Medical Humanities Blog

On Research Ethics & Private Physician-Investigators

Jill Fisher (Women & Gender Studies - Arizona State ) has authored a fascinating, provocative new article in the latest Social Science & Medicine entitled Practicing research ethics: Private-sector physicians & pharmaceutical clinical trials.

Here is the Abstract:

This paper focuses on constructions of research ethics by primary care physicians in the USA as they engage in contract research for the pharmaceutical industry. Drawing first on historical studies of physicians as investigators and then on 12 months of qualitative fieldwork in the Southwestern US, this paper analyzes the shifting, contextualized ethics that shape physicians' relationships with patients/subjects and pharmaceutical companies. Just as physicians followed professional codes of ethics prior to the codification of acceptable research conduct in the 1980s, physicians today continue to develop tacit systems of research ethics. This paper argues that private-sector physicians primarily conceptualize their ethical conduct in relation to the pharmaceutical companies hiring them, not to human subjects they enroll in clinical trials. This is not to say that these physicians do not follow the formal U.S. regulation to protect human subjects, but rather that their financial relationships with the pharmaceutical industry have a greater influence on their identities as researchers and on their constructions of their ethical responsibilities.

I agree with many of the author's arguments and conclusions, though not all of them.  For example, while many scholars have noted the errors in the traditional belief that human participants research prior to WWII was not governed by norms, it hardly follows from the fact that such research was norm-governed that the norms that did govern were ethical.  To infer otherwise would be a rank instance of the naturalistic fallacy.  Thus, the fact that the author's research suggests a continuity in the way that "physicians continue to develop their own codes of ethics in response to their professional roles and responsibilities" does not imply that these constructions are ethically adequate.

Still, the author's conclusion seems sound to me: "Although physicians are not immune to the critiques of the bioethics community and the mainstream media regarding their work, they construct their sense of what is ethical through their everyday practices in the clinic in relation to the needs of the pharmaceutical industry and their own business bottom-lines."

Recommended.

Transdisciplinary Bibliography on Emotions

Bibliographic machine Patrick S. O'Donnell has kindly allowed me to post a version of his bibliography on emotions.  As usual, O'Donnell's research is exhaustive, and crosses various disciplines.

Download emotions_bibliography.doc 

Call for Applications

The Institute for Medical Humanities at the University of Texas Medical Branch (where I am a graduate student) has announced a Call for Applications for a tenure-track faculty position.

The Call may be downloaded here (*PDF):

Download call_for_applications.pdf 

On Education and Disparities

Here at MH Blog, I've discussed on multiple occasions the strong correlations between education and health, suggesting that if we really want to improve population health and reduce human suffering, allocating larger proportions of resources to education is likely one of the best means of improving health.  This in turn highlights the idea supported by many SDOH theorists, that social policy is health policy, and vice-versa.

Though there is quite literally a mountain of evidence linking education and population health, it never hurts to have more, as a new study released in PLoS One demonstrates.  The study, authored by investigators from ACS and the CDC, set out to examine trends in inequalities related to education using national U.S. data.  The authors conclude that

"Socioeconomic inequalities in mortality are increasing rapidly due to continued progress by educated white and black men and white women, and stable or worsening trends among the least educated."

Social policy is health policy.  And vice-versa.  The evidence is there, and it has been there for at least 30 years (to the famous 1974 Lalonde Report (*PDF)).  It's beyond sad to me that (in my view) discussions of specific health policies typically exclude from the discourse analyses of relevant social policies.  We can (and should) do as excellent a job as we wish in more justly allocating access to care; but if we continue to fail at translating the evidence that education -- amidst other social and economic determinants -- is a powerful determinant of both population health and disparities into public health policies, I submit that we are unlikely to have the effect on population health that we wish for and that we ought to have.

(h/t Kaiser Daily Health Reports)   

On Useful Bodies

The always provocative and interesting Aubrey Blumsohn has an outstanding series of posts up at Scientific Misconduct documenting the CIA's role in performing LSD experiments on human participants after WWII, with the active participation of the pharmaceutical industry.  The series is divided into five parts and  was prompted by the recent death of Albert Hoffman, the inventor of LSD.

