Industry - Searles

Industry - Searles - Medical Education and the...

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Unformatted text preview: Medical Education and the Pharmaceutical Industry: Biting the Hand That Feeds Us In praise of the “devil” • “Most research based companies behave ethically most of the time” • Pharmaceutical companies have played a vital role in the development of life changing remedies for decades. Chris Searles, MD, FAAFP H.S. Associate Clinical Professor Director, Combined Family Medicine & Psychiatry Residency Program University of California, San Diego Industry strongly supports CME A Brief History… Patients benefit from industry support and will “experience the consequences if physicians are not fully informed about the latest medical advances.” • In the late 80’s, physicians were “caught” in seemingly difficult ethical circumstances (e.g. redeeming their prescriptions for frequent flyer miles, the AMA preparing to endorse health related products for a fee) and the media focused its attention on the problem. - Alan F. Holmer, JD (PhRMA) A Brief History • In response: AMA, ACP, and other organizations rushed to formulate ethical guidelines regarding physicians and industry. A Brief History • AMA Council on Ethical and Judicial Affairs 1990, first guidelines published REVISED: 1992,1994,1996,2000 • ACP-ASIM: 1990 Guidelines published 2002 Position Paper published • ACGME: 2001 “White Paper” • PhRMA: PhRMA Code April 18, 2002 Promotional spending on prescription drugs l996-2002 The Pharmaceutical Industry Promotional expenditures ($ billions) 25 21 20 17.8 15.7 13.9 15 12.5 11 10 9 5 0 1996 1997 1998 1999 Source: NIHCM, 2003 2000 2001 2002 Promotional spending on prescription drugs, 2002 Hospital detailing 4.1% $861 million Direct to consumer advertising spending in the U.S., 2000 Journal ads 2% $480 million 180 161 Detailing to doctors 25.3% $5.3 billion Samples 56.1% $11.78 billion (up from $7.9 billion – 2000) Sp d g ($ m en in illions) 160 140 146 125 120 100 80 60 40 20 0 DTC ads 12.5% $2.63billion Pepsi Budweiser Vioxx Total spending: $21 billion Source: IMS Health FDA Innovation Assessment • From 1989 to 2000, the US Food and Drug Administration judged 76% of all approved new drugs to be no more than moderate innovations over existing treatments Drug company jobs in marketing and research, 1995-2000 Marketing to Physicians 100,000 87,810 Marketing 80,000 60,000 Research 55,348 49,409 48,527 40,000 20,000 • In 2000, Pharm spent about $5.5 billion marketing to MD’s • $9000 per physician • There is 1 “drug rep” for every 11 doctors (and 4.7 office based physicians) in the United States 0 1995 1996 1997 1998 1999 2000 N Engl J Med 351(18): 1886-1890 Haddad J. June/July SFMS Newsletter Marketing to Physicians Marketing to Physicians The Industry compiles extensive data: • The AMA generates $20 million annually selling biographical data on every AMA physician (identified by DEA) to industry. • This, and prescribing data from pharmacies allows them to “profile” their target market… Physicians. • Visits last 1.3 to 6.5 minutes (average 1.9 minutes) • “70% of physicians report considering changing their prescribing habits in response to detailing messages delivered by sales reps” Marketing to Physicians What about Pharmacists? • “Reps must become familiar with their doctor’s offices, gather intelligence.. and cultivate relationships” • Community Pharmacists.. Do they influence doctors? Jun 1, 2004 “Pharmacists have a lot of say in the day-to-day prescribing habits of physicians.” • Perfect Partners Jul 1, 2003 “Working with pharmacists to influence doctors.” • “The mind of the physician -- Part 3 Behind the conscious decision” by J.P. Thompson (PHARMACEUTICAL REPRESENTATIVE – Nov 2005) • The Neglected Pharmacist Jun 1, 2003 “Why reps can't afford to skip pharmacy visits.” • The Evolving Role of the Pharmacist Sep 1, 2001 “The role of the pharmacist has moved more toward knowledge of the product, and interaction with the patient.” Of principles and pens Attitudes and Practices of Physicians • Population: 117 1st and 2nd year residents at a university-based IM training program. • Assessed attitudes toward 9 types of promotion. • 90% response rate (105/117 residents). Of principles and pens Of principles and pens Practices Among Residents Who Consider Promotion Appropriate Percent who did or would have participated Percent Who Consider Appropriate Very appropriate Somewhat