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HEALTH STUDIES PROGRAMME
HUMAN BIOLOGY PROGRAMME
UNIVERSITY OF TORONTO
FALL 2015
HST440H1
HEALTH AND PHARMACEUTICALS
WORKING DRAFT
Classes:
Tuesdays, 1:00 pm - 3:00 pm
September 15 to December 1, 2015 inclusive
Room:
University College Room 85
Instructors:
Dr. Nancy Olivieri
Office: Toronto General Hospital
Eaton Wing North, 12th floor, Room 238
nancy@hemoglobal.org
Dr. Elia Abi-Jaoude
Office: The Hospital for Sick Children, Room 4288C
elia.abi.jaoude@utoronto.ca
Texts:
1. Elliott, Carl 2010. White Coat, Black Hat. Adventures on the Dark Side of Medicine. Boston: Beacon
Press.
2. Light, Donald (ed.) 2010. The Risks of Prescription Drugs?. New York: Columbia University Press.
Purchase on Amazon/ read on Google Books on-line.
3. Mintzes, Barbara, Dee Mangin and Lisa Hayes et al (eds) 2011. Understanding and Responding to
Pharmaceutical Promotion: A Practical Guide. WHO/HAI Manual.
Available online at:
http://www.haiweb.org/11062009/drug-promotion-manual-CAP-3-090610.pdf
Assignments (=100 marks):
A.
1.
2.
3.
B.
Reflections (4, worth 5 marks each = 20 marks)
Students will submit a “reflection” (500 words of analysis, thoughts and opinions) of the weekly
lecture and readings.
Over the weeks of September 21 to October 12, inclusive, FOUR (4) reflections are expected.
Only one reflection may be submitted per week.
By October 13, students will have submitted their 4 reflections. For those not satisfied with
their grades, they may submit ONE more reflection for either the topic discussed on October 20
or that discussed on October 27. This optional extra reflection is to be submitted by October 27
at the latest. For those who choose to submit the additional reflection, we will give the best 4
out of 5 marks.
Book Review (due on October 20, worth 20 marks)
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1.
2.
This is a 1500 ± 200 words review of a book;
Books to be reviewed are to be drawn from a list provided (“Book List”)
C.
In-class student presentations (30 marks)
1.
Each student along with 4 to 5 other students will be assigned a topic that extends
analysis to new topical, ethical, and epidemiologic areas. This round of presentations will begin in
November for 4 weeks.
2.
On Tuesday September 29, these topics will be assigned.
D.
Final essay (30 marks).
Schedule of Lectures
1st Lecture:
Tuesday, September 15, 2015:
Health And The Pharmaceutical Industry: an overall view: what do we know and understand? What is
fact? What is myth?
Discussion led by: Professor Olivieri
This lecture will be a general introduction to the course. The central problematic will be discussed: what
the course is about; discussion of the outline, readings, assignments, presentations, and the final essay
will be provided.
The industry that produces drugs for human health presents itself as a unique combination of
humanitarian enterprise wedded to capitalist business practices and goals. How successful is this
synthesis? And how closely does the rhetoric correspond to the reality?
A growing number of critics, representing health professionals, patients and patient advocates,
government watchdogs and industry whistle-blowers have found the high-minded language of Pharma’s
stated goals departing radically from the actual practices observed. These widening gaps are manifest on
a variety of levels: ethical, legal, and scientific; and at every stage in the process of drug development.
Each drug can been seen as having a life history: from laboratory development, to construction of clinical
trials, to submission to government for evaluation and approval, to writing of scientific results, to
marketing to doctors and to the public, and post-market monitoring of efficacy and of side-effects and
adverse events.
This course will explore the expanding bodies of evidence that document the ways in which Pharma
currently operates in the intersecting worlds of science, ethics, business, and human health.
Required reading: None assigned.
2nd lecture: Tuesday, September 22, 2015:
The fundamental problem of conflicts of interest: in development, prescription, promotion, and
marketing of drugs.
In class movie: Big Bucks, Big Pharma (45 minutes)
Discussion led by: TBA
A crisis in medicine and research? Consider the following:
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Why have former editors of world’s most prestigious medical journals expressed alarm about relations
between the pharma industry and medicine using terms like “corruption”?
