I spent some of last week at Davidson College in North Carolina, in the company of Dr. Thomas P. Stossel, driving force behind ACRE (Association of Clinical Researchers and Educators). Both Dr. Stossel and ACRE have come in for considerable criticism on this blog, so I thought a brief report was appropriate. I am first happy to be able to say that Danny Carlat, over at his psychiatry blog, was correct--I found Dr. Stossel to be personally very congenial and affable regardless what one thinks of his opinions on medicine-Pharma issues. I discovered that he and I have equally compelling reasons for psychopathology, having each of us been raised in our tender years as Chicago Cubs fans.
He and I each spoke at the Speas Colloquium, an annual medical ethics program at Davidson (where our host was Lance Stell, philosopher and another ACRE stalwart). I spoke in defense of the meaningfulness and relevance of the notion of conflict of interest. Dr. Stossel gave an overview of the ACRE position that defends financial ties between medicine and Pharma as the engine that drives innovation, and that sees all recent attempts to limit those ties as both unnecessary and harmful. My limited attempt to hold out an olive branch was to note that ACRE contains a lot of expertise on how medicine can collaborate with Pharma around biotech and pharmaceutical research, so that they could be leading the way to develop an ethically sounder relationship between medicine and the pharmaceutical industry--if only they would admit, for starters, that we currently have a problem. Dr. Stossel obviously was having none of that. He continues the trend in his previously published work of minimizing all bad stuff that happens at the med/Pharma interface--the stuff I have to find time weekly or even more often to post here--as disconnected, rare anecdotes, not as any sort of recurring or worrisome pattern.
In most respects I thought that the talk he gave at Davidson was more or less what we would expect, based on his previous publications. The exception was one slide that he presented on professionalism. The primary source he cited was the recent book by David Wootton, Bad Medicine. The point seemed to be that when folks like me who are concerned about undue influence of commercial interests on medical practice cite "professionalism" as our concern, this ought to be questioned if not dismissed--that much more harm than good has been done over the centuries by invoking "professionalism" in medicine, that "professionalism" has often stood in the way of accepting new scientific evidence, and that it is simply wrong to characterize medicine as something over and above a business. (In short, the sorts of arguments that result when one ignores the more recent, ethical sense of 'professionalism' and invokes only the descriptive, sociological sense of the term.)
My comment here would be that it is perhaps indicative of the strength of the arguments raised by the ACRE folks, to see how wide a swath of ethical countryside they have to lay waste to, in order to defend their chosen position. They want to defend docs taking bundles of cash from Pharma; we invoke conflict of interest as an ethical concern with that approach; so they decide they have to throw out conflict of interest. (Not limit or refine the scope of conflict of interest, mind you, but completely dispense with it.) So now we continue to worry about their heels with some quaint ideas of medical professionalism; and they now find it necessary to dispense completely and totally with medical professionalism. It is not merely a matter of throwing out the baby with the bathwater. It appears to be the baby, the rest of the family, the dog, and the hearth, and still they are not done.
Showing posts with label conflict of interest; professional ethics. Show all posts
Showing posts with label conflict of interest; professional ethics. Show all posts
Tuesday, April 20, 2010
Saturday, November 14, 2009
COI: Further Response from Stell
Folks, I trust this will be the last post on this particular exchange; any further discussion will be relegated to comments to posts. However, I think the topic is well worth the headlines because the definition of "conflict of interest" is central to our discussion--if we do not know what COI is, then much of the rest of our ethical concerns fall down. (Hence the shrewdness of a counterstrategy that attacks the definition directly.)
Lance Stell has kindly replied to my most recent post (one down) as follows:
...here’s how I summarize your [Brody's] response.
· Langbein is sensible, but is not obviously relevant to the question at hand –
o Comment: How could Langbein not be obviously and directly relevant where the underlying ethical issue is fiduciary trustworthiness?.
· Langbein really provides more support for your (prohibitionist) view than my view (a management/disclosure view).
o Comment: Huh?
o With regard to overlapping relationships, Langbein makes “management/disclosure” the default. He is not a prohibitionist.
o Langbein does allow that some relationships are so toxic that prohibition is the right prescription. But even in proven toxic circumstances, he argues for a “reasonableness, best-interest” defense.
o You probably assume that your book provides ample empirical proof of severe toxicity.
o But no. Influence, even when established, is not thereby “undue-influence,” let alone toxic influence.
o There is ample evidence that doctors chronically fail to intensify therapy as they should (esp. in DM and HTN).
o Doctors’ clinical inertia is a chronic problem. Good quality CME may offset it somewhat.
