner party at a restaurant should not. A pharmaceutical company should not be expected to extend hospitality to the spouse of a physician.”

  • “ . . . A useful criterion of acceptability may be ‘would you be willing to have these arrangements generally known?’”


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“A useful criterion in determining acceptable activities and relationships is: Would you be willing to have these arrangements generally known?” (ACP)____________

[Image of flyer]


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Distinguish? and relationships is: Would you be willing to have these

  • Pens, notepads, stethoscope tags

  • Sponsored conferences/lunch

  • Unrestricted grants

    from

  • Dinners

  • Happy hours

  • Sporting events


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But and relationships is: Would you be willing to have these

Gifts:

  • Create relationship, obligation.

  • Erode professional values, damage image of profession.

  • Cost money -- patients pay?

  • Influence behavior.

    (Chren, Landefeld, Murray, JAMA ‘89)


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Pharmaceutical industry promotion, and relationships is: Would you be willing to have these pharmaceutical industry profits


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Farmaceutical Facts: and relationships is: Would you be willing to have these

  • The pharmaceutical industry spent $15.7 billion dollars in 2000 on promotion, up from $ 13.9 billion in 1999.

  • Most of this was spent on promoting products to doctors and free drug samples.

  • Sixty million “details” were made by 83,000 reps in the year 2000. $7.2 billion dollars worth of free samples were distributed.

  • The “Research-based” pharmaceutical industry spends more on promotion and administration than it does on research and development.


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Promotional spending on prescription drugs, and relationships is: Would you be willing to have these

in billions of dollars, l996-2000 .

Source: NIHCM


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Promotional spending on prescription drugs 2000 and relationships is: Would you be willing to have these

Total spending: $l5.7 billion dollars

Source: IMS Health


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Pharmaceutical Industry Profits and relationships is: Would you be willing to have these

  • Source: Public Citizen update of Stephen W. Schondelmeyer calculation, Competition and Pricing Issues in the Pharmaceutical Market, PRIME Institute, University of Minnesota based on data found in Fortune magazine, 1958 to 1999; Fortune magazine, April 2000, Fortune 500 (www.fortune.com).


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Pay, Profits, and Spending by Drug Companies: and relationships is: Would you be willing to have these

  • All of the 9 U.S. drug companies that market the top-selling 50 drugs for senior citizens spent more money on promotion and administration than on research and development in FY 2000.

  • 6 of these 9 companies made more money in net profits than they spent on R&D.

  • For the highest-paid executive in each of the 9 companies, the average compensation was almost $19,000,000.

Source: Families USA


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Source: Public Citizen analysis of company annual reports; and relationships is: Would you be willing to have these Fortune magazine, April 2001


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Main task of drug company employees, 2000 and relationships is: Would you be willing to have these

Source: PhRMA Industry Profile 2000; percentages calculated by Sager and Socolar


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Farmaceutical Facts: and relationships is: Would you be willing to have these

  • 2.9 billion prescriptions were written in 2000, an average of 10.4 prescriptions per person.

  • Drug costs increased 18.8% to $131.9 billion dollars in 2000

    • 42% of increase attributed to increase #prescriptions

    • 36% to a shift to more expensive drugs

    • 22% to an increased price of drugs

  • The best selling category of drugs in 2000 was anti-depressants


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Prescription drug expenditures, and relationships is: Would you be willing to have these

in billions of dollars, l993-2000 .

Source: IMS Health


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Drug costs increased 18.8% in 2000 and relationships is: Would you be willing to have these

Source: NIHCM


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Farmaceutical Facts: and relationships is: Would you be willing to have these

  • $2.5 billion dollars were spent on advertising to consumers in 2000; $468 million dollars were spent on journal ads.

  • Increases in the sales of the 50 drugs most heavily advertised to consumers in 2000 were responsible for almost half (47.8%) of the $20.8 billion increase in spending on drugs that year.

  • Over 40% of DTC spending was concentrated on ten products, among them Claritin, Prilosec, Viagra, Paxil, and Meridia.

Source: NIHCM


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Ideal Direct to Consumer Ad Target? and relationships is: Would you be willing to have these


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Farmaceutical Facts and relationships is: Would you be willing to have these

In 2000, Merck spent $161 million on advertising for Vioxx.