What should we make of research in leading media such as Bloomberg Markets which headline “Big
Pharma’s Crime Spree” in relation to civil and criminal findings in the billions of dollars of penalties?
Why have medical ethicists recently called for legal penalties for ghost-writing/guest-authorship
practices, using terms such as “fraud” and “racketeering?”
Why has a Canadian Member of Parliament written a book called “Death by Prescription”, about his
daughter’s death from a prescription drug (Prepulsid)?
Why did the associate director of drug safety at the Food and Drug Administration testify before the US
Congress in 2005 against his own agency and hold it responsible for the “single greatest drug safety
catastrophe in the history of this country or the history of the world”?
The ways that Pharma and medicine intersect are extremely complex. As we begin to unravel these
complexities, we turn to the work of Carl Elliott, a physician, ethicist, and courageous activist, to shine
light on some of the darker corners of the medical profession as it actually functions today.
We begin our examination by looking at Elliott’s own awakening to the seriousness of the crisis in
medicine. The Donald Light chapter offers an introduction to the key issue of harm, to
consumers/patients and harm to bio-medicine and its credibility. Light provides an overview of the
extent and types of harm. Elliot documents the institutional arrangements (and others) which allows
harm to proliferate.
Required reading:
Elliott, Carl 2010. White Coat, Black Hat. “Introduction” pp. ix-xvi.
Elliott, Carl 2010. White Coat, Black Hat. Chapter 3: “The Detail Men” Pp. 51-73; & Chapter 4: “The
Thought Leaders” pages. 75-108.
HAI Manual Chapter 1; Mintzes B et al. “Promotion of medicines and patient health”
Recommended reading:
Light, Donald 2010. The Risks Of Prescription Drugs. Chapter 1 Bearing the risks of prescription drugs,
pp. 1-39
HAI chapter 3: Analyzing pharmaceutical advertisements in medical journals
HAI chapter 4: Pharmaceutical reps
Schafer A. Biomedical conflicts of interest: A defense of the sequestration thesis-learning from the cases
of Nancy Olivieri and David Healy. J of Med Ethics 2004;30:8-24. (16 pages)
Stossel TP. Has the hunt for conflicts of interest gone too far? Yes. Brit Med J 2008; 336: 476-477. (1
page)
Lee K. Has the hunt for conflicts of interest gone too far? No. Brit Med J 2008; 336: 477-478. (1 page)
Wazana A. Physicians and the pharmaceutical industry: Is a gift ever just a gift? JAMA 2000;283: 373-80.
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(7 pages)
Willman D. Stealth Merger: Drug Companies and Government Medical Research. Los Angeles Times.
Dec 7, 2003: A1, A32-33. (20 pages)
Stossel TP. Response to AMA's council on ethical and judicial affairs draft report on “ethical guidance
for physicians and the profession with respect to industry support for professional education in
medicine.” Medscape J Med 2008;10:137-43. (7 pages)
Brody H. A reply to Thomas Stossel on the AMA-CEJA draft report. Medscape J Med 2008;10:154-6. (2
pages)
Multiple Authors responding to Stossel TP, N Engl J Med 2005. Academic-industrial relationships:
Correspondence (Howard Brody, Thomas Stossel, Ehud Arbit). N Engl J Med 2005; 353:2720-2. (2 pages)
Steinbrook R. Financial conflicts of interest and the NIH. N Engl J Med 2004; 350:327-330. (3 pages)
3rd lecture. Tuesday, September 29, 2015:
(i)
(ii)
Big Pharma and Medical Education
Ghost Authorship and “Ghost-writing” In Industry-sponsored Research
Discussion led by: Ms. Adrienne Shnier, Health Policy and Equity, School of Health Policy and
Management, York University, Toronto, Canada
Big Pharma and Medical Education Conflicts of interest with industry may occur in medical education in
the classroom, in the conduct and reporting of research, at the bedside, and in the treatment of patients.
