Wednesday, July 29, 2009

Senate Hearings on Continuing Medical Education

Today the Senate Special Committee on Aging (chaired by Herb Kohl, D-WI) held hearings on conflict of interest in medical education and research. Several speakers provided testimony, and if I have spare time in the coming days I will review their statements and maybe find some time for a separate entry on them. But one witness caught my eye, and his statement I read, and that is the subject of today's entry.

Thomas Stossel is a senior physician (Hematology) at the Brigham and Women's Hospital and a professor at Harvard Medical School. As I wrote last week, Stossel was the prime mover & shaker in arranging a conference for a group dedicated to the proposition that industry collaboration with physicians has been much more beneficial than harmful to patients over the past several decades. The goal of the group (Association of Clinical Researchers and Educators, or ACRE) is to organize a pushback against what they see as a movement comprised of anti-industry "zealots" who are out to "infect...medical school ethics instruction with guilt." (NB: this is more a paraphrase than an exact quote, although every word in quotations comes directly from his testimony.)

I noted after perusing their website that they were long on hot rhetoric but short on facts, and after reading Dr. Stossel's statement to the Senate Special Committee I remain not terribly impressed. His thinking seems to rely on a characterization of industry-funded CME critics as Luddites, who have a reflexive hatred of the profit motive: the "oft-repeated mantra that 'companies have a fiduciary responsibility to shareholders whereas physicians' fiduciary responsibility is to patients'...[is an] opaque platitude imply[ing] that business has no social responsibility and that physicians only behave in a venal manner when contaminated by business." In other words, Stossel believes his opponents think that industry (or profit, or both) is always equivalent to evil, and that physicians must remain pure from the evil profit motive.

Of course, that notion itself is so facile it can only induce a sigh. The issue, at least from my perspective, has always been one of bias. Physicians are a bit like little siblings of scientists in that scientists try to discover "truth" and in doing so are constantly vigilant against anything that could bias their view, while physicians have more practical concerns (their ultimate goal is generally to heal patients) but still are, and should be, deeply preoccupied with bias. Well, if lucrative financial deals don't constitute a profound source of bias, then pray tell what does?! It's not about the good or evil that comes of the profit motive, and indeed, the absolutely abominable behavior of some of the drug companies has given a bad name to the many good corporate citizens who do churn out useful products and deserve to profit from them. But to pretend that such bad behavior doesn't exist is to stick one's head in the sand. Moreover, regardless of the extent of bad behavior that has gone on in the past several years (of which there are an ample number of examples), ignoring the potential bias that can result in a physician's mind from financial perks doesn't merely ignore common sense, it ignores a great deal of psychology research that would suggest otherwise.

One can get a yuk or two in (should one be inclined to get yuks out of reading congressional testimony) by glancing at the beginning of Dr. Stossel's statement, in which he alleges that even the use of the phrase "conflict of interest" is a ploy (his exact word! see shortly) designed by that coterie of critics who wish to create an uneven playing field in the public relations war designed to win the hearts and minds of the public, and that nobody has any business even bringing the phrase to the discussion. I'm not kidding. Here is the paragraph (which, as a former English teacher, induces a cringe in me for being the polar opposite of lucid, with all of its subordinate clauses piled on top of one another, but you be the judge):

"'Conflict of interest' is only a meaningful term in terms of regulatory implications in the context of self-dealing by persons in positions of political or judicial power--and physicians and researchers do not even come close to having such influence. Therefore, the intent of the phrase in the context of medicine is a ploy, used since the beginning of recorded history, of adversaries to invoke allegedly evil motives of an opponent--such as greed--as a weapon in an argument they cannot win on substance."

Got that? Only someone in a position of political or judicial power can have a conflict of interest. Alas, this very, very narrow reading of the term is not what most people think when they utter the phrase "conflict of interest." Take this very simple, workman-like definition from Webster's New World College Dictionary: "a conflict between one's obligation to the public good and one's self-interest." That's how lots of people would define it, although even "public good" seems a touch narrow, since teachers or lawyers or the clergy have obligations to students, clients, and parishioners respectively rather than the public good. You can see how this contention that "conflict of interest" is a manufactured phrase doesn't hold up under even cursory scrutiny.

