Thursday, April 28, 2011

Perception and reality of economic inequality


We see a lot written about how political views in the US are very polarized. As an example, the April 17, 2011 “Doonesbury”, portrays Donald Trump bragging that he is polling 41% against President Obama and is not even running yet; the interviewer, Mark, replies “It’s a divided country. Virtually anyone who’s not Obama gets 40%. My mailman could get 40%.” The idea is that we cannot reach accommodation because we have such different basic understandings, “belief systems”, “worldviews”.

Certainly this has been the case in Congress, although recently, in passing a budget for the remainder of FY 2011, there were actually some Democrats and Republicans voting on the same side. It is important, however, to note that the Republicans who voted against the budget condemned those who did precisely because they did not hold rigidly and intransigently to their positions, even if, as in the case of Congressman Paul Ryan’s budget proposal, those positions are based in mythological faith rather than in data. Paul Krugman, (“Who’s Serious Now?”  April 16, 2011, writes that Ryan’s proposal was “In fact, it was a sick joke. The only real things in it were savage cuts in aid to the needy and the uninsured, huge tax cuts for corporations and the rich, and Medicare privatization. All the alleged cost savings were pure fantasy.” The threat to Medicare is critical, given both the role that health reform, ACA, “Obamacare”, has played as a touchstone of evil in the fantasy world of Ryan and his party, and the real loss of healthcare, along with their jobs, faced by so many Americans.

A lot of people wonder how it is that such a large portion of the US population, can support Republican proposals that are so obviously about increasing the financial benefit to the richest Americans while hurting most everyone else, including, obviously, most of those supporting the Republicans. Are they selfless advocates of big money, such that they are willing to sacrifice their own interests to aid the least needy? Do they truly believe that each of them, despite the mathematical odds, has a good chance of becoming part of that select group? Are they stupid? It may be that either or both of the last two are true, but the first, unsurprisingly, is not. This is demonstrated in a very interesting study by Michael I. Norton, of the Harvard Business School, and Dan Ariely, a psychologist from Duke, recently published in Perspectives on Psychological Science.

In “Building a better America: one wealth quintile at a time[1], Norton and Ariely present a large (5522) random sample of Americans three pie charts showing possible distributions of wealth among income quintiles as possible ideal models. One is equal: 20% in each. One is less equal and is in fact the distribution of income (not wealth) in Sweden The third is the distribution in the US. (That the second one is not in fact the wealth distribution in Sweden is not really important here; it could be called “Mars”; it is just an intermediate distribution).  About equal percents chose the “equal” and “Swedish” distributions, 77% preferred “equal” to the US, and 92% preferred the Swedish to the US. Given that people were told to assume that they had a random chance of themselves being in any quintile in any of the distributions, the preference for a more equal distribution may be unsurprising; indeed it suggests that more than half of those in the top quintile are less selfish and would support a more equal distribution of wealth. This, by the way, is consistent with a report by CBS news report from April 17, 2011 “The US Tax code: a ‘huge convoluted mess’”, in which several multi-millionaires argue against the idea that “…the rich can't afford higher taxes.“ One says “Every time I get a tax cut, I get richer…‘I don't buy one thing that I don't already have. I don't put money back into the economy. I just get richer.

An even more interesting part of Norton and Ariely’s study involved asking their subjects what they though an ideal distribution of wealth among Americans should be and what they thought it actually was.  While their ideal was not “equal” – it assigned over 30% to the highest quintile and just over 10% to the lowest –it was much more equal than their perception of the actual distribution, which had the top quintile having nearly 60% of the wealth, and the lowest quintile only about 2%.

But, as the figure shows, their estimates were way off; in actuality the top quintile has 84% of the wealth, the third (middle) quintile well less than 5% (not much more than their estimates gave to the lowest quintile), and the two lowest quintiles are not even visible on the graph, with a total of 0.3% of the wealth. More important, there was little difference between various groups such as men and women, income levels (<$50K, $50-100K, >$100K), or whether they had voted for Bush or Kerry in 2004 (the data was collected in 2005). All groups felt that the ideal wealth distribution should be significantly more equal than they believed it to be, and all groups believed it to be far more equal than it actually is.  