That is:

  • More than Pepsico spent advertising Pepsi. ($125 million)

  • More than Anheuser-Busch spent advertising Budweiser. ($146 million)

    The increase in VioxxTM sales in 2000 accounted for 5.7% of the 1 year increase in drug spending!


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Pharmaceutical promotion in clinical practice. and relationships is: Would you be willing to have these Why is this important?

A matter of:

  • Ethics

  • Good medical practice

  • Medical education

  • Cost


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“That stuff doesn’t influence me at all. I don’t even know what drug is on my pen. I just go for the food.”--Fill in your name here?


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Evidence that: know what drug is on my pen. I just go for the food.”

  • Physicians don’t believe promotion influences their own behavior.

  • Promotion does influence behavior.

  • Promotion is often biased and inaccurate.

  • Promotion may lead to inappropriate prescribing.


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What’s the Evidence? know what drug is on my pen. I just go for the food.”



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The Evidence on drug promotion in the U.S. . .

  • Attitudes and Practices

  • Influence of promotion on behavior

  • Bias in promotion

  • The use of pharmaceutical samples


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Attitudes and Practices on drug promotion in the U.S. . .


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Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical promotions. Steinman MA, Am J Med, 110, 2001.

  • Survey of 117 1st and 2nd year residents at a university-based IM training program

  • Attitudes towards 9 types of promotion assessed . Promotions categorized on basis of cost (inexpensive, < $10) and educational value

  • 90% response rate (105/117 residents)


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Attitudes Toward PR Promotions housestaff toward pharmaceutical promotionsPercent Who Consider Appropriate


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Practices Among Residents Who Consider Promotion housestaff toward pharmaceutical promotionsAppropriate


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Practices Among Respondents Who Consider Activity housestaff toward pharmaceutical promotionsInappropriate


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Perceived Influence of PRs housestaff toward pharmaceutical promotionson Prescribing Practices

p <.0001


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Interactions with the pharmaceutical industry: experiences and attitudes of psychiatry residents, interns, and clerks. Hodges B, CMAJ, 153 (5); 1995

  • Survey of 105 residents, interns, and clerks rotating through 7 teaching hospitals in Toronto, Canada.

  • Self-report questionnaire

  • 70% response rate


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Interactions with the pharmaceutical industry: experiences and attitudes of psychiatry residents, interns, and clerks. Hodges B, CMAJ, 153 (5); 1995

  • The mean estimate of the value of gifts received was $60, range $0 to $800.

  • 37% reported attending dinners, 43% reported receiving books.

  • The number of promotional items received was positively correlated with the belief that discussions with reps have no impact on prescribing behavior.


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Interactions with the pharmaceutical industry: experiences and attitudes of psychiatry residents, interns, and clerks. Hodges B, CMAJ, 153 (5); 1995

  • 34% said discussions with reps do not impact prescribing behavior.

  • 56% said accepting promotional items does not impact prescribing.

  • 42% disagreed with the statement “I would maintain the same degree of contact with reps if no gifts were distributed.”


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The pharmaceutical industry’s influence on chief medical residents.Adler, L, Muller D, Bao P, Lan J, Haddow S.JGIM. 1999; 14[supplement 2]:128.

  • National survey of chief medical residents. 84 responded.

  • 100% reported that their programs participated in pharmaceutical company-sponsored theatre or sporting events; 67% had personally participated in such events.

  • Thirty per-cent said that the reps were more likely to get access to the housestaff if they left gifts; 27% asked for gifts.

  • One in four chief residents never asked for references when discussing products with reps; one in ten ranked the drug reps above the medical literature, their attendings, and their peers as sources of information about new drugs.


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Is there free lunch? Resident and faculty perceptions at the turn of the century.Hulgan TM, Wilson MC, Applegate WB. JGIM. 2000; 15[supplement 1]:35.

  • Questionnaire at academic medical center

  • 83/84 housestaff, 90/103 faculty responded

  • 60% of faculty and 37% of housestaff felt that interaction with reps could influence prescribing patterns of other physicians

  • 44% of faculty and 22% of housestaff felt their own decisions had ever been influenced by these interactions.

  • 13% of faculty and 54% of housestaff felt that overnight/weekend trips for conferences sponsored by drug companies were acceptable gifts.


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Patient Perceptions of Physician Acceptance of Gifts from the Pharmaceutical Industry Mainous lll AG, Hueston WJ, Rich EC.. Arch Fam Med. 4; 1995: 335-9.

