Medical Humanities Blog

On (What Passes For) Oversight of Clinical Trials

Admittedly, this comes from one who could hardly be more cynical about what passes for oversight of clinical trials and biomedical research in general, but this report does not shock me:

The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found.

In a report due to be released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.

It's hard to study the history of human subjects research in the 20th century without healthy dubiety regarding either public or private "oversight" of such practices.  There are inherent reasons to doubt the effectiveness of the general system we have for regulating human subjects research, as well, which I shall not go into here in any great detail, mostly because these are topics I am currently thinking about and working on.  More grist for the mill!

(h/t Bioethics.net)

More on Ghost Management: Thoughts About Rhetoric

Roy Poses over at Healthcare Renewal has a lengthy analysis of the recent article out in PLoS Medicine on ghost management, the process by which so-called medical education and communications companies (called "med-eds" or MECCs) manage all aspects of publication planning for industry sponsors of clinical research.  I agree with Poses's analysis, and heartily encourage you to read it.

However, there were some aspects of the article I wonder about.  First, I wonder if it is the case that "[c]urrent practices in the medical sciences legitimately allow people to serve as authors on the basis of narrow contributions" (Sismondo 2007, 1431).  There certainly exists such a tradition within biomedical publications, but it has come under significant fire in at least the last decade.  The Uniform Requirements for Manuscripts Submitted to Biomedical Journals lists extensively the standards required for authorship, including II.A.1:

Authorship credit should be based on 1) substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.

Accordingly, I wonder whether it is really the case that current practices legitimately allow people to serve as authors on the basis of "narrow contributions."  The World Association of Medical Editors provides:

Only an individual who has made substantial intellectual contributions should be an author.  Performing technical services, translating text, identifying patients for study, supplying materials, and providing funding or administrative oversight over facilities where the work was done are not, in themselves, sufficient for authorship, although these contributions may be acknowledged in the manuscript, as described below.  It is dishonest to include authors only because of their reputation, position of authority, or friendship (“guest authorship”).

Of course, it could well be the case that the practices depart from the established standards.  I am just cynical enough to suspect that this might well be the case.  I honestly do not know, but I do wonder.

But this post is not meant to be a critique of Sismondo's paper.  Far from it; the paper is an original, important contribution on a topic of grave significance.  As Sismondo explains, "the ghost management of articles is a step in the intervention into medical practice" (Sismondo 2007, 1431).  Because medicine is just as Sismondo describes, one could fairly use a phenomenological term and say that the ghost management of articles is constitutive of medical practice.

There is another approach I want to take in unpacking some of the significance of the article, from a medical humanities perspective.  Here at MH Blog, I've tried to stress how important the art of rhetoric was to the humanists, and how significant it remains to the medical humanities and to contemporary medical practice.

And what struck me most about Sismondo's article is that the med-eds are essentially professional, corportatized rhetoricians.  And they are extremely proficient rhetoricians, as the article demonstrates.  What is it effective rhetoricians do?

First, they identify the audience for whom persuasion is intended.  (And make no mistake about it, rhetoric is ineliminably persuasive in nature).  Second, they tailor their voice, language, tone, diction, they refine their narrative, to the persuasive aims intended.  Third, they tell a story or multiple stories that convey meaning and facilitate interpretations favorable to the rhetorical objectives.  Consider these notions in light of Sismondo's description of one of the med-eds' promotional literature on its web site:

Another [med-ed], Envision Pharma, says that "data generated from clinical trials programs are the most powerful marketing tools available to a pharmaceutical company."  Envision will work from early on in the process to ensure "consistent message dissemination," will plan and track the "data dissemination plan" and will produce "scientifically accurate, commercially focused abstracts, posters, and primary and secondary publications."

(Sismondo 2007, 1431).

Envision is a corporate rhetorician.  They collate the information, the res, and construct narratives suitable to the chosen medium (biomedical journals), such narratives being verba.  Sismondo notes that "[med-eds] are effective at creating publishable articles and getting them published in peer review journals" (Ibid., 1432).  These rhetoricians are highly skilled at what they do, then.  And why shouldn't they be? One med-ed "boasts a team of 40 medical writers, editors, and librarians" (Ibid., 1431).

