Health Expenditures vs. Life Expectancy

(See link for larger version.)

The graph is a ranking of industrialized countries by per-capita healthcare expenditures. The average figure is $2,986/year; Finland and Spain come in a little below that, and Australia and Sweden are a little above. Canada spends about $1,000 more per person per year than the major-nations average; free-wheeling Switzerland is about $1,400 above average.

See that lone, single red figure wa-a-a-a-a-y up in the left-hand corner? That’s the US. Our per-capita healthcare expenditures, at $7,290/year (!), are more than 240% of the average of all those nations together (actually, more than 260% of the average of all those nations other than the US, which comes to only $2,771/year if you leave the US out of it). And note that those expenditures, in the US, are for only 85% or less of the population; for every other country on the graph except Mexico, that figure covers every permanent resident of the country without exception.

Now look on the right-hand column: the same nations are ranked by average life expectancy. This is a crude, but still useful, indicator of what we’re getting for our healthcare costs. (Crude, because simple measures like sanitation and nutrition can contribute a great deal more to life expectancy than high-tech medical care. But the whole point is that better medical care produces longer and better lives, at the margin at least, and there is good evidence that this is true. So this is not a bad way to scale things out for quick and easy comprehension.) Implicitly, this graph establishes a relationship: assuming all things are equal, average healthcare expenditures should produce average life expectancies (which you could quantify as a numerical ratio, though that would be taking the thing rather too literally). In fact, that is almost exactly what the UK achieves ($2,992/year for about 79.1 years lifespan). About two-thirds of the countries on the list do better than that: their life expectancies, relative to average, are greater than would be expected given their healthcare costs relative to average. (This is indicated by the lines sloping up to the right on the graph. The slopes are not precisely indicative, because the right-side scale range does not match the left-side scale – the ranges should have been correllated better. But a positive or negative slope indicates an above- or below-average ratio, respectively.) A relatively small number of countries do worse.

Whether above or below average, the deviations tend to fall into a small range – note that most of the lines up, and down, are roughly parallel. All except one, of course: the US, as usual, is completely alone in its breathtakingly negative ratio of cost to life-expectancy benefit. That screaming red line plunging down the graph from off-the-charts high expenses to below-average benefits has no peer among any industrialized country: nowhere in the world does any country get such an incredibly below-average relative return for its healthcare expenses (and in fact below average in absolute terms compared to all other countries). The US, with per-capita healthcare expenses 260% highher than its peers, actually averages a total life expectancy almost 1.5% lower. (Only one other country, Denmark, manages to achieve above-average expenditures and below-average life expectancy; their expenditures are still less than half ours and their life expectancy is higher).

Note finally the width of the lines, which indicates average number of doctors’ visits provided per year by each country: the fat lines are 12 or more; the medium lines are 4 to 8; the US comes in at an average number of visits per year per person that rounds off most closely to . . . zero. (Note also that of the 4 countries that average effectively 0 visits per year, two of them are the only two on the graph that do not provide universal coverage.) Not only does every other country on this list except Mexico manage to provide universal healthcare coverage at vastly lower expense than the US, not only do 2/3 of them achieve greater life expectancies than the US, not only do 2/3 of them achieve an above-average ratio between relative expenditure and relative life expectancy, but over 80% of them provide an average of at least 4, and in some cases 12 or more, covered visits per person per year for their entire populations.

Note in passing, too, that the only other nation that can’t afford to provide universal health coverage is Mexico, which spends less than 30% of the average among these nations on healthcare and is still getting a vastly greater bang for its its bucks than is the US.

The utter, abject failure of the US’s profit-sucking healthcare morass is made as stark here as it has ever been. Basically, we’re spending over $4,300 per year for every covered person for nothing whatsoever, and giving up over a year of average life expectancy as our reward – while leaving tens of millions of people with no coverage whatsoever for most or all of their needs! It would be almost impossible to have a healthcare system worse than this, other than one with even less protections for patients than the US already has.