More damning to Stossel's contention, however, is the definition provided by the National Institutes of Health. That is, this is the principal body in the US that defines the ethical behavior of medical research: "a conflict of interest occurs when individuals involved with the conduct, reporting, oversight, or review of research also have financial or other interests, from which they can benefit, depending on the results of the research." Their definition doesn't even trouble itself with the characters that Stossel wants to reserve for exclusive use--judges and politicians.

Ignoring such obvious interpretations of the term might be viewed as, you know, maybe, um, a weapon in an argument one cannot win on substance.

(If the former English teacher can also get in a teaching point here, it is this: please read out loud your statement to a Senate committee before you go to Washington! The phrase the intent of the phrase in the context of medicine is a ploy really should have been written the phrase is a ploy--an "intent" can't be a ploy. Eliminate useless words, class! If there is evidence in this blog entry to the contrary, keep in mind that this blog is pretty much a first-version essay each time out with no time for revisions, and I'm not testifying before Congress.)

It's quite tedious to have to respond to the more fanciful accusations riddling Dr. Stossel's remarks: that nobody wants industry to fail, that physicians can have collegial relations (or even productive collaborations) with medical industry corporate employees, that...oh, you get the picture. The point that has to be made, again and again apparently, is that physicians can be biased by pharmaceutical companies, and that pharmaceutical companies have a responsibility to make money while physicians have a responsibility to treat patients. It's good that there's a profit incentive for corporations. It's bad when physicians are given financial incentives to try to influence the prescription patterns of their colleagues--precisely because those financial incentives allow bias not merely to creep in, but rather knock down the door, barge in, put up its feet on the coffee table, pop open a beer (or, since were talking about physicians, uncork a nice bottle of cabernet) and watch TV. That's bad for patients.

Dr. Stossel also implies that critics of my ilk are clamoring for governmental oversight into every nook and cranny of the industry-physician relationship. For my part I would prefer that government not have to legislate on such matters. Honestly. But here's the rub: I would likewise prefer that my professional brethren and sistren regard the baubles offered by the pharmaceutical industry with contempt, for after all, if the drugs the company makes are good, they will surely flourish under a peer-reviewed system in which no conflict of interest exists, right? I would hope that this would be the prevailing attitude among medical students, for instance. But--good God!--it's not even the majority position among the faculty! And if we can't get the house in order, and further and further evidence of abuses mounts, leading any sane person to conclude that there's a systemic problem out there, well...that's when you get Congress to take note. And as we have found in so many recent episodes in our country, it's not necessarily a good thing when Congress gets involved. But if it does, the fault will lie at the doorstep of the physicians who have abused the goodwill of their patients, as well as their apologists like Dr. Thomas Stossel.

Dr. Stossel's statement can be found here. It takes some time to get through but for those interested in the CME issue it's worth the time investment. In the coming days I hope to have more to offer on some of the other witnesses (or even some of the Senators!).

Hat-tip to the Carlat Blog for the link as well as his attendance. I wanted to make it to the conference as it's down the road from my house, but pressing research issues (including a meeting with the boss) took precedence.
--br

8 comments:

  1. Dr. Rubin,
    Since you continue to write posts against industry supported CME let's revisit your Feb 11 post in which I questioned you about your attendance at, and attitudes toward, the industry supported IDSA meetings. You didn't answer this question:

    *I’m still curious as to why you even bother to go to IDSA in view of your answer: “Anyway--how do I deal with the pervasive bias at the premiere meeting for ID docs? The quick answer is: not very well.” If that’s true wouldn’t you be better off, and save yourself considerable time away from practice and family, to get the same information from sources like Medical Letter, UptoDate, or independent literature searches?*

    Your attendance at such meetings, along with the expense and time they entail away from practice and less biased educational alternatives, would seem to imply that you feel the benefits of such meetings, possible in their present form only with commercial support, outweigh the bias. That contradicts many of your statements. Please explain.

    In the post above you said “I would likewise prefer that my professional brethren and sistren regard the baubles offered by the pharmaceutical industry with contempt...” If mere baubles are worthy of contempt in your view you must be in a seething rage about industry's substantial contribution to your registration fee at those meetings. How do you manage that anger?

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  2. Well, I'll tell you: I drink heavily, nearly to the point of stupor, while tears run down my eyes--indeed I weep--as I rue the day that my hypocrisy and seething rage was exposed by that intrepid, eagle-eyed observer and defender of freedom and truth, Dr. RW Donnell. Alas! Woe is me!