appropriate 100 80 60 40 20 0 abx guide conf. lunch dinner lect. article pen social text CME luggage 100 90 80 70 60 50 40 30 20 10 0 abx guide conf. lunch dinner lect. article pen social text CME luggage Of principles and pens Of principles and pens Practices Among Respondents Who Consider Activity Inappropriate Perceived influence of pharmaceutical reps on Prescribing Practices 100 90 80 70 60 50 40 30 20 10 0 Percent who did or would have participated 100 90 80 70 60 50 40 30 20 10 0 abx guide conf. lunch dinner lect. article pen social text CME luggage "Other Physicians" "You" 61 51 38 33 16 1 None A little Mod. / A lot Industry Support of Internal Medicine Residency Training Attitudes and Practices of Resident Pharmacists • 236 of the nation’s 381 internal medicine program directors • 55% accepted industry support* • pocket guides – 83%, meals - 90%, office supplies - 68%, drug samples - 57%. • South>North Macdonald FS. Association of Program Directors in Internal Medicine Survey 2006-2007. Archives of Internal Medicine. 2/2011 Pharmacy residents’ attitudes toward pharmaceutical industry promotion • Population: 496 1st and 2nd year residents at a university and non-university based hospitals and in the community. • Assessed attitudes toward 5 types of promotion, and interactions with industry. Pharmacy residents’ attitudes toward pharmaceutical industry promotion Percent Who Consider Appropriate Very appropriate Somewhat appropriate 100 80 60 40 20 0 conf. lunch S Ashker, JS Burkiewicz. Pharmacy residents’ attitudes toward pharmaceutical industry promotion. Am J Health-Syst Pharm—Vol 64 Aug 15, 2007 dinner lect. edu gifts non-edu gifts drug samples S Ashker, JS Burkiewicz. Pharmacy residents’ attitudes toward pharmaceutical industry promotion. Am J Health-Syst Pharm—Vol 64 Aug 15, 2007 Pharmacy residents’ attitudes toward pharmaceutical industry promotion Knowledge • • • • • • PR events are promotional>educational… 55% PRs provide misleading information… 33% PR events enhance my knowledge… 89% PR contact helps me learn about meds and diseases… 68% Promotional materials enhance my knowledge… 58% Respondents were 3x more likely to think other residents and fellows would be influenced by free gifts and meals compared with themselves Patient Attitudes S Ashker, JS Burkiewicz. Pharmacy residents’ attitudes toward pharmaceutical industry promotion. Am J Health-Syst Pharm—Vol 64 Aug 15, 2007 A comparison of physicians’ and patients’ attitudes toward pharmaceutical industry gifts • Survey of physicians and patients at 2 tertiary care medical centers (1 military, 1 civilian). • 196 patients and 268 physicians completed survey. • 54% of patients were aware that pharmaceutical industry gave gifts to physicians. • Does your own doctor accept gifts? 27% yes, 20% no, 53% unsure. A comparison of physicians’ and patients’ attitudes toward pharmaceutical industry gifts A comparison of physicians’ and patients’ attitudes toward pharmaceutical industry gifts Percentage that considered gift inappropriate Percentage that considered gift influential 50 60 40 50 40 30 Patients Physicians 20 48 31 29 30 24 20 10 10 0 8 Patients Physicians 12 0 Pen Lunch Dinner “The public image of the medical profession has been hurt by doctors who accept freebies from pharmaceutical companies…It is hard for the patient to know whether a doctor is prescribing the bestpromoted rather than the most cost effective drugs. But when you walk into your doctor’s office and she’s using a Zoloft pen to write on a Zocor notepad next to a Zyrtec coffee mug, feel free to ask questions.” NY Times editorial Sep 10, 2001 Pen Lunch Dinner Patients Perception Survey • 1,154 patient currently taking Rx drugs • 50% said their doctor was too eager to prescribe drugs in general • 66% felt industry held too much influence over physician prescribing behavior • 47% thought industry gifts influence their doctors to prescribe “their” drugs Consumer Reports National Research Center – Phone Survery May 2010 Industry strongly supports CME How We Interface With the Pharmaceutical Industry... “Patients benefit from:” • Industry sponsored CME • Industry support of scientific studies • Advertisements in medical journals • Pharmaceutical Representative (PR) visits to MD’s and subsequent learning • Medication Samples Industry strongly supports CME “Patients benefit from:” • Gifts??? Gifts and Influence Mr. Mucus The Effects of Pharmaceutical Firm Enticements on Physician