On the Declaration of Helsinki

These days, Stuart Rennie seems to be doing a terrific job of voicing many of my own perspectives on global ethical issues.  So why not continue to link to his posts?

His latest effort assesses the FDA's decision to abandon the ethical dictates of the Declaration of Helsinki, moving instead to the weaker protections of the Good Clinical Practices of the International Conference on Harmonization.  Notwithstanding my own skepticism about the utility of ethical codes, Rennie provides good reason for thinking the decision is quite important, if not substantively, at the very least as a signal as to current priorities in global research:

The Declaration of Helsinki has its own problems, not the least of which are problems of ambiguity in its language and limited enforceability. But even its most uncharitable critic can see that the document has an ethical backbone. What impact the FDA's decision will have on clinical trials around the world remains to be seen, but the decision would seem to encourage pharmaceutical companies to cut ethical corners when working abroad.

Indeed.  Merrill Goozner comments here.

On the Moral Imagination

An evocative phrase within the medical humanities lexicon (I know, I know, I'm way behind in this series . . . ) is the "moral imagination," which we've briefly discussed.  The idea, roughly, is that a healer's ability to imagine what it might be like to experience the illness phenomena the patient narrates is itself of moral significance.  The healer who has a better developed imaginative faculty, IMO, is that much more likely to heal the patient, as opposed to merely treat the disease.  David Henderson Slater has an excellent post underscoring the importance of the moral imagination for the physician over at the Literature, Arts, and Medicine Blog.

Excerpts:

When we see a patient in clinic, or in the operating theatre, or on the ward, we see only a tiny part of their lives. We tend to see what they want to present to us. The clinic and the ward are not real life, or only a tiny part of it. If I really want to know what life is like for my patient I have to spend hours at it - perhaps also visiting them at home (something I often do) or in the Nursing Home. That way I get a feel for the things that get forgotten in clinic- such as the long hours of inactivity, or the financial poverty of the family, and an appreciation of what is important to them - for example the religious artefacts on the walls, the family pets, the old cars littering their garden, the half finished Do-it-Yourself projects.

While narrative studies are not my area of focus within the medical humanities (I gravitate to ethics, policy, and the history of medicine & public health), there is no doubt in my mind that narrative is important academically because it is so important phenomenologically.  What I mean by that is, in Slater's articulation, the idea is that the visits between doctor and patient are merely one tiny slice of the larger stream of narratives that comprise the patient's life.  To actually understand what it might be like to experience the illness(es) that the patient is living and/or dying with, attention simply has to be given to the larger context in which the patient is living out his or her life.  As Slater notes,

But sometimes we can’t access the patient in this direct way, and sometimes we don’t notice things. Our minds and our eyes need to be trained to spot things; so does our imagination. As trainee doctors we get extensive training in physical examination. I believe we also need to train our imagination, to learn to think what life is like for others, to experience things vicariously.

Indeed.  The suggestion here is not that the healer must go out and examine how the patient lives his or her life -- although that is probably a very good idea, and seems to me to characterize some of what medical anthropologists "do" and why it might be important -- but rather that the imagination is a faculty, and can be honed and refined like any other.  And the more developed this faculty is, the more effective, IMO, the healer is likely to be.

In any case, go read the whole post, which includes some perspectives from an Oxford medical student on disability and film.

Book Notice: Shrader-Frechette on Environmental and Public Health

Having read three of her previous books, Risk and Rationality: Philosophical  Foundations for Populist Reforms (Berkeley, CA: University of California Press, 1991), Environmental Justice: Creating Equality, Reclaiming Democracy (New York: Oxford University Press, 2002), and Ethics of Scientific Research (Lanham, MD: Rowman & Littlefield, 1994), I'm pleased to learn from Notre Dame Philosophical Reviews (NDPR) of a fairly new title from Kristin Shrader-Frechette: Taking Action, Saving Lives: Our Duties to Protect Environmental  and Public Health (New York: Oxford University Press, 2007). From the review by Madison Powers:

At the outset, it should be noted that environmental ethics is a comparatively small sub-set within practical ethics. Shrader-Frechette occupies a particularly small niche within that already small area of expertise.