    In abject despair,
    Billy

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  3. Please do me the courtesy of giving a straightforward answer. I'm genuinely curious as to how you resolve this.

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  4. Let me make sure I have this straight: you come on to my site and psychoanalyze my “seething rage,” wondering how I manage the anger I must have toward The Man, and you all but call me a hypocrite…and you want a gentlemanly reply as if this was all a pleasant chat? I don’t think so, pardner. You’re welcome to leave your thoughts, as you’ve written nothing abusive, but it did show contempt, however innocuous, and so I have replied in kind.

    You have wondered aloud—twice, in fact, since you reference our correspondence in February—how I can manage to square the circle of going to IDSA knowing that IDSA receives large corporate contributions. This time out, I gave a prickly indirect reply. Why could that be? Hmmm. Oh, I remember! This ain’t about me. But you’ve got this strange preoccupation with centering this discussion around my personal practices and thus totally ignore what’s actually relevant.

    The question about industry funding of CME should be debated on its own merits. You have spent the bulk of your comments, then as now, turning it into a personal matter. Sorry, but I think that’s exceedingly dirty pool: to me it seems a pretty weak rhetorical device when you pretend that what’s really important here is whether or not I attend a conference.

    Incidentally, Dr. Stossel did the same kind of thing in his personal statement before the Senate, though to a much lesser degree. He said that current CME critics, who “vary in stridency,” show a “profound animus against money” while “uttering platitudes” about ethics and “infecting medical schools…with guilt.” What the &#$@?! Ain’t none of that got to do with the actual evidence about how industry biases physicians. Argue the points on the merits.

    So let’s review: your question about my attendance at IDSA is not the point. It’s irrelevant. It’s distracting. It is, to use an old-school term, ad hominem. To get caught up in a debate about my personal practices is just plain wrong. That said, in the spirit of giving I will try to give you a roundabout reply. But do please understand that I have absolutely zero interest in discussing this matter further for the reasons I’ve given above. If you want to take up the banner every single time I write about CME and point out to the twelve or so readers of my blog that I do indeed attend conferences that are in part sponsored by heavy industry players, feel free, but my participation in the extended debate about my ethics on this matter ends here.

    Think of it this way: isn’t the logical extension of your argument that I shouldn’t even practice medicine at all? After all, since modern medicine is driven at least in part by for-profit industry who have to greater or lesser degrees of influence on both individual physicians as well as larger health care organizations, am I not participating in something unseemly when I prescribe any medicine? Forget conferences: the hospitals I work for have agreements with drug companies that determine that when a patient comes to the hospital, they will get Brand Name Drug X instead of Drug Y. I personally have no power to determine which drugs are on the hospital’s formulary, but I live with it. I try to practice medicine the best I can; I’m aware the system ain’t perfect—the health care system or any other system in this country—but I go forward regardless. Yes, it would be most consistent of me if I moved out into the woods and lived off the grid as an alfalfa sprout farmer, but I’ve opted to live with some contradictions. Being a doc is one of them. Prescribing medications, many of which are life-saving miracles, but not all of them all the time, is one of them. And going to IDSA, the premier meeting of infectious disease docs in the United States, is one of them. Reading Up To Date is just not the same thing, and so I live with it, but it doesn’t mean that I should just give up arguing for a better system. If that answer isn’t consistent enough for you then no further explanation will be.

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  5. OK, so my rhetorical device was weak. But my weak rhetorical device may have exposed some weaknesses in your argument.

    You asked: “Think of it this way: isn’t the logical extension of your argument that I shouldn’t even practice medicine at all?” No, it's a distortion. An implied premise of my question is the generally accepted notion that doctors in the real world should manage their conflicts as best they can. Some can be managed to varying degrees but not eliminated, e.g. those inextricably tied to the practice of medicine. Others, such as your attendance at IDSA, can be eliminated easily. You can just say no.

    Am I making this about you? In part, yes. I find it astonishing that you regard pharmaceutical baubles with such contempt yet think nothing of benefiting from industry largess yourself. The finger pointing and ridicule in your February post about doctors feeling entitled to their “nice things” comes to mind. If you can ridicule the ethics of other physicians (and Stossel's use of language) then it's fair game to question---merely question, mind you---your own ethics. It's not dirty pool to wonder aloud whether you practice what you preach.

