Transcript Drug Company-Physician Relationships

Drug Company-Clinician and Drug Company
Health Professional Student Relationships
Frederick S. Sierles, M.D.*
Professor and Director of Medical Student Education in Psychiatry and Behavioral
Sciences
Rosalind Franklin University of Medicine and Science
RFUMS August 29, 2012 Pharmacology Course
Amy C. Brodkey, M.D.*
Associate Clinical Professor of Psychiatry
University of Pennsylvania
*No financial ties with, or gifts accepted from, drug companies
1
This Presentation Will Cover
• Interactions between the pharmaceutical industry,
physicians and medical students
• Characteristics of the pharmaceutical industry
• Characteristics of the information that industry
provides to us
• Our denial of industry influence
• Our efforts to reduce industry influence
• RFUMS’ policies about industry-clinician and industrystudent interaction
• Outcomes of our efforts to reduce industry influence.
2
Objectives of this Presentation
Please read these. I will not discuss them in class.
• Define a conflict of interest.
• Discuss the characteristics of information that the pharmaceutical
industry provides to us health professionals and health professional
students.
• Using data about pharmaceutical industry-clinician or industrystudent interactions, given a vignette of an interaction between a
typical (modal) drug rep and a typical (modal) clinician or health
professional student, summarize what is most likely to occur during
and after the interaction.
• Summarize the factors contributing to pro-industry outcomes in
research (published and un-published) and publications that are
sponsored by drug companies.
• State the RFUMS policies concerning industry-clinician and industrystudent interactions.
3
Main Theme: The Disappearing Boundary Between the Health
Professions and Industry—Particularly the Pharmaceutical Industry—
and its Consequences
• From 1980-2009, we health professionals interacted
progressively more frequently with industry (particularly the
pharmaceutical and medical device industries), with fewer
boundaries between us and them. Between 2009 and today,
this may have reached a “plateau.”
• In the past 13 years, enormous public and health professional
attention has been given to these interactions and their
consequences. This has taken the form of scientific journal
articles, books, media coverage, governmental investigations
and health profession policy statements.
4
5
6
7
8
9
Health Professional Responses to the
Decreasing Boundary
• As a consequence of this attention, influential
national organizations like the Institute of
Medicine and the Association of Medical
Colleges, have urged that our health professions
set boundaries between us and industry, and
teach about our interactions with industry.
• Most US medical and health sciences schools—
including RFUMS—have developed policies about
industry-clinician and industry-student
interactions.
• But industry—more powerful than ever—still
tries to maximize its interactions with us.
10
Disappearing Boundary and Conflicts of
Interest
• These ties between doctors and the drug industry
often create conflicts of interest, defined as
• A set of conditions in which professional judgment
concerning a primary interest, such as a patient’s
health or the validity of research, tends to be unduly
influenced by a secondary interest, such as financial
gain.
Source: Thompson DF. NEJM 1993;329:573-576
11
Source: Catherine de Angelis, MD, at UIC Pharmacy School, 10/27/07
12
Effects of the Disappearing Boundary and
Conflicts of Interest
• The more that the boundary between the health professions
and industry disappears (i.e., the more we interact with and
receive gifts from industry),
• The more we are exposed to and influenced by information
that favors the sponsor’s product.
• An extraordinary body of literature uniformly demonstrates
that for virtually every type of drug industry-clinician
interaction, including advertising, education and research, the
outcome is the presentation of information that favors the
sponsor’s drug.
13
Effects of Receiving Information that Favors the
Sponsor’s Product
• This increases the likelihood of our prescribing the
sponsor’s product and teaching that the product
(i.e., the drug) is effective. This often occurs
– Regardless of whether the drug is best for the
patient,
– Despite scientific evidence to the contrary
– Against our better judgment
14
Compounding the Problem
• This problem is compounded by
– Our proneness to deny that the influence
exists
– Our passivity
15
The increased likelihood of our prescribing the sponsored product,
even when scientific evidence and our better judgment says
otherwise, leads to…
• Poorer patient care
• Poorer health science education
• Scandalously high costs of drugs
16
The Pharmaceutical Industry
• From 1973-2003, and 2008-present, the
highest return on sales, assets and equity of
any industry, overall a 38-year-long pattern.
• From 2003-07, the industry came in third,
below mining/crude oil production and
commercial banks.