o What may be said at CME events is tightly scripted, especially where drugs are concerned.
o Doctors have been criminally indicted for off-label use promotion. Free-speech anyone?
o At industry-sponsored CME, the corporation’s legal department screens the Power Points for staying well-within the FDA’s PI.
o The issue w/ CME is educational quality, not provenance.
o IMHO, Pharmascolds tend to have a provenance-fixation, rather than a quality-fixation.
o Huddle and Stossel have completely shredded the pharmascold COI research as having somehow proven “toxicity-with-patient-harm-resulting.”
o Even Wazana, a lead pharmascold, candidly admits that the COI research that she has reviewed hasn’t even examined patient outcome.
· As a card-carrying pharmascold you suggest (and by your book title imply) that doctors who consult for industry or attend sponsored CME should bear a “black box” warning. “Patients beware, your doctor maybe have acquired drug-company dependency.”
· This is an ad hominem (circumstantial), isn’t it?
· Finally, your working diagnosis for me: I naively “inhaled” at ACRE’s founding in July and am now either early-onset addicted or at-risk for – drug-company dependency myself.
o Comment: I was invited to speak at the ACRE meeting. No one paid my way. I attended on my own dime.
***
OK, that's Lance. Just a few comments in reply.
Prof. Stell appears to be astounded, first, that I sugggested that Langbein may not even be relevant to the Pharma issues; and second, he is even more astounded that I suggest that if Langbein is relevant, he actually defends the pharmascold view more than the views of pharmapologists like ACRE (which whom Stell has now thrown in his lot completely I gather).
The reason why Langbein is not (very) relevant is simple. His article is about trust law and the sole-interest rule. The criticism he lodges against that rule is quite dependent upon the detailed history of trusts and trust law that he provides in the article. So yes, it is about a fiduciary relationship, but one that has very different features (and a completely different set of empirical facts) from the impact of Pharma on the physician-patient fiduciary relationship.
The reason why despite that, Langbein offers more comfort to pharmascolds is more complex and I tried to give the detailed case in my previous post. But by way of a quick summation, the case is basically this. Stell and his ACRE colleagues realize that the only way to ward off the attack of the pharmascolds is to redefine 'conflict of interest' in such a way that it either disappears as a factor, or else that it becomes so widespread and omnipresent that one cannot distinguish financial COI with drug companies from a host of other COI's that we find acceptable in everyday life (which is just another way of making it disappear as an ethically relevant feature of the landscape). By contrast, Langbein offers no redefinition of COI and sees no need to do so. The pharmapologists see no ethical problem where the pharmascolds see a ton of them. Langbein sees exactly the same ethical problems as do his opponents who favor retaining the sole interest rule in trust law; he simply proposes a different solution.
Now, here is where we pharmascolds may have been sloppy in our arguments so as to have misled folks like Stell to think he has scored points against us. Stell seems puzzled that I would defend Langbein as reasonable, since my position against the pharmapologists is that most COIs between medicine and Pharma should be avoided, not accepted and "managed"; whereas Langbein obviously calls for managing COI in the area of trust law. (As a sidebar let me say that a "management strategy" makes more sense in trust law than in medicine/Pharma because the trustee is more directly under judicial control and review.) However, the argument I make in HOOKED has two parts: 1) a definition of COI that explains why it is a serious ethical problem that implicates patient trust; and 2) a further argument that most COI in medicine should be divested and not merely managed. If I were trying to claim that #2 followed directly from my definition, then indeed I would be open to all the criticisms that Stell throws in my direction.
It is important that we not expect the definition of COI to do more work for us than it can. Let's go back to Erde's fundamental analysis as I review in HOOKED. Erde insists that a statement that a COI exists is not a statement that a person has necessarily done anything ethically wrong. The person has, rather, placed herself in a position where she is at risk of doing things that are ethically wrong. The actual wrongdoing is a rebuttable presumption (which seems to be exactly what Langbein is saying).
Now suppose that in addition to the fact that a COI is present, we have some additional facts. First, significant patient harms have actually occurred as a result of those sorts of COIs in the recent past. (ACRE and Stell apparently deny that this is true in the Pharma case, and that is what would lead me to ask what he had been inhaling at their meeting--I made no suggestion whatever as to financial ties.) Second, the protections that have been offered to "manage" these COIs (such as disclosure) have been ignored or widely abused. Third, the COI is not a part of any arrangement that is necessary for medical practice or research to be properly conducted. Now, if all these things are true, it becomes more reasonable to blame the individual for entering into the arrangements that constitute the COI (such as signing up for a company speaker's bureau). But notice that the blame arises from the extra facts. It does not arise from the mere definition of COI. The charge of wrongdoing implicit in the label 'COI' remains a rebuttable presumption, by definition.
