There is a lot to say about how lame most statements about "conflict of interest are". To summarize most of what needs to be said: (1) COIs among researchers are real and matter. (2) Most (not all) of the time when someone screams "he has a conflict of interest!" it represents a political ploy to try to advance a particular agenda rather than a genuine concern about COI. (3) The conflict of interests generally identified are not really the ones that matter; often they are not really even COIs, and typically they ignore most of the most important COIS. I have written a lot more about these points in the past and will likely do so in the future. For today, I will just comment specifically on the problem definition in an Archives of Internal Medicine article that was reported in the medical news today.
The abstract reports that the study totaled up the number of what they called conflicts of interest:
Let's think about that list.
Owning a substantial amount of stock in a company with an interest in a study's result or board's recommendation is obviously a glaring financial conflict of interest, perhaps second only to owning intellectual property whose value will change dramatically based on those results. Being on a speaker's bureau tends to mean a continuing flow of outrageous fees for repeating some party line, which would tend to have the same pull as owning a lot of stock. Someone's belief in that party line my have been come to honestly, but the financial incentive to not waver is a strong interest. However, "receiving honoraria" can mean anything from basically the same as the speakers bureau concept to having gotten a reasonable compensation for taking the time to go to a meeting and present one's honest views. The latter will have little or no influence on someone's opinion and create little or no incentive.
Being a consultant or advisor is also pretty tricky to interpret. This can be anything from working as a corporate hired hack, writing whatever the corporation asks to support filings, litigation, etc. Or it could mean that you are the best in your field and scrupulously honest, and so corporations want your honest opinion. Or anything in between.
Similarly, receiving a research grant can mean doing funder-directed research (typical for government grants, for example) with an implicit promise about what the results will be (often offered in grant proposals for those funder-directed projects), or giving the funder the right to suppress the result if they do not like it (common for some industries' funding). Those actually do not cause a conflict of interest: They are dishonest and/or bad scientific conduct, but only when there is a hope of future funding is there a COI (and that is regardless of whether there was past funding). Otherwise there is no remaining interest once the funding is in place (unless the funder has the right to take it away if they do not like what the researcher is doing; that is a much worse, but slightly different, problem). One of my colleagues insists that out of consideration for this, he will take grant money from anyone, but never more than once. That way, there is no way that hoping to get more funding from the particular organization can influence the ongoing research.
Alternatively, a research grant can be largely free of COI, consisting of designing investigator-initiated projects and then asking for money to support them, not changing anything to please the funder. Or anything in between.
These observations barely scratch the surface of the topic, but they should be sufficient to show that simply identifying one of these phenomena tells us little, let alone arbitrarily adding them up. The authors of the article seem to want to make a big deal about how some members of the boards do not have any of these COIs, implying that the boards should be made entirely of such individuals. But their list of types of COIs ignore the ones (political preferences) that are next most important behind a chance to make a personal fortune. Moreover, ensuring that a board has no apparent COI with respect to an issue is an easy matter of picking members who have never said anything important about the subject or had any significant involvement. After all, do you really want your experts to have done so little work on a topic that they have never received a grant or consulting fee? Not too expert, I suspect.
Oh, wait. It turns out that the authors are interested only in grants, honoraria, etc. that come from industry sources. They do not bother to mention this in the abstract, apparently believing that only industry money can create COI. That is an incredibly naive notion of COI. They do not tell us "we are only concerned here with the COIs that result from industry ties, not those resulting from government grants, advocacy group funding or involvement or even being employed by an interest group, personal inventions, pet theories, and many other sources of COI". That would be a very partial analysis, but at least it would be an honest portray of what it was. Rather than admitting that, however, the authors try to imply that one specific source of COI is all of COI.
The people with the most expertise and interest in a topic inevitably have some of the listed COIs and others too, unless they are extremely anti-social. Indeed, for many medical or health matters, the greatest experts, who could contribute the most to an advisory board, work for an interested industry. Why not include them as panelists if they are willing? Better still, include several, whose employers have differing interests to get the crucible of scientific inquiry boiling. They might tell us something useful, and if they simply demand actions that are in their employer's interest without justification, there is no obligation to pay attention to what they say. A good open fight among the most invested parties is generally a good way to figure things out, so long as those evaluating the results have the competence to recognize which arguments are more compelling (and if they do not, they should start reading my Sunday posts).
