Friday, November 13, 2009

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

Thursday, November 12, 2009

COI: Define It Narrowly Enough and It Goes Away

Thanks to a couple of friends for alerting me to Dr. Michael A. Weber's editorial in the Journal of Clinical Hypertension, entitled, "Academic Physicians Confront a Hostile World: The Creation of ACRE." You can get a sense from the "poor us" tone of the title what this defense of the Association of Clinical Researchers and Educators is going to be like. I could go on for a while about the "hostile world" that expects that academic physicians might actually manage to live on their salaries, that are generally several times greater than those of any other academics, without also stuffing their pockets with industry largesse. But of greater interest is the discussion of the definition of conflict of interest (COI).

In a section labeled "Conflict of Interest: A Disturbing Misnomer," Dr. Weber quotes with approval a speaker at the inaugural ACRE meeting, Prof. Lance Stell of Davidson College, whom he described as a "nationally recognized medical ethicist." I consider Lance a good friend of many years standing and a fully legitimate philosopher-ethicist, but the fulsome description leaves out that on this particular issue, Lance's stance is probably quite atypical of bioethicists (though no one has done a survey so I could never prove that).

The reason Dr. Weber likes Lance Stell's definition so much, and no doubt why Lance was the only bioethicist I am aware of that was invited to speak at the ACRE conference, is that he is said to define COI as what "occurs when practitioners accept personal rewards...in return for actions that could violate their professional obligations. In essence, to accuse a physician of conflict of interest would require empirical proof that, in return for a reward, an action was taken that resulted in diminished care or even harm to patients." Given that starting point, Dr. Weber then says very reasonably, "Clearly such occurrences are extraordinarily rare..."

This definition contrasts quite markedly with the definition of COI that I offer in HOOKED, which in turn is based on a definition constructed by philosopher Edmund Erde. By the definition I favor, a person may be involved in a COI if she becomes involved in certain social arrangements, which would cause a reasonable observer to believe that a person of normal human psychology would (under those arrangements) be tempted to forsake her professional obligations. Erde, in constructing his definition, explains that he did so with the idea that the core concept that COI needed to be grounded in was trust in a social role. I believe that judgment to be exactly correct-- it is precisely the concerns we have about loss of public trust in physicians and in medicine as a whole that motivates our present concerns about COI.

It should be no great surprise that we could make COI go away if we engaged in the right sort of definitional gerrymandering. The question is whether that sort of definition seems genuinely to enlighten us about the core ideas and behaviors, or whether it rather serves to obfuscate the issues.

I am going to stick my neck out here as I am not schooled in the laws regarding bribery. But my current state of understanding is that you could arrest a public official on a charge of bribery if, say, he was observed to have been offered money in exchange for his vote on some pending legislation, and on accepting the money he indicated his willingness to vote the way that the payer wished him to.

Now, imagine that we were to apply the logic Lance Stell uses to define COI to the bribery case. The first thing we would note is that we cannot arrest the corrupt politician just because he takes the bribe and agrees to change his vote. We have to wait until the vote occurs and see that he actually does vote the way the bribe required. Nor are we done yet. We also have to see the outcome of the vote. Let's imagine that despite the politician voting "no," as the person paying the bribe wished, the legislation passes anyway. Then there was no harm, associated with the bribe; and so by the Stell approach, there would have been no crime of bribery. I would not be surprised under those circumstances to be told that the cases in which public officials are bribed are vanishingly rare.

I suggest that the bottom line is:
  • What we are concerned about in the COI issue is public trust in medicine.
  • Public trust can be lost just as much by the appearance or suggestion of compromising behavior as by the behavior itself.
  • Therefore things that create appearances or suggestions that would reasonably cause public trust to be lost ought to be included in the definition of COI.
  • This is especially true when the social arrangements that give rise to the suggestions or appearances are not essential to the conduct of medical practice or medical research, and consist of extra perks for the academic physician. (I gather that the ACRE folks argue that taking money from industry is essential to medical research, beause absent the good ol' entrepreneurial spirit and profit motive, many fewer discoveries will be made. That debate will have to occur on a different occasion.)

