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HEALTH STUDIES PROGRAMME
HUMAN BIOLOGY PROGRAMME
UNIVERSITY OF TORONTO
FALL 2014
UNI 440H1F HEALTH AND PHARMACEUTICALS
Classes:
Thursdays 1:00-3:00
Room:
University College 152
Instructor:
Dr. Nancy Olivieri,
Office: Toronto General Hospital
Eaton Wing 10th floor Room 225
nancy@hemoglobal.org
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-manualCAP-3-090610.pdf
Assignments (=100 marks):
A.
B.
Reflections (4, worth 5 marks each = 20 marks)
1. Students will submit a “reflection” (500 words of analysis, thoughts and
opinions) of the weekly lecture and readings.
2. Over the 5 weeks September 18, 25, and October 2, 9, 16, FOUR (4)
reflections are expected. The student has the choice of which four of the five
weeks in which to submit a reflection. Only one reflection may be submitted
per week.
Book Review (due on October 23, worth 20 marks)
1.
This is a 1500 ± 200 words review of a book;
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List”)
2.
Books to be reviewed are to be drawn from a list provided (“Book
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 October for 4 weeks.
2.
On Thursday September 25, these topics will be assigned.
D.
Final essay (30 marks)
Schedule of Lectures
1st Lecture. Thursday, September 11, 2014:
Health And The Pharmaceutical Industry: an overall view.
Discussion led by: Professor Olivieri
This lecture will be a general introduction to 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 giant 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. Thursday, September 18, 2014:
The fundamental problem of conflicts of interest: in development,
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prescription, promotion, and marketing of drugs.
Discussion led by: Professor Olivieri
A crisis in medicine and research? An important and legitimate question. Consider
the following:
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 ghostwriting/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.
Light, Donald 2010. The Risks Of Prescription Drugs. Chapter 1 Bearing the risks of
prescription drugs, pp. 1-39
HAI Manual Chapter 1; Mintzes B et al. “Promotion of medicines and patient health”
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Rosenberg, H, Allard, D 2007. Evidence for Caution: Women and Statin
Use. Toronto: Women and Health Protection.
Recommended reading:
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. (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)
Stossel TP.
Regulating academic-industrial research relationships-solving
problems or stifling progress? N Engl J Med 2005; 353:1060-5. (5 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. Thursday September 25 2014:
Selling drugs: marketing to patients and to doctors: the roles of the Drug Reps and
“Key Opinion Leaders” in driving pharmaceutical sales
Discussion led by: Profesor Olivieri.
In class movie: Big Bucks, Big Pharma (45 minutes).
Drug Reps Currently an army of over 100,000 pharmaceutical sales
representatives work the halls of doctors’ offices in North America, trying to
influence doctors’ prescribing habits through a wide range of practices. At the same
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time both doctors and reps connive in the fiction that reps do not influence a
doctor’s prescribing practices: that the reps are engaged in medical education, not
flogging drugs of dubious value. The chapter tells the stories and revelations of
Gene Carbona and Michael Oldani, two highly successful reps turned
whistleblowers.
“Key Opinion Leaders” In this pivotal chapter, Elliott gets to the heart of the matter
in one key respect: the use and misuse of science in development and marketing of
drugs. KOLs tend to be senior scientists or rising young stars who have developed a
deserved reputation for cutting-edge science and then are recruited by industry to
speak at medical meetings, especially at the Continuing Medical Education sessions
that doctors are required to attend. The relationship between Companies and KOLs
is like an intricate dance. Each needs the other, but there are pitfalls: an
independent thinking KOL may not tow the companies’ party-line and affect their
profits; and a company marketing a bad drug can ruin a KOL’s credibility.