Norton and Ariely express the hope that this study will inform public policy creation; that by showing that the American people are much closer together in their vision of a just distribution of wealth in society than are the politicians and pundits we hear so much from, there is a chance of reaching some greater consensus in terms of economic policy. This hope is endorsed, from several different perspectives, by the 4 commentaries that accompany it in the same issue of the journal, by Dunn et al (“Consensus at the heart of division”), Tyler (“Procedural justice shapes evaluations of income inequality”), Kagan (“Unclear implications”), and Schwartz (“A new veil of ignorance?”).

So why do we have such divisions? Schwartz notes that T. Frank (2004) argued, somewhat insultingly, that average Americans are being duped to vote against their real economic interests. But the Norton and Ariely data suggest that people vote against their preferences. How can people be duped to vote against their preferences?” That he can ask this question means perhaps Frank was correct. Kagan beings to get to the answer when she writes “To start with the obvious, precisely because such a huge portion of American wealth is held by such a tiny percentage of individuals, these individuals have an extraordinary interest in maintaining the currently inegalitarian distribution. And unlike the vast majority of Americans, who have so little and thus have so much to gain, this tiny minority has the immense resources to see to it that their interests are carefully attended to by lawmakers.”

Moreover, people do not vote on one issue, even if the issue is their economic self-interest. Indeed, this is what Thomas Frank writes about in “What’s the Matter with Kansas?” Frank says people may vote for candidates because of their stands on social issues (e.g., abortion, gay marriage) rather because of their positions on economic issues. On the other hand, in the recent (2010) elections, we observed a justified anger at the economic situation that led to a massive shift to those who were not in power (the Republicans), who have responded not with plans to increase jobs or equalize wealth but to dismantle all the progressive reforms of the last 100 years; not to get government out of people’s lives, but even more into their bedrooms.

And the economic arguments, as Krugman notes, have tremendous implications for health and health care, given the size of health spending as a portion of our economy. Rep. Ryan’s “solution” for the deficit relies in great part on the restructuring of Medicare to reduce its support for the health needs of American seniors, when indeed what is needed is the expansion of Medicare, as a single-payer, more-controllable, health financing model, to all Americans. Ryan’s attack on Medicare is part of his attack on any semblance of a social contract or social justice, and is part of the continued redistribution of wealth from the less-well-off to the rich.

In the CBS report discussed above, David Cay Johnston, who teaches tax regulation at Syracuse University Law School, notes that  "All the data are overwhelmingly showing that for the last 30 years, we've been redistributing wealth upwards….It's not trickle-down economics; it's Niagara-up!" The Norton and Ariely data suggest that the American people do not support such a flow, and this is consistent with the fact that every poll for the last 20 years notes that we would support a universal health insurance plan. Maybe Paul Ryan’s attack on Medicare will finally be the impetus for us to go beyond the limitations of ACA and get real health-care-for-all.

[1] Norton MI and Ariely D, “Building a better America: one wealth quintile at a time”, Perspectives on Psychological Science, 3Feb2011;6(2):9-12 doi: 10.1177/1745691610393524

Saturday, April 23, 2011

"Cabaret" and "Inherit the Wind": Will we again reap what is being sowed?


Last year at this time, March 31, 2010, I wrote a piece about Obama and the Seder: Freedom and Multiculturalism, trying to capture the importance of the concept of freedom, and the historical relationship between African-Americans and Jews in this story of emancipation. In addition to enslavement, ancient for one and much more recent for the other, the two groups share both oppression, and, to a large extent, empathy for the oppression of others, and Passover is a good time to remember this. This weekend it is also Easter (after all, the Last Supper was a seder), during which Christians celebrate the resurrection of a prophet who preached against oppression and for peace.

Recently, I saw a very good performance of “Cabaret” at the Kansas City Repertory Theater. Of course, I had seen it before, or rather, had seen the Bob Fosse film version of this Kander and Ebb musical starring Liza Minelli. It has a long pedigree: the musical is an adaptation of the 1951 play “I am a Camera”, by John Van Druten, which was also made into a film in 1955 (both starring Julie Harris). It, in turn, was based on the story “Sally Bowles”, written by Christopher Isherwood and published in 1941. In 1972, when the movie “Cabaret” came out, it was a period piece, portraying the libertine “degeneracy” of Weimar Berlin set against the rise of the Nazis. The horror of this was not lost on me, or on the rest of the audience; for my generation, born soon after WW II, with fathers who had fought in the war, it was not that far away. For those of us who are Jewish, whose grandparents were immigrants, whose grandparents entire families were wiped out in the Holocaust, the story was more bitter than sweet. After all, 1972 was much closer to WWII than it is to the present; it was only 27 years after the end of the war, but it was 39 years ago.