One area of overlap between the concerns of a minority camp within bioethics and those of many who do environmental ethics is the question of whether humans have any moral duties to non-human animals. For the most part, however, environmental ethics focuses on a set of questions that occupies the attention of very few bioethicists. Does the natural world possess any intrinsic moral value independent of its instrumental value for sentient beings? Is biodiversity itself a morally significant matter?

Such questions often proceed to resolution under cover of an overarching question. Does our ethical focus on human welfare, especially human health, represent an unacceptably anthropocentric way of framing questions about the place of humans in nature? These specific questions are not Shrader-Frechette's questions, and the overarching issues they presuppose are not ones that animate her work. Instead, she works on a parallel track. Her concern lies with the relation between risks to human health and attempts to control, manipulate, and remake the natural environment.

In-depth scholarship within environmental ethics that has human health as a central concern is therefore relatively rare.

Public health ethics is perhaps the field having the closest intellectual kinship with Shrader-Frechette's work, but there too there is a considerable difference in emphasis. The bulk of the public health ethics literature concentrates either on the ethics of interference with individual liberty through various public health interventions, or on the distributive justice issues that arise out of public policy priority setting with respect to the promotion and protection of population health. Contributions to human health deficits by way of environmental risk factors are more widely discussed than acted upon within public health practitioner circles, but within the literature of public health ethics, these issues generate little more than footnotes.

There are, nonetheless, very significant overlaps between public health ethics and environmental ethics as Shrader-Frechette approaches the subject. Her sub-title, Our Duties to Protect Environmental and Public Health, reflects her synthetic ambitions for bridging this gap. Public health ethics, like the central practice paradigm of public health itself, is traditionally concerned with disease prevention and control, and of course, more recently with behavioral risk factors that can be addressed through health education or marketplace regulation. But with more than 80,000 chemical compounds in the workplace, the home, and the broader environment, remarkably little in any great detail has been written on these arguably more substantial risk factors, or on the enormous range of ethical issues that are raised by our largely unreflective but ubiquitous alterations of the natural world.

Readers not familiar with the literatures of the various sub-disciplines of practical ethics may marvel that such a gap would exist. How, they might ask, could scholars in this area have failed to map the obvious connections?

There are, of course, many factors that account for what academics choose to study and what they overlook, but the sheer range of expertise and mix of disciplinary competences necessary to map the terrain goes a long way toward explaining why Shrader-Frechette has a unique voice in the field, and why this, and other books by her, are of such great (and I think, overlooked) intellectual importance.

This book offers an accessible primer for anyone who wants to know the kinds of things one needs to know in order to reflect on questions of environmental ethics from a perspective that elevates human health risks to the foreground.

It's interesting to consider this book in light of Onora O'Neill's suggestion that the "two principal domains of bioethics are medical ethics (broadly interpreted to include the ethics of bio-medical research) and environmental ethics."

Professor Shrader-Frechette taught in the Philosophy Dept. (and the Dept. of Environmental Studies) of my alma mater, UC Santa Barbara, back in the 1980s and I've always wondered how or why they let her get away.

Patrick S. O'Donnell

Health Wonk Review

Welcome to this edition of the Health Wonk Review.  For those of you new to the blog, and wondering what the heck the medical humanities are, and what their relation is to health policy, I'll quote from our previous opportunity to host:

As I see it, the key role for a medical humanist – if they wish to be consistent with an ethos of medieval and Renaissance humanists – is to focus on the translation of theory into practice.  Humanists eschewed the logic and abstractions that Scholastics privileged, reasoning that they did little to move those outside the cloisters and universities to live virtuously.

This ideal is perhaps most easily exemplified by Erasmus, who, in the humanist tradition, prioritized the study of rhetoric because, as Petrarch put it in citing Cicero and Quintillian, rhetoric was what moved people’s hearts.

Erasmus saw the handwriting on the wall, and devoted much of his life to a kind of moral epistolary practice, exchanging letters with Luther in the hope of averting bloodshed.  Erasmus deemed the prospect of war obvious given Luther and the ‘schismatics’ belief system.