At the core are two questions. The first is ethical: do the KOL/Industry
relationships create conflicts of interest (COI)? Can a KOL retain independence
while accepting gifts and remuneration from industry? The second is the question
of science. What is the scientific evidence for or against a product? What is the
relative weight of efficacy and harm for a given drug? The problem, as discussed
earlier, is that drug companies often hold back key parts of the evidence and reveal
only that which is favorable to approval or boosting sales. This practice is at odds
with the most basic elements of science: transparency and impartiality. This is not
just an academic question: bad drugs like the notorious case of Vioxx go on the
market with basic flaws that cause thousands and thousands of preventable deaths.
Required reading:
Elliott, Carl 2010. White Coat, Black Hat. Chapter 3: “The Detail Men” Pp. 51-73; &
Chapter 4: “The Thought Leaders” Pp. 75-108.
Note: It is recommended to read the first 50 pages for this lecture since they are
part of the required reading for lecture 6 anyways.
HAI chapter 3: Analyzing pharmaceutical advertisements in medical journals
HAI chapter 4: Pharmaceutical reps
Recommended Reading
The Push to Prescribe. Women’s Health Protection: Toronto
Worst Pills Best Pills Newsletter article September, 2013.
Market for Statins, At the Expense of the Public's Health.
4th Lecture. Thursday October 2, 2014.
TV Ads Expand the
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Cholesterol-lowering drugs (statins): “so safe they should be in the drinking
water”?
Discussion led by: Lejla Halilovic, Research Assistant, Toronto General
Hospital & York University
Cholesterol-lowering drugs, statins, are now an industry in and of itself. For the drug
Lipitor alone, sales have reached $131 billion since 1996, being prescribed to ~30M people
in the USA alone. Statins have been described to be “so safe they should be in the drinking
water”. But are they really so safe? And does the public, regulators and prescribing
physicians know the full benefit and safety profile of statins?
Using a scaffold of recent lipid-lowering clinical guidelines (USA, UK) and the complex
issues of harm associated with statins, students will have an opportunity to learn about
some of the most polarizing topics concerning statins today. Topics of discussion will
include conflict of interest (both in clinical guidelines and clinical research), clinical trial data
transparency in statins research, problems with meta-analyses which inform clinical
guidelines, “statinization” (i.e. clinically indiscriminate statins-prescribing practices), low risk
vs. high risk prevention, documented statin harms (e.g. myopathy, diabetes,
rhabdomyolysis, cognitive/psychiatric adverse events, peripheral neuropathy, as well as
other areas of concern like cancer and cataract), and academic bullying as a communication
tool of corporate agenda. Conclusion will focus on some important mainstream responses
that question recent lipid-lowering clinical guidelines and statinization.
Required Readings (5 articles)
Cholesterol-lowering guidelines
Ioannidis, J.P.A. More than a billion people taking statins? Potential implications of the new
cardiovascular guidelines. JAMA 2014 Feb 5;311(5):463-4. doi: 10.1001/jama.2013.284657.
Thompson, R., Gerada, C., Haslam, D. et al. Concerns about the latest NICE draft
guidance on statins. Zoe Harcombe blog. June 10, 2014. Retrieved on August 20, 2014 from
http://zoeharcombe.co.uk/assets/media/Newsletter/2014/Open_letter_to_NICE_statins.