    But I am questioning, not calling names. I am not about to call you a hypocrite. If that shoe doesn't fit don't wear it. I am open to other explanations for your inconsistency (see below).

    True, reading UpToDate is not the same thing as attending IDSA---UpToDate is unbiased! But you seem to imply that these meetings have some educational value that you can't obtain from non industry supported, less biased sources of information.

    That brings me to the relevance of my question to the merits of the debate about industry supported CME. If you think your attendance at these meetings has value then that speaks against an industry ban. So do you think these meetings are beneficial or not? That's very relevant in this debate because if industry support goes away many of them will cease to exist. I know you don't want to debate this further but that's a question you've dodged, and it's one that's central to the debate about industry support.

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  6. A final thought

    Perhaps I should have worded my comments differently. On reflection, the issue of your attendance at IDSA is about you only in the sense that it is about many physicians, all of whom have good ethics, who object to industry funding yet attend supported CME meetings. I regret not making it clear enough, but it was not my intention to impugn your ethics. Yes, I have been annoyed at the ridicule and finger pointing. But my real purpose was to force the question “if the adverse effect of bias outweighs any advantages of support why even go”, hoping to get you to re-examine your position. I also wanted to force the question of unintended consequences which many critics seem to ignore. I hope this helps.

    All the best,
    rw

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  7. Fair enough, I'll try to turn the heat down a notch as well.

    But.....

    a. I would argue that one can’t say no to IDSA if one is an ID doc. There’s nothing really like it that allows for the opportunities to hear an incredible variety of talks about what’s going on in the field, to listen to debates about current controversies, and above all to network. You just can’t do that online while perusing Up To Date.

    And of course I think IDSA is beneficial. When you write things like that it makes me think that you want to reduce everything to a nice, binary good/evil discussion.

    b. I’m not sure I see the logic in calling me out for my supposed inconsistencies as a defense of taking those industry-offered baubles. To wit: I happen to think that I am pretty much consistent in my personal policy about my relationships with drug reps and the companies they represent (see "e" below), but even if I weren’t and you are right, how does that make drug-rep dinners any more ethical? I just don’t see how it’s a great defense of the current state of affairs.

    Guess what? The northern abolitionists who railed against slavery were preachy and often racist. Pointing that out at the time wouldn’t have made slavery any more defensible.

    c. Stossel’s defense of the relationship between docs and drug makers, I’ll give him credit, has some meat on its bones. Unfortunately, I think it’s largely missing the point. Carlat discusses this in his own blog, so I won’t elaborate here.

    d. There is room for genuinely fruitful discussion about how docs should have business relationships with drug and other medical industry people. Such as: surgeons have got to meet with device makers to work out new instruments and gadgets. By all means, let ‘em do it over dinner on the company tab! Would it be good to stamp out a relationship like that? Potentially not. But that’s not the same as the drug-rep dinner, it’s not the same as accepting “gifts” from a drug rep, it’s not the same as earning tens (or hundreds!) of thousands of extra dollars serving on a “speaker’s bureau,” and so far in several letters I have only read your defense of what to me are indefensible behaviors. I just don’t think that doctors are entitled to those things if they want to call themselves doctors.

    I guess I’m old-school about this, but I think a doctor should make his or her money only by treating his or her patients. If they want to work for industry, that’s fine, but then they have to step into a different set of shoes; if they want to work with industry doing research, they should avoid any appearance of financial impropriety. But look out at the things that have been going on since the early-mid 90s and you don’t see subtle conflict problems; you see remarkable abuses that, to me anyway, no ethical person can defend. Stossel at least is framing his argument around the what-if of going too far in overregulating what he views as mostly a beneficial system, but even he admitted during his testimony that there have been some unseemly arrangements. Correct me if I’m wrong, but I haven’t read anything suggesting that you think there’s anything wrong with what has heretofore been the norm in terms of these practices that I’ve outlined above.

    e. I think I wrote this before in Feb but if not here is my philosophy: don’t accept money that isn’t yours (that covers speaker’s bureaus), don’t accept gifts that don’t belong to you (there’s the baubles), there is no such thing as a free dinner, never do anything that your (reasonable) patients, if they were looking over your shoulder, would regard as inappropriate when you are dealing with someone from some company that stands to profit from your behavior as a physician. I don't see how that conflicts with anything I've written. I know you think that going to IDSA falls under the "gift" proscription, and I think my patients wouldn't consider that inappropriate.

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