Lance Stell has kindly replied to my most recent post (one down) as follows:
...here’s how I summarize your [Brody's] response.
· Langbein is sensible, but is not obviously relevant to the question at hand –
o Comment: How could Langbein not be obviously and directly relevant where the underlying ethical issue is fiduciary trustworthiness?.
· Langbein really provides more support for your (prohibitionist) view than my view (a management/disclosure view).
o Comment: Huh?
o With regard to overlapping relationships, Langbein makes “management/disclosure” the default. He is not a prohibitionist.
o Langbein does allow that some relationships are so toxic that prohibition is the right prescription. But even in proven toxic circumstances, he argues for a “reasonableness, best-interest” defense.
o You probably assume that your book provides ample empirical proof of severe toxicity.
o But no. Influence, even when established, is not thereby “undue-influence,” let alone toxic influence.
o There is ample evidence that doctors chronically fail to intensify therapy as they should (esp. in DM and HTN).
o Doctors’ clinical inertia is a chronic problem. Good quality CME may offset it somewhat.
o What may be said at CME events is tightly scripted, especially where drugs are concerned.
o Doctors have been criminally indicted for off-label use promotion. Free-speech anyone?
o At industry-sponsored CME, the corporation’s legal department screens the Power Points for staying well-within the FDA’s PI.
o The issue w/ CME is educational quality, not provenance.
o IMHO, Pharmascolds tend to have a provenance-fixation, rather than a quality-fixation.
o Huddle and Stossel have completely shredded the pharmascold COI research as having somehow proven “toxicity-with-patient-harm-resulting.”
o Even Wazana, a lead pharmascold, candidly admits that the COI research that she has reviewed hasn’t even examined patient outcome.
· As a card-carrying pharmascold you suggest (and by your book title imply) that doctors who consult for industry or attend sponsored CME should bear a “black box” warning. “Patients beware, your doctor maybe have acquired drug-company dependency.”
· This is an ad hominem (circumstantial), isn’t it?
· Finally, your working diagnosis for me: I naively “inhaled” at ACRE’s founding in July and am now either early-onset addicted or at-risk for – drug-company dependency myself.
o Comment: I was invited to speak at the ACRE meeting. No one paid my way. I attended on my own dime.
***
OK, that's Lance. Just a few comments in reply.
Prof. Stell appears to be astounded, first, that I sugggested that Langbein may not even be relevant to the Pharma issues; and second, he is even more astounded that I suggest that if Langbein is relevant, he actually defends the pharmascold view more than the views of pharmapologists like ACRE (which whom Stell has now thrown in his lot completely I gather).
The reason why Langbein is not (very) relevant is simple. His article is about trust law and the sole-interest rule. The criticism he lodges against that rule is quite dependent upon the detailed history of trusts and trust law that he provides in the article. So yes, it is about a fiduciary relationship, but one that has very different features (and a completely different set of empirical facts) from the impact of Pharma on the physician-patient fiduciary relationship.
The reason why despite that, Langbein offers more comfort to pharmascolds is more complex and I tried to give the detailed case in my previous post. But by way of a quick summation, the case is basically this. Stell and his ACRE colleagues realize that the only way to ward off the attack of the pharmascolds is to redefine 'conflict of interest' in such a way that it either disappears as a factor, or else that it becomes so widespread and omnipresent that one cannot distinguish financial COI with drug companies from a host of other COI's that we find acceptable in everyday life (which is just another way of making it disappear as an ethically relevant feature of the landscape). By contrast, Langbein offers no redefinition of COI and sees no need to do so. The pharmapologists see no ethical problem where the pharmascolds see a ton of them. Langbein sees exactly the same ethical problems as do his opponents who favor retaining the sole interest rule in trust law; he simply proposes a different solution.
Now, here is where we pharmascolds may have been sloppy in our arguments so as to have misled folks like Stell to think he has scored points against us. Stell seems puzzled that I would defend Langbein as reasonable, since my position against the pharmapologists is that most COIs between medicine and Pharma should be avoided, not accepted and "managed"; whereas Langbein obviously calls for managing COI in the area of trust law. (As a sidebar let me say that a "management strategy" makes more sense in trust law than in medicine/Pharma because the trustee is more directly under judicial control and review.) However, the argument I make in HOOKED has two parts: 1) a definition of COI that explains why it is a serious ethical problem that implicates patient trust; and 2) a further argument that most COI in medicine should be divested and not merely managed. If I were trying to claim that #2 followed directly from my definition, then indeed I would be open to all the criticisms that Stell throws in my direction.
