Sunday, December 6, 2009

An Intractable Conflict of Interest

(see previous entries)
If the Canadian Institutes of Health Research exists to promote the public interest, why has a VP at Pfizer been named to its governing body?

Francoise Baylis

Canadians are being invited to sign a petition against the appointment of Dr. Bernard Prigent, a senior executive of Pfizer, to the Governing Council of the Canadian Institutes of Health Research (CIHR) So far, over 3,000 Canadians have signed, including senior health researchers, clinicians, ethicists, health policy experts, as well as ordinary Canadians who understand that this appointment represents a significant threat to the integrity of CIHR by entrenching an intractable structural conflict of interest.

To quote from one of the signatories, “You don’t put the rooster in charge of the hen house.” The duty of pharmaceutical companies (e.g., Pfizer) is to make money for their shareholders. The duty of CIHR is to promote the public interest. The interests of shareholders and the interests of Canadians are not one and the same.

CIHR was created in 2000 as an arms-length federal agency responsible for funding health research in Canada. The 2009-2010 total budget for CIHR was just under a billion dollars. This is a lot of money and it is important that Canadians understand how their tax dollars are being spent.

The CIHR Governing Council sets the strategic direction for CIHR and determines where money should be invested. According to the CIHR Act, its members are “to contribute to the achievement of the objective of the CIHR in the overall interests of Canadians.” The prime directive of CIHR is to improve the health of Canadians by “accelerating the discovery of cures and treatments and improvements to health care, prevention and wellness strategies.”

Lately, this mission has been taking a back seat to a different objective: the commercialization of health research. On November 30, 2009, in describing the objective of CIHR to the Standing Committee on Health, the President of CIHR, Dr. Alain Beaudet, spoke about the agency as though its mandate was to stimulate the Canadian economy. There was nary a mention of promoting, assisting, and undertaking research to improve the health of Canadians. What was once supposed to be a means to that end has now become an end in itself.

This worrying trend is most evident in the recent appointment of Dr. Prigent, the Vice President and Medical Director of Pfizer Canada, to the Governing Council . Pfizer is the largest pharmaceutical company in the world with 2008 revenues of over $70 billion. It also has the dubious distinction of having the largest criminal fraud fine in the history of the U.S. Department of Justice (the full bill was $2.3 billion for the illegal marketing of certain pharmaceutical products). And now our federal government has honoured Pfizer with a seat at Governing Council where decisions are made about how to invest your health research dollars.
Sadly, not everyone objects to this appointment.

Some argue that Dr. Prigent was appointed as an individual, not as a representative of the company for which he has worked for the past 25 years. Dr. Prigent is not described as a leader in Pfizer, but as “a leader in the promotion of Research and Development within the Canadian Life Science Sector.” Supporters further note that Governing Council members are expected to place personal agendas aside, and promote the best interests of CIHR, the broad research community, and all Canadians. But if Dr. Prigent puts those interests above those of his company, how will he answer his shareholders? He has a legal obligation to serve the interests of the corporation.

Supporters of the Pfizer appointment further remind us that all members of the CIHR Governing Council must observe the Conflict of Interest Act, the Ethical Guidelines for Public Office Holders, and the Guidelines for the Political Activities of Public Office Holders as a condition of appointment. This is as it should be. But adherence to these guidelines does not address the structural conflict of interest. Dr. Prigent cannot serve two masters with potentially conflicting interests. Moreover, if Dr. Prigent sees and understands the deep-seated conflicts, he will need to recuse himself from the very discussions where advice from the business sector is needed.

Another reason given for supporting his appointment is that the CIHR Act mandates improving the health of Canadians by “encouraging innovation, facilitating the commercialization of health research in Canada, and promoting economic development through health research in Canada.” Conveniently, this forgets about the parts of the Act that refer to “promoting, assisting, and undertaking research that meets the highest international scientific standards of excellence and ethics and that pertains to all aspects of health” and “fostering the discussion of ethical issues and the application of ethical principles to health research.” Are these parts ignored because they set standards that Pfizer cannot meet? Pfizer’s well-documented history of transgressions against the integrity of science goes well beyond the most recent $2.3 billion settlement.