As Ezra Klein notes:

consider this: If we spent what Canada spends per person, our deficit problem would go away entirely. And Canada’s per-person average is in a country where everybody is fully covered and so has full access to care. America’s is in a country with 47 million uninsured, and so many people skimp on needed care. So the comparison is actually unfair to Canada. . . .

This is serious pitchforks-and-torches stuff, if only people really understood it. I continue to believe, however, that the improbable size of the disparity is a barrier to understanding. People just don’t believe these numbers. America may not be the best, but we’re not supposed to be the worst by such a large margin.

Oh, yes, we are. The system is designed to suck money out and deny care. It’s working perfectly. But why do we have a system designed to do that?

UPDATE:

There are some problems with the above graph, which I somewhat glossed over in the original post. DanM alludes to them in his comment below. It’s just as well to clarify some of these points.

First, the graph is somewhat misleading because it seems to position life expectancy as a direct function of healthcare spending: a certain amount of money buys you a certain number of years of life, and the slope of the line from one axis to the other describes the mathematical relationship between them. That is the inevitable broad-brush interpretation of the data, that is true (the whole point is that there is a link between the two factors, otherwise there’d be no point graphing them – and indeed the relation is clearly non-random as even a casual inspection of the graph shows) – but the line-graph format makes it much too literal.

Second, the scales of the axes are distorted. There is most obviously the fact that neither the expenditures axis, on the left, nor the lifespan axis, on the right, start at zero. The actual spread between high and low values on both axes is thus exaggerated, especially for lifespan. Also, the data ranges shown for each bear a very different relationship to the total range for data of each type: the top and bottom entries for healthcare expenditures span about 90% of the value of the top end of the scale, or about 80% if you exclude the US; the top and bottom entries for life expectancy span only about 12% of that range. If the two axes were scaled similarly, the right-hand values would all cluster into a tight knot and the blue lines would converge from high and low on the left into that small range, diminishing the impression of a clear correlation between the two values which is created by spreading the lifespan values out so much.

In addition, setting the average values of the two scales at the same vertical level is an arbitrary decision that reinforces the implicit message that the two are correlated. (A ratio between healthcare spending and lifespan that matches the dollars/years ratio of those average values will be a horizontal line at any level on the graph – thus those countries doing better on a dollars/years basis will have lines that slope up, and others will have lines that slope down.) Again, this is not unreasonable as a way of displaying this data, but it requires as an organizing assumption that the implicit correlation illustrated by the graph is in fact true – which puts the cart before the horse.

Finally, as Dan notes, there are other factors influencing lifespan, and implying that it is a direct function of healthcare expenditure, as this graph seems to do, is much too crude.

Nate Silver, brilliant statistical interpreter at “538“, recasts the same data in this fashion (click graph for larger version):

Healthcare Expenditure vs. Life Expectancy Scatterplot

This graph is much fairer in certain ways. By removing the horizontal lines, it removes the visual implication of a direct mathematical function linking the two data sets. By graphing the data as a scatterplot on two orthogonal axes, it allows the viewer to draw their own conclusions without dictating a relationship in the design of the graph. Silver also takes the obvious steps of scaling the axes fairly and accurately, starting a zero for each.

However, this graph also supports the basic point made in the original version: there is an obvious trendline through the data set, and the US is an extreme outlier that falls insanely far below that trend. (To see how far, hold a ruler against your screen, paralleling the slope roughly marked out from the origin through the data cluster running up to the right – about where Canada falls out. Continue that line up to the right until it is directly above the red “USA” below. It should run off the graph up to somewhere in the third paragraph above the graph. That’s where the US should be, given what we spend (on only a fraction of our population). If you want it in numerical terms (and again taking the implied correlation rather too literally), US citizens who actually have access to healthcare should live more than 193 years, on average, if we were spending that money as effectively as most other countries do. From the reverse perspective, given the below-average life expectancy we get for our healthcare dollars, we could spend at least $4,000 per person per year less than we do  and still achieve our current quality outcome, if we were merely as efficient in our expenditures as, say, Denmark. That $4,000 – more than the average amount other industrialized nations spend per person in total – is the amount we are throwing away on our for-profit healthcare system, for no benefit whatsoever to ourselves.