It is important that we not expect the definition of COI to do more work for us than it can. Let's go back to Erde's fundamental analysis as I review in HOOKED. Erde insists that a statement that a COI exists is not a statement that a person has necessarily done anything ethically wrong. The person has, rather, placed herself in a position where she is at risk of doing things that are ethically wrong. The actual wrongdoing is a rebuttable presumption (which seems to be exactly what Langbein is saying).
Now suppose that in addition to the fact that a COI is present, we have some additional facts. First, significant patient harms have actually occurred as a result of those sorts of COIs in the recent past. (ACRE and Stell apparently deny that this is true in the Pharma case, and that is what would lead me to ask what he had been inhaling at their meeting--I made no suggestion whatever as to financial ties.) Second, the protections that have been offered to "manage" these COIs (such as disclosure) have been ignored or widely abused. Third, the COI is not a part of any arrangement that is necessary for medical practice or research to be properly conducted. Now, if all these things are true, it becomes more reasonable to blame the individual for entering into the arrangements that constitute the COI (such as signing up for a company speaker's bureau). But notice that the blame arises from the extra facts. It does not arise from the mere definition of COI. The charge of wrongdoing implicit in the label 'COI' remains a rebuttable presumption, by definition.
Friday, November 13, 2009
COI: My Reply to Stell
In the last post I turned the microphone over to my esteemed colleague, philosopher and bioethicist Lance Stell. He apparently accepted the definition of 'conflict of interest' attributed to him in the editorial by Michael Weber that was the subject of the post immediately preceding. He then proceeded to offer a further defense of that definition of COI, and cited as his inspiration for that definition the work of a Yale law professor, John Langbein.
I have now spent a pleasant couple of hours reading the 63-page article by Langbein that Prof. Stell refers us to. My conclusion is that it makes excellent sense, is grounded in what appears to be a thoughtful historical analysis, and I have no problem at all saying that he makes a good case for the conclusions that he argues for. (Whether he is actually right or not hinges on matters of trust law about which I am wholly ignorant, so I must withhold judgment. All I can address is the internal logic of his arguments.)
It also seems clear to me that Prof. Langbein's article has nothing at all to do with the debate over physicians and COI in relation to Pharma--or, if it does, that it supports conclusions opposite to those drawn by Stell and ACRE.
What Prof. Langbein sets out to show is that a principle of the law of trusts, the sole interest principle, is outmoded and should be replaced. According to this principle, if you are a trustee, you are assumed to be disloyal to the person you are the fiduciary for, if you enter into any deals that benefit you in any way--even if the result for the trust is a net benefit from the deal.
Prof. L. notes that the law has already been modified to grant him a good deal of what he wants--because the law now recognizes a bunch of exceptions to the sole-interest principle. That is, the law recognizes now that there are many ways in which it might be in the mutual interests of both trustee and fiduciary to carry out certain business arrangements. All Prof. L asks for is that these exceptions be made the new default principle.
Thus far it is not at all clear why Prof. Stell should imagine that this article is at all informative about COI in medicine/Pharma. The key line he quotes is, "The very term 'conflict' is an epithet that prejudices our understanding..." So I read Prof. L's article with the question in mind--does what he say here undermine or support the view of COI that I , as a card-carrying "pharmascold," propose is best? My conclusion is that Prof. L. says a lot more in support of my preferred view of COI.
Prof. L. wishes to allow transactions in which a COI exists but in which the interests of all parties are nevertheless best served by allowing what the sole-interest rule would prohibit. This is completely in keeping with most COI policies in academic medical centers. An example commonly discussed is the physician who owns a business interest in some new discovery. The ordinary rules would preclude that doc from running a research trial to test that discovery. But the discovery may be such that the only person on earth with sufficient knowledge of the new discovery, to be able competently to carry out the necessary research, is the doc who discovered it in the first place. The policies then commonly state that the doc may serve as the principal investigator for the study, but that he must accept additional oversight to be sure that he is not abusing his privilege as PI. So far nothing here to disagree with Prof. L's take on the matter. Prof. L at several places in his article calls for further regulation to prevent possible abuses.