Incidentally, you might wonder why a hypertension journal seems to be going out of its way to provide a platform for ACRE and its preaching. You can get a sense of why this is so by reading more about where some of the ACRE leaders get their money, in Danny Carlat's recent blog on the topic: http://carlatpsychiatry.blogspot.com/2009/11/tom-sullivan-of-acre-fame-is-swimming.html

Weber MA. Academic physicians confront a hostile world: the creation of ACRE. Journal of Clinical Hypertension 11:533-36, 2009.

Erde EL. Conflicts of interest in medicine: a philosophical and ethical morphology. In: Speece RG, Shimm DS, Buchanan AE, eds. Conflicts of interest in clinical practice and research. New York: Oxford University Press, 1996:12-41

Tuesday, November 10, 2009

Retraction: Nemeroff and Ghostwriting

In a previous blog post:
http://brodyhooked.blogspot.com/2009/11/u-miami-send-us-your-professionally.html
--I did too little factchecking and accordingly made an incorrect assertion regarding Dr. Charles Nemeroff and ghostwriting.

The facts on which I was relying, and which do not support what I said at first, can be found in two posts on Danny Carlat's psychiatry blog:
http://carlatpsychiatry.blogspot.com/2007/09/author-calls-his-own-cns-spectrums.html
http://carlatpsychiatry.blogspot.com/2007/09/devane-mounts-defense-of-cns-spectrums.html

Here's a recap. Dr. Nemeroff approached two of his academic psychiatry colleagues to participate in a discussion at a psychiatry meeting in Hawaii, to be videotaped by Bristol Myers Squibb, regarding the company's antidepressant patch, EMSAM. An article based on a transcript of that video was then published in the journal CNS Spectrums.

Critics noted apparent errors in that article, leading one of Dr. Nemeroff's co-participants (and listed co-authors of the article), Dr. C. Lindsay DeVane, to protest to Dr. Carlat that the article as a "piece of commercial crap" that did not accurately reflect his views. Dr. DeVane implied to Dr. Carlat that the first draft of the article had been written by a ghostwriter hired by the drug company, and contained numerous inaccuracies; Dr. DeVane denied having seen the final draft before publication. The former editor of CNS Spectrums, James M. La Rossa, Jr., then wrote a comment to Dr. Carlot's post, complaining about current company-sponsored practices in the publishing world, and adding, "I am willing to bet dollars to doughnuts that Nemeroff never saw proofs of the article either."

Dr. Carlat said in his later post that somebody must have gotten to Dr. DeVane, as he later retracted his comments and claimed that the CNS Spectrumsarticle was accurate, not ghostwritten, and that all three co-authors were "heavily involved in multiple edits." There were, as Dr. Carlat said, several reasons to regard Dr. DeVane's later retraction as disingenuous, especially because as he noted the first time out, his published research had stressed the lack of drug-drug interactions as a problem with antidepressants, whereas the CNS Spectrumsarticle seemed especially to claim that EMSAM was a superior product because it avoided drug-drug interactions.

Bottom line: others alleged (though one later retracted) that Dr. Nemeroff was involved with a ghostwritten article, but Dr. Nemeroff himself never admitted to this, in the specific instance that I was referring to.

I stand by my initial observation however in that anyone who claims to have written 450 articles, who keeps up the sort of travel and speaking schedule that Dr. Nemeroff apparently does, and who is well known to be extremely cozy with numerous pharmaceutical companies, has to be under suspicion of at least some of those articles being ghostwritten for him. Which is part of the reason why ghostwriting as a practice is such a basic threat to the integrity of medical science.