Telephone survey of 649 adult patients in Kentucky

Response rate 55%

82% were aware that physicians received gifts that were of potential value to patients.

32% were aware that physicians received personal gifts.


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Influence the Pharmaceutical Industry


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Physicians' Behavior and their Interaction with Drug CompaniesChren MM, Landefeld CS. JAMA. 1994;271:684-689.

Case-control study at a University Hospital

Cases: 40 physicians who had requested formulary additions

Controls: 80 physicians who had made no such requests

Information regarding interaction with drug companies obtained by survey instrument.


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Physicians' Behavior and their Interaction with Drug Companies (continued)

  • Case and control physicians were similar with respect to age, academic rank, tenure status, and number of publications indexed in MEDLINE.

  • Case physicians were more likely to be male.


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Physicians' Behavior and their Interaction with Drug Companies (continued)

  • Physicians who had requested formulary changes were more likely to have accepted money from drug companies to attend or speak at symposia.

    (OR=5.1, 95%CI, 2.0 - 13.2)

  • Physicians were more likely to have requested additions of drugs made by companies with whose reps they had met (OR=4.9, 95%CI, 3.2 - 7.4).

  • These results were consistent in multivariate analysis adjusting for potential confounders.


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The Effects of Pharmaceutical Firm Enticements on Physician Prescribing Patterns. Orlowski JP, Wateska L Chest 1992 Jul;102(1):270-3

Pharmacy records were reviewed 22 months before and 17 months after two pharmaceutical company sponsored symposia on two medications:

Drug A: New intravenous antibiotic; all-expenses-paid trip to “luxurious resort on West Coast (n=10)

Drug B: New intravenous Cardiac drug; all-expense-paid trip to island resort in the Caribbean (n=10)


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The Effects of Pharmaceutical Firm Enticements on Physician Prescribing Patterns. (continued)

  • The majority of participating physicians interviewed did not believe the free trip would influence their prescribing patterns.

  • There was a statistically significant increase in prescribing of both medications following the meeting (p<.001).

  • This increase differed form national prescribing patterns at similar hospitals during this period.


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The effects of pharmaceutical firm enticements on physician prescribing patterns.Orlowski JP. Chest 1992; 102: 270-3.


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Scientific versus Commercial Sources of Influence on the Prescribing behavior of PhysiciansAvorn J, Chen M, & Hartley R. A m J of Med. 1982. 273; 4-8.

  • Telephone questionnaire of randomly selected internists in Boston area (n=85)

  • Questioned about two drugs (propoxyphene analgesics and cerebral and peripheral vasodilators) which medical literature clearly showed were ineffective, yet were heavily advertised as being effective.


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Scientific versus Commercial Sources of Influence on the Prescribing behavior of Physicians (continued)

  • Drug advertisements were felt to be “minimally important” in influencing prescribing habits by 68%; very important by 3%.

  • Academic sources felt to be “very important” influences by 62%, “minimally important” by 4%.


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Scientific versus Commercial Sources of Influence on the Prescribing behavior of Physicians (continued)

  • 71% believed that “impaired cerebral blood flow is a major cause of dementia.”

  • 32% said they found cerebral vasodilators useful in managing “confused geriatric patients.”

  • 49% believed propoxyphene to be more potent than aspirin.

  • None of these responses was supported by the medical literature.


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Scientific versus Commercial Sources of Influence on the Prescribing behavior of Physicians (continued)

  • For vasodilators, there was a significant tendency towards greater reliance on commercial sources of information among advocates (p=0.006) .

  • For propoxyphene, those who found these compounds very effective were no more likely than their colleagues to report greater influence from commercial than academic sources.


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The role of commercial sources in the adoption of a new drug Prescribing behavior of Physicians (continued). Peay MY and Peay ER Soc Sci Med, 1988;26:1183-89

  • Interviews with 124 doctors in private practice in 2 distinct geographical areas in Australia. 40% specialists.

  • Response rate 60%

  • Target drug: temazepam

  • Interviews conducted 13 months after its release


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The role of commercial sources in the adoption of a new drug. (continued)

  • 68% of physicians received their first information about the drug from commercial sources; 40% from detail-people in particular.

  • 28% received initial information from professional sources, 13% medical journals.

  • 60% said commercial sources were the most influential factor in decision to prescribe.

  • 35% said professional sources were most influential.