Despite the pain, however, the events that were portrayed, we knew, were in the past, bad memories. 1972 was really still part of the “‘60s”. We believed that this was all behind us and we were in a new world, a new era. “Cabaret” was there to remind us of how bad things had been; most of us did not see it as a warning that it could happen again, to us. I’m not sure that this is still true. I am not sure we will not be seeing it again. I mean Nazism. Not as an accusation made as often by the right against those to their left as vice versa, but for real.

Let’s see. We have very serious, financially well-backed efforts to reverse not only the social changes implemented beginning about the time of “Cabaret” by the New Deal, but of even earlier changes, from the “Progressive Era” at the turn of the 20th century. We have attacks on government and taxation, funded by billionaires but apparently bought into by regular people. (Question: How will they – the regular people, not the billionaires -- hire their own police and build their own roads?)  We have attacks on collective bargaining and the very existence of unions. We have increasingly restrictive laws about who we can be in relationships or have sex with (“gay marriage”), whether we can control our own bodies, whether we can use contraception or have abortions. State, and sometimes the federal, governments, led by those who say are against any kind of government regulation, are dictating how people should carry out the most personal of acts. I guess they are only against regulation of what they want to do; they’re into regulating things they don’t like. We have a tax breaks for billionaires and policies (pro-finance, anti-regulation) that have essentially transferred everyone’s wealth to those billionaires. Since they and their corporations don’t pay taxes, and those who are left no longer have enough money to pay enough taxes, we are getting cuts in essential services. And we are fighting several unfunded wars, we have demagogues demonizing “the other” (currently Muslims), and we are pretty far down the road to a religiously-driven, corporate funded, hypocritically moralistic military state.

OK, fascism. That’s where we’re headed. A state that is geared toward the interests of corporate power, that regulates people’s lives, that is militaristic and intolerant. But surely not Nazism? After all, they are not calling for the extermination of the Jews.


“Cabaret” is not the only musical that may be more literally relevant now than when it first appeared. A few years ago I saw a wonderful production of “Inherit the Wind” on Broadway with Christopher Plummer and Brian Dennehy. When the play was written in 1955, and later (1960) made into a movie starring Spencer Tracy and Frederic March (with several versions since then), it was conceived of by its authors, Jerome Lawrence and Robert Edwin Lee, as a metaphor for the McCarthy era. The actual topic, the Scopes “monkey trial” in which a high school teacher is found guilty of teaching evolution, was not really the topic; after all, that had been nearly 40 years earlier. By the late 1950s no one doubted evolution. It was settled. But it made a great allegory for the close-mindedness and repression of that period.

They thought. But a few years ago, the state school board in Kansas, where I live, branded evolution a “theory” and mandated teaching “alternative theories” – such as creationism. The supporters of that policy were defeated in a later election, but turnout is light in school board elections and they could be back. No one doubts it could happen again. Powerful interests are questioning science; leading politicians attack those who question “American exceptionalism” – that we are different from everyone else, and programs that work in other countries are not for us. Is this different from the righteous xenophobia of the Master Race?

I do not mean to imply that the only or greatest racist threat is to Jews. Clearly, in this country the oppression of African-Americans is built into our very fabric. The great post-911 hostility is to Muslims. Jews are “our friends” (well, Israel is). Jews are powerful in Washington, as the American Israel Political Action Committee. Some Jews are even right-wing leaders. To the extent that they worry about oppression of Jews, they try to isolate anti-Semitism and oppose it, separating it from anti-Muslim hate (as the Israeli government is so good at), from racism.

They are a minority of Jews and they are outside the tradition of a people that has always recognized its own oppression in the oppression of others. Who were the majority of the international volunteers who fought in Spain against Franco and fascism. Who, way out of proportion to their numbers in the population, were active in the civil rights movement in the US and in the anti-apartheid struggle in South Africa. Who are disproportionately represented among scientists and human rights attorneys and advocates for social justice. They are also disproportionately represented among the leaders of the rapacious finance industry that led us to the Great Recession.

What a combination! A small number of people, tiny in comparison to white Christians, Muslims, Hindus, Blacks, Asians. Who have the poor judgment to both be out-front critics of racism and oppression, members and leaders of every progressive movement from unionism to socialism, and to have among them the leaders of the financial class that has wreaked havoc on the world’s economy. What a great target! No wonder Hitler could demonize them!