Sources: Angell M. The Truth about
the Drug Companies, 2004; IMS
17
Health; Brody H: Hooked, 2007
Drug Companies’ Return on Revenues: The Highest
Profit Margins of All Industries
Source: Time Magazine, February 2, 2004
18
Pharmaceutical Industry and Government
• There is more than one drug company lobbyist
for every member of Congress.
• The pharmaceutical industry is taxed less than
any other industry.
Source: Public Citizen 7/6/2000,
NEJM 6/22/2000,
Time Magazine 2/6/2000,
Common Cause, 6/2001
19
Source: Catherine de Angelis, MD, at UIC Pharmacy School, 10/27/07
20
The Pharmaceutical Industry Lobby is so
Powerful that, for Example…
• In the 2004 Medicare Part D law, Medicare is forbidden to
negotiate prices with drug companies, which maintains the
high costs of drugs.
– Subsequently, Rep. Tauzin, pro-Pharma House leader in
this Medicare Part D debate, retired from Congress and
became CEO of the Pharmaceutical Manufacturers’
Association.
• In the 2009-10 health care reform debate, to obtain drug
company support for the Affordable Health Care Act—and
ward off company opposition to the bills—President Obama
privately told them that, once again, the reform bill would not
include government negotiation of drug company prices.
Sources: Public Citizen Congress Watch, July 2001;
Angell M. The Truth about the Drug Companies, 2004 21
Costs of Marketing to Doctors
• In marketing and promotion to doctors, in the
U.S., the pharmaceutical industry spends
between $61,000/practicing physician/year.
• These costs are borne largely by patients and
the public (as taxes) to whom the marketing
costs are transferred in the huge costs of
drugs.
Source: Gagnon M-A, Lexchin J, PLoS Medicine 2008;5:1-5
22
MD Profiling: An Ethically Troubling
Marketing Technique
• Drug companies find out how often each doctor
prescribes each drug. They obtain this information
from a combination of
– The American Medical Association, whom they
pay ~$44,000,000/year
– Pharmacy chains like Walgreens, CVS, OSCO
• They use this information to pitch their products to
individual doctors.
Greene JA. Ann Int Med. 2007 May 15;146:742-8;
Steinbrook R. NEJM. 2006 Jun 29;354(26):2745-7.
23
Drug Companies Spend Nearly Three Times as Much on
Marketing and Administration as on R&D
(11 Fortune 500 drug companies)
30%
30%
25%
20%
15%
17%
12%
10%
5%
0%
R&D
Profits
Marketing & Administration
52
Sources: Edwards J. Brandweek. 2005 Feb 7; ;46(6):24-6; Public Citizen, 2001
24
Strongly Affected by Marketing Costs, U.S.
Prescription Drug Expenditures Are Increasing
Dramatically.
55
Source: IMS Health
25
Drug Detailing
• In 2000, the pharmaceutical sales force was
88,000, and there was one drug rep for every
7-8 MDs and the number of details (visits by a
drug rep to an MD) was 60,000,000.
• Currently it is 100,000 sales reps, and for highprescribing doctors, the ratio is 1 rep per 2.5
MDs.
Source: Presentations by Amy C.
Brodkey, MD, Adriane Fugh-Berman, MD
Sources: New York Times 1/11/99;
Scott Levin Consulting, PhRMA
Pharmaceutical Industry Profile
(2001 appendix); Goldberg M et. al.
Pharm Exec. 2004 Jan 1;24:40-5. 26
Types of Health Professional-Pharmaceutical
Industry Interactions
•
•
•
•
•
•
•
•
•
•
Gifts
Meals
Honoraria
Clinician self-esteem
Detailing
Medication samples
Continuing education (CE) events
Fellowships
Stage 3 and 4 drug trials
Consultancies
• Speakers’ bureaus
• Ghostwriting
• Professional society and society
meeting support
• Medical Education Companies
(MECs)
• Investments
• Patient advocacy groups
• Contract research organizations
• Academic-industry partnerships
• Direct-to-consumer ads
Modified from 2003 presentation by Amy C. Brodkey, MD
27
Continuing Medical Education (CME)
• The pharmaceutical and medical device industries
pay for over 50% of the $2.3 billion spent annually
for continuing medical education (CME).
