Research Ethics Blog

An interesting story recently from CBC highlights some of the difficulties with the topic of conflict of interest in medicine and biomedical research.

Here’s a link to the story:

CBC Tamiflu Probe Sparks Drug Policy Review

“In the course of the CBC investigation, Zalac also reported that three of Canada’s most prominent flu experts — Dr. Donald Low and Dr. Allison McGeer of Mount Sinai Hospital in Toronto, and Dr. Fred Aoki of the University of Manitoba — had received research funding or acted as a consultant or speaker for Roche during the period when Tamiflu was being promoted.

Their research involvement with Roche and other anti-viral drug makers was not a secret within the industry.

All three would sign the now standard conflict-of-interest declarations when speaking at professional events or publishing papers. And the Public Health Agency says it has always been aware of the drug industry affiliations of its private sector advisers and takes these into account. But these relationships were rarely reported in broader public forums, in the media or even when some of these individuals would appear in marketing videos or flu-warning commercials on television produced by Roche.”

In biomedical research, typically ethics review boards ask researchers to “declare” potential conflicts of interest to them. That’s great. It’s certainly a start. But once potential for conflicts of interest have been “declared” to ethics review boards (in what is, essentially, a confidential review process), what happens then? Do research participants always know about potential conflicts of interest that researchers have? Is this made explicit in an understandable way to participants?

This story demonstrates that conflicts of interest in health care and medicine (and biomedical research) are, often, handled in a fairly superficial or limited way with an emphasis on disclosure and little beyond that. In this story, the three key “flu experts” who were, in 2009, promoting Tamiflu as a key defense against the H1N1 flu were also found to have received research funds or acted as a speaker or consultant for Roche, the company that makes Tamiflu.The Public Health Canada Agency of Canada (PHAC) states that it was aware that these experts had affiliations with the drug company, but these relationships were not reported broadly to the public. The public were watching these experts and PHAC closely for advice and guidance. Should they have known more about the relationships between these experts and Roche, the company who makes Tamiflu?

Tamiflu was seen, by much of the public, as the panacea for H1N1 and avian flu. Governments stockpiled the drug, hoping never to have to use their vast stores. Now that these stores are approaching expiry, a decision needs to be made about either replenishing them or exploring new alternatives. Over the last few years, while these stockpiles of Tamiflu have been sitting in storage, other independent researchers have been exploring whether or not Tamiflu really is all it’s cracked up to be as a first-line drug for H1N1 flu. As the story notes, researchers are challenging the “fact” that Tamiflu reduces morbidity and hospitalizations from the flu. Furthermore,the side effects (including bizarre behaviours and delusions) thought to have resulted from taking Tamiflu are viewed as serious enough to perhaps warrant exploring other options.

When we look closely at this, it may well be that the relationships that these experts had with Roche do not constitute an obvious conflict. As science moves forward, recommendations and best practices change and this may well have been the case with Tamiflu. It may also be true that Tamiflu was the first line defense in 2009 and the research since then has shown that it may not be as good as we thought. These three experts may have truly felt that Tamiflu was, in fact, the best treatment for the flu at that time, while they were vigorously promoting it. However, without full disclosure of the relationships that they had with Roche and some clarity from the PHAC on how these potential conflicts would be managed, the public may well doubt their abilities to be objective about Tamiflu. It now appears that the PHAC may well be making changes to how they manage such potential conflicts of interest, in regards to their experts and advisors.

From the CBC story:

“As for the Public Health Agency of Canada, it released a statement that said it would be inappropriate at this point to release the drug company connections of its advisers without their consent.

PHAC says that its advisory committees provide advice but that the agency makes the final decisions. However, because of the questions raised in the CBC documentary, the agency said it “intends to establish a policy on the release of information relating to members of its expert or advisory groups/committees.””

~ by Nancy Walton on June 3, 2011.

Posted in ethics committees, pharmaceuticals, regulations, Uncategorized