pdf
Issues of Transparency
Burne, Jerome. SOS – Sanity Over Statins: CTT the house of statin secrets. Health Insight
UK blog. March 4, 2014. Retrieved on August 20, 2014 from
http://healthinsightuk.org/2014/03/04/sos-sanity-over-statins-ctt-the-house-of-statinsecrets/
Statin-associated harms and adverse events
Therapeutics Initiative. Statins: proven and associated harms. Therapeutics Initiative’s
Therapeutics Letter. Issue 89. Apr-May 2014. Retrieved on August 20, 2014 from
http://www.ti.ubc.ca/letter89
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Academic bullying
Collins, R. and Godlee, F. The BMJ Independent statins review panel report: SP13 Emails
between Rory Collins and Fiona Godlee. BMJ. August 1, 2014. Retrieved on August 20,
2014 from
http://journals.bmj.com/site/bmj/statins/SP13%20Emails%20between%20Rory%20Colli
ns%20and%20Fiona%20Godlee.pdf
Recommended Readings (19 articles)
Cholesterol-lowering guidelines
USA
Abramson, J.D. and Redberg, R. Don’t give more patients statins. NY Times. November 13,
2013. Retrieved on August 20, 2014 from
http://www.nytimes.com/2013/11/14/opinion/dont-give-more-patientsstatins.html?_r=0
Silverman, E. The new cholesterol guidelines and conflicts of interest. Forbes. November 11,
2013. Retrieved on August 20, 2014 from
http://www.forbes.com/sites/edsilverman/2013/11/20/the-new-cholesterol-guidelinesand-conflicts-of-interest/
UK
Harcombe, Z. NICE has ended any debate about its independence. Zoe Harcombe blog. July
18, 2014. Retrieved on August 20, 2014 from
http://www.zoeharcombe.com/2014/07/nice-has-ended-any-debate-about-itsindependence/
Rabar, S. et al. Lipid modification and cardiovascular risk assessment for the primary and
secondary prevention of cardiovascular disease: summary of updated NICE guidance. BMJ.
2014;349:g4356 doi: 10.1136/bmj.g4356 (Published 18 July 2014)
Issues of Transparency
Heath, I. et al. Report of the independent panel considering the retraction of two articles in
the BMJ. BMJ. 2014;349:g5176 doi: 10.1136/bmj.g5176 (Published 15 August 2014) -> see
p. 6
Low-risk vs. High-risk prevention
High-risk
Newman, D. Statins Given for 5 Years for Heart Disease Prevention (With Known Heart
Disease). The NNT website. November 2, 2013. Retrieved on August 20, 2014 from
http://www.thennt.com/nnt/statins-for-heart-disease-prevention-with-known-heartdisease/
Low-risk
Newman, D. Statin Drugs Given for 5 Years for Heart Disease Prevention (Without
Known Heart Disease). The NNT website. November 2, 2013. Retrieved on August 20, 2014
from http://www.thennt.com/nnt/statins-for-heart-disease-prevention-without-priorheart-disease/
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Therapeutics Initiative. Do statins have a role in primary prevention? An update. Therapeutics
Initiative’s Therapeutics Letter. Issue 77. Mar-Apr 2010. Retrieved on August 20, 2014 from
http://www.ti.ubc.ca/letter77
Worst Pills, Best Pills. Statins for Primary Prevention: Risks Without Benefits. Worst Pills,
Best Pills Newsletter. June 2013.
a)
Abramson, J.D. et al. Should people at low risk of cardiovascular disease take a statin?.BMJ.
2013;347:f6123 doi: 10.1136/bmj.f6123 (Published 22 October 2013)
b)
Abramson, J.D. et al. Should people at low risk of cardiovascular disease take a statin?BMJ.
Corrections. 2014;348:g3329 doi: 10.1136/bmj.g3329 (Published 15 May 2014)
Statin-associated harms and adverse events
Golomb, B.A. and Evans, M.A. Statin Adverse Effects: A Review of the Literature and
Evidence
for a Mitochondrial Mechanism. Am J Cardiovasc Drugs. 2008 ; 8(6): 373–418.