Monday, November 9, 2009

"Health Care Renewal" on AAFP's Tone-Deaf Reaction to Coke Controversy

I appreciate our fellow blogger Roy Poses over at Health Care Renewal adding some further insights to the American Academy of Family Physicians (AAFP)/Coca-Cola controversy:
http://hcrenewal.blogspot.com/2009/11/paging-and-paying-dr-coca-cola.html

Dr. Poses wonders, as I have, why the leadership of AAFP seems so tone-deaf to the outcry that points out how bad the organization has made itself look by signing the deal with Coke to support public "education" about obesity. Dr. Poses, however, was far more energetic in doing some research, and his results are as follows:

"Nonetheless, one would think that the latest round of criticism would make the top leaders of this august professional society less comfortable about the organization's financial relationships with pharmaceutical, biotechnology, and now beverage corporations. I fear, though, that they may live too much in the sort of bubble that now protects top executives of most large health care organizations to really question their corporate ties. After all, according to the most recent (2007, covering 6/2007-5/2008) US Internal Revenue Service form 990 filed by the AAFP (via Guidestar), its leaders get sufficient compensation to put them into such a bubble. For example, Dr [Douglas] Hensley [AAFP CEO] received $441,027 regular compensation and $108,930 in benefits and deferred compensation, compared with a median compensation for family physicians in 2008 reported as $159,000 ..."

I guess that when your ears are stuffed with that many dollar bills, tone-deafness is the logical result.

Saturday, November 7, 2009

U. Miami: Send Us Your Professionally Challenged

When the poster child for everything this blog inveighs against, Dr. Charles Nemeroff, was finally stripped of his chairmanship of psychiatry at Emory after many years of blatant conflicts of interest, I had finally hoped I could continue these discussions without again having to mention his name. But I had reservations. The uncharacteristic meekness with which Dr. Nemeroff appeared to accept his chastisement and demotions somehow seemed to hint that there were more episodes of this soap opera yet to come.


We now read that Dr. Nemeroff has been hired by the University of Miami as its new chair of psychiatry: http://www.miamiherald.com/living/health/costs/v-fullstory/story/1319569.html


At first blush this would appear to indicate that Miami has put up a neon sign, "Want to Get Rid of Your Problem Faculty Who Appear to be Ethically and Professionally Challenged? Send Them Here! Group Rates Negotiable."


Miami's response? "Pascal Goldschmidt, dean of UM medical school, called Nemeroff ``an exceptional psychiatrist and an exceptional scientist who has one issue in which he recognizes he made a mistake,'' in not telling Emory how much he was getting from drug makers."


To anyone who has followed Dr. Nemeroff's career, this is sort of like saying that Jack the Ripper was a dedicated feminist, only he had one issue. The specific question of whether he honestly reported to Emory how much outside income he had made is just the tip of the iceberg. To reduce the question of his professionalism to that single matter indicates either denial or willful ignorance of the record.

"In Miami, Goldschmidt said Nemeroff was multidimensional -- strong in basic research, treatment of patients and building programs such as suicide prevention.
His biography lists stints as president of the American College of Neuropsychopharmacology and the American College of Psychiatrists. He has published more than 750 research reports and reviews.
``I know I'm going to take a little smack in the face for this hire,'' Goldschmidt said. ``But you don't do anything important without taking some risks. It's very important that the people of Miami have access to a phenomenal psychiatrist like this.''



How does a person of Nemeroff's age and rank get to have written 750 publications--especially with how busy he obviously was with administration, fundraising, and schmoozing with corporate bigwigs? (Academics 10 years older than Nemeroff would ordinarily be considered superstars if they had 200 articles to their credit.) Given that Nemeroff admitted on at least one occasion that he put his name to a ghostwritten paper, and given what we know about the frequency of ghostwriting in psychopharmacology specifically, one has to question just what percentage of his actual output is honestly attributable to him.


And what exactly does the Dean mean by calling Nemeroff "exceptional...phenomenal"? This is a person who has probably done more than any single individual to reduce academic psychiatry to a crassly commercial enterprise. In the process, he has always kept a stream of corporate cash flowing into whatever institution currently harbors him. That appeared to many skeptics to be the reason why Emory took as long as they did to seriously get on his case. That would appear also to be the main attraction for Miami.