But it couldn’t happen here. At least we don’t think so now. Like Herr Schultz, the fruit merchant in “Cabaret”, who says “I am Jewish, but I am also German!” as he minimizes the significance of the broken windows in his store, who stays in denial for a long time. A lot of good it did him.

We have to fight all forms of intolerance, of racism, of know-nothingness. All forms of oppression and repression. All forms of “we are better than them” which can lead to “let’s kill them” pretty quickly. The memory of the Holocaust is “never to forgive, never to forget”. And to not forget that Jews can still be victims, and that they will never be safe as long as anyone is a victim. It is never too early to oppose bigotry, hate, and the loss of human rights.

Or we will surely inherit the wind.

Sunday, April 17, 2011

Do resident work hours limits create better physicians?

On a few previous occasions (e.g., Student Debt, Resident Hours, and Primary Care Redux, Jan 2, 2009) I have written about the issue of medical residents’ work hours and the implications that it had, good or bad, for patient care. A recent article in the British Medical Journal (BMJ) by Moonesinghe et al, “Impact of reduction in working hours for doctors in training on postgraduate medical education and patient outcomes: systematic review”, provides the most thorough review to date of studies evaluating the impact of work hours reductions for medical residents in the US and the United Kingdom, where they are even more stringent. They looked at studies examining both “training” (how are the residents learning?) and patient quality and safety.

This was not an easy task; true “meta-analysis” (grouping all the studies together as if they were one and re-analyzing the data) was not possible because they were so different in methodology, issues studied, and quality. In fact, the quality of most of the studies was not terribly high, and they often looked at several different outcomes making it hard to understand whether the changes all went one way, or there were some things that were better and some worse and whether the net result could be stronger (or weaker) if we could focus on only one at a time.

The good news for those who have implemented, supported, and argued for the work hours restrictions is that they seem to have improved the private life of residents, and to have not significantly harmed either the quality of training or patient care, at least insofar as these somewhat contradictory studies seem to indicate. Most of the studies were done in the US, and most were of surgical (28 of 41) or “hospital-based” (e.g., anesthesiology, critical care) trainees, rather than primary care.

Here are some of the results:

Training outcomes:
·    2 papers (both of “low methodological quality”, one of medical residents in the UK and one of surgical residents in the US, which “did not report statistical analyses of the results”) reported an improvement in training outcomes.
·   12 studies found a detrimental association; half from the US (all surgical) and half from the UK.
·    27 studies found no change (20 US and 7 UK)
·    There were also mixed results regarding the quality of “training opportunities” (exam scores, caseload)

Patient outcomes:
·    31 of 34 papers were US
·    4 studies showed improved patient outcomes, including the only randomized controlled trial in the group (note: this was in critical care and coronary care units, where shift work may arguably be more effective)
·    2 studies (in trauma and orthopedics) found increased complications
·    28 studies showed no significant difference

Surgeon and NY Times writer Pauline Chen commented on this article in “Is a well-rested doctor a better doctor?”, April 7, 2011. She describes talking with a surgical resident she knows who is very pleased at how much better her life is than she had feared. “’Training has changed a lot…My life is different than yours was — I have a lot of time outside the hospital.’ She described how she loved her work but was able to sleep at home most nights, go out regularly with friends, stay involved with her church and take an improv class.”  Cool. It is good to know that surgical residents are not acting as slaves, and can have some kind of life outside the hospital.

However, her resident friend was less sure about learning and patient care: “’To be honest, I don’t really know if this is better or worse,’ she said, recounting how she felt she was signing over responsibility for her patients more often than she ever imagined she would, missing key events in their hospital course and even getting dismissed during the middle of a patient’s operation in order to stay within the limits on work hours. ‘Sometimes it seems so counterintuitive to just sign out as if we were shift workers, but this is all any of us know right now…We have nothing to compare it to.’”

So, probably, as Dr. Chen observes, the discussion will go on. Those who believe that working longer hours results in tired physicians and therefore bad patient outcomes will continue to push those ideas; those who (largely, it seems, surgeons) believe that artificial limits on work hours compromise resident learning, thus not only having a negative impact on their current care of patients but, more importantly, their care of patients in the future care because they haven’t had sufficient experience in their residencies. One “side” says “Do you want to be operated on by a surgeon who has been up all night?”, while the other says “Do you want to be operated by a surgeon who is not as skilled because they were coddled in their training and didn’t get sufficient experience?”