• CME programs are biased in favor of the sponsor’s
products.
Sources: ACCME, 2006; Bowman & Pearle.
J Contin Educ Heal Prof 1988; Relman A
28
Fees to MDs to Enroll Patients in Clinical Trials
• Drug companies pay an average of $7,000 to enroll one of
their patients in a clinical trial, sometimes with bonuses for
rapid enrollment.
• In one trial, MDs were paid $12,000 for each patient enrolled,
plus another $30,000 for enrollment of the sixth patient.
– “If it means an extra $30,000 to you to enroll a patient in
an asthma study, you might very well be tempted to decide
your next patient has asthma, whether he does or not.
(‘Sounds like a little wheeze you have there’)”
Source: Angell M. The Truth about
the Drug Companies, 2004, p. 31
29
Physicians Who Participated in Sponsored Clinical Trials Were More
Likely to Prescribe Sponsored Drug in their Practices than NonParticipating Physicians (Chart review for 55,013 patients)
Source: Andersen M et al. JAMA 2006;295:2759-2764 30
Consultancies to Drug Companies
• In the commonest type of “consultancy,” clinicians
are invited to expensive restaurants or on trips to
luxurious settings. “The doctors listen to speakers
and provide some minimal response about how they
like the company drugs or what they think of a new
advertising campaign. This enables drug companies
to pay doctors just for showing up.”
Source: Boston Globe,
December 15, 2002
31
Speakers’ Bureaus and MECs
• Many clinicians are recruited to serve on speakers’ bureaus,
typically run by for-profit medical education companies
(MECs).
• MECs are
– Typically supported by drug companies
– Sometimes owned by advertising agencies
– Accredited to provide CME programs
• MECs
–
–
–
–
Plan meetings
Suggest topics and speakers
Prepare slides
Coach speakers on how to use the slides and what to say
Source: Angell M. The Truth about the
Drug Companies, 2004, p. 139
32
Ghostwriting
• Approximately 11% of medical
journal articles are ghostwritten by
professional writers working for
medical education companies (MECs)
largely funded by DCs.
Sources: Moffatt B, Elliott C Perspect Biol Med 2007; Healy D, Cattell D.
Brit J Psychiatry 2003; Flanigin et al., JAMA 1998
33
Support of Professional Meetings
• “Many big professional meetings resemble
bazaars, dominated by garish drug company
exhibits and friendly salespeople eager to ply
doctors with gifts while they pitch their
companies’ drugs…Instead of sober
professionalism, the atmosphere of these
meetings is now trade-show hucksterism.”
Source: Boston Globe, May 28, 2002
34
American Psychiatric Association Convention, 2005
(photo by F. Sierles)
35
American Psychiatric Association Convention,
2005 (photo by F. Sierles)
36
American Psychiatric Association Convention,
2005 (photo by F. Sierles)
37
American Psychiatric Association Convention, 2005
(photo by F. Sierles)
38
Support of Professional Meetings (cont.)
• “Most professional societies support this because
the drug companies support the meetings. At the
American Psychiatric Association (APA) annual
meeting in 2002, drug companies spent between
$200,000 and $400,000—plus a $60,000 direct
payment to the APA—for each of ~50 “industrysponsored symposia.”
• APA officials state that drug companies provide one
third of the APA’s budget.
Sources: Boston Globe, May 28, 2002;
Brody H: Hooked, 2004, p. 215
39
Consultation to the Investment Industry
• Almost 1 in 10 physicians has a formal
consultancy with the investment industry.
• Hourly rates range from $200-1,000.
• For example, New York’s Gerson Lehrman
Group has contracts with over 60,000
physicians.
Source: Topol EJ, Blumenthal D JAMA 293:2364-65
40
Patient Advocacy Groups
• Many patient advocacy groups receive drug company
support.
• In some instances, the drug company actually creates
the advocacy group. For example,
– The American Reye’s Syndrome Association was
created by Bayer aspirin to oppose the FDA’s
proposal of a warning label for use of aspirin for
viral illnesses.
Source: Washington Post, September 12, 2000
41
Examples of Patient Advocacy Groups
Created by Industry
• The majority of donations to the National
Alliance for the Mentally Ill (NAMI) comes
from drug companies.
