Should Pfizer VP Sit on CIHR's Governing Council?

Controversy has arisen over the appointment of one of Pfizer's VPs to the governing council of the Canadian Institutes of Health Research (CIHR). (For those who don't know, CIHR is the Canadian government's main agency for funding research in the area of health.)

Here's the story, as reported by the CBC: Appointment of Pfizer exec to health funding body criticized

Prominent bioethicists have expressed alarm at the recent appointment of a senior pharmaceutical executive to the Canadian Institutes of Health Research (CIHR), the government's funding arm for medical research.

They hope to have their concerns about the three-year appointment of Dr. Bernard Prigent, vice-president and medical director of Pfizer Canada, to the governing council of the CIHR addressed at a parliamentary meeting Monday....

The CBC story also refers to a petition recently begun, in opposition to Prigent's appointment. Here it is: Petition Against the Appointment of the VP of Pfizer Canada to CIHR Governing Council.

The main worry here is conflict of interest. Perception plays a big role in conflict of interest. In this regard, both the government and their critics are wrong. It's not a matter of whether Prigent will be able to avoid letting his obligations to his shareholders affect his obligations as a member of the Council. The problem is whether his job at Pfizer will jeopardize the reputation of CIHR (and more particularly its governing council) by rendering its judgment suspect. I don't know anything about Dr. Prigent & he may well be an individual of outstanding integrity. The point is, that doesn't matter. Even if he does exercise his best, publicly-minded judgment on behalf of CIHR, his presence could still render the governing council's judgment suspect.

It's also worth noting that opposition to this appointment involves 2 separable issues. One is the appointment of someone from the pharmaceutical industry to CIHR's governing council. The other is the appointment of someone from Pfizer, in particular.

So one issue is Pfizer's less-than-stellar reputation. As the CBC story notes, Pfizer recently paid a record-breaking $2.3 billion fraud settlement. And I've also blogged about just a handful of the many cases of wrongdoing at Pfizer, including here and here and here. And because of Pfizer's poor reputation, I think the petition-writers are right that Prigent is a bad choice to be on CIHR's governing council. Pfizer's reputation is not good, and so many people will justifiably be suspicious of the intentions and judgment of its senior executives. That's crucial to the worry about conflict of interest.

The other issue is whether anyone from the pharmaceutical industry could ever be on CIHR's governing council, and that I think is a harder issue, one on which the writers of the petition have overreached. I for one would need to know much more about the governing council, its mandate, and its operations, to know whether an executive from a small or mid-sized pharmaceutical company with a good reputation could be valuable in that role. "Divergence of interests" between a company's shareholders and the public isn't sufficient reason to exclude executives from that company. Nobody's interests are perfectly aligned with the public's. What matters is whether the divergence is sufficient to render an individual's advice suspect in a way that cannot be remedied through standard mechanisms used to mitigate the effects of conflict of interest (mechanisms such as disclosure and recusal). So simply working for industry doesn't strike me as an insurmountable flaw, particularly if (if!) the governing council's role makes an intimate understanding of the drug industry useful.

But the main point remains: it's very hard to support the inclusion of an executive from this pharmaceutical company on the governing council of Canada's most important health-research-funding organization.

The Newest Place to Connect On-Line: The Participant Pool!

It was with some surprise that I happened across this website. It's called ResearchMatch and it's described as a "National (US) Research Study Recruitment Registry". The press release that led me to the ResearchMatch website was one announcing that Rockefeller University was now joining the registry.

Here's the press release: Rockefeller joins first national research study recruitment registry

“The Rockefeller University Center for Clinical and Translational Science is proud to be a founding collaborating institution of ResearchMatch,” says Barry S. Coller, vice president for medical affairs and codirector of Rockefeller’s CCTS. “ResearchMatch is an important initiative in speeding both the discovery of new knowledge and the translation of that knowledge into improved health. It incorporates a number of confidentiality and privacy protections and has been approved by a human subjects ethics committee.”

ResearchMatch, at first glance, appears to be almost as appealing as any other social networking site. The taglines and catch phrases include (wildly out of context) inspirational quotations by Carl Sagan and Jane Goodall alongside pictures of very happy, very interesting, diverse persons who we assume are potential research participants. People who, according to Barbara Alving, director of the National Center for Research Resources (a part of the National Institutes of Health) are contributing "to advancing new treatments.”

Participant pools have been around in clinical research for quite a while. Usually situated in academic centres, and quite often in psychology departments, they often include only students who are enrolled in first year clinical courses, such as pscychology or medicine. They're typically students who are also learning how to conduct research themselves, and taking part in research is a necessary aspect of this learning. This is, in essence, just another very large participant pool, isn't it? Well, yes, it is. However, a few things worry me about this site.