One point that Prof. L. makes, that would at first glance seem to recommend his views to Prof. Stell and to ACRE, is the ubiquity of COI. You cannot get rid of COI because it's everywhere you look, he says. But then see where he takes this point. First, he distinguishes unavoidable and avoidable COI and agrees that it may generally be sound policy to prohibit the avoidable COI even if you end up having to tolerate the unavoidable. We pharmascolds, of course, argue that most of the COI we object to is avoidable. Docs can buy their own dinners and pay for their own CME. Academic docs who want to promote new discoveries can communicate freely with industry, but need not become paid consultants and speakers on behalf of industry--or, if they do want to do this, they can work part-time as salaried industry employees, and only part-time at the academic medical center. Famous academic "thought leaders" can actually write their own articles--or, if they want hired ghostwriters to do it for them, admit that and make the real writer the first author.
Further, while demanding changes in the sole-interest principle, Prof. L. nevertheless acknowledges the core reasons why the principle exists. For example (p. 953), he criticizes the principle, "What the sole interest rule does in such a case is to identify some conceivable but conjectural evil and then conclusively presume that this farfetched plot actually transpired, by refusing to let the putative evildoer prove that no such thing happened." Sounds pretty uncompromising. But he follows quickly with, "I do not mean to say that the trust tradition is wrong in being alert to the possibility of abuse [in the sorts of cases being referred to]." Now, this is precisely where we pharmascolds and ACRE/Stell seem to part company. Because they think that COI is sometimes applied in too sweeping a fashion, or because they think COI is ubiquitous and unavoidable, they do conclude that it is all a lot of hogwash, and that Pharma money and gifts and inducements create no ethical problem of any sort whatsoever, except in the fevered imagination of people like me. But if they conclude that, I would say, they cannot turn to Langbein for support.
Another point at which Prof. L. seems to offer much more support for my own position than for Stell and ACRE is where we call upon heightened standards of professionalism in medicine to get docs to refuse to accept Pharma freebies and bribes/handouts. Prof. L. includes in his historic survey (947-48) that one of the changes that has occurred since the sole interest rule made sense, is that the business of being a trustee has become much more professionalized. He mentions as his key example enhanced recordkeeping, driven by the "process values" that charaterize "good trust administration." With these improved records, if the trustee actually cheated the trust, you an always go back into the records and find out when and where this happened; and knowing this provides a strong incentive to the trustee not to abuse his power. Gosh--sounds to me as if Prof. L. is invoking professional standards as a defense against abuse and misconduct.
Final matter--I take Prof. L. to be making a claim that could be characterized as an account of successive pendulum swings. There was a time in history, he says, when the sole interest rule made good sense. Then a bunch of things changed, but the rule remained petrified. Nonetheless the pendulum has swung back toward the middle because more and more exceptions to the rule have been recognized. Prof. L. now calls for the final pendulum correction by replacing the rule with a more up-to-date principle.
Again we see why this analogy is superficially attractive to ACRE adherents. But let's ask--over the past several decades, which way has the Pharma pendulum actually swung? ACRE claims that at least in the last few years, the pendulum has swung wildly in the direction of discouraging financial exchanges between docs and Pharma, even when these exchanges might make patients better off (as they believe nearly always occurs). We pharmascolds on the other hand believe that the past 30-40 years have seen a huge pendulum swing in the direction of normalizing and accepting all sorts of blatant abuses and unprofessional behavior on the part of docs, and the reforms of the last few years have only just begun to edge the pendulum a few notches back toward the center-- though we still have an incredibly long way to go. I leave it to the reader to fill in your preferred account of which "pendulum" narrative seems more plausible to you.
So for all these reasons I believe that a fair-minded reading of Prof. Langbein's paper, far from undermining my own preferred definition of COI, would actually support it. As to what Prof. Stell said in the post that I reprinted from his e-mail to me, the only point to which I would call attention is his remark, "Some commentators quote GB Shaw as holy scripture [presumably when he said that it makes no policy sense to pay a surgeon or cutting off your leg unless you want surgeons to cut off a lot of legs]. And if so, buy into his socialist biases, whether self-consciously or not." C'mon, Lance--you cannot mean that in order to decide that fee-for-service payments to docs constitute a form of COI that incentivizes overtreatment, you have to be a socialist? Whatever those ACRE people were smoking at their July meeting, you should never have inhaled.
Langbein JH. Questioning the trust law duty of loyalty: sole interest or best interest? Yale Law Journal 114:929-990, 2005.
I have now spent a pleasant couple of hours reading the 63-page article by Langbein that Prof. Stell refers us to. My conclusion is that it makes excellent sense, is grounded in what appears to be a thoughtful historical analysis, and I have no problem at all saying that he makes a good case for the conclusions that he argues for. (Whether he is actually right or not hinges on matters of trust law about which I am wholly ignorant, so I must withhold judgment. All I can address is the internal logic of his arguments.)