It must be acknowledged that that correlation has not been subjected to statistical analysis, but the basic point is that the original graph, though its designers made some questionable choices, was not as bad as all that.

Hat Tip: to Andrew Gelman at Columbia, who did the original re-analysis from which Silver took his own version.

Happy Fetus

Feto Incognito

Adam Lambert Embryo

The purveyor of the site insists that “Feti is just for fun, no political statements being made here.” I’m tempted to believe that in her case, but the thing still strikes me as weird,  and indicative of a mindset that is worth noting.

The vendor suggests these are intended as gifts for expectant parents, as appropriate additions to the “Baby’s First _____” category of remembrances. (Exactly how, I’m not sure: “Baby’s First Disembodied Hanging on a Christmas Tree”?) In that vein, they play off the very common and understandable practice of many expectant parents in personifying their fetus as it develops – talking to it, playing music, naming it before it is born, and so on. They also seem to accept as a cultural commonplace the fetishizing – literally, in this case! – and personifying of the fetus that is a mainstay of anti-choice propaganda. (Anti-choicers often wear gold-plated fetal-footprint jewelry, and they are forever trying to force abortion patients to look at pictures or sonograms of the fetus.)

I don’t know if the anti-choice movement has so far succeeded in turning the fetus into a fetish object that you can now literally market them to the general public as holiday ornaments, or if the common desire to see fetuses as sort of reverse-extensions of babies simply makes this a natural marketing move, like Cabbage Patch dolls or those weird Anne Geddes photographs of babies in flower petals, and the right wing has merely piggybacked off that common emotional trope for their own purposes. The former would scare me a bit, the latter is merely infuriating. Either way, this sort of thing leaves me with a creepy feeling.

I’m happy for people to be happy about their pregnancies, and to embue their future offspring with emotional valence or even a somewhat overgrandiose sense of promise or accomplishment. In the same way that all parents think their kids are smart and talented, and I wouldn’t quarrel with that, expectant parents can and should go ga-ga over the cute little buns in their respective ovens. There is no point, in the case of people’s emotional experience of the events in their lives, to go around insisting to them “you know it has no functional higher nervous system, right?” . . . “that’s not a ‘person’ you’re carrying, in any meaningful sense of the term – just wanted to let you know” . . . “don’t get too close to it – there’s about a 1-in-12 chance you’ll lose the pregnancy”. But when it comes to law and policy-making, clear distinctions do have to be made – and at that point, the conflict between stark reality and parents’ expectations may be uncomfortable.

Regardless of parental beliefs, not all kids are smart or talented, and thus some won’t make it into selective academic or sports or art programs. And regardless of the fervent, desperately dishonest myth-making of the anti-choice right, the early fetus is not a person and does not make moral claims on a woman’s body and life sufficient to override her autonomy. It is unfortunate to have to disappoint people emotionally invested in believing otherwise, but it is far worse to make policy based on wishful thinking in defiance of the truth.

By all means, have yourself a merry little Christmas, and hang a smiling Adam Lambert Jewish punk fetus upon the highest bough. But let’s keep the “personified fetus” myth firmly in its place when we go to making important decisions about real issues in real people’s lives.

It is.

Thanks, Penn.

(See here for a similar observation from an equally-surpising source.)

Predictably, Michael Steele, the hapless RNC head, announced less than 24 hours after the story broke that that coverage provision had been rescinded unilaterally. The usual right-wing hysteria has erupted, with demands that people be fired and angry denunciations that donors to the RNC had not been allowed to deny healthcare to its female employees as they wanted to do. As Ben Smith rightly points out, not one female employee of the RNC – the ones whose coverage has now been stripped without their consultation (and presumably without any reduction in their premium contributions) – has been quoted or consulted in this move.