First, it's very slick. Nothing wrong with that, but it makes you want to join just to see who you'll meet! (It is, after all, called ResearchMatch!) There are options on the site to "share with friends!" Visitors to the site are encouraged to "Join today! It only takes a few minutes!" and "Create your profile now! It's free and and everyone can join!" I found the kinds of motivational statements that are flashed across the website to inspire participation most interesting. One famous quote from Jane Goodall ("Every individual matters. Everyone has a role to play. Every individual makes a difference") seems to be referring to participation in studies through ResearchMatch. This quotation, in fact, does not refer to research at all, according to The Jane Goodall Institute of Canada. Rather it refers to our individual obligation to protect the environment, ensure animal welfare and try to better understand of relationships between humanity, the animal world and the natural environment. Now, there isn't anything wrong with taking a good inspirational quote out of context if it applies to the situation. And there isn't anything wrong with using slick and attractive lifestyle advertising to get people's attention. However, I'd recommend against doing any of that in the context of recruitment. Most ethics boards strongly and appropriately discourage "slick" recruitment processes. Transparency and clear information are a key part of any recruitment process, including a process to recruit into a participant pool.

My biggest concern with this service comes out of the following statement on the website: "You may either register yourself or someone else as their parent, guardian or caretaker." This statement is repeated on the profile creation page, accompanied by a picture of a young handsome dad in front of his laptop in the backyard with his toddler son in his lap, apparently signing the boy up for participation in research studies. With 52 institutions taking part in this initiative, and countless trials and studies coming out of those institutions, it's unclear who is overseeing it and who would ensure that the best interests of those who are not signing up for themselves would be protected. The website refers to the activities of ResearchMatch as being overseen by "an" Institutional Review Board but the provided link simply takes you to the US Office of Human Research Protection. Are they overseeing it? Again, it's unclear. Awfully worrying is the fact that while it's emphasized that if you sign up, you always "have a choice" to participate or not in research studies, there are no clearly stated safeguards in place for those who are signed up by others.

It's clear that human participants are needed in order to advance research. Of course. I'm just not sure that what appears to be pretty slick lifestyle advertising without clarity of information is the best way to do it.

Sex-Toy Research: Nothing Wrong With a Little Controversy

Conducting research with all due attention to regulations and ethical standards doesn't automatically insulate it from criticism and controversy. Nor, for that matter, should adherence to rules & regs necessarily imply that one's research cannot be the subject of ethical scrutiny. Even when researchers are careful not to cross those lines, there's often still plenty of room for disagreement about what is ethically better and ethically best, and about what research is minimally useful versus what research really makes a significant contribution. And as we've blogged about here before, research on sex is liable to garner more that its share of critical attention.

Now, according to the Associated Press, Sex-toy study at Duke raises some eyebrows:

DURHAM, N.C. — A campus religious leader is unhappy about a study at Duke University that invites female students to attend parties where they can buy sex toys.
The News & Observer of Raleigh reported Friday that the director of the Duke Catholic Center has lodged a complaint with researchers. The Rev. Joe Vetter says the study doesn't promote relationships.

Here's a longer version of the story, from The News & Observer of Raleigh: Sex toy research causes a stir at Duke.

(Note: I'm not a fully disinterested commentator, here. The principal investigator in the study under discussion is a Fellow at Duke's Kenan Institute for Ethics, where I'm also a Fellow.)

The first thing to note is that the criticism is off-target. University-based research studies are not typically aimed at promoting relationships, or promoting anything at all; they're about generating generalizable knowledge. Of course, the job of the ethics board that approved the Duke study is to make sure that the risks to which participants are exposed are reasonable, and that those participants understand those risks prior to participation. But, to the best of my knowledge, no one seriously argues that ethics boards should be contemplating whether the conducting of a study in itself contributes to the social good, independent of the knowledge it is likely to generate. (Then again, to his credit, Rev. Vetter isn't complaining to the ethics board; he's complaining directly to the researchers.)

The other thing to note is the (rightly) timid tone of the headlines above. There's no implication of scandal here. This is about a study that is causing "a stir" and raising "some eyebrows." Those things are in fact healthy. If university researchers never caused a stir or raise eyebrows, it might just be that, collectively, they're not doing their job.

Michael Schoenfeld, Duke's VP for public affairs, quoted here, gets it right:

"Not all research will make people comfortable. In fact, there's a lot of things, there are a lot of questions, there are a lot of issues that are studied at a university that make people uncomfortable," Schoenfeld said. "That's how we get an understanding of things like ethics (and) behavior."

-----
p.s. here's a useful blog entry over at Science Blogs that tells a bit more about the controversy, as well as about the scholarly reputation of the study's P.I.: Response to Dan Ariely's Duke Sex Toy Study