It also seems clear to me that Prof. Langbein's article has nothing at all to do with the debate over physicians and COI in relation to Pharma--or, if it does, that it supports conclusions opposite to those drawn by Stell and ACRE.
What Prof. Langbein sets out to show is that a principle of the law of trusts, the sole interest principle, is outmoded and should be replaced. According to this principle, if you are a trustee, you are assumed to be disloyal to the person you are the fiduciary for, if you enter into any deals that benefit you in any way--even if the result for the trust is a net benefit from the deal.
Prof. L. notes that the law has already been modified to grant him a good deal of what he wants--because the law now recognizes a bunch of exceptions to the sole-interest principle. That is, the law recognizes now that there are many ways in which it might be in the mutual interests of both trustee and fiduciary to carry out certain business arrangements. All Prof. L asks for is that these exceptions be made the new default principle.
Thus far it is not at all clear why Prof. Stell should imagine that this article is at all informative about COI in medicine/Pharma. The key line he quotes is, "The very term 'conflict' is an epithet that prejudices our understanding..." So I read Prof. L's article with the question in mind--does what he say here undermine or support the view of COI that I , as a card-carrying "pharmascold," propose is best? My conclusion is that Prof. L. says a lot more in support of my preferred view of COI.
Prof. L. wishes to allow transactions in which a COI exists but in which the interests of all parties are nevertheless best served by allowing what the sole-interest rule would prohibit. This is completely in keeping with most COI policies in academic medical centers. An example commonly discussed is the physician who owns a business interest in some new discovery. The ordinary rules would preclude that doc from running a research trial to test that discovery. But the discovery may be such that the only person on earth with sufficient knowledge of the new discovery, to be able competently to carry out the necessary research, is the doc who discovered it in the first place. The policies then commonly state that the doc may serve as the principal investigator for the study, but that he must accept additional oversight to be sure that he is not abusing his privilege as PI. So far nothing here to disagree with Prof. L's take on the matter. Prof. L at several places in his article calls for further regulation to prevent possible abuses.
One point that Prof. L. makes, that would at first glance seem to recommend his views to Prof. Stell and to ACRE, is the ubiquity of COI. You cannot get rid of COI because it's everywhere you look, he says. But then see where he takes this point. First, he distinguishes unavoidable and avoidable COI and agrees that it may generally be sound policy to prohibit the avoidable COI even if you end up having to tolerate the unavoidable. We pharmascolds, of course, argue that most of the COI we object to is avoidable. Docs can buy their own dinners and pay for their own CME. Academic docs who want to promote new discoveries can communicate freely with industry, but need not become paid consultants and speakers on behalf of industry--or, if they do want to do this, they can work part-time as salaried industry employees, and only part-time at the academic medical center. Famous academic "thought leaders" can actually write their own articles--or, if they want hired ghostwriters to do it for them, admit that and make the real writer the first author.
Further, while demanding changes in the sole-interest principle, Prof. L. nevertheless acknowledges the core reasons why the principle exists. For example (p. 953), he criticizes the principle, "What the sole interest rule does in such a case is to identify some conceivable but conjectural evil and then conclusively presume that this farfetched plot actually transpired, by refusing to let the putative evildoer prove that no such thing happened." Sounds pretty uncompromising. But he follows quickly with, "I do not mean to say that the trust tradition is wrong in being alert to the possibility of abuse [in the sorts of cases being referred to]." Now, this is precisely where we pharmascolds and ACRE/Stell seem to part company. Because they think that COI is sometimes applied in too sweeping a fashion, or because they think COI is ubiquitous and unavoidable, they do conclude that it is all a lot of hogwash, and that Pharma money and gifts and inducements create no ethical problem of any sort whatsoever, except in the fevered imagination of people like me. But if they conclude that, I would say, they cannot turn to Langbein for support.
Another point at which Prof. L. seems to offer much more support for my own position than for Stell and ACRE is where we call upon heightened standards of professionalism in medicine to get docs to refuse to accept Pharma freebies and bribes/handouts. Prof. L. includes in his historic survey (947-48) that one of the changes that has occurred since the sole interest rule made sense, is that the business of being a trustee has become much more professionalized. He mentions as his key example enhanced recordkeeping, driven by the "process values" that charaterize "good trust administration." With these improved records, if the trustee actually cheated the trust, you an always go back into the records and find out when and where this happened; and knowing this provides a strong incentive to the trustee not to abuse his power. Gosh--sounds to me as if Prof. L. is invoking professional standards as a defense against abuse and misconduct.