I note also that pro-choice ideology within the Republican party has run at about a steady 35-38% for most of a decade (a recent poll shows it down somewhat among Republicans, but is widely regarded as an outlier). I presume the large majority of those are women. Assuming further that women are half the GOP membership, that would mean that roughly two-thirds of GOP women are pro-choice (I suspect they’re actually less than half the membership, which would push the prevalence of pro-choice ideology even higher within that smaller female group). Now, I don’t know if the RNC employee base is representative of the Republican Party generally, but if it is, that would mean that about a third of its staff, and about two-thirds of all its female staff, are in favor of abortion rights. There are other factors to be considered, for which we don’t have data (what percentage favor having abortion covered in their health plan, as opposed to its just being legal; to what degree the RNC staff skew even crazier on abortion than the rank and file; what percentage of the staff are female; and so on), but any way you slice it it seems inevitable that there is at least some considerable degree of support for abortion services among the RNC’s staff, to say nothing of the GOP generally. Yet the RNC leadership revoked their own staff’s coverage without consultation, and without the slightest apparent consideration for that staff’s wishes, needs, or rights.

The message is clear enough, and, I suppose, fair and consistent in that peculiar GOP way: for Republicans, hurting women is more important than anything else – certainly more important than providing real healthcare for an entire nation, but more important also than seeing to the needs of their own membership. The Republican National Committee – a body that exists solely to cater to the interests and welfare of registered Republicans – stripped healthcare services that had been available for almost 20 years away from Republican women employed in the service of that body and their party, without the slightest hesitation or apparently without even talking to them.  Within the highest levels of the Republican Party itself, your lack of status as a woman trumps your preferential status as a Republican.

Michael Steele could have just made it much more simple and direct:

In other words: the current disaster of a system is the one that provides the greatest possible profit potential to the insurance industry; any effort at increasing access to care is against that industry’s interests, and a robust and successful reform effort is the worst possible thing from an industry whose profits are entirely dependent on charging the highest possible premiums and delivering the least possible care.

The Senate Finance Committee bill, which Goldman’s analysts conclude is the version most likely to survive the legislative process, is described as the “base” scenario. Under that legislation (which did not include a public plan) the earnings per share for the top five insurers would grow an estimated five percent from 2010 through 2019. And yet, the “variance with current valuation” — essentially, what the value of the stock is on the market — is projected to drop four percent.

Things are much worse, Goldman estimates, for legislation that resembles what was considered and (to a certain extent) passed by the House of Representatives. This is, the firm deems, the “bear case” scenario — in which earnings per share for the top five insurers would decline an estimated one percent from 2010 through 2019 and the variance with current valuation is projected to be negative 36 percent.

What the firm sees as the best path forward for the private insurance industry’s bottom line is, to be blunt, inaction.

The study’s authors advise that if no reform is passed, earnings per share would grow an estimated ten percent from 2010 through 2019, and the value of the stock would rise an estimated 59 percent during that time period.

The next best thing for the insurance industry would be if the legislation passed by the Senate Finance Committee is watered down significantly.

Coincidentally, no doubt, the report arrives from Goldman Sachs – recipient of uncountable billions in public bailout dollars for their executives’ bonuses, from the Obama administration – just as the healthcare access reform plan being pursued right now by that same administration is nearing its final legislative conflict. Goldman helpfully notes in a disclaimer that the firm “does and seeks to do business with companies covered in its research reports.”

All you have to do to see how utterly repulsive the healthcare insurance industry is is to simply watch how they talk about their own business. It is impossible to be disgusted enough by an industry that – uniquely in the industrialized world – treats people’s bodies, health, and lives as saleable commodities in a free market in misery.

The real question is whether those who are so agitated about real or imagined terrorism of other kinds (especially by Muslims), and who have been so complacently accepting of anti-woman terrorism in the US for decades, will condemn or even acknowledge an open statement of Christian religious-terrorist ideology in the case of yet another anti-choice fanatic.