The education of medical students should be based on the best clinical information available, unbiased
by the commercial interests of industries marketing pharmaceutical or other health products. In many
Canadian medical schools, students are taught by faculty who work in partnership with industry, e.g.,
receive research grants from companies, serve on companies’ speakers’ bureaus or advisory committees,
or own shares in companies. The financial relationships of faculty with industry may affect, or
reasonably appear to affect, the integrity of their academic or publishing interests, professional medical
opinions, and the information that they disseminate to medical students. These relationships between
medical faculty and industry represent conflicts of interest and compromise not only the public’s
confidence and trust in medical researchers and universities, but also the potential for robust, evidencebased clinical education for medical students.
Ghost Authorship and “Ghost-writing” In Industry-sponsored Research The publication of research
articles in refereed journals is held up as the gold-standard in academic achievement and advancement.
In most non-medical fields, claiming authorship of work not written by the listed author is a major
breach of academic ethics, and penalties can be severe. Yet in medical journals a significant percentage
of major articles are written by anonymous professional writers (usually at the direction of Pharma
companies) and then “authored” by senior academic researchers. Until recently this was considered
normative, and not ethically questionable. Today’s readings and lecture focus in some part on the
ghost/guest authorship in publishing pharmaceutical research.
Required Reading
Shnier A., Lexchin J., Mintzes B, Juttel A., and Holloway K. Too Few, Too Weak: Conflict of Interest
Policies at Canadian Medical Schools. PLOS ONE 2013: 8(7): e68633.
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Elliott, Carl 2010. White Coat, Black Hat. Pp. 1-23 and Chapter 2: “The Ghosts”, Pp. 25-49.
Recommended reading:
Medical Education
Relman AS. Separating Continuing Medical Education From Pharmaceutical Marketing. JAMA 2001; 285:
2009-2012
Elliott C. Pharma Goes to the Laundry: Public Relations and the Business of Medical Education. Hastings
Center Report. September-October 2004.
Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic industry relationships. JAMA 2007;
298(15):1779-1786 (doi:10.1001/jama.298.15.1779)
http://jama.ama-assn.org/cgi/content/full/298/15/1779
Brennan TA, Rothman DJ, Blank L et al. Health Industry Practices That Create Conflicts of Interest: A
Policy Proposal for Academic Medical Centers.
JAMA 2006; 295(4):429-433 (doi:10.1001/jama.295.4.429)
http://jama.ama-assn.org/cgi/content/full/295/4/429
Mello MJ, Clarridge BR, Studdert DM. Academic Medical Centers’ Standards for Clinical-Trial Agreements
with Industry. N Engl J Med 2005;352: 2202-10.
Ghostwriting
Anekwe, T. (2009). Profits and Plagiarism: The Case of Medical Ghostwriting. Bioethics, 24 (6), 267-272.
Barbour, V. (2010). How Ghost-Writing Threatens the Credibility of Medical Knowledge and Medical
Journals. Haematologica, 95 (1), 1-2.
Elliott, C. (2010a). Chapter 2: The Ghosts. In C. Elliott, White Coat Black Hat: Adventures on the Dark
Side of Medicine (pp. 25-49). Boston: Beacon Press.
Fugh-Berman A (2010). The Haunting of Medical Journals: How Ghostwriting sold “HRT” PLoS Medicine 7
(9): 1-11.
Gotzsche, P. et al. (2007). Ghost Authorship in Industry-Initiated Randomised Trials. PLoS Medicine, 4 (1),
47-52.
Gotzsche, P. et al. (2009). What Should be Done to Tackle Ghostwriting in the Medical Literature? PLoS
Medicine, 6 (2), 0122-0125.
Grassley, C. (2010). Ghostwriting in Medical Literature. Senate Committee on Finance. United States
Senate.
http://www.grassley.senate.gov/about/upload/Senator-Grassley-Report.pdf
Lacasse, J. & Leo, J. (2010). Ghostwriting at Elite Academic Medical Centres in the United States. PLoS
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Medicine, 7(2): 1-4.
Ngai, S., Gold, J., Gill, S. & Rochon, P. (2005). Haunted Manuscripts: Ghost Authorship in the Medical
Literature. Accountability in Research, 12, 103-114.
Sismondo S (2007) Ghost Management: How Much of the Medical Literature Is Shaped Behind the
Scenes by the Pharmaceutical Industry? PLoS Med 4(9): e286.