Final matter--I take Prof. L. to be making a claim that could be characterized as an account of successive pendulum swings. There was a time in history, he says, when the sole interest rule made good sense. Then a bunch of things changed, but the rule remained petrified. Nonetheless the pendulum has swung back toward the middle because more and more exceptions to the rule have been recognized. Prof. L. now calls for the final pendulum correction by replacing the rule with a more up-to-date principle.
Again we see why this analogy is superficially attractive to ACRE adherents. But let's ask--over the past several decades, which way has the Pharma pendulum actually swung? ACRE claims that at least in the last few years, the pendulum has swung wildly in the direction of discouraging financial exchanges between docs and Pharma, even when these exchanges might make patients better off (as they believe nearly always occurs). We pharmascolds on the other hand believe that the past 30-40 years have seen a huge pendulum swing in the direction of normalizing and accepting all sorts of blatant abuses and unprofessional behavior on the part of docs, and the reforms of the last few years have only just begun to edge the pendulum a few notches back toward the center-- though we still have an incredibly long way to go. I leave it to the reader to fill in your preferred account of which "pendulum" narrative seems more plausible to you.
So for all these reasons I believe that a fair-minded reading of Prof. Langbein's paper, far from undermining my own preferred definition of COI, would actually support it. As to what Prof. Stell said in the post that I reprinted from his e-mail to me, the only point to which I would call attention is his remark, "Some commentators quote GB Shaw as holy scripture [presumably when he said that it makes no policy sense to pay a surgeon or cutting off your leg unless you want surgeons to cut off a lot of legs]. And if so, buy into his socialist biases, whether self-consciously or not." C'mon, Lance--you cannot mean that in order to decide that fee-for-service payments to docs constitute a form of COI that incentivizes overtreatment, you have to be a socialist? Whatever those ACRE people were smoking at their July meeting, you should never have inhaled.
Langbein JH. Questioning the trust law duty of loyalty: sole interest or best interest? Yale Law Journal 114:929-990, 2005.
COI: Reply from Lance Stell
Since I posted the commentary just downhill from this post, I received a quick response from my colleague Lance Stell. I am pleased to quote here the meat of his reply, toward the goal of promoting scholarly inquiry and discussion.
***
You acknowledge drawing inspiration for thinking analytically about COI from Erde. I draw mine from John Langbein, a trust law scholar.
Langbein writes, “The very term “conflict” is an epithet that prejudices our understanding that some overlaps of interest are either harmless or positively value enhancing for all affected interests.” [ “Questioning the Trust Law Duty of Loyalty: Sole Interest or Best Interest?” 114 Yale L J 929 (2005)].
If you’re not familiar with this article or Langbein, I highly recommend both.
In my view, Langbein is correct. COI, as used in pharmascold-commentary on the physicians’ relationships with industry, is an epithet.
How so? “Harmless” or “value-enhancing conflicts”, if not oxymoronic for pharmascolds (Tom Stossel’s term), languish as empty ethical categories. If populated at all, it’s token “tip of the hat.”
Traditionally, physicians’ relationships with a patient have involved that of a diagnostician, a therapist and a source of billing. The physician is permitted to offer treatment for conditions he diagnoses and to bill or somehow be reimbursed for doing these. This manifests acceptance of Plato’s opportunity-cost axiom – “no one takes on the troubles of strangers, to straighten them out, but everyone expects pay for that.”
The relationships of diagnostician, therapist and biller for services overlap, to use Langbein’s term. The associated incentives involved are very complex. Some incentives incline to advantage taking (medicalization, sometimes to the point of quackery, over-utilization in FFS or under-utilization in capitated settings, over-billing/up-coding, and the encouragement of valetudinarianism with a resulting loss of patient autonomy).
Reputational incentives and disciplinary incentives (because of physicians’ relationships w/ colleagues, licensing boards, pharmacy benefits managers, credentials committees, the plaintiff’s bar, third-party insurers, and the general public) work in off-setting directions.
On the whole, we all seem quite confident that allowing physicians to offer treatment for what they diagnose encourages dutifulness (w/ allowances for referral, but w/ scorn for fee-splitting, a practice common in Japan). Yet Westerners are vexed over the third relationship, that of reimbursement. Some commentators quote GB Shaw as holy scripture. And if so, buy his socialist biases, whether self-consciously or not. GB Shaw is not lionized among intellectuals in Japan, where specialists pay up to $2500 for a referral.