Just this week we’ve seen a terrible mass murder committed by a Muslim military officer who was apparently distraught over the war in Afghanistan and his possible deployment. Literally before the bodies were cool, various right-wingers jumped in to denounce “Muslim terrorism” and to cite vague links between the suspect and Al Qaeda (he visited a mosque which was also visited by someone who knew someone who was connected with Al Qaeda); however, it is not clear that the apparent perpetrator’s motives were intended for a political end at all – as opposed to merely an outburst of personal anxiety – and there is little to suggest that it was terrorism in any reasonable sense. The murders of doctors by anti-choicers, beyond any question, are defined by the features of terrorism found in most of the commonly-used definitions: they are acts of violence committed against civilians for the purpose of inciting fear in other, third-party individuals, to promote a particular political end. We heard nothing of this at the time of Dr. Tiller’s death (nor of any of the previous murders and other acts of violence); will we hear it acknowledged now that the terrorist has so openly proclaimed his murderous religious ideology?

Anti-choice terrorism is intended to prevent women from exercising a legal and moral right involving their bodily health and autonomy, by terrorizing those women and their healthcare providers – it is violence intended not merely against its chosen (often random) targets, but to terrorize and thus paralyze a larger group, to further the religious and political ideology of the perpetrators and their vast army of supporters and admirers within the religious right. Yet it has never been acknowledged as such, and the large subculture on the right wing who have made a profession of terrorism scare-mongering have never acknowledged the persistent anti-choice terrorism ongoing in the US. (Nor has the FBI: fake anthrax attacks had been staged on almost 700 abortion clinics in the US in the days before 9/11 – not one of them resulted in an arrest, or any obvious urgency about the issue, and they were not treated as domestic terrorism. One person was charged with terrorism for fake anthrax attacks on clinics in the wake of 9/11 and the Congress anthrax mail attacks – the first and only such charge in the entire history of anti-choice terrorism. None of the anti-choice murderers, including Roeder, have been charged as terrorists.)

Now we have an admitted terrorist openly advocating further political killings to promote his religious obsessions. If Roeder were a Muslim and his targets were not women and their healthcare providers, the shrieking loons of the right would be off their heads screaming about his crime, his religious beliefs, his unrepentant stance, his advocacy and rationalization of violence, and his links to other extremists with similar religious and political beliefs. Will we see even the slightest acknowledgment of Christian anti-choice religious terrorism and its dangers in this blatant case?

The bill on offer is far from optimal. It locks in the profiteering on death and misery that the vast majority of the country is burdened with, and is needlessly complicated and limited in what it offers to the rest. It deliberately cripples its own modest offering by restricting it only to those whom the profiteers have absolutely refused to serve at any price, prohibiting the rest of the country from accessing healthcare organized on any saner and more humane basis. But worst of all, the bill is being held hostage by the insane and vicious anti-choice army that infests the right wing and has wholly captured the Republican party. And, too predictably, the omnipresent contingent of grandstanding asshole Democrats is giving them exactly what they want, as they always do.

Right now, the “Stupak amendment” is being debated: an amendment that will prohibit any person enrolling in the government-backed “healthcare exchange” – which is to say, the poorest and most desperate, who are the only ones eligibel to enroll in that plan – from being offered a full range of healthcare services in cases of unwanted pregnancy. For those people, the “public options” will be forced pregnancy, death in childbirth, or an abortion that she likely can’t afford and the right-wing terrorists have likely made unavailable anyway. The Republican House caucus has already stated explicitly that they will refuse to vote for the healthcare bill in any form. But they – with their unconscionable Democratic allies – are holding up the bill to demand the anti-choice amendment in a bill they will not support even if they get it. And enough Democrats are equally indifferent to women’s lives and women’s needs to help them do it.

Democratic women are putting up a good fight – and their male allies deserve thanks, too. The Republicans have shrunk from merely legislative misogyny to outright thuggery, as they so commonly do. Michele Bachman led crowds of right wingers through the Congressional office buildings earlier today, invading offices and screaming at people to, in her words, “scare” them away from supporting women and healthcare for all. House Republicans staged an organized disruption on the floor today, systematically interrupting Democratic women as they spoke in favor of women’s interests and full healthcare coverage. The healthcare debate is being conducted the same way the Florida recount was in 2000: in the face of Republican assaults and intimidation, and without regard for the truth or significance of the actual substantive issue.