A contemporary of Martin Luther’s and a devoted Catholic,

What could be more virtuous than using scholarship and language in the hopes of preventing violence and horror?

Not even his best efforts could prevent the coming storm, but his ideal remains one worth emulating, in my view.  Such is the need to translate scholarship into practice, and this is a quintessentially humanist precept.

As such, health policy remains a particular province of interest for me, and one in which I submit the medical humanist may have something to offer.  With this said, let us see what rhetoric our interlocutors have prepared for us, and what voices they speak in.

Over at Health Disparities Blog, David Porter links to a current debate within Australia over universal care.  But not quite the debate you might imagine.  He notes: "Here in the U.S. the debate is focused on whether or not universal health care should exist. In Australia the issue is how young a person should be when they get their own private universal health care account."

Speaking of Australia, health care systems around the world is the topic of Jason Shafrin's collection of posts over at Healthcare Economist.

Back on our shores, Roy Poses challenges CMS's inclusion of delirium as a non-reimbursable event within hospitals.

As to hospitals, Henry Stern wonders aloud whether the movement of health care out of hospitals and into specialty clinics may actually be advantageous.  Perhaps, though there is good reason to bemoan the increasing specialization of acute care in the U.S., as such care is a significant driver of health care costs, and diverts resources from primary care.

Something I've learned both in studying health policy and in practicing insurance law: insurance is complicated.  David Hamilton breaks it all down for you, courtesy of a WellPoint conference call, so you can see exactly where the incentives are aligned.

Seeing as how the health insurance industry might need some good publicity, Richard Eskow over at The Sentinel Effect notes the strange bedfellows who have rallied behind attempts to limit the sale of alcopops.  Yes, alcopops.

Eric Turkewitz, a general must-read on tort law and medicine, cites evidence that less than 2% of matriculating medical students from New York leave New York due to malpractice concerns.

Sticking with malpractice, the Canadian Medicine Blog details the development of apology laws -- which we've touched on here from a U.S. perspective -- in Ontario.

From lawyers to laws: At Drug Channels, Adam Fein lauds the introduction of H.R. 5839, which would preempt state standards regarding the pharmacy supply chain.

The likely passage of the Genetic Information Nondiscrimination Act made news this past week, and Louise over at Colorado Health Insurance Insider analyzes the ramifications for -- you guessed it -- Colorado health insurance.

Following a long and distinguished line of critics pointing out the inadequacies of much of the Bush Administrations' science and health policies, Mark Schauss notes that the White House could hardly look siller in denying the evidence-based link between smog and premature death.

Tackling a particularly troubling quality of care problem, Emily Cleath outlines the myriad problems plaguing the veterans health care 'system.'

Over at GoozNews, Merrill Goozner notes, as did many others, the long-awaited release of the AAMC's report on conflicts of interest in medical education.

You didn't think we'd get through an entire HWR without mentioning coverage, did you? Brian Klepper delivers the goods in his analysis of a new study documenting the general coverage erosion as to employer-sponsored health insurance.  And see Anthony Wright's excellent discussion of John McCain's health care plan, if it can be called as such.

You didn't think we'd get through an entire HWR without mentioning health care technology, did you? Fellow Cardinal David Williams eases your suffering with this discussion of Aimee, a web-based tool that helps providers understand typical radiation exposures associated with certain scans.

Sometimes, technology actually improves quality, as Tom Emswiler notes.  Huzzah!

Over at e-CareManagement, Vince Kuraitis wonders if the medical establishment is actually the best caretaker for your medical records.  Reminds me of a particularly humorous Seinfeld episode . . .

Speaking of humorous Seinfeld episodes, Jaan Sidorov has a thoughtful analysis of the recent fat-vs-fit study, sounding a pleasant note of skepticism, always welcome here at MH Blog in thinking about fatness and obesity.

Last, but obviously not least: Over at the Blogfather of the HWR, Jon Koppelman reasons that Tier 4 pricing for certain pharmaceuticals is unquestionably rationing.