The abstract reports that the study totaled up the number of what they called conflicts of interest:
Using disclosure lists, we cataloged COIs for each participant as receiving a research grant, being on a speaker's bureau and/or receiving honoraria, owning stock, or being a consultant or member of an advisory board.They looked at cardiology guidelines advisory boards, though what amounts to a COI there is basically the same as what is a COI for reporting research results. They concluded that "Fifty-six percent of the 498 individuals reported a COI".
Let's think about that list.
Owning a substantial amount of stock in a company with an interest in a study's result or board's recommendation is obviously a glaring financial conflict of interest, perhaps second only to owning intellectual property whose value will change dramatically based on those results. Being on a speaker's bureau tends to mean a continuing flow of outrageous fees for repeating some party line, which would tend to have the same pull as owning a lot of stock. Someone's belief in that party line my have been come to honestly, but the financial incentive to not waver is a strong interest. However, "receiving honoraria" can mean anything from basically the same as the speakers bureau concept to having gotten a reasonable compensation for taking the time to go to a meeting and present one's honest views. The latter will have little or no influence on someone's opinion and create little or no incentive.
Being a consultant or advisor is also pretty tricky to interpret. This can be anything from working as a corporate hired hack, writing whatever the corporation asks to support filings, litigation, etc. Or it could mean that you are the best in your field and scrupulously honest, and so corporations want your honest opinion. Or anything in between.
Similarly, receiving a research grant can mean doing funder-directed research (typical for government grants, for example) with an implicit promise about what the results will be (often offered in grant proposals for those funder-directed projects), or giving the funder the right to suppress the result if they do not like it (common for some industries' funding). Those actually do not cause a conflict of interest: They are dishonest and/or bad scientific conduct, but only when there is a hope of future funding is there a COI (and that is regardless of whether there was past funding). Otherwise there is no remaining interest once the funding is in place (unless the funder has the right to take it away if they do not like what the researcher is doing; that is a much worse, but slightly different, problem). One of my colleagues insists that out of consideration for this, he will take grant money from anyone, but never more than once. That way, there is no way that hoping to get more funding from the particular organization can influence the ongoing research.
Alternatively, a research grant can be largely free of COI, consisting of designing investigator-initiated projects and then asking for money to support them, not changing anything to please the funder. Or anything in between.
These observations barely scratch the surface of the topic, but they should be sufficient to show that simply identifying one of these phenomena tells us little, let alone arbitrarily adding them up. The authors of the article seem to want to make a big deal about how some members of the boards do not have any of these COIs, implying that the boards should be made entirely of such individuals. But their list of types of COIs ignore the ones (political preferences) that are next most important behind a chance to make a personal fortune. Moreover, ensuring that a board has no apparent COI with respect to an issue is an easy matter of picking members who have never said anything important about the subject or had any significant involvement. After all, do you really want your experts to have done so little work on a topic that they have never received a grant or consulting fee? Not too expert, I suspect.
Oh, wait. It turns out that the authors are interested only in grants, honoraria, etc. that come from industry sources. They do not bother to mention this in the abstract, apparently believing that only industry money can create COI. That is an incredibly naive notion of COI. They do not tell us "we are only concerned here with the COIs that result from industry ties, not those resulting from government grants, advocacy group funding or involvement or even being employed by an interest group, personal inventions, pet theories, and many other sources of COI". That would be a very partial analysis, but at least it would be an honest portray of what it was. Rather than admitting that, however, the authors try to imply that one specific source of COI is all of COI.
The people with the most expertise and interest in a topic inevitably have some of the listed COIs and others too, unless they are extremely anti-social. Indeed, for many medical or health matters, the greatest experts, who could contribute the most to an advisory board, work for an interested industry. Why not include them as panelists if they are willing? Better still, include several, whose employers have differing interests to get the crucible of scientific inquiry boiling. They might tell us something useful, and if they simply demand actions that are in their employer's interest without justification, there is no obligation to pay attention to what they say. A good open fight among the most invested parties is generally a good way to figure things out, so long as those evaluating the results have the competence to recognize which arguments are more compelling (and if they do not, they should start reading my Sunday posts).
Carl, if you have time there is a new study out in the The Canadian Journal of Psychiatry, Vol 56, No 3, March 2011 that you might find interesting.
ReplyDeleteThe Relation Between Nicotine Dependence and Suicide Attempts in the General Population
Conclusions: Nicotine dependence is associated with suicide attempts, independently of
comorbid mental disorders and physical disease. The association attenuates when a person ceases using nicotine, suggesting a state, rather than trait, effect. These findings provide evidence for additional concern regarding the deleterious health effects of tobacco.
http://publications.cpa-apc.org/media.php?mid=1129