• Consumer groups fully funded by Eli Lilly
bombarded Kentucky state agencies when
they proposed to remove olanzapine from its
formulary.
Source: Brody H: Hooked, 2007; Harris G:
Drug makers are advocacy group’s biggest
Donors. NY Times, October 21, 2009.
42
Too Many “Me-Too” Drugs: Characteristics
of 78 Drugs Approved by the FDA in 2002
8.9%
12.8%
No New Ingredient
78.3%
New Ingredient, No
Better than Older
Drug
Sources:
www.fda.gov/cder/rdmt/pstable.htm
Also Angell M, 2004
43
60
Criminal and Civil Penalties for Drug Companies’ Illegal
Marketing of Drugs, or Kickbacks to Doctors
• Pfizer. $240 million for off-label marketing of gabapentin
(Neurontin)
• TAP. $875 million for illegal kickbacks to doctors who
prescribed leuprolide (Lupron)
• Pfizer. $2.3 billion for off-label marketing of valdecoxib
(Bextra), ziprasidone (Geodon), linezolid (Zyvox) and
pregabalin (Lyrica)
• Lilly. $800 million for off-label marketing of olanzapine
(Zyprexa)
• Glaxo Smith Kline. $3 billion for off-label marketing of
paroxetine (Paxil) and failing to report safety data about
rosaglitazone (Avandia)
Sources: Steinman MA, Bero LA, et al. Ann Int Med 2006; Spielmans GI. Soc Sci Med 2009; Harris G. NY Times,
October, 2009; Brody H. Hooked. Rowman & Littlefield, 2007; NY Times, July, 2012)
44
Profits and Laws
• “Managers do not have an ethical duty to obey economic
regulatory laws just because the laws exist. They must
determine the importance of these laws. The penalties
Congress names for disobedience are a measure of how
much it wants firms to sacrifice in order to adhere to the
rules; the idea of optional sanctions is based on the
supposition that managers not only may but also should
violate the rules when it is profitable to do so.”
Source: Easterbrook FH, Fischel DR,
“Chicago School”: Antitrust Suits
by Targets of Tender Offers.
Michigan Law Rev 1982;80:1155-78 (p. 1157)
45
Visits per Month with Drug Reps in National Survey of
Physician-Industry Relationships, 2003
Anonymous mail survey 3167 clinicians, 52% response rate
Visits/
Month
Source: Campbell EG et al. NEJM April 26, 200746
Residents Used to Be “Walking Billboards”
for New Drugs:
(items found in residents’ white coats)
100%
95%
95%
85%
79%
80%
60%
Carrying the item
58%
55% 55%
41%
40%
20%
98%
28%
14%
31%
51%
45%
Percent of items
with drug
company brand
0%
Source: Sigworth et47al.,
56
New Yorker, September 2008
48
% of Medical Students Experiencing Various
Types of DC Marketing
(826 3rd year students at 8 schools)
Source: Sierles et al.,
JAMA, 2005
49
NOT ME
• “I can see how other students and doctors
could be influenced by gifts and sponsored
presentations. But NOT ME. I’m objective and
scientific and I know when what I hear is
biased and I can’t be influenced.”
Attitude of most doctors and medical students
50
MD Denial of Expected Influence of an All-Expenses-Paid
Symposium About Drug A
• 10 MDs were invited to an all-expensespaid trip to a symposium on Drug A, an
intravenous antibiotic, at a sunbelt
vacation site.
• Before the symposium, the MDs were
asked about whether the trip and
symposium would affect their prescribing
of Drug A.
• The researchers gathered data about
prescribing patterns of Drug A at that
medical center and nationally.