In thinking about this in context of the medical humanities, in my haste to participate in the reclamation of rhetoric that has picked up some mild academic traction, I have omitted to acknowledge that which Socrates and Plato warned of: the Dark Side of rhetoric.  Since res and verba can be separated, skill in the art of persuasion is not inherently connected to the good.  Hence the Socratic challenges posed to the rhetors Lysias and Prodicus in the Phaedrus.

Medieval mind, if such a thing even existed, was all too aware of the dangers of rhetoric.  This was partly why discursive argument, or logic, was emphasized over rhetoric in the trivium.  But at MH Blog I've also mentioned the medieval focus on order, reflected in the crystalline spheres of cosmogony, and resonant in many of the most significance pieces of medieval literature (the Divine Comedy being one excellent example).  Respect for authority was a means of sustaining order for medieval (wo)man, and too much time spent bandying words about could conceivably affront the commitment to gradualism (the historiographical term for this medieval focus on order).

The separation of res from verba would continue to resonate during the Renaissance and into the early modern era.  Indeed, as Bouwsma demonstrates nicely, it is one of the characteristic themes of the waning of the (humanist) Renaissance.  Poor misunderstood Machiavelli, so insistent that the good was not necessarily the useful, did nothing to ameliorate the growing suspicion of rhetoric disconnected from conceptions of the good.

While the humanists privileged rhetoric, and with good reason, a skilled rhetorician is no guaranteed of moral goodness.  But this says nothing about the power the skilled rhetorician wields; it is an awesome meaning-making device, and we would do well to pay more attention to its effects on our daily practices, including our medical practices, as Sismondo explains.

 

On Ghost Management

A new article is out in PLoS Medicine on "ghost management."  Here is an excerpt from the open-source essay:

This article enlarges the focus from ghost writing to the more general ghost management of medical research and publishing: when pharmaceutical companies and their agents control or shape multiple steps in the research, analysis, writing, and publication of articles. Such articles are “ghostly” because signs of their actual production are largely invisible—academic authors whose names appear at the tops of ghost-managed articles give corporate research a veneer of independence and credibility.

They are “managed” because those companies shape the eventual message conveyed by the article or by a suite of articles. As discussed below, a substantial percentage of medical journal articles (in addition to meeting presentations and other forms of publication, which are not the focus here) are ghost managed, allowing the pharmaceutical industry considerable influence on medical research, and making that research a vehicle for marketing.

Recommended.

(h/t LL)

Medical Humanities Lexicon: Therapeutic Misconception

Today's long overdue entry in the Medical Humanities Lexicon is "therapeutic misconception."  This is a topic of particular interest of mine for a variety of reasons.  The phrase was, as far as I can tell, first used in 1982 by Paul Appelbaum et al., who along with Charles Lidz, has published some of the most important empirical studies of the phenomenon.  The therapeutic misconception refers to the general conflation of research with therapy.

Why are they distinct in some important senses? Why should they not be conflated?

On Lethal Injections

The Supreme Court has granted cert in a Kentucky case regarding the constitutionality of lethal injections:

The high court will hear a challenge from two inmates on death row in Kentucky — Ralph Baze and Thomas Clyde Bowling Jr. — who sued Kentucky in 2004, claiming lethal injection amounts to cruel and unusual punishment.

Baze has been scheduled for execution tonight, but the Kentucky Supreme Court halted the proceedings earlier this month.

The court has previously made it easier for death row inmates to contest the lethal injections used across the country for executions.

But until today, the justices had never agreed to consider the fundamental question of whether the mix of drugs used in Kentucky and elsewhere violates the Eighth Amendment's ban on cruel and unusual punishment.

Baze and Bowling say the procedure inflicts unnecessary pain and suffering on the inmate.