More reason to suppose that COI is an epithet.
To say of a professional, “Over the past year, Dr. S has substantially increased her conflicts,” implies presumptively (& especially for pharmascolds) that she now has a professionalism-based reason to “eliminate, reduce, minimize and/or to disclose” all of them.
There is additionally the blind spot in the jihad against physicians’ relationships with industry that financial relationships are more ethically toxic than non-financial sources of bias. Levitsky is one of the few commentators to acknowledge that non-financial relationships may be more toxic ethically than financial ones.
In my view, the COI-label is not only an “epithet” (Langbein’s characterization) it has all the properties characteristic of a “framing bias” (a point I made in my OPC supporting Tom Huddle’s article in AJOB). I’ve agreed to write an article further elaborating this claim.
Best regards, Lance
Lance K Stell, PhD, FACFE
Thatcher Professor of Philosophy
Director, Medical Humanities Program
Davidson College
PO Box 7135
Davidson, NC 28036
Clinical Professor of Medicine
UNC-Chapel Hill School of Medicine
Medical Ethicist
Department of Internal Medicine
Carolinas Medical Center
PO Box 32861
Charlotte, NC 28232
***
You acknowledge drawing inspiration for thinking analytically about COI from Erde. I draw mine from John Langbein, a trust law scholar.
Langbein writes, “The very term “conflict” is an epithet that prejudices our understanding that some overlaps of interest are either harmless or positively value enhancing for all affected interests.” [ “Questioning the Trust Law Duty of Loyalty: Sole Interest or Best Interest?” 114 Yale L J 929 (2005)].
If you’re not familiar with this article or Langbein, I highly recommend both.
In my view, Langbein is correct. COI, as used in pharmascold-commentary on the physicians’ relationships with industry, is an epithet.
How so? “Harmless” or “value-enhancing conflicts”, if not oxymoronic for pharmascolds (Tom Stossel’s term), languish as empty ethical categories. If populated at all, it’s token “tip of the hat.”
Traditionally, physicians’ relationships with a patient have involved that of a diagnostician, a therapist and a source of billing. The physician is permitted to offer treatment for conditions he diagnoses and to bill or somehow be reimbursed for doing these. This manifests acceptance of Plato’s opportunity-cost axiom – “no one takes on the troubles of strangers, to straighten them out, but everyone expects pay for that.”
The relationships of diagnostician, therapist and biller for services overlap, to use Langbein’s term. The associated incentives involved are very complex. Some incentives incline to advantage taking (medicalization, sometimes to the point of quackery, over-utilization in FFS or under-utilization in capitated settings, over-billing/up-coding, and the encouragement of valetudinarianism with a resulting loss of patient autonomy).
Reputational incentives and disciplinary incentives (because of physicians’ relationships w/ colleagues, licensing boards, pharmacy benefits managers, credentials committees, the plaintiff’s bar, third-party insurers, and the general public) work in off-setting directions.
On the whole, we all seem quite confident that allowing physicians to offer treatment for what they diagnose encourages dutifulness (w/ allowances for referral, but w/ scorn for fee-splitting, a practice common in Japan). Yet Westerners are vexed over the third relationship, that of reimbursement. Some commentators quote GB Shaw as holy scripture. And if so, buy his socialist biases, whether self-consciously or not. GB Shaw is not lionized among intellectuals in Japan, where specialists pay up to $2500 for a referral.
More reason to suppose that COI is an epithet.
To say of a professional, “Over the past year, Dr. S has substantially increased her conflicts,” implies presumptively (& especially for pharmascolds) that she now has a professionalism-based reason to “eliminate, reduce, minimize and/or to disclose” all of them.
There is additionally the blind spot in the jihad against physicians’ relationships with industry that financial relationships are more ethically toxic than non-financial sources of bias. Levitsky is one of the few commentators to acknowledge that non-financial relationships may be more toxic ethically than financial ones.
In my view, the COI-label is not only an “epithet” (Langbein’s characterization) it has all the properties characteristic of a “framing bias” (a point I made in my OPC supporting Tom Huddle’s article in AJOB). I’ve agreed to write an article further elaborating this claim.
Best regards, Lance
Lance K Stell, PhD, FACFE
Thatcher Professor of Philosophy
Director, Medical Humanities Program
Davidson College
PO Box 7135
Davidson, NC 28036
Clinical Professor of Medicine
UNC-Chapel Hill School of Medicine
Medical Ethicist
Department of Internal Medicine
Carolinas Medical Center
PO Box 32861
Charlotte, NC 28232
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