Rosenberg, H. and Allard, D. Women and statin use: A women’s health advocacy
perspective. Scandinavian Cardiovascular Journal. 2008; 42: 268-273
Academic bullying (Rory Collins vs. Fiona Godlee)
Collins.R. The BMJ Independent statins review panel report: SP17 Letter 1 from Royal
Collins to FG dated 31 March Not for Publication. BMJ. August 1, 2014. Retrieved on
August 20, 2014 from
http://journals.bmj.com/site/bmj/statins/SP17%20Letter%201%20from%20Rory%20Col
lins%20to%20FG%20dated%2031%20March%20Not%20for%20Publication.pdf
Collins, R. The BMJ Independent statins review panel report: SP18 Letter 2 from Royal
Collins to FG dated 14 April Not for Publication. BMJ. August 1, 2014. Retrieved on
August 20, 2014 from
http://journals.bmj.com/site/bmj/statins/SP18%20Letter%202%20from%20Rory%20Col
lins%20to%20FG%20dated%2014%20April%20Not%20for%20Publication.pdf
Collins, R. The BMJ Independent statins review panel report: SP19 Letter 3 from Royal
Collins to FG dated 25 April Not for Publication. BMJ. August 1, 2014. Retrieved on
August 20, 2014 from
http://journals.bmj.com/site/bmj/statins/SP19%20Letter%203%20from%20Rory%20Col
lins%20to%20FG%2025%20April.pdf
Collins, R. The BMJ Independent statins review panel report: SP20 Letter 4 from Royal
Collins to FG dated 28 April Not for Publication. BMJ. August 1, 2014. Retrieved on
August 20, 2014 from
http://journals.bmj.com/site/bmj/statins/SP20%20Letter%204%20from%20Rory%20Col
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lins%20to%20FG%2028%20April%20Not%20for%20Publication.pdf
Ray of light
Lopez-Jimenez, F. et al. A Summary and Critical Assessment of the 2013 ACC/AHA
Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular
Disease Risk in Adults: Filling the Gaps. Mayo Clin Proc. September 2014
http://www.mayoclinicproceedings.org/article/S0025-6196(14)00570-9/abstract
Price, C. Majority of GPs reject NICE proposals to extend statins to millions more. Pulse
Today. March 3, 2014. Retrieved on August 20, 2014 from
http://www.pulsetoday.co.uk/clinical/therapy-areas/cardiovascular/majority-of-gps-rejectnice-proposals-to-extend-statins-to-millions-more/20005985.article#.VASkuvldWSo
5th Lecture Thursday October 9 2014:
The influence of the pharmaceutical industry in psychiatry, and how to
mitigate it
Discussion led by: Dr. Elia Abi-Jaoude:
Elia Abi-Jaoude, MSc, MD, FRCPC
Fellow, Department of Psychiatry, University of Toronto
Dr. Elia Abi-Jaoude is a psychiatrist, clinical educator, and research fellow at the
University of Toronto. His area of clinical specialization is in developmental
neuropsychiatry, and he is pursuing a PhD in the cognitive neuroscience of selfregulatory control. Dr. Abi-Jaoude is Associate Director of the Advanced Child
Psychopharmacology course at the Hospital for Sick Children, and he teaches
medical trainees and psychiatrists about critical appraisal and how to mitigate
commercial bias in literature evaluation, professional development and clinical
practice. He has organized several symposia and advised the College of Physicians
and Surgeons of Ontario on the topic. He was a member of the Faculty of
Medicine’s Task Force on Relations with Industry and the Private Sector, which
drafted a set of guidelines on the issue, as well as the Department of Psychiatry
Interactions with the Pharmaceutical Industry Committee.
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.
 Paris, J. (2012, April 4). Over-prescribing: a worrisome trend. The Montreal
Gazette
Recommended Reading

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

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

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.
6th lecture. Thursday October 16, 2014:
(i)
Big Pharma and Medical Education
(ii)
Ghost Authorship and “Ghost-writing” In Industry-sponsored
Research
Discussion led by: Ms. Adrienne Schnier, 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, evidence-based clinical education
for medical students.
Ghost Authorship and “Ghost-writing” In Industry-sponsored Research
The
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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
Schiner A., Lexchin J., Mintzes B, Juttel A., and Holloway K. Too Few, Too Weak:
Conflict of Interest Policies at Canadian Medical Schools. PLOS ONE. 8(7): e68633.
If you did not read the chapters for lecture 3: Elliott, Carl 2010. White Coat, Black
Hat. Pp. 1-23 and Chapter 2: “The Ghosts”, Pp. 25-49.
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.