“The most important test of success of postgraduate training,” say Moonesinghe and colleagues, “is the professional performance of those who reach the end of it.” They go on to make several suggestions, including, most importantly I believe, that “a consensus should be reached by the medical profession on appropriate measures to assess the quality of postgraduate medical training.” They agree with the assertion (from Temple, et al, “Time for training. A review of the impact of the European Working Time Directive on training 2010”) that “training is patient safety for the next 30 years”. Wise regulation must understand the balance, the risk-benefit of any change, and try to reach the greatest benefit with the least risk.

I would like to comment a bit upon the issues as they relate, in particular, to primary care training. Most of the studies that have been done have been on surgical specialties, which can measure surgical complications, deaths or morbidity, or in anesthesiology or critical care, because these are hospital based and more amenable to shift work. While a very few of the studies were in pediatrics, they also examined hospital work; none were looking at the training of primary care or family doctors. One of the other reasons that the surgical specialties have been so studied is that they have long been those with the longest work hours; thus, they are both the greatest target of reformers and the greatest resistance by current surgeons and teachers who fear that work hours restrictions will jeopardize the skill of their future colleagues.

The irony is that, as in so many areas, when laws or rules are being violated by one group, they are tightened on everyone, and those who were not violators of the old rules find their greater restrictions to comply with while, often, those who were violating it before continue to. In the 1970s when I was in training at Cook County Hospital, we had a resident union (yes!) and were limited to every-4th-day overnight call. But the surgeons were on more often. If family medicine or internal medicine or pediatrics violated the rule, they were penalized, but the surgery residents were afraid to complain. And so, today, the violations of hours rules in some specialties increases the restrictions for all.

The problem with applying these rigid rules to primary care is that it is not shift-based. While residents spend time on inpatient services, the core of family medicine training is the continuity clinic where those doctors-in-training follow their own patients. It is important to be able to do this, to show up for your office hours to see your patients who are expecting to see you, even if you were up much of the night delivering the baby of one of your patients. If that happened every day, it would be a big problem, but it doesn’t. Yet there is a “zero tolerance” for work hour violations by the Accreditation Council for Graduate Medical Education (ACGME), so the program would be cited. Rigid cut-offs, indiscriminately applied, are a bad idea.

Residents should have work hour restrictions; they shouldn’t be on call every third night and up all night. They should get days off, should get time to spend with friends and family or sleeping. But the restrictions need to regulate hours in a more global fashion: hours in a week, days off in a week, average or typical number of hours off between shifts. They should not be counting minutes (and they currently do!), not create automatic violations for each instance in which, say, a resident returns to clinic after only 9 ½  instead of 10 hours off. They also should be specialty-specific, examining the character of the specialty’s practice, not to allow exploitation but to make them appropriate to how the specialty is practiced.

Some fields, like ER and critical care, work well with shifts. Some, like most hospital work that characterizes internal medicine and pediatrics training, generally work pretty well with “night floats” and days off, as long as there is careful attention paid to information transfer at the shift changes (“hand-offs”). Surgery may require longer shifts with more days off. And family medicine needs to allow residents to occasionally deliver their babies at night without canceling all the patients on their schedule the next day, as long as it is not the everyday norm.

We can do this rationally. We can have training that both provides time for the non-work lives of residents and good training for their careers; that ensures quality care of their patients now and in the future.

Friday, April 15, 2011

Disincentives to rural practice: from "Training Family Doctors" blog

Excellent post about the market disincentives to providing rural health care by Allen Perkins on his blog "Training Family Doctors".
Dr. Perkins goes on to quote from President Obama, who quotes Abraham Lincoln, about the need to care for others; this is a core principle of social justice, and one that I have addressed explicitly in the past both from a principled point of view (Does the nation need a clear policy on a right to basic health care?, April 10, 2009) and from one of enlightened self interest (Red, Blue, and Purple: The Math of Health Care Spending, Oct 20, 2009).

The market, well-regulated, can serve many purposes and be of value, but it cannot, by its nature, be relied upon to serve social justice needs.

Saturday, April 9, 2011

Conflict of interest 2: Clinical practice guidelines and Deans

My last blog post was about conflict of interest (COI) in medicine; there has been some recent literature on the subject, so I am providing a second posting on the topic.