Prescribing Patterns • Pharmacy records reviewed 22 months before and 17 months after two pharmaceutical company-sponsored symposia on two medications: • Drug: New intravenous antibiotic – Promotion: All-expenses-paid trip to “luxurious resort on West Coast” (n=10 travelling MDs) Drug "A" Usage Index Institution “Patients benefit from:” • Industry sponsored CME • Industry support of scientific studies • Advertisements in medical journals • Pharmaceutical Representative (PR) visits to MD’s and subsequent learning • Medication Samples Ju l Se pt N ov Ja n M ar M ay Ju l Se pt N ov ay M M ar 450 400 350 300 250 200 150 100 50 0 Ja n • The participating physicians were asked beforehand about likely bias postattendance. • 9 out of 10 said they “would not be influenced.” • 1 out of 10 said he was “unlikely to be influenced.” The Effects of Pharmaceutical Firm Enticements on Physician Prescribing Patterns Units The Effects of Pharmaceutical Firm Enticements on Physician Prescribing Patterns Major Medical Centers Pharmaceutical Industry Sponsorship and research outcome and quality: systematic review • Review of 30 studies that compared industry sponsored trials with studies funded by other sources. • Industry sponsored research was less likely to be published in peer-reviewed journals. • Industry sponsored research was 4 times more likely to favor the sponsor’s product.(OR 4.05; 95% CI 2.98-5.51) Evidence b(i)ased medicine - selective reporting form studies sponsored by pharmaceutical industry: review of studies on new drug applications Evidence b(i)ased medicine - selective reporting form studies sponsored by pharmaceutical industry: review of studies on new drug applications • Reviewed data submitted to Swedish regulatory authority for 5 different SSRI’s • 42 placebo-controlled studies were reviewed: 21 with positive results, 21 with inconclusive or negative results. • Of the 21 studies showing the SSRI’s to be more effective than placebo, 19 were published. • Of the 21 inconclusive studies, only 6 were published. Melander et al. Evidence b(i)ased medicine… BMJ. 2003 May 31;326(7400):1171-3 Evidence b(i)ased medicine - selective reporting from studies sponsored by pharmaceutical industry: review of studies on new drug applications • Authors of the studies also noted the following potential biases: - Multiple publications - Selective publication - Selective reporting Melander et al. Evidence b(i)ased medicine… BMJ. 2003 May 31;326(7400):1171-3 Melander et al. Evidence b(i)ased medicine… BMJ. 2003 May 31;326(7400):1171-3 “Patients benefit from:” • Industry sponsored CME • Industry support of scientific studies • Advertisements in medical journals • Pharmaceutical Representative (PR) visits to MD’s and subsequent learning • Medication Samples The New Pill… “The pill for wellbeing…” “will not lead to weight gain and promotes a woman’s sense of well-being…” Off-Label Marketing Astra-Zeneca • $520 million – Seroquel (Apr 2010) Pfizer • $2.1 billion – Bextra (Sep 2009)* • $301 million – Geodon (Sep 2009) Eli-Lilly • $1.4 billion – Zyprexa (Jan 2009)* BMS • $500 million – Abilify (Jun 2007) “For $520 Million, AstraZeneca Settles Case Over Marketing of a Drug.” NY Times. D Wilson “Patients benefit from:” • Industry sponsored CME • Industry support of scientific studies • Advertisements in medical journals • Pharmaceutical Representative (PR) visits to MD’s and subsequent learning • Medication Samples The Accuracy of Drug Information From Pharmaceutical Sales Representatives • Setting: IM noon conferences • A pharmacist sat in front row and tape-recorded comments made by drug reps prior to faculty lecture. • 106 statements made by drug reps at 13 conferences were analyzed. • Statements classified as inaccurate based on predefined criteria. The Accuracy of Drug Information From Pharmaceutical Sales Representatives 100% 100% 80% 60% 40% 20% 27% 11% 0% Inaccurate Errors Residents favorable to recalling single company's drug inaccurate statement The Accuracy of Drug Information From Pharmaceutical Sales Representatives • A group of housestaff in attendance were surveyed at the end of the study: • 85% thought drug reps provided useful information, 42% thought it misleading • 26% recalled a false statement as true • 52% sought out drug reps for information • 37% changed prescribing their practices as a result of the new information Treatment of hypertension: Scientific or commercial influence? Commercial vs Scientific Evidence • All prescriptions for HTN Rx dispensed by 35,000 pharmacies (62% of all US retail pharmacies) between 1992 and 1995 were tabulated. 