Number OF MDs
(interviews of 10 MDs in a Cleveland medical center)
9
8
7
6
5
4
3
2
1
0
9
1
0
Will not
Unlikely to Could possibly
influence my influence
influence
prescribing
practices
Source: Orlowski and Wateska
64
Chest 1992;102:270
51
Source: NoFreeLunch website
52
Denial of Influence: Proportions of Residents or Medical Students
Who Perceive that They, or Doctors in General, Are Not
Influenced by Gifts
Sources: Hodges, 1995; Reeder, 1993; Steinman, 2001; Wilkes, 2001; Sierles 2005; Austad, Avorn,
Kesselheim 2011
53
Students’ Perceive that They Are
1) Minimally Influenced by and 2) Entitled to DC Gifts
Source: Sierles et al.,
JAMA, 2005
54
“I’m Not Biased: The Other Guy Is”: Resident Perceptions of
Whether DC Gifts Can Influence Their Prescribing Practices
Source: Steinman et al. Am J Med
55
2001;110:551
BIAS IN INFORMATION PROVIDED
BY DRUG COMPANIES TO DOCTORS
56
Other Data about DCs: Virtually All Information Presented by
Industry to Physicians is Biased in Favor of the Sponsor’s
Product. This Includes…
•
•
•
•
•
•
•
Journal articles
Journal supplements
CME presentations
Grand rounds
Details by reps to doctors
Journal advertisements
National medical meetings
Sources:
1. Bekelman et al.,
JAMA 2003
2. Bero LA, Rennie D. Int J
Technol Assess Health Care 1996
3. Lexchin J Bero L
et al. BMJ 2003
4. Safer DJ. J Nerv Ment Dis 2002
5. Cho MK, Bero LA. Ann Int Med
1996
6. Bowman MA. Mobius 1986, 1988
7. Spingarn RW, et al. Acad Med
1996
8. Ziegler MG. JAMA 1995
9. Villanueva et al. Lancet 2003
10. Fries JF, Krishnan E.
Arthritis Res Ther 2004;6:250-355
57
Abstracts on Randomized Controlled Trials
Presented at 2001 American College of
Rheumatology Meetings
Source: Fries JF, Krishnan E.
Arthritis Res Ther 2004;6:250-355
58
Abstracts in Scientific Program at 2005 and 2006 American
Psychiatric Association Annual Meetings: IndustrySponsored Research or Author’s Ties Listed in Program
Source: Sierles FS, Gill T. Unpublished
Manuscript, 2008.
59
Conflicts of Interest in Research: Sponsored Studies Tend to Have Pro-Drug
Company Conclusions (11 articles that evaluated 1140 original studies)
60
Source: Bekelman et al., 2003
61
Bias in Research: Relationship between Industry Sponsorship and Study
Outcome in 16 Additional Studies of Clinical Trials
Source: Lexchin J
Bero L et al. BMJ
2003;May 31, 2003
62
Copyright ©2003 BMJ Publishing Group Ltd.
Sponsor’s Drug Beats Comparison Drug in 18/21
Head-to-Head Studies of Atypical Antipsychotics
Source: Heres et al. Am J Psychiatry, Feb, 2006
63
Factors Contributing towards Bias in Studies
• Selecting healthier (younger, fewer co-morbidities) patients
• “Enriching” randomized double-blind trials by including patients who
previously responded to sponsored drug in open-label trials
• Withholding unfavorable data (about lack of effect, or bad outcomes)
• Comparing high dose of sponsored drug with low dose (or ineffective
route of administration) of competitor’s product
• Comparing sponsored drug to a placebo
Sources: Bero L, Rennie D. Int J Technol Health 1996;12;209-237;
Lexchin J, Bero LA. BMJ 2003;326:1167;
Melander H et al. BMJ 2003;326:1171;
Dubovsky S, Dubovsky A. Psychotropic Drug Prescriber’s Survival Guide, 2007
64
Factors Contributing towards Bias in Studies
(cont.)
•
•
•
•
Conflating statistical significance with clinical importance
Emphasizing lab values over meaningful clinical effects
Including the same data and patients in multiple publications
Publishing in non-peer-reviewed symposium proceedings and
journal supplements, not peer-reviewed journals
• Drawing conclusions not based on the data
Sources: Bero L, Rennie D. Int J Technol Health 1996;12;209-237; Lexchin J,
Bero LA. BMJ 2003;326:1167; Melander H et al. BMJ 2003;326:1171;
Dubovsky S, Dubovsky A. Psychotropic Drug Prescriber’s Survival Guide, 2007
65
Positive Studies of Antidepressant Efficacy are More Likely
than Negative Studies to Be Published
Review of 74 Studies involving 12,564 Patients
Turner EH et al. NEJM, Jan. 17, 2008
66
Positive Studies of Antidepressant
Efficacy are More Likely than
Negative Studies to Be Published
(cont.)