I have little to say about the whole thing. I feel helpless – particularly frustrating in the face of an issue so central to my personal and professional concerns – and am waiting as on election night for the outcome of votes that will – with great good luck – mean so much to so many, and move American one huge step closer to the decency and commitment to humanity that has been so sadly lacking in so much of our history. I can only wait and hope, like everyone else. In the meantime, there is an organized, vicious, and relentless minority that is fiercely dedicated to their own hostility to any notion of a decent regard for others, and to the freedom of others to live their own lives unconstrained by that minority’s backward and reactionary values. They are fighting – in the most literal sense – right now to keep tens of millions of people at the mercy of any illness they may suffer, to keep hundreds of millions at the mercy of an insurance system that rivals only those reactionaries themselves in its hostility to the needs of the people they nominally serve, and to keep every woman in America at the mercy of the nasty and bitter men who despise them and their bodies.

I can’t stand watching this unfold. And I can’t say, can’t express even fractionally, how much, how gut-wrenchingly much, I hate and revile these disgusting creeps.

UPDATE: Rayne at Firedoglake reports “Stupak Amendment Passes: 64 Dems Ask for Primary Opponents“. That’s exactly how I feel about it. I had already promised myself that I would contribute to the primary opponents of any misogynist Democrats; I’m saddened, and shocked, that there are so many of them. I will certainly target all that I can afford to. Read the rest of the post; it’s exactly right.

UPDATE: The final bill has passed, 220 – 215. Exactly one Republican voted in favor – 39 Democrats voted to withhold healthcare from over 40 million Americans. This is a great – but very partial – victory. There still remains the Senate bill – which will be a far tougher fight, with looser rules and a larger percentage of heartless and misogynist Democrats in the mix – followed by the conference committee and the final vote. The Republicans and reactionaries will do everything they can to destroy other people’s hopes for a decent life, and their control over their own bodies and life plans – the rioting, disruption, demagoguery and thuggery seen today are just a taste of what is coming. And this step, momentous as it is, comes bitterly. The discussion in the followup post at Firedoglake captures it perfectly; as one commenter put it: “It’s like winning a huge battle, but half of your friends were killed or wounded.”

UPDATE: I’ve added the reference to Democrats in the headline. I didn’t make it clear above that Bart Stupak, who led the charge to destroy healthcare reform for over 300 million Americans if they didn’t let him destroy autonomy for 150 million female Americans, is a Democrat. Along with 63 other misogynist traitors, he put the people’s party against 51% of the people, to indulge their personal medieval religious obsessions. Fuck him and all of them.

UPDATE: Scott Lemieux at Lawyers, Guns, and Money gets the power dynamic exactly right: “Certainly, there are many potential criticisms of how Democratic leadership has dealt with health care, although when you actually care about expanding access to health care it’s hard to negotiate with the Stupaks of the world who don’t, but want to use other people’s progressive impulses to attack women.”

I just thought I can’t do this anymore, and it was just like a flash that hit me and I thought that’s it,” said Jonhson. . . .

Johnson said she was told to bring in more women who wanted [icky procedures], something the Episcopalian church goer recently became convicted about.

“I feel so pure in heart (since leaving). I don’t have this guilt, I don’t have this burden on me anymore that’s how I know this conversion was a spiritual conversion.”

Johnson reports that she is likewise convicted about gall bladder removals, most forms of cancer surgery, and liposuction, although she does not criticize the decisions several of her friends have made to have such procedures, because “that’s different”. She is semi-convicted about breast implants, believing they are the work of the Whore of Babylon but also something you could understand that a woman needs sometimes. She justifies these distinctions with random Bible quotes and references to her own idiosyncratic feelings, which she cannot coherently articulate but is happy to impose on others by law.

This otherwise trivial story about one small-town individual’s weird religious hangups was trumpeted by the religious right as a stunning victory over the right of other people to make healthcare choices they don’t like, claiming other people’s healthcare was now “in meltdown mode” and “total disarray”. Every healthcare clinic in the country, including the one that has now hired a new director, went about its business as usual.