In “Conflicts of interest in cardiovascular clinical practice guidelines[1], in the March 28, 2011 issue of Archives of Internal Medicine, Mendelson and colleagues reviewed the 17 most recent guidelines regarding the diagnosis and management of heart disease promulgated by the American College of Cardiology (ACC) and the American Heart Association (AHA), the most important issuers of such guidelines. These clinical practice guidelines (CPGs) are important, as not only do physicians use them as authoritative sources to inform their patient care, but increasingly payers – and courts -- are looking at whether they were followed to determine payment and bonuses, or culpability in malpractice cases. While thorough review of the published (and unpublished) evidence is required (indeed is a sine qua non) in the issuance of guidelines, these panels of experts are convened to allow their collective experience and knowledge fill the gaps where there is no evidence. The authors point to the 2009 Institute of Medicine (IOM, a group of distinguished physicians and medical scientists convened by the National Academies, which are private citizens gathered with federal support to advise on science and technology) report from its Committee on conflict of interest in medical research, education and practice, which states that there is insufficient study of COIs in guideline reporting, as the fact that both ACC and AHA have “recently placed restrictions on official participation in educational events and guidelines production”.

Using the concept of an “episode” to mean that 1 person participated 1 time in production of 1 guideline, there were a total of 651 episodes by 498 people in the production of the 17 guidelines. Overall, 56% of individuals (277) had some COI, and (coincidentally) a COI was present in 56% (365) of the total episodes, with a range among the 17 guidelines of 13% (2 of 15) to 87% (13 of 15). Interestingly, actual members of the guideline committees, as opposed to those who just reviewed the guidelines (“peer reviewers”) were more likely (63%, a level reaching statistical significance for those who care, p=.006) to have COIs, as were the chairs of the committees (or first authors) compared to committee members, 81% (p=.03). Only 6 of the 17 guideline committees reported whether the COIs were “modest” or “significant”; the authors found that of those 54% were modest and 29% significant. Perhaps more important, according to the authors, was that it was only a few companies, presumably those with the greatest economic stake in the outcomes, who were involved in most of the COIs. They also note that this is “a particular cause for concern given the fact that many of the newest ACC/AHA guideline recommendations are based more on expert opinion than on clinical trial data”.

Dr. Steven Nissen, commenting on the article in the same issue (“Can we trust cardiovascular practice guidelines?”[2]), calls the “depth and breadth of industry relationships reported in this article…extraordinary,” in that they go beyond scientific collaboration to include significant stock ownership and serving as promotional speakers, and states that “no conceivable logic can defend [this] practice.” He continues “Such relationships are so antithetical to the academic mission that many medical schools have now forbid such relationships for their faculty. To allow such individuals to write CPGs defies logic.” I imagine his use of the word “extraordinary” is in the sense of “amazing”; since this is the first such study, we do not know if such COIs are indeed “extraordinary” in the sense of “well out of the ordinary”, or if they are, indeed, quite typical. Indeed, Mendelson et al cite a 2002 study by Choudry et al[3] in which the found that of the 52% of the authors of 100 CPGs for a variety of adult diseases who responded to their survey, 87% had “some type of relationship with the pharmaceutical industry” (and we would not imagine that the 48% who didn’t respond had fewer!) Dr. Nissen, who is from the Cleveland Clinic, reveals his own potential COIs, including research support from a number of companies and honoraria for speaking which he has turned directly over to charity. As covered in the New York Times (Duff Wilson, “Study finds conflict among panels’ doctors”, March 28, 2011), Dr. Nissen calls for “banning most of these conflicts rather than just disclosing them”.

But sometimes COIs are not even disclosed. The same issues of Archives of Internal Medicine contains a “research letter” titled “Failure by deans of academic medical centers to disclose outside income[4]. The authors, Freshwater and Freshwater, looked at holdings of deans of allopathic and osteopathic medical schools on the Morningstar directory of US corporate directors and executives, and EDGAR, the Securities and Exchange Commission database. They found that while there were only a few deans who served as directors of public companies involved in health care (9 of 161, with one serving as a director of 2 companies and one of 4), this information was not always disclosed on the schools’ websites, nor was the compensation received. This compensation for each directorship ranged from $11,250 to $386,439 with a mean of $217,454, with one dean who served on multiple companies receiving $640,038. “One dean’s official Web page disclosed the 2 directorships, but it did not disclose the compensation. Two medical schools’ Web sites disclosed 3 directorships, with one dean holding 1 and the other 2 directorships; however the Web sites underreported the deans’ compensation by 39%, 56%, and 80% compared with the compensation calculated from the companies’ EDGAR forms.” These deans are the same people who are expected to enforce the rules against COIs that Nissen refers to above. In a commentary[5], Lo (who was the chair of the 2009 IOM committee) et al, say that disclosure is not enough, and that “Some relationships need to be managed or even prohibited”. They do not go so far as to suggest that all should be banned, although I would note that 152 of 161 deans seem to do OK without serving as corporate directors.