Review of 74 Studies involving 12,564
Patients. Turner EH et al. NEJM, Jan. 17, 2008
67
Direct-to-Consumer (DTC) Ads Depictions of
Illness and the Company Drug
(Peak TV viewing times x 1 mo.)
Source: Frosch et al. Ann Fam Med 2007;5:6-1368
When a Behavioral (Lifestyle) Change is as Good as Medication for a
Condition, How Do Direct-to-Consumer Drug Ads (DTCA) Address This?
(Peak TV viewing times x 1 mo.)
Source: Frosch et al. Ann Fam Med 2007;5:6-13
69
Characteristics of Direct to Consumer Ads
(Peak TV viewing times x 1 mo.)
Source: Frosch et al. Ann Fam Med 2007;5:6-13
71
Statements by Drug Reps Tended to Favor the Promoted Drug Rather than the
Competitor’s Drug (recordings of 106 statements by 12 reps speaking to 27
medicine residents at 8 lunch conferences)
Source: Ziegler et al. JAMA 1995;273:1296-1298
72
Conflicts of Interest in Research: Clinical Trial Agreements Don’t Comply with
Standards of Int’l Committee of Medical Journal Editors
(interviews of officials at 108 medical schools)
Sponsor must follow protocol
0%
Institution must follow protocol
100%
All trial results must be published
0%
Authors must have access to all data
1%
Must have independent safety monitoring board
1%
Must have independent steering committee
2%
0%
10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Source: Schulman et al. NEJM
2002;347:1335.
69
73
MD Passivity (cont.): ~7% of Patients Requested Specific Drugs, and 3/4
Received Them
(1431 patients, pre-visit questionnaires; 78 MDs, post-visit questionnaires)
74
Too Often, Primary Care MDs Who Prescribed the
Requested Drug Might Not Have Prescribed it for Another
Patient.
75
Free Drug Samples Are More Likely to Be Given to
Privileged than Underprivileged Persons
Source: Cutrona SL, Woolhandler S, et al. Am J Pub Health, 2008
76
Conflicts of Interest in Patient Care: MDs Who Request Additions
to a Hospital Formulary Are Much More Likely to Have Received
Drug Company Funds, Compared to Controls
(written survey of 40 MDs who requested additions, 80 control MDs)
77
66
Conflicts of Interest in Patient Care: Authors of Clinical Practice Guidelines’
(CPGs) Relationships With Drug Companies
(written survey of 100 authors of 44 CPGs)
Source: Choudary et al. JAMA
2002; 287:612-617.
78
However, Authors Declared Conflict of Interest
in Only 1 of 44 Guideline Sets
Source: Choudhry et al.
JAMA 2002; 287:612-617.
79
Percentage of DSM-IV Panel Members With and Without
Ties to Pharmaceutical Industry—Yet No Ties Were
Disclosed
Source: Cosgrove L, Krimsky S, et al.
80
Psychother Psychosom 2006;75:154-160
Proposed Solutions
81
The Association of American Medical Colleges (AAMC),
which accredits all medical schools, expects/urges
all medical schools and academic medical centers
to have rules about drug company-physician and drug
company-student interactions.
Association of American Medical Colleges (AAMC). Industry
Funding of Medical Education: Report of an AAMC Task Force.
Washington, DC: AAMC, June 2008
82
Medical Students at U. of Miami (Gifts Permitted) Are More Apt than
Students at Penn (No Gifts) to Perceive that They Are 1) Minimally
Influenced by and 2) Entitled to DC Gifts.
(Sources: Grande et al., 2009; Sierles et al., 2005)
83
RFUMS Rules about Drug Company-Physician
and Drug Company-Student Interactions
84
Gifts to Individuals
• Gifts to an individual (e.g., doctor, student) from the
health care industry are prohibited.
• A gift from the health care industry to the University
is not a “gift to an individual” if
– The gift is processed by the Office of Institutional
Advancement.
– Health care industry does not give the gift directly to an
individual.
– Health care industry does not select the recipient of the
gift.
85
Food
• No food from industry UNLESS
– The event is an approved Continuing
Medical Education event.
– The sponsor gives a grant to the
college’s/school’s Office of Continuing
Education.
86
Drug Samples
• Samples, which are gifts, may not be given
directly to doctors or patients by drug
company representatives.
• They may be given by drug reps to the
university health system to centrally manage
the giving of samples.