Fugh-Berman A (2010). The Haunting of Medical Journals: How Ghostwriting sold
“HRT” PLoS Medicine 7 (9): 1-11.
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
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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.
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 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.
7th Lecture. Thursday, October 23, 2014:
Global Health and The Pharmaceutical Industry
Discussion led by: Professor Olivieri
In-class Movie: Dying for Drugs: 30-minute segment
An overview of the situation in emerging countries focusing on clinical trials, drug
promotion and intellectual property rights.
Required Reading:
A Bitter Pill: The risks of carrying out clinical drug trials in developing countries. The
Wemos Foundation.
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http://www.fairdrugs.org/uploads/files/A_Bitter_Pill.pdf
Sterkx S. (2004). Patents and access to drugs in developing countries: an ethical analysis.
Developing World Bioethics. 4(1): 58-75
’t Hoen E. TRIPS pharmaceutical patents and access to essential medicines. HeinOnline 3
Chi J international Law Spring 200
http://www.who.int/intellectualproperty/topics/ip/tHoen.pdf
Consumers International. Drugs, doctors and dinners: how drug companies influence
health in the developing world, 2007.
http://www.consumersinternational.org/shared_asp_files/GFSR.asp?NodeID=97128
Mullan F. The Metrics of the Physician Brain Drain. N Engl J Med 2005; 353:18101818 DOI: 10.1056/NEJMsa050004
http://www.nejm.org/doi/full/10.1056/NEJMsa050004#t=articleBackground
Lincoln C. Chen and Jo Ivey Boufford. Fatal Flows — Doctors on the Move (Editorial
reviewing the above paper)
http://www.nejm.org/doi/full/10.1056/NEJMe058188
Moran M et al. Neglected disease research and development: how much are we really
spending? PLoS Medicine 2009; 6:e 1000030.
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000030
Recommended Reading
Schipper I et al. Ethics for drug testing in low and middle income countries: considerations
for European market authorization. SOMO 2008.
http://somo.nl/publications-en/Publication_2472
’t Hoen EFM. The global politics of pharmaceutical monopoly power: drug patents, access,
innovation and the application of the WTO Doha Declaration on TRIPS and public health.
AMB, 2009 (Chapters 1 – 4).
http://www.msfaccess.org/main/access-patents/the-global-politics-of-pharmaceuticalmonopoly-power-by-ellen-t-hoen
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Wolinsky H. The battle of Helsinki Two troublesome paragraphs in the Declaration of
Helsinki are causing a furore over medical research ethics EMBO reports (2006) 7, 670-72
doi:10.1038/sj.embor.7400743.
http://www.nature.com/embor/journal/v7/n7/full/7400743.html
Campaign for Access to Essential Medicines. Fatal imbalance: the crisis in research and
development for drugs for neglected diseases. Geneva: MSF Access to Essential Medicines
Campaign, 2001.
http://www.msf.org/source/access/2001/fatal/fatal.pdf
Attaran A et al. The World Bank: false financial and statistical accounts and medical
malpractice in malaria treatment. Lancet 2006;368: 247-52.
Homedes N et al. The World Bank, pharmaceutical policies and health reform in Latin
America. International Journal of Health Services 2005;35: 691-717.
HAI Europe/BUKO Pharma-Kampagne Seminar. Public-private ‘partnerships’: addressing
public health needs or corporate agendas, 2000.
http://www.haiweb.org/campaign/PPI/seminar200011.html
8th Lecture
Thursday October 30, 2014. Student Presentations 1 and 2
9th Lecture
Thursday November 6, 2014: Student Presentations 3 and 4.
10th Lecture
Thursday November 13, 2014
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. Joel Lexchin examines in detail the ways in which agencies like FDA
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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.
promotion: Why does regulation matter?
Regulation of pharmaceutical
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.
11th Lecture
November 20, 2014: Student Presentations 5 and 6
12th Lecture
November 27, 2014: Student Presentations 7 and 8