So should all such conflicts, whether deans serving on boards of directors, guideline authors having financial relationships such as major stock holdings or speakers’ fees, or receiving grants from corporations, be disclosed or prohibited? I think that there is clear consensus that disclosure is the de minimis requirement. As I have noted before, without disclosure there is no way for the consumer of information in a research study to decide if their might be bias; this is at least as important for are those writing CPGs or presiding over our academic medical centers. But, as Nissen states explicitly and Lo hints at, disclosure is not sufficient. To extend the metaphor of the judge referred to by Howard Brody in his article Professional Medical Organizations and Commercial Conflicts of Interest: Ethical Issues and cited by me in The AAFP, Coca-Cola, and Ethics: Serving the public interest? August 20, 2010, knowing that a judge in a case you are party to owns large amounts of stock in the company you are suing is not sufficient to make you feel alright about her presiding in the case.

Mendelson et al note that “It has also been argued that relationships with industry may also bring a breadth of perspective and experience, especially if individuals have relationships with multiple different companies. Theoretically, these individuals may be less conflicted than those with fewer industry affiliations…”. Right. Taking graft from many sources makes you less beholden to any one of them. Unfortunately, if you buy this argument, then their study should disappoint you, as only a much smaller percentage of the CPG authors had more than one COI.

Come on. Prominent scholars take money from industry for the same reason that others do. They like the money. Perhaps they are eminent enough that their heads are so swelled that they can believe both that they are being paid solely for their wisdom, and not for any bias they might bring to the deliberations of academic groups like those writing CPGs or in the administration of medical schools, and that, in any case, they are so distinguished that there is no way they would demonstrate such bias. If so, they are deluded. No one else believes it, most especially the companies giving them money. These COIs need to be completely banned if we are to be able to trust their academic integrity and intellectual honesty.

[1] Mendelson TB, et al, “Conflicts of interest in cardiovascular clinical practice guidelines”, Arch Int Med 28Mar2011;171(6):577-85. (only abstract available on line without subscription).

[2] Nissen SE, “Can we trust cardiovascular practice guidelines?” Arch Int Med 28Mar2011;171(6):584-5.

[3] Choudhry NK et al, “Relationships between authors of clinical practice guidelines and the pharmaceutical industry”, JAMA 2002;287(5):612-17.

[4] Freshwater DM and Freshwater MF, “Failure by deans of academic medical centers to disclose outside income”, Arch Int Med 28Mar2011;1717(6):586-7.

[5] Lo B, Kelch RP, Grady D, “Illuminating physicians’ financial relationship with industry”, Arch Int Med 28Mar2011;1717(6): 587-8.

Friday, April 1, 2011

Conflict of interest reporting

looks like using Google Chrome instead of IE8 solves the problem. Hmm.

This is the first of a two-part series on conflict of interest, medical ethics, and whether we can trust recommendations.

In several posts last year (Harvard Medical School limits outside income: a good start January 10, 2010, Statins and scientific integrity July 6,2010 and especially The AAFP, Coca-Cola, and Ethics: Serving the public interest? August 20, 2010), I discussed the question of conflict of interest, citing the work of ethicists such as Howard Brody, along with common sense, to demonstrate that a “conflict of interest” is simply that; a conflict between one set of a person or organization’s interests and another. In the case of the American Academy of Family Physicians (AAFP) and its relationship with the Coca-Cola Company or that between the American Dietetic Association (ADA) and Hershey’s Chocolate, the conflict is between what is in the best interests of the health of the patients that the AAFP’s member physicians or ADA’s member dieticians serve and what is in the best interests of Coke or Hershey (making money). The latter is only important to the professional organization because those companies share some of the money they make with them. In defending themselves against what appears to many people, both within and outside the organizations, to be corruption, the leaders who made these deals (such as then AAFP-President Lori Heim, MD) make the argument that only by looking at whether the information presented on the AAFP’s website (for which Coke provided support) is biased (presumably toward Coke) can the presence of a conflict be determined.

