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Blogging Ethics

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06/07/2010 - 8:53pm

On Saturday, my Journal of Policy History article, "How Talking Became Human Subjects Research: The Federal Regulation of the Social Sciences, 1965–1991," was honored with that journal's Ellis Hawley Prize. In presenting the prize, Professor Hawley--one of the leaders of my profession--mentioned that he himself used to ask his students to interview someone who had lived through the Great Depression. On being told that he would have to submit to IRB review, he abandoned the assignment. If IRBs can deter Ellis Hawley from learning more about the 1930s, we have a problem.

06/07/2010 - 12:30pm

Hat tip to Business Week for shedding some light on U.S. Supreme Court nominee Elena Kegan's views on bioethics. Here's the rundown: She's pro-physician assisted suicide and opposed proposals to ban it in 1997 and has said the DEA lacks...

06/07/2010 - 7:30am

Justice Nicholas Colabella recently ruled in Levine v Werboff that an aggrieved husband is entitled to bring suit against his wife's psychiatrist.

Carl Levine alleges that Werboff had unprotected sex with his wife without revealing that he was infected with the herpes virus and without using precautions to prevent transmission. Levine claimed that as a result of Werboff's actions his wife contracted herpes and passed on the infection to him.

Werboff argued that Levine did not have standing to sue him. Judge Colabella disagreed. Here's the judge's reasoning:

1. New York Public Health law "makes it a misdemeanor for a person, knowing himself to be infected with an infectious sexually transmitted disease, to have sexual intercourse with another."

2. Although judges are concerned about expanding the scope of duties, "there is nothing unfair about extending such a duty to a spouse of the infected person."

3. The judge, however, rejected Levine's effort to charge Werboff with malpractice - "the doctor-patient relationship that is the basis for a malpractice claim was between defendant and plaintiff's wife, not plaintiff."

I found nothing in Judge Colabella's decision that attributed a greater duty to Dr. Werboff than to any person with herpes alleged to have infected Levine by infecting his wife. But my hunch is that the Judge was influenced by the fact that a psychiatrist has a well-known and unambiguous ethical commitment not to have sexual relations with a patient. This means that if Dr. Werboff had such a relationship with Levine's wife, he was committing a seriously unethical act quite apart from transmitting herpes.

The question of how far to extend a physician's scope of duty is challenging. If a patient on a medication falls asleep in his car and injures a pedestrian, can the injured pedestrian sue the physician? (I discussed this issue in a previous post about Coombs v Florio, a Massachusetts case.) But in the Levine case, the alleged action was a gross violation of medical ethics and a potential basis for malpractice action, should Levine's wife choose to complain. From the perspective of ethics as well as law, Judge Colabella got it right!

06/05/2010 - 8:00am

An article published online by Health Affairs is more frightening than a horror movie for those of us who try to bring reason to bear on health policy and the health system:The key finding from focus groups, interviews, and the online survey is that there is a fundamental disconnect between the central tenets of evidence-based health care and the knowledge, values, and beliefs held by many consumers. For health care experts, variation—in quality among health care providers, the evidence base regarding therapies, and the effectiveness and cost-effectiveness of treatment options—is a well-established fact of the health care delivery system, documented extensively in the published literature and well understood after years of careful study. Yet such concepts are unfamiliar to many Americans and may even seem threatening, to the extent that they raise unwelcome questions about the quality of medical care that people receive.The majority of consumers believe that all care meets minimal quality standards, that more care means higher quality care, that newer care is better care, that treatments costing less are inferior, and that medical guidelines "represent an inflexible, bargain-basement approach to treating unique individuals."

The news for health reform could hardly be worse! Reformers and consumers are talking different languages - the language of rationality and the language of faith. But the findings shouldn't surprise us. Since the time of Hippocrates we humans have schooled ourselves into a trusting worship of the healers. That faith helps us ward off the terror engendered by our awareness of vulnerability and mortality.

At the level of clinician-patient interaction, it's possible to bridge the gap. I frequently said to patients suffering from depression some version of - "Of course none of us can be a hundred percent certain about the future...but that said, I'm sure we can make this depression go away." Or, as a wise and caring oncologist said to a dear friend of mine at the point when the chemotherapies he was master of had come to an endpoint - "X, the best thing I can do for you now is to give you a hug" - a "treatment" he promptly delivered!

Consumer skepticism about evidence-based medicine reflects our effort to deal with mortality, not stupidity. To effect change health care professionals and policy leaders need to learn how to explain the importance of practice variation, comparative effectiveness research, and all the other wonky concepts those of us concerned with health reform are so fond of, in ways that respect our human need for solace in the face of finitude and vulnerability.

I've often used the example of how the wise oncologist dealt with my friend with medical students. He applied evidence-based technologies in prescribing therapies that prolonged my friend's life. But when life prolongation was no longer possible, he remained in the role of reassuring healer and provided a different form of evidence-based practice - laying on of hands in the form of a hug, and a commitment to be part of my friend's life to the end.

Wise clinicians understand and apply the aphorism "To cure sometimes, to relieve often, to comfort always." For the public to develop more belief in evidence-based medicine it will have to develop a stronger faith that our health system will "comfort always."

06/01/2010 - 6:00am

A recent New York Times article about federal judge Jack Weinstein's view that the law requiring mandatory sentences for possession of child pornography is "unnecessarily cruel" raised three important points about ethics and ethics education for me.

  1. The relationship between law and ethics. In ethics discussions with students and practicing physicians, participants often start by asking "what is the law?" My response is always the same. "First let's decide what we think is the right thing to do. Then we can ask about the law." If the law disagrees with our conclusion, that's a reason to reassess our analysis. After all, the law reflects society's view of how we should govern ourselves. Maybe our reasoning was wrong.

    But maybe the law is wrong. Judge Weinstein abhors child pornography. But he believes that many of those prosecuted for possession of pornographic images do not present a risk to children, and that mandatory long term prison sentences are sometimes unjust. The judge now proposes to tell the jury what kinds of mandatory sentences guilty verdicts will require, so that the juries will consider the punishment as well as the crime.

    This is not a typical court practice. Whether the judge's view of the degree of threat possession of child pornography poses or does not pose to children is correct, he'd making an important distinction between law and ethics.

    Law tells us what's legal, but not necessarily what's right.

  2. Wishful thinking about human nature and the effectiveness of "treatment." In a recent case, Judge Weinstein did impose the mandatory five year prison sentence. But he wasn't happy about it - "This is an unnecessarily harsh and cruel sentence under the circumstances. This defendant requires treatment and a stable life outside of prison..."

    A social worker who wrote in response to the article spoke in a similarly optimistic way about mental health assessment and treatment: For some, if not most, collectors, child pornography films are a relatively harmless way of dealing with feelings of sexual attraction to minors. Such individuals would not think of actually touching a child inappropriately.

    For others, however, the viewing is a step on the way to actually performing the acts they view. To imprison the former group is a waste of taxpayer money; for the latter group, imprisonment is essential, and sentencing laws should be based not on a fixed time period but on the likelihood of repeating the abuse upon release.

    To distinguish between those who will and those who will not move on to abuse of children, the court should request assessment by mental health professionals. Such assessment is also needed for the decision whether to release the prisoner.But as Hamlet said to Horatio - "There are more things in heaven and earth than are dreamt of in your philosophy." Human nature is too complex and mysterious for our mental