A third defence of the appointment is that the CIHR Governing Council has long recognized a gap in its membership relating to the commercialization of research. I disagree with this view insofar as there has always been a person with business expertise on the Council to advise on such matters. But, assuming there is a more specific gap requiring someone with international experience in pharmaceutical innovations, it could be filled by an individual without the intractable conflict of interest faced by Dr. Prigent (or any other active member of the pharmaceutical industry). Why not choose a retired member, or someone who has worked in the pharmaceutical industry but now works in another industry, in academia, or for a non-profit company instead?

Francoise Baylis is Canada Research Chair, bioethics and philosophy, Dalhousie University.

RE: Appointment of Dr. Bernard Prigent to the Canadian Institutes of Health Research (CIHR) Governing Council (GC)

(See previous entry) The basic assumption in Steven Lewis' argument is that because Dr. Pringent works for a pharmaceutical company and may have an obligation to protecting shareholder interests, he will not be able to play an unbiased or in anyway valuable role on the Governing Council (GC).

By using such language as, "Seemingly countless systematic transgressions of pharma against scientific integrity and honest marketing", Lewis appears to imply that no representative of “evil-pharma” deserves a seat on the Council.

While making no apologies for pharma's sales practices, in light of the recent "climategate" scandal and the countless examples of systematic transgressions of researchers against scientific integrity, one could easily make a similar case for not having any scientists on the GC. I am not sure that this would be in line with what Lewis is trying to achieve.

Furthermore, as pointed out by David Allison, Professor of Biostatistics at University of Birmingham, Alabama, in a letter to Science [1] and in an article in the International Journal of Obesity [2], it appears that scientists are not in any way "immune" to taking a biased view of scientific data. Indeed, one may argue that industry driven bias may be far less perfidious (because the cards and intentions are on the table for everyone to read) than the many biases that are far more difficult to recognize, like the ideological (anti-industry) "white-hat” bias, self-aggrandization bias, or simply the all-too-prevalent “love-for-their-favorite-hypothesis” bias.

In fact, if we accept Lewis' argument against having representative of "evil-pharma" at the table, we may as well exclude all industries (certainly no food industry, no energy companies, no banking, no private health care, no information technology, no medical devices, in fact, no representation from any sector that is primarily driven by profit and could potentially benefit from strategic decisions made by the GC).

In contrast to what Lewis implies, I would readily assume that everyone on the GC likely represents a constituency or interest group and brings a bias to the table even if their views are only coloured by their personal perspectives, ideologies, views, or beliefs. Indeed, I have no doubt that were I to be offered a seat at the GC, in my role as Scientific Director of the Canadian Obesity Network, I would do my best to promote more investment in obesity research and vehemently oppose any attempt of other GC members to cut funding for obesity because of their personal beliefs that obesity is simply a "self-inflicted" matter of choice and does not deserve public funding to address (incidentally, it turns out that individual choice has surprisingly little to do with the obesity epidemic after all [3]).

Nor does the argument that a seat on the GC would provide an unfair advantage to Prigent, and thus Pfizer, over its competitors fly. The same could easily be said for any researcher who sits on the GC. Indeed, I have sat on numerous scientific review panels that have provided me with (unfair?) insight into the projects of my (scientific) "competitors" and I have often had the opportunity to steer committees towards funding projects that I thought and felt were more important and away from others that I believed (for whatever reasons) were perhaps less deserving of funding. The notion that scientists on committees are not in someway representing their own views, areas of interest, and ideologies is naive and unfounded. Nor do I expect representatives from research institutes, foundations, patient-advocacy groups or any other constituency to be fair and unbiased towards all possible decisions of the GC. In fact, it is this very diversity of opinions and interests that makes for a strong and effective Council.

I believe that having an industry representative at the table provides an important voice in the discussion, a chance to bring in arguments and views that may be important to consider and insights that may not be immediately obvious to GC members with little insight or experience in the private sector. The "holier-than-thou" argument presented by Lewis is simply discriminatory and unfair in singling out one member on arguments that may in principle apply to all members of the GC
Finally, simply in light of a democratic process one could even make the argument that the pharma industry, as a major tax payer and player in the health sector, very much has a right to sit at this table - after all a significant chunk of public funding that the GC will decide over comes from the taxes that this very industry pays into the government coffers - no taxation without representation?