This is patently absurd; the conflict is there, and along with it the suspicion that information may be skewed. This is particularly true when dealing with a site such as, on which the information is intended for the general public, not for professionals. Its value depends entirely upon the trust of the members of the public who use it, and such conflicts of interest undermine that trust. “How can I trust information provided on a medical site with ads from a company that my doctor says makes stuff that is bad for me – heck, that everyone knows is bad for them?” is a reasonable question, a reasonable suspicion, and a legitimate reason for concern by the public. “Hey, take our word for it; taking Coke’s money (or Hershey’s, in the case of the ADA) didn’t influence the content of the information on our website,” is a pretty weak defense, not one that is likely to engender trust of the organization or, of greater concern, of its member professionals.

The issue of conflict of interest has been a significant focus in the medical literature. Most major journals now require the authors of original research studies, particularly those that evaluate the effectiveness of drugs, to indicate if they have conflicts of interest; that is to say, financial connections with the manufacturer of the drug (or any other drug manufacturer or potential conflict of interest). This is in addition to identifying the source of funding for the study – mainly whether it was funded by a drug (or device) manufacturer as opposed to funded by the federal government (through NIH or another agency) or, much less common for such studies, a not-for-profit foundation. Again, the reason is obvious: if the author has a conflict of interest (gets money for speaking for a drug company, say, that manufactures the drug being examined, we all have reason to be more guarded in our interpretation of the results, or at least the confidence that we have that the study was done completely without bias. One problem is that bias can creep in unconsciously, even if there is not intentional fraud. Another problem is selective publication: we may only see the papers that report on studies where the drug had a positive benefit, because negative studies are suppressed; this is further complicated by the general preference of journals for positive results, regardless of who is funding the research. If the authors do not disclose their conflicts of interest, we have no way of knowing about them, and may not be sufficiently skeptical in interpreting the findings.

Am I saying we need to be skeptical? Is it not possible to be paid for speaking by a drug company and still do unbiased scientific research on their drugs? Is it not possible even when the drug company is funding the research? Of course it is possible, but unfortunately the data show that it is less likely. In the Introduction to their recent article in JAMA, Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments[1], Michelle Roseman and colleagues note that “Results from positive trials and from favorable analyses are more likely to be published than results unfavorable to sponsors. Compared with nonindustry-funded trials, pharmaceutical industry–funded studies more often yield results or conclusions in support of the sponsor's drug, and authors' relationships with drug manufacturers have been linked to favorable assessments of drug efficacy and safety,” with numerous references for each of these assertions. The actual focus of their study is to look at meta-analyses to see whether they report conflicts of interest (COIs) in the original studies that they are analyzing. Meta-analyses can be the most potent source of information about a question, as they analyze the results of many studies (ideally, all randomized controlled trials) on a particular topic, and if well done can help to resolve the question of conflicting results from different studies. Of course, if the studies that are included are in themselves biased (either intentionally or not) it will of course impact the results of the meta-analysis. Roseman and her colleagues found that, while the authors of the meta-analyses reveal their own conflicts of interest (if any), consistent with the policies of the journals they publish in, they rarely indicate whether the many studies that they are re-analyzing had such conflicts.

This can be important. For example, if the different studies examined by the meta-analysis tend to show differences in the benefit of a drug treatment, it would be good to know if the ones that showed greater benefit were sponsored by a drug company, or if the authors were on that drug company’s speaker’s bureau. It just might make a difference. Wealth makes a difference because it can buy loyalty, buy favors. The old saw “It is as easy to love a rich man as a poor one” can be modified to “it is as easy to use a product made by someone who pays you as by someone who doesn’t”. Or even “it is as easy to believe an idea supported by the rich and the powerful as one supported by only the poor and disenfranchised”. The problem is that the connections are not random – the ideas of the rich and powerful are too frequently self-serving, and “just so happen” to favor them over the poor and disenfranchised. An excellent example, featuring Ayn Rand and her disciple Alan Greenspan, is provided to us by Matt Taibbi in chapter 2 of his book “Griftopia”[2].

Then it isn’t as easy. Then it is corrupt. Then it is immoral. Then it is selling your soul.

[2} Taibbi M. “Griftopia: Bubble machines, vampire squids and the long con that is breaking America“. Speigel and Grau. New York. 2010. Ch. 2, “The biggest asshole in the universe

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