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The role of commercial sources in the adoption of a new drug. (continued)

  • 54/88 physicians familiar with temazepam reported contact with detail-people about the drug. Doctors who had such contact were:

    • more likely to rate it as a moderate advance (as compared to minimal or no advance).

    • more likely to have prescribed it.

    • more likely to have prescribed it in preference to alternatives.

      Those with >= one contact with detailers/week were more likely to prescribe it than those with less.


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The role of commercial sources in the adoption of a new drug. (continued)

  • Physicians who cited professional sources as their 1st source of information were more likely to prefer alternatives. (They were also more likely to become aware of it later)

  • Doctors who had received a sample were more likely to prescribe it than those who hadn’t.


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Physicians, Pharmaceutical Sales Representatives, and the Cost of PrescribingCaudill TS, Johnson MS, Rich EC, McKinney P. Arch of Fam Med. 5; April, 1996; pp. 237-240.

Questionnaires Mailed to primary care adult medicine practitioners in Kentucky (family medicine, general practice, general medicine; n=1603) about attitudes toward and use of information provided by pharmaceutical representatives.

Main Outcome Measure: Relative cost of prescribing, based on responses to treatment choices for clinical scenarios.


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Physicians, Pharmaceutical Sales Representatives, and the Cost of Prescribing(continued)

446 questionnaires were suitable for analysis.

Positive correlation found between physician cost of prescribing and perceived credibility of information provided by pharmaceutical reps (p<.01).

This remained significant in multivariate regression model.


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Pharmaceutical Representatives in Academic Medical Centers: Cost of PrescribingInteraction with Faculty and Housestaff. Lurie N, Rich EC, Simpson DE, et al. JGIM. 1990. 5;240-3.

  • Self administered questionnaires at seven university hospitals in the Midwest.

  • 240(78%) of faculty and 131(75%) of residents responded.


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Pharmaceutical Representatives in Academic Medical Centers (continued)

  • 25% of faculty and 32% of residents reported that they changed their practice at least once in the preceding year on account of contact with a drug rep.

  • 20% of faculty and 4% of residents said they had recommended formulary additions on the suggestion of a drug rep.

  • For faculty, brief conversations, research support, and lecture honoraria were associated with formulary requests. Age, academic rank, or subspecialty were not.


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Trends in antihypertensive drug use in the U.S: (continued) Do the JNCV recommendations affect prescribing?Siegel D and Lopez J, JAMA. 1997. 278, pp 1745-1748

  • All prescriptions for HTN Rx dispensed by 35,000 pharmacies (62% of all US retail pharmacies) between 1992 and 1995 were tabulated.


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“Because diuretics and (continued)b-blockers have been shown to reduce cardiovascular morbidity and mortality in controlled clinical trials, these two classes of drugs are preferred for initial drug therapy.”-- The Fifth Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V, 1993)


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Despite the JNC recommendations, diuretic and B-blocker use decreased, while calcium-channel blocker use increased


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“When the decision has been made to initiate anti-hypertensive therapy and there are no indications for another type of drug, a diuretic or b -blocker should be chosen because numerous RCTs have shown a reduction in morbidity and mortality with these agents”-- The Sixth Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI, 1997)In 1998, Norvasc a calcium channel blocker,was the most prescribed anti-hypertensive. How to account for this? (Hint: have you ever seen a sample of HCTZ?)


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Pharmaceutical Samples anti-hypertensive therapy and there are no indications for another type of drug, a diuretic or


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A physician survey of the effect of drug sample availability on physicians’ behaviorChew LD, et al. J Gen int med, 2000. 15; 478-83.

  • Setting: University-based clinics at one academic medical center.

  • Participants: 154 general medicine and family physicians (96 residents, 58 attendings)

  • Questionnaire; response rate 85%

  • 3 clinical scenarios: Patient with uncomplicated UTI; HTN; depression.


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A physician survey of the effect of drug sample availability on physicians’ behavior (continued)

UTI scenario:

  • Preferred initial therapies were TMP/sulfa (92%), amoxacillin (7%), and ciprofloxacin (1%).

  • When samples were made available, 22 (17%) of the physicians said they would choose ciprofloxacin.

  • For 21 of these 22 physicians, ciprofloxacin was not their preferred initial therapy.


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A physician survey of the effect of drug sample availability on physicians’ behavior (continued)

HTN scenario:

  • 92% said they would prescribe a diuretic or beta blocker as initial therapy.

  • Of the 35 physicians who said they would give a drug sample , 32 selected a drug that differed from their preferred choice.