I don’t have much to say about that, except to offer support and the wish that the homophobia that infects our society, among other lingering forms of discrimination and prejudice, will soon fade, and “coming out” can be the act of celebration and affirmation that it should be, rather than an act of courage and risk-taking in the face of dangers that should not be allowed  to exist.

I’ll note, by way of parochial hyper-focus, that the pressures and threats that impede coming out and living openly in one’s chosen orientation have health consequences as well as many other harmful impacts; they cause stress and depression, create barriers to healthcare access, often result in abusive or discriminatory treatment in emergency care, and not infrequently result in violence. And of course the pervasive legal discrimination LGBTQ people face, in particular regarding health insurance, visitation and decision-making rights for gay couples, and barriers to assisted fertility and adoption, are also health and family-rearing issues as well as being rank discrimination in the basic sense.

Ending homophobia for reasons of good health is an odd and circumlocutory approach to the problem, but it’s one reason among many. Simple moral necessity is a better one. It’s long past time.

The consequences:

At least two patients in the study died shortly after receiving the fluid and more than two dozen others required transfusions, according to documents submitted to the federal government by the hospital and obtained by the Huffington Post Investigative Fund.

There were attempts to rein in the problem as it developed:

In November 2000, two Columbia anesthesiologists – Marc Dickstein and Mark Heath- sought out the head of the institutional review board, Paul Papagni, a lawyer. They told Papagni that they had been in the operating room when a number of patients had hemorrhaged. They feared the study’s design virtually guaranteed that there would be more who would suffer hemorrhaging

However, their objections were derailed by internal politics. Columbia did later act decisively to crack down on the lead investigator, Dr. Elliott Bennett-Guerrero and report the breaches of protocol to the HHS, but they also downplayed the severity of the consequences, in part by reporting only a narrow range of outcomes from selected patients, not including the most severe adverse outcome, the bleeding that was the most important known side effect. The hospital also ignored advice from the HHS that it contact patients from the study and apprise them of the truth. Dr. Bennett-Guerrero has now been dismissed from the hospital (he landed in a Directorship and medical-school professorship at Duke – guess they’re OK with all this). Columbia has now been ordered by HHS to contact its former patients.

So, all in all, a serious problem plagued by misbehavior at every level, and an apparent partial coverup.

That’s all very worrisome, but it is the investigator’s attempted defense that particularly caught my attention:

Bennett-Guerrero . . . said in e-mails: “It is hard to imagine that an unbiased expert in cardiac surgery clinical trials could conclude that subjects were harmed in this study, since with only 50 patients per group the study was not designed or powered to prove any differences in major complications including death.”

What he’s saying is that because the sample size was so small, the statistical error in the results is necessarily mathematically too large to be able to show that the deaths or other events that resulted are clearly more numerous that would be expected by chance in such a group of patients.

There are a couple of real problems with this.

First, with a sample size of 50 and, as the article notes, varying dosages of the expander given, up to “three times the level recommended by the manufacturers”, this appears to have been a Phase I Ascending Dose trial. Phase I trials are conducted expressly for the purpose of monitoring safety and adverse side effects of the experimental treatment – they are intended to weed out unsafe treatments before they are tried on large groups of patients. In such trials, safety monitoring is paramount; the first sign of harm to patients should bring the trial to a halt. It’s true that such trial sizes are often too small for statistical significance, but the whole point is to gain confidence before exposing a larger sample size – so empirical monitoring is vital. In this trial, two patients died and numerous others suffered serious hemorrhaging – severe-enough outcomes that experienced clinicians complained directly to the IRB – but the lead investigator never reported a problem or stopped the trial.

(It is possible this was a Phase II or combined Phase I/II trial – though again the facts still seem to suggest Phase I. But if so, the sample size should have been large enough to be likely to return statistically significant results. The trial would be worthless without them.)