Rather than demonizing or declaring outrage about the appointment of representatives of certain constituencies to the GC, the simplest way to deal with any actual or perceived conflicts of interest is to have these openly declared (my guess is that it is likely far easier for Pringent to identify and declare his obvious areas of conflict than for most other members on the Council, who I am sure all have interests and biases of their own). It is easy enough (and hopefully common practice during GC sessions) to expect Pringent (and others) to excuse themselves from voting or even from being in the room when matters are discussed where such a conflict occurs.

Excluding anyone with a putative personal, professional, ideological or political conflict of interest from the GC will most likely result in not having a council at all.

Arya M. Sharma, MD/PhD, FRCPC
Professor and Chair of Obesity Research and Management
University of Alberta

1. Allison DB. The antidote to bias in research. Science. 2009;326:522-3

2. Cope MB, Allison DB. White hat bias: examples of its presence in obesity research and a call for renewed commitment to faithfulness in research reporting. Int J Obes. 2009. [Epub ahead of print]

3. http://www.drsharma.ca/obesity-lifestyle-choice-or-lifestyle-chance.html

Saturday, December 5, 2009

Where There’s Smoke, There’s Pfizer: Sparks Fly Over Recent CIHR Appointment




Where There’s Smoke, There’s Pfizer:  Sparks Fly Over Recent CIHR Appointment
The Canadian Institutes of Health Research (CIHR) Governing Council (GC) has a new member:  Dr. Bernard Prigent, the Vice-President of Medical Affairs for Pfizer Canada. 

Steven Lewis, former (and founding) member of the Governing Council is outraged.

In an essay to be published on Tuesday by Longwoods Publishing (and pre-released here) he writes:

·         Seemingly countless systematic transgressions of pharma against scientific integrity and honest marketing have been documented in grisly detail. 
·         How does a Pfizer VP remain agnostic about whether an institute as the Institute for Health Services and Policy Research should be renewed if it supports research that shows a Pfizer drug is dangerous or identifies the massive public subsidies that flow to drug companies?
·         Dr. Prigent’s company recently paid a whopping $2.3 billion for fraudulently marketing Bextra, a painkiller withdrawn from the market in 2005, and 3 other drugs.  Dr. Prigent’s signature adorns the confessional letter that alerted Canadian practitioners to the company’s malfeasance. 
·         There are innumerable alternatives to get commercialization advice -- all of them cleaner and more transparent. 
·         As a member of GC, Dr. Prigent,  will from time to time have access to information that his competitors do not, and he can exert a steering effect where they cannot.
“Given these facts,” notes Mr. Lewis, “one is hard pressed to view the appointment as anything other than a deliberate provocation.”

According to Mr. Lewis, at least  3300 people have signed a petition protesting the appointment, many of them prominent researchers, ethicists, and public policy experts.  He warns that the government and the CIHR want this to go away; their biggest allies are silence and resignation. He calls for more people to sign the petition, write their MPs  and write op-eds for local newspapers. 

The complete essay is posted here:


For more information contact:
(Author) Steven Lewis at Steven.Lewis@shaw.ca
(Editorial Director) Dianne Foster Kent at dkent@longwoods.com or (business hours 416 864 9667)

Steven Lewis is a health policy and research consultant based in Saskatoon, and Adjunct Professor of Health Policy at the University of Calgary and Simon Fraser University (where he was Visiting Scholar in 2007). Previously he headed a health research granting agency and spent 7 years as CEO of the Health Services Utilization and Research Commission in Saskatchewan. He has served on various boards and committees, including the Governing Council of the Canadian Institutes of Health Research, the Saskatchewan Health Quality Council, the Health Council of Canada, and the editorial boards of several journals including Healthcare Papers and Open Medicine. His published work covers topics such as reforming and strengthening Medicare, improving health care quality, primary health care, regionalization, and the management of wait times.

Longwoods Publishing Corporation  (Longwoods) publishes academic and professional information and journals covering health and health care ideas, policies and practices and works in collaboration with governments, institutes, health care organizations, academe, and the the private sector including the Institute for Health Services and Policy Research and pharmaceutical companies.