The two inmates sued in 2004 and a trial was held the following spring. A state judge upheld the use of lethal injection and the Kentucky Supreme Court affirmed that decision. The appeal taken up today stems from that decision.

"This is probably one of the most important cases in decades as it relates to the death penalty," said David Barron, the public defender who represents Baze and Bowling.

Barron is right.  We have previously covered this issue here, and will continue to follow this important case.

One State's Struggle with Mental Health Care

I do hope Daniel and the readers of this blog will indulge me yet one more mention of some articles, and once again from the Los Angeles Times. I well realize everyone is pressed for time these days, but I'd rather err on the side of abundance (of information) rather than the converse (after all, that's one of the better pedagogical functions of blogs such as this).

The articles in question are part of a series called "Breakdown," which is described as follows: "For California's estimated one million people with mental illness, life is a daily struggle. Times reporters Scott Gold, Lee Romney and others are chronicling their lives and the strained system meant to serve them."

While I suspect these stories are representative of the state of mental health care in much of the country, they are moving enough on their own, painting a deeply human portrait of what individuals face day-to-day in dealing with various forms of mental illness. Of course one needs to keep in mind that "the set of instances available to us might form a very biased sample of the set to which we wish to generalize when we make our frequency estimates," in short, what is termed the "availability bias," and described by Robyn M. Dawes as "quite common and robust"(See his wonderful book, Everyday Irrationality, 2001). Inasmuch as this series consists of "good stories," they can be the vehicle for an availability bias.

Permit me a powerful illustration of the kind of problems associated with undue reliance on the availability heuristic (such heuristics, as mental 'short-cuts,' are in themselves neither good nor bad), one not unrelated to the subject matter of the Times series. It is from a book by Dawes and Reid Hastie titled Rational Choice in an Uncertain World: The Psychology of Judgment and Decision Making (2001):

"[C]onsider the current widespread belief that much of the 'homelessness problem' in the United States is due to the 'deinstitutionalization' of mental patients, which simply releases them into the streets without the ability to obtain or hold jobs. This belief was expounded in a 1986 cover story of Newsweek magazine, which began with the provocative headline "Abandoned" (and subsequently failed to recount a single instance of an emotionally disturbed individual requesting psychiatric hospitalization and being denied it). The homeless are 'America's cast-offs--turned away from mental institutions and into the streets. Who will care for them?' The story continues by quoting from a number of eminent psychiatrists and mental health workers: 'It is true that up to 65% of the liberated mental patients have successfully adapted to life outside, but as any psychiatrist can testify, "success" among the long-term mentally ill is a very sometimes thing.' (Our own observation is that 'success' for all of us is a 'sometimes thing').

What do actual surveys of the homeless show? Estimates of the proportion who are mentally ill vary from locality to locality, but the average is about one third, with the criterion for categorizing someone as 'mentally ill' being either current mental distress or a history of psychiatric hospitalization. The vast majority of the homeless are poor, just plain poor. Why do so many people accept the conclusion that homelessness is due to deinstitutionalization of mental patients? Search your memory for the homeless people you saw most recently. What were they like? The unobtrusive homeless person is easily forgotten. We tend to remember the person who sings on the bus, who intrudes on passersby, who is drunk, or who is obviously high on some drug. Moreover, we prepare ourselves to behave in certain ways if such a person approaches us, such preparation being exactly the type of ancillary event that--as Willem Wagenaar points out--enhances recall of the event leading to it. Hence our view of 'the homeless' is based on the memorable homeless, people whose emotional and physical debilitation is so severe that it suggests poverty alone cannot be the cause of their problems. The judgment quoted earlier of 'any psychiatrist' is also subject to a memory selection bias. Unlike family doctors, psychiatrists do not see their patients for periodic check-ups. They see their former patients, if at all, only when subsequent emotional problems develop. This selective sampling is particularly severe for psychiatrists who work in mental institutions, because discharged patients tend to be very disturbed when a former psychiatrist sees them on readmission." [Please do not infer that Dawes and Hasties are not concerned about those who are both mentally ill and homeless, as they simply want to make the point that too many people believe mental illness is the primary causal reason in accounting for the sheer number of homeless individuals, thereby refusing to admit the realities of poverty in this country. Homelessness is difficult enough, being homeless and mentally ill is terrible testimony to the often 'unbearable heaviness of being.']