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A physician survey of the effect of drug sample availability on physicians’ behavior (continued)

HTN “follow-up” scenario:

Patient now has health insurance, blood pressure controlled on drug sample

  • 69% said they would write a prescription for the sampled medication rather than switch therapy.

  • 88% of sample users would have written a prescription for a drug that differed from their preferred choice.


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Ubel PA and Adler MA. Primary Care Physicians believe that CA blockers and ACE inhibitors are superior to B-blockers and diuretics in treating uncomplicated hypertension. JGIM. 1999; 14[supplement 2]:125.

  • Mail survey of 1,200 U.S. primary care physicians

  • 40% of respondents incorrectly believed that Ca- blockers and ACE-inhibitors had been shown to reduce the risk of stroke in hypertensive patients.

  • Respondents incorrectly believed that Ca-blockers and ACE-inhibitors were approximately 50% more likely to achieve normal blood pressure than thiazide diuretics.

  • Physicians who said they occasionally provide drug samples were significantly more likely to recommend ACE inhibitors and Ca-blockers (for hypothetical patients) than physicians who never provided samples.


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Personal Use of Drug Samples by Physicians and Office Staff CA blockers and ACE inhibitors are superior to B-blockers and diuretics in treating uncomplicated hypertensionWestfall JM, Maccabe J, Nicholas RA. JAMA. 278, July 9, 1997, pp141-3

Survey of Physicians and staff in a family practice residency

about personal use of drug samples in the preceding 12 months (12 faculty, 21 residents, 8 nurses, 9 office staff, 3 unknown).

53/55 responded.

Total of 230 samples taken

158 for personal use, 78 for family use

Only 2 respondents reported never taking samples in previous year

Retail cost of samples taken: $10,000.


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Do pharmaceutical representatives misuse their drug samples CA blockers and ACE inhibitors are superior to B-blockers and diuretics in treating uncomplicated hypertension? Tong KL, Lien CY Can Fam Physician 1995. 41:1363-6

  • Setting: Family practice office.

  • Pharmaceutical representatives visiting office during 3-month period were surveyed.

  • 27 representatives were surveyed. 16 (59%) had provided prescription drug samples to individuals other than physicians. 13 (48%) either self-medicated or provided samples to friends or relatives. Seven (26%) exchanged drug samples with other representatives.

  • Samples were most often given to friends and spouses. NSAIDS were the most commonly used.


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Bias in promotional materials CA blockers and ACE inhibitors are superior to B-blockers and diuretics in treating uncomplicated hypertension


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The Accuracy of Drug Information From Pharmaceutical Sales RepresentativesZiegler MG, Lew P, Singer BC. JAMA. 273; April 26, 1995, pp 1296-1298

  • Setting: Noon housestaff conferences at a large university-based internal medicine residency program.

  • Pharmacist sat in front row and tape-recorded comments made by drug reps prior to faculty lecture.

    Statements classified as inaccurate if:

  • Contradicted PDR or literature handed out by rep;

  • Pharmacist and physician-clinical pharmacologist independently assessed statement as incorrect;

  • No support for statement found in literature;


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The Accuracy of Drug Information From Pharmaceutical Sales Representatives (continued)

  • 106 statements made by drug reps at 13 lunchtime conferences were analyzed.

  • 12 (11%) of statements were inaccurate.

  • All inaccuracies were favorable to drug being promoted.

  • Only 7 out of 26 physicians surveyed recalled any false statement made by a representative.


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Characteristics of Materials Distributed by Drug Companies: An Evaluation of AppropriatenessStryer D, & Bero, LA. JGIM. 1996. 11; 575-583

  • Setting: Academic internal medicine residency program, an HMO, and a private internist’s office.

  • All materials left behind by drug reps or mailed to offices over a 7 month period were analyzed.

  • Determined if items met FDA requirements for 1) fair balance, 2) presence of adequate instructions for use, 3) discussion of approved uses only


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Characteristics of Materials Distributed by Drug Companies (continued)

  • 482 items analyzed

  • 202 (42%) failed to comply with at least one FDA requirement:

    • 158 (33%) did not meet FDA definition of fair balance.

    • 41 (9%) did not include required instructions for use.

    • Of 428 items that mentioned at least one indication, 17 (9%) described unapproved uses.