4th Lecture: Tuesday, October 6, 2015:
The role of government regulation in approval and marketing of drugs.
Discussion led by: Dr. Joel Lexchin, Professor, School of Health Policy and Management, Faculty of
Health, York University.
All members of the public eventually become patients in need of some combination of products from
Pharma. In medicating ourselves we count on government regulatory agencies to evaluate all potential
medications and to approve only those that have proven efficacy and an absence (or at least low
incidence) of serious side effects. Then how do we account for the all too numerous drugs approved and
then taken off the market because of adverse side effects, up to and including death. The NSAID
painkiller Vioxx, passed all regulatory hurdles and was approved for sale to the public. It was estimated
to have caused between 40,000-60,000 excess deaths in the United States before it was removed from
the market in 2004. Today`s lecture by Dr. Lexchin examines in detail the ways in which agencies like
FDA and Health Canada, do or do not live up to their mandate and meet the rightful expectations of the
public to have medicines that are effective and affordable and above all, safe.
Required Reading
WHO/HAI chapter 3 Lexchin J. Analyzing pharmaceutical ads in medical journals and chapter 6: Learning
how not to do the pharma industry tango.
WHO/HAI chapter 7 Zinganshina and Lexchin. Regulation of pharmaceutical promotion: Why does
regulation matter?
Light, Donald 2010. Chapter 2: The Food and Drug Administration: Inadequate Protection from Serious
Risk. Pp. 40-68
Herder, Matthew 2011. Unlocking Health Canada`s cache of trade secrets: mandatory disclosure of clinical
trial results. CMAJ 2012;184(2): 194-9.
5th Lecture: Tuesday, October 13, 2015:
Pharmacare: An idea long overdue
Discussion led by:
Professor Marc-André Gagnon
School of Public Policy and Administration
Carleton University
Required and recommended readings: TBA
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6th Lecture: Tuesday, October 20, 2015:
Practical approaches to addressing the harms associated with current practices of drug evaluation and
prescribing
Discussion led by: Dr. Derelie Mangin
7th lecture: Tuesday, October 27, 2015:
The influence of the pharmaceutical industry in psychiatry, and how to mitigate it.
Discussion led by: Dr. Elia Abi-Jaoude
Psychiatry is the area of medicine that has reputedly been the most influenced by the pharmaceutical
industry. In this session, we will look at specifics of this influence in psychiatric research and clinical
practice. We will draw on evidence from the published literature, as well as from internal industry
documents. Subsequently, we will discuss ways to mitigate commercial bias so psychiatric care can be
delivered in an independent fashion to the benefit of patients.
Required Reading
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Spielmans, G. I. & Parry, P. I. (2010). From Evidence-based Medicine to Marketing-based Medicine:
Evidence from Internal Industry Documents. Journal of Bioethical Inquiry, 7, 13-29.
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Paris, J. (2012, April 4). Over-prescribing: a worrisome trend. The Montreal Gazette
Recommended Reading
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Moncrieff, J., & Timimi, S. (2013). The social and cultural construction of psychiatric knowledge: an
analysis of NICE guidelines on depression and ADHD. Anthropology & medicine, 20(1), 59–71
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Bracken, P., Thomas, P., Timimi, S., Asen, E., Behr, G., Beuster, C., … Yeomans, D. (2012). Psychiatry
beyond the current paradigm. The British journal of psychiatry: the journal of mental science, 201(6),
430–434
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Schiff, G. D., Galanter, W. L., Duhig, J., Lodolce, A. E., Koronkowski, M. J., & Lambert, B. L. (2011).
Principles of conservative prescribing. Archives of Internal Medicine, 171, 1433-1440.
8th Lecture: Tuesday, November 3, 2015:
Student Presentations 1 and 2
9th Lecture: Tuesday, November 17, 2015.
Student Presentations 3 and 4
10th Lecture: Tuesday, November 24, 2015:
Student Presentations 5 and 6
11th Lecture: Tuesday, December 1, 2015:
Student Presentations 7
12th Lecture: Tuesday, December 8, 2015:
LAST DAY OF CLASS
Summary discussion: where do we go from here?
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