1992 33 38 18 8 11 Treatment of hypertension: Scientific or commercial influence? “When the decision has been made to initiate antihypertensive therapy and there are no indications for another type of drug, a diuretic or -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) 25 Bbl oc ke r Ca -b lo ck er A CE in hi bi to r 16 tic • The Fifth Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V, 1993) 100 90 80 70 60 50 40 30 20 10 0 Di ur e “Because diuretics and -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.” Treatment of hypertension: Scientific or commercial influence? Percentage of antihypertensive prescriptions Treatment of hypertension: Scientific or commercial influence? Why? 33 1995 A Physician Survey of the Effect of Drug Sample Availability on Physicians’ Behavior • Setting: University-based clinics at an academic medical center • Participants: 131 of 154 General medicine and family physicians • 96 residents, 58 attendings • Questionnaire • Hypothetical clinical scenario: Patient with newly diagnosed hypertension A Physician Survey of the Effect of Drug Sample Availability on Physicians’ Behavior HTN scenario: • 92% said they would prescribe a diuretic or -blocker as initial therapy. • When samples were made available, 32 of the 35 physicians who said they would give a drug sample selected a drug that differed from their preferred choice. A Physician Survey of the Effect of Drug Sample Availability on Physicians’ Behavior 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. Aaaah…. The Samples. Personal Use of Drug Samples by Physicians and Office Staff • Population: 53 MD’s and staff in a FP residency (12 faculty, 21 residents, 8 nurses, 9 office staff, 3 unknown) • Surveyed personal use of drug samples in the preceding 12 months. • Total of 230 samples taken (158 for personal use, 78 for family use) • • Only 2 people denied taking samples Retail cost of samples taken: $10,000. AMA Guidelines • The Council's guidelines permit personal or family use of free pharmaceuticals: • 1. In emergencies and other cases where the immediate use of a drug is indicated, • 2. On a trial basis to assess tolerance and • 3. For the treatment of acute conditions requiring short courses of inexpensive therapy The ACP and Samples • 1/3 of samples go to MD’s, staff, families. • Encourages a “gift relationship” • Social scientists note that “the prevailing purpose of the gift is to establish the identity of the donor in the mind of the recipient and to oblige the recipient to reciprocate.” Samples Raise Costs Who Really Pays for the Samples? The Patients • 5709 patients • The primary outcome measures were sample receipt and prescription expenditures. • 180 day OOP expenditures: $178 pre-sample… $244 post sample • Individuals receiving samples have higher prescription expenditures than their counterparts. Caleb et al. Characteristics of Patients Receiving Pharmaceutical Samples and Association Between Sample Receipt and Out-of-Pocket Prescription Costs. Medical Care. 46(4):394-402, April 2008. The WalMart $4 Dollar Program • 157 drugs • $610 million dollar cost savings (old price – new price x RXs) • “Wal-Mart is not selling any of the $4 prescriptions at a loss… The generics are profitable” Who is this guy? Meet Minnesota Pharmacist Jim Witt… • "If my cost for a bottle of pills is, ya know, a dollar… Why should I charge $25 for that?" Pharmacy students in action… • Jim’s Goal: prices between 35 and 40 percent less than the so-called discount pharmacies Pharmacists as “Drug Reps” • An educational program was implemented at UC Davis in 2001 with Pharmacists portraying drug reps “pitching” new products. Pharmacists as “Drug Reps” • The Goal: to generate critical thinking among medical students regarding the influence of drug reps on their prescribing behavior. Resources • Nofreelunch.org • AMA Ethical Opinions/Guidelines http://www.ama-assn.org/ama/pub/category/4001.html • AMSA PharmFree http://www.amsa.org/prof/pharmfree.cfm • National Institute for Health Care Management www.nihcm.org • www.healthyskepticism.org • WHO Database Thank You… ...
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This note was uploaded on 09/14/2011 for the course PHARM di taught by Professor Staff during the Spring '11 term at UCSD.

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