So, without further ado, here is the link to the Times series (11 articles up to this point): http://www.latimes.com/news/science/la-me-breakdown-sg,1,1610997.storygallery

Patrick S. O'Donnell

"The C-Section Epidemic"

Today's Los Angeles Times has an important article by Jennifer Block (author of Pushed: The Painful Truth about Childbirth and Modern Maternity Care, 2007):

"Pre-term births are on the rise. Nearly one-third of women have major abdominal surgery to give birth. And compared with other industrialized countries, the United States ranks second-to-last in infant survival. For years, these numbers have suggested something is amiss in delivery wards. Now there is even more compelling evidence that the U.S. maternity care system is failing. For the first time in decades, the number of women dying in childbirth has increased.

The Centers for Disease Control and Prevention last month released 2004 data showing a rate of 13.1 maternal deaths per 100,000 live births. For a country that considers itself a leader in medical technology, this figure should be a wake-up call. In Scandanavian countries, about 3 per 100,000 women die, which is thought to be the irreducible minimum. The U.S. remains far from that. Even more disturbing is the racial disparity. Black women are nearly four times as likely to die during childbirth than white women, with a staggering rate of 34.7 deaths per 100,000." Block notes that CDC epidemiologists "have acknowledged that deaths related to childbirth are probably underreported by a factor of two to three."

Block believes the C-section, "now used to deliver 30% of American babies," is the prime culprit behind this country's comparatively dismal rate of childbirth deaths: "Caesareans are inherently riskier than normal, vaginal birth. They also lead to repeat caesareans. And repeat caesareans carry even greater risk."

I was astonished to learn that "some U.S. hospitals are are now delivering half of all babies surgically. Across the nation, 1 in 4 low-risk, first-time mothers will give birth via caesarean, and if they have more children, 95% will be born by repeat surgery. In many cases, women have no choice in the matter. Though vaginal birth after caesarean is a low-risk event, hundreds of institutions have banned it, and many doctors will no longer attend it because of malpractice liability."

Something is indeed seriously amiss in American maternity wards to the extent that they are "fast becoming surgical suites."

For the entire article:  http://www.latimes.com/news/opinion/la-oe-block24sep24,0,6378847.story?coll=la-opinion-rightrail

On Artificial Nutrition and Hydration

Among several fascinating blog posts here over the last few days (thanks, y'all), Kelly writes about the latest development in the Holy See's complicated (some might say 'tangled') thinking on the ethics of artificial nutrition and hydration. 

For those who have not seen it, the letter reads as follows:

Vatican on Nutrition to Patients in Vegetative State

"A Person With Fundamental Human Dignity"

VATICAN CITY, SEPT. 14, 2007 (Zenit.org).- Here is the note published today by the Congregation for the Doctrine of the Faith entitled "Responses to Certain Questions of the United States Conference of Catholic Bishops Concerning Artificial Nutrition and Hydration."

* * *

First question: Is the administration of food and water (whether by natural or artificial means) to a patient in a "vegetative state" morally obligatory except when they cannot be assimilated by the patient's body or cannot be administered to the patient without causing significant physical discomfort?

Response: Yes. The administration of food and water even by artificial means is, in principle, an ordinary and proportionate means of preserving life. It is therefore obligatory to the extent to which, and for as long as, it is shown to accomplish its proper finality, which is the hydration and nourishment of the patient. In this way suffering and death by starvation and dehydration are prevented.

Second question: When nutrition and hydration are being supplied by artificial means to a patient in a "permanent vegetative state," may they be discontinued when competent physicians judge with moral certainty that the patient will never recover consciousness?

Response: No. A patient in a "permanent vegetative state" is a person with fundamental human dignity and must, therefore, receive ordinary and proportionate care which includes, in principle, the administration of water and food even by artificial means.