Another concern is that no early-Phase trial is supposed to be conducted on patients receiving conventional therapy or in lieu of conventional therapy, where such therapy exists. They are conducted on healthy volunteers. Partly this is to ensure that participation is truly voluntary (i.e., that patients are not being enticed into trials because they see it as a requirement for receiving other therapy), partly precisely to avoid this problem of contaminating apparent adverse consequences of the experiment with the patients’ underlying pathologies.

So it is difficult to see how this trial could have been appropriately designed, aside from the question of informed consent. Either it was a safety trial conducted on patients whose health was already compromised to the point that adverse effects could not be identified as the results of the experimental medication, or it was a dosage-efficacy trial conducted on a sample size too small to provide reliable results, either positive or negative. And in either case, clinical judgment seems to have been dispensed with as patients died but – because of the built-in lack of confirmatory mathematics – no suspicion was entertained about a possible link to the experiment they were participating in.

That raises questions of the investigator’s intent. At this point, I want to step away from this particular incident, and make it clear I am not making insinuations about Dr. Bennett-Guerrero or others from the Columbia trial. Clearly things went badly there but I don’t know what was going through his mind or what his intentions were. I want to use this situation to illustrate ways in which clinical trial design can be (again, I am saying nothing about this particular case) manipulated to  evade ethical protections for subjects.

If a trial is deliberately designed with a sample size too small to return significant results, then by definition no negative results can ever be discerned (nor can any positive results, either, of course). At the Phase I level, where harm is the only reported result, lack of positive results is not a problem, but the impossibility of negative results means that the candidate drug will automatically pass the screening. (Since you can’t find any statistically significant negative results, there will be no statistically significant negative results to report, thus the drug can never be proven to have failed the test. And since, at Phase I, “not failing” is a good-enough result to justify further research, the lack of a robust experimental design can, paradoxically, be a very useful feature.) With a lax IRB focusing only on the mechanics of the informed consent procedure, and not the possible pathways for harm or the mathematical intricacies of the results testing, one can easily get permission to conduct a “drug test” that no drug can possibly fail.

Doing so, of course, requires that you suspend judgment as to the empirical/clinical course demonstrated by the subjects. With no mathematical test for success/failure, an ethical researcher must rely on careful clinical monitoring to detect problems with individual patients or the trial as a whole. Starting with healthy subjects makes such problems obvious, since they aren’t supposed to die at all, but conducting the trial on subjects already sick (or, in fact, pulled directly out of the ER into heart surgery) creates a ready explanation why some of them may die, if in fact they do. So, again, there is an incentive to conduct the trial in what would otherwise be a scientifically invalid manner, essentially building in negative outcomes from the beginning (if the patients already have life-threatening illnesses, you’re going to get some bad outcomes no matter what) as a screen for the negative outcomes that may arise from the experimental procedure. This makes it difficult to honestly answer the question whether the procedure harmed the subjects, but makes it easy to argue that it did not provably harm them.

Thus, for an unscrupulous researcher (and again, this part of the discussion is hypothetical; it is not aimed at a particular individual), it may be possible to design a trial that cannot deliver honest and reliable results, but which also cannot fail to provide the preferred result from the point of view of a drug manufacturer or funding source. Doing so requires conducting a trial that is both scientifically non-decisive by intention and which lacks the ability to identify clear harms to subjects. It may also require deliberately enticing patients into the trial for whom better and safer therapies are available, precisely to use their pathologies as a ready excuse for adverse clinical outcomes which the trial may produce in them. And, it necessarily requires vacating the professional obligation to use vigilance and judgment to monitor and protect patients in all circumstances, and especially the experimental environment – and to instead rationalize patients’ outcomes away in order to avoid public knowledge, and possibly self-knowledge, of the harms inflicted upon them.

Convenient rationalizations are not an acceptable mindset for those who take vulnerable others into their care. The fact that a trial design cannot determine whether its subjects have been harmed is not an acceptable exculpation of those whose obligation was to watch for, detect, and ameliorate such harms. It is a reason why such trials must not be conducted in the first place.