I will once again protest, despite apparently mounting evidence, that I have no personal vendetta against Dr. Nemeroff. I have never met the man. He may be, for all I know, a charming fellow, though one would imagine that whatever behavior earned him the nickname among his fellow academic psychiatrists of "boss of bosses" would argue against too benign a portrayal. I am beating this dead horse, that refuses to stay dead and keeps rearing up, for one simple reason. Grossly unprofessional behavior that is nevertheless highly profitable for both individuals and their institutions will never stop unless engaging in it brings down consequences upon one's head. If the reward for being Charles Nemeroff is to be offered a chair at one medical school when one has been kicked out of one's chair in disgrace at another, then the consequences appear to be pointed in exactly the wrong direction.

Wednesday, November 4, 2009

Family Docs Resign from AAFP over Coke

I am proud of my fellow family physicians who are making their objections loudly known to the American Academy of Family Physicians over the deal with Coke that I addressed a few posts back, according to this new story: http://news.yahoo.com/s/ap/20091104/ap_on_he_me/us_med_doctors_coke_deal

Sadly, if the responses to this news report from AAFP leadership are accurate, the AAFP still does not get it. "[AAFP CEO Dr. Douglas] Henley said the academy regrets the resignations and hopes other members will not "rush to judgment" before seeing the new content." News flash: we don't need to see the content to know there's something rotten in Denmark. The deal itself raises concerns about the credibility of anything AAFP posts about diet and obesity from now on. Even if the message the AAFP posts condemns sugar-containing soft drinks, no one will ever know if the alternative message, that might have been posted had not Coke funded the program, would have been even more critical. It's the fact that such questions will inevitably be raised, and not what the actual content says, that's the problem.

"Henley said the academy is in talks with other foundation contributors to fund other materials for the group, but he declined to say which ones." Gee, isn't that reassuring. At least when the AMA was caught looking like jerks over their Sunbeam endorsement deal, they pulled out of the deal and heads rolled in AMA top offices. They did not rush out to try to find more commercial firms to sell their soul to.

It's depressing that the AAFP found it possible to jump into bed with Coke in the first place--especially given all the recent publicity calling attention to the risks of commercial bias and entanglements (for just one example, see http://brodyhooked.blogspot.com/2008/07/hard-hitting-look-at-medical.html). What's even more depressing is that with the whole world telling them that they mishandled this affair, the AAFP still seems to think that the problem is someone else's.

Monday, November 2, 2009

NAMI and Pharma: New Revelations

For a good while, Sen. Grassley and his team seemed focused on one specific area of Pharma--outing academic docs who are on the take for big bucks, and who may not have fully disclosed their takings to their institutions or to NIH. Now, it seems, the good Senator is after astroturf. We read that he sent letters last spring to a dozen or so disease and patient advocacy organizations to ask about how much money they received from drug and device makers.

One result is reported by Gardiner Harris in the New York Times:
http://www.nytimes.com/2009/10/22/health/22nami.html?_r=1

The National Alliance on Mental Illness (NAMI) has historically treated detailed information about its donors as private. We now learn that over the past three years, drug firms have provided about 3/4 of the organization's budget. Its executive director, interviewed by Harris, admitted that this was excessive and that it was the goal of NAMI (as well, he implied, as many of its peer organizations) to reduce this level of dependency.

That said, there was no admission that when in the past, NAMI lobbied state governments to insist that Medicaid programs continue to pay for even the most expensive and sometimes least effective psychotropic medications, it could have been doing the bidding of its pharmaceutical-industry sponsors rather than expressing the wishes of its membership.

Some of our fellow bloggers followed up with pointed comments about NAMI:
http://www.furiousseasons.com/archives/2009/10/nami_lies_in_nyt_letter_to_the_editor.html
http://hcrenewal.blogspot.com/2009/10/alliance-on-mental-illness-or-for.html

As I explained in HOOKED, the term "astroturf" refers to fake grass roots--an advocacy organization that claims to represent people concerned about a disease, that is in actuality a front organization supported almost solely by drug industry money. NAMI is not a fake organization; it has real members and real chapters, offices, etc. (As I found out a while back when a local NAMI chapter sponsored a visit to Portland, OR for me to talk about concerns at the medicine/Pharma interface). The problem is the hybrid--a real organization that accepts so much money from drug and device companies that it no longer has true independence.