* * *

The Supreme Pontiff Benedict XVI, at the audience granted to the undersigned cardinal prefect of the Congregation for the Doctrine of the Faith, approved these responses, adopted in the Ordinary Session of the Congregation, and ordered their publication.

Rome, from the Offices of the Congregation for the Doctrine of the Faith, Aug. 1, 2007.

William Cardinal Levada
Prefect

Angelo Amato, S.D.B.
Titular Archbishop of Sila
Secretary

[Original text: Latin; translation distributed by the Holy See]

As best I understand it (having written on it in a forthcoming co-authored article), Pope John Paul II issued an allocution, which does not carry the same authority as a bull or an encyclical, opining that food and water are never extraordinary means, but are morally obligatory.  This view caused something of an uproar among some Catholic theologians and ethicists, who noted the long tradition in Catholic medical ethics of the proportionality test.

The idea here is that any clinical intervention is subject to a balancing test of burdens and benefits.  In cases where the burden to the individual, endowed with innate dignity, exceeds the potential benefits, the intervention is not morally obligatory.  This is why removing life-sustaining measures such as, say, artificial ventilation, has long been considered ethical among Cathlolic medical ethicists.  Indeed, Karen Anne Quinlan and her family were Catholic, and her family consulted a priest who stated that cessation of LST was ethical.

Similarly, secular or non-Catholic bioethicists have often struggled to draw satisfactory moral distinctions between artificial nutrition and hydration and other LSTs (resuscitation, artificial ventilation, etc.).

In this context, Pope John Paul II issued a subsequent letter on the issue which featured no retraction, but a generic acknowledgement that the traditional proportionality test was appropriate in assessing the legitimacy of clinical interventions.  While it may be difficult to draw meaningful distinctions between nutrition and hydration and other means of LST, that does not change the fact that many Westerners seem to feel differently when it involves food and water.

Viewed from a medical humanities lens, this is somewhat unsurprising.  The connection between nutrition, hydration, and health has ancient roots in Western culture.  One hardly need discuss the significance of food (Epicurus), drink (Bacchus), and hydration (bathing) to concepts of health and illness in Greek and Roman culture.  Consumption of alcohol was long thought to be a predisposing cause of disease (one can find instances of this view in Europe during the prima pestilentia, in yellow fever outbreaks in the 18th century in the U.S., and in cholera outbreaks in both Europe and the U.S. in the middle decades of the 19th century).

Also during the 19th century, hydropathy was an extremely popular means of ensuring health and treating illness.  So basic do food and water seem to our existence and our very conception of health that to intentionally deprive others of it seems to many to be a transgression.  At risk of invoking Godwin's Law -- the heavy plight of a would-be ethicist -- the Nazi atrocities conjures for many images of skeletal concentration camp victims, deprived of sustenance.

Finally, the current discourse on obesity again demonstrates the significance of nutrition in conceptualizing health and illness in Western society. 

I have argued, as a co-author, that the difficulty of assessing the ethical and social significance of nutrition and hydration is one of the complicating features of the Cruzan case, as opposed to the Quinlan case, which solely involved the right to cease artificial ventilation for Karen Ann Quinlan.  Nancy Cruzan, on the other hand, like Terri Schiavo, was spontaneously respirating, which meant that cessation of LST involved withdrawing nutrition and hydration.

The point of the above is not to reach any definitive conclusions regarding the ethics of artificial nutrition and hydration.  Rather, the humanists' emphasis on bringing learning to bear on practices (and vice-versa) shows the need to think carefully about the difficulty of drawing satisfactory moral distinctions between forms of LST and the empirical fact-on-the-ground that many persons and communities, providers and caregivers see a difference of profound moral weight. 

My co-author and I concluded in our forthcoming essay that the U.S. discourse towards death and dying has consistently remained unsettled over the last half-century.  This social and cultural uncertainty on such issues continues, including as to artificial nutrition and hydration.   