87
Ghostwriting
• Health care professionals and students may
not accept credit for articles ghostwritten by
others.
88
Meetings with, or Presentations by, Drug
Reps
• Drug reps may not meet directly or make
appointments with students or residents, and
vice versa.
• A faculty member may invite a drug rep to
discuss a topic with him or her, and may
include a trainees in that meeting.
89
Pharmaceutical Manufacturers of America
2009 Code about Their Drug Reps’ Interactions with
Healthcare Professionals
• Providing items for healthcare professionals’ use that do not advance
disease or treatment education—even if they are practice-related items of
minimal value (e.g., pens, note pads, mugs…) may foster misperceptions
that company interactions are not based on informing them about medical
and scientific issues. These (pens, notepads, mugs) should not be offered
to healthcare professionals or members of their staff.
• Companies should provide
– No entertainment or recreational items like theater or sporting event
tickets
– No golf balls or sports bags
• It is inappropriate to include a healthcare professional’s spouse or other
guest in a meal accompanying an informational presentation made on
behalf of a company.
90
Monthly Frequency of Drug Company Lunches Provided to Third Year
Students at Three Medical Schools, 2003 vs. 2012
(Source: Sierles FS, Kessler KH et al., 2012)
F=31.54
P <.001
91
Monthly Frequency of Drug Company-Sponsored Grand Rounds Attended by
Third Year Students at Three Medical Schools, 2003 vs. 2012
(Source: Sierles FS, Kessler KH et al., 2012)
F=57.1
P <.001
92
Monthly Frequency of Drug Company-Sponsored Grand Rounds Attended by
Third Year Students at Three Medical Schools, 2003 vs. 2012
(Source: Sierles FS, Kessler KH et al., 2012)
F=57.1
P <.001
93
Monthly Frequency of Small Gifts Provided by Drug Companies to
Third Year Students at Three Medical Schools, 2003 vs. 2012
(Source: Sierles FS, Kessler KH et al., 2012)
F=172.9
P <.001
94
Monthly Frequency of Snacks Provided by Drug Companies to Third
Year Students at Three Medical Schools, 2003 vs. 2012
(Source: Sierles FS, Kessler KH et al., 2012)
F=20.18
P <.001
95
Monthly Frequency of Reprints or Glossy Brochures Provided by Drug
Companies to Third Year Students at Three Medical Schools, 2003 vs. 2012
(Source: Sierles FS, Kessler KH et al., 2012)
F=25.5
P <.001
96
Monthly Frequency of Physicians Asking Third Year Students at Three
Medical Schools to Attend a Drug Company Sponsored Lunch or Dinner,
2003 vs. 2012
(Source: Sierles FS, Kessler KH et al., 2012)
F=4.02
P <.045
97
Changes in Physician-Industry Relationships from 2004 to
2009 (Random Sample of 2,938 Physicians)
Source: Campbell E. et al. Arch Int Med 2010;170:1820-1826
98
Change in Medical Students’ Attitudes about Drug
Company Interactions in Response to a Teaching
Intervention
Source: Kao AC, Braddock C.
Academic Medicine, November 2011
99
List of Unbiased Drug Sources
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Medical Letter www.medletter.com
Prescriber’s Letter www.prescribersletter.com
Therapeutics Letter (Canada) www.ti.ubc.ca/
Drug and Therapeutics Bulletin (UK) www.dtb.org.uk
Infopoems www.infopoems.com/
Cochrane Database www.cochrane.org/reviews/clibintro.htm
Consumer Union Best Buy Drugs www.crbestbuydrugs.com/
Carlat Report (psychotropic drugs)
Prescrire (France)
100
Health Sciences Schools—Not Drug Companies—Are
Responsible for Health Science Education
• “Medical education worthy of the name requires an impartial
analysis of all the available evidence, led by experts who have
no vested interest in the drugs they are discussing. It is the
job of medical schools and their faculty, and of professional
societies, to educate doctors in that way. To abdicate that
responsibility is wrong, and it is doubly wrong to leave it to an
industry with an obvious financial interest in the enterprise
and then pretend it is otherwise. That a noble profession has
been willing to do this is a testament to the power of ‘food,
flattery and friendship’—and money, lots of it.”
Source: Relman A, Angell M. America’s other drug problem:
101
New Republic, December 16, 2002