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Pharmaceutical advertisements in leading medical journals: experts’ assessmentsWilkes MS, Doblin BH, Shapiro MF. Ann Int Med. 1992; 116.

  • “Peer review” of ads from 10 journals

  • 109 advertisements were analyzed by 113 experienced physician peer reviewers and 54 clinical pharmacists. (Initially intended to exclude reviewers who received more than $300 from the pharmaceutical industry in the past 2 years, but this was not feasible!)

  • 71% of reviewers had received money from the drug industry within the past 2 years; 53% had received more than $5000.


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Pharmaceutical advertisements in leading medical journals: experts’ assessmentsWilkes MS, Doblin BH, Shapiro MF. Ann Int Med. 1992; 116.

FDA regulations specify that ads are false, lacking in fair balance, or otherwise misleading if:

  • They make claims about relative safety and efficacy or about the populations in which the drug is useful that are not supported by the current literature

  • Use literature or references inappropriately to support claims in the advertisement.

  • Use statistics erroneously

  • Use headlines, sub-headlines, or pictorial or other graphic material in way that is misleading


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Pharmaceutical advertisements in leading medical journals: experts’ assessmentsWilkes MS, Doblin BH, Shapiro MF. Ann Int Med. 1992; 116.

  • In 30% of cases where “drug of choice” claim was made, reviewers disagreed with this claim.

  • Reviewers responses indicated that 92% of ads were not in compliance with at least one area of FDA criteria. (15% had 8 or more areas that were not in compliance)

  • 57% of ads were felt to have little or no educational value.

  • Only 44% of reviewers felt the ad would lead to proper prescribing if the physician had no other information other than that in the advertisement


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Pharmaceutical advertisements in leading medical journals: experts’ assessmentsWilkes MS, Doblin BH, Shapiro MF. Ann Int Med. 1992; 116.

“If this advertisement were subject to the same review criteria as a scientific article, would your suggestion be to accept in present form, accept with minor revisions, accept with major revisions, or reject the advertisement?”

Reject 24%

Accept with major revisions 34%

Accept with minor revisions 34%

Accept 8%


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Logical Fallacies in Pharmaceutical Promotion experts’ assessments

(Shaughnessy, et al, J Gen Int Med, October 1994)

[Note: The following slides should be accompanied by slides of representative ads. While not difficult to find, images of ads are available upon request.]


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Logical Fallacies in Pharmaceutical Promotion experts’ assessments

Argumentum ad populum

Appeal to popularity


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Logical Fallacies in Pharmaceutical Promotion experts’ assessments

Argumentum ad verecundiam

Appeal to authority


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Logical Fallacies in Pharmaceutical Promotion experts’ assessments

Argumentum ad celebritam

Appeal to celebrity


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Logical Fallacies in Pharmaceutical Promotion experts’ assessments

Fallacy of ignoratio elenchi

(or fallacy of irrelevant conclusions,

or fallacy of ignoring the issue

or the non-sequitur)


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Logical Fallacies in Pharmaceutical Promotion experts’ assessments

Fallacy of equivocation

“When I use a word, it means just what I choose it to mean -- neither more nor less.”

--H. Dumpty


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Logical Fallacies in Pharmaceutical Promotion experts’ assessments

Argumentum ad misericordiam

Appeal to pity


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Logical Fallacies in Pharmaceutical Promotion experts’ assessments

Appeal to emotion


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Logical Fallacies in Pharmaceutical Promotion experts’ assessments

Argumentum ad sexum

Appeal to sex


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Logical Fallacies in Pharmaceutical Promotion experts’ assessments

  • Post hoc ergo propter hoc

    • After this, therefore, because of this

  • Post prandium ergo propter prandium

    • After lunch, therefore, because of lunch


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Conclusion experts’ assessments

  • Practicing on the basis of promotion may lead to inappropriate prescribing.

  • Gifts:

    • Cost money

    • Damage image of the profession

    • Influence behavior


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The 4 Steps to Drug Company Independence experts’ assessments(for the busy clinician who hasn't time for 12)

1. We admitted we were powerless over pharmaceutical paraphernalia--that our lives had become unmanageable.

2. We made a searching and fearless moral inventory of ourselves and our desks.

3. We were entirely ready to remove all these defects of character, as well as pens, penlights, and notepads.

4. Having had a spiritual awakening as the result of these steps, we tried to carry this message to others and to practice these principles in all our affairs.


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Just say no to drug reps experts’ assessments