Article Alert

I'm still working on the conclusion to my series of posts on TCM/CCM, which I hope to have up soon, but until then I wanted to alert readers to two recent articles: the first by Gary Taubes on epidemiology ('Do We Really Know What Makes Us Healthy'?), using the paradigmatic story of hormone replacement therapy (H.R.T.) to illustrate the truth of the following comment from Richard Peto, professor of medical statistics and epidemiology at Oxford University: "'Epidemiology is so beautiful and provides such an important perspective on human life and death, but an incredible amount of rubbish is published,' by which he means the results of observational studies that appear daily in the news media and often become the basis of public-health recommendations about what we should or should not do to promote our continued good health." It is in yesterday's New York Times Magazine, a link to which is found at Arts & Letters Daily under "Articles of Note": http://www.aldaily.com/

The second piece is by one of--if not the--foremost scholars in the field of public health, namely Lawrence O. Gostin: "Meeting Basic Survival Needs of the World's Least Healthy People: Toward a Framework Convention on Public Health," Georgetown Law Journal, Vol. 96, 2008 Available at SSRN: http://ssrn.com/abstract=1014082 (I learned of it through Larry Solum's indispensable Legal Theory Blog, which posts the abstract: http://lsolum.typepad.com/legaltheory/

Patrick S. O'Donnell

The Vatican Letter, in Light of Pain and Suffering

Daniel has, in the past, invited me to cross post things that I have blogged elsewhere here, and today I'm taking him up on that - not in the least because my initial, running out the door right before the end of the day, blog post at the AJOBlog has been generating commentary and repostings of its own. This, then, is what I posted this morning at my own blog. I repost here, because I think the audience might be interested in it, and potential discussion around the subject of pain, suffering, and feeling.

In light of yesterday's Vatican letter clarifying the former Pope's commentary on food and hydration for PVS patients, I offer a snippet of McCann et al's 1994 JAMA article on comfort care for terminally ill patients:

While much attention has been focused on the rights of patients to refuse medical interventions, little has been written about the benefits that competent terminally ill patients may experience by exercising this right, particularly in regard to artificial feeding. We found that patients with terminal illness can experience comfort care despite minimal if any intake of food or fluids. This is consistent with the experience that others have had in caring for dying patients. Using a patient-centered team approach, we were able to direct our efforts toward each patient's particular needs. (1)

When you cannot communicate directly with the patient, you communicate with the caretakers and family. What then, is the benefit for these actual people you interact with, that these surrogate patients might receive and experience by exercising the right to refuse for the body/person they stand in for?

Part of the Catholic ruling is based on the notion that the PVS patient, unable to communicate with the world at large, is still able to communicate with the world internal, that is, with God, and we humans should not step around the authority of God to circumvent His will.

Looking at the ruling, we can see that the focus is, beyond this focus on fundamental human dignity (which is intimately tied to communion with God), the alleviation of suffering - or more specifically, the avoidance of causing suffering to begin with. But as McGee asked in a lecture given a year ago in front of a variety of students, and I tied into Cassell, what does it mean to suffer? Can a PVS patient suffer, if by definition of PVS we are saying there is nothing left to return? That the body has become a biologic husk, no longer a Being in the world as much as a Memory in the world? Doesn't there need to be something there beyond chemical and biologic processes in order for there to be suffering? (And to keep Cassell in the picture, there is of course a difference between pain and suffering (2). Suffering is feeling, experiencing, while pain is 'just' the biological response. A sea anemone can 'feel' pain without suffering, and it's an important distinction to make, and keep in mind.)

The letter from the Offices of the Congregation for the Doctrine of the Faith emphasizes the alleviation of suffering, but makes an error in focusing only on the potential suffering of the patient, while ignoring the entirely probable suffering of those around the patient, the affective whole of family and friends. It's almost ironic, given the Catholic emphasis on non-individuality, that the letter and ruling itself focus on the individual to the detriment of the whole.

(1) McCann et al, Comfort Care for Terminally Ill Patients. JAMA, October 26, 1994. Vol 272, No 16.
(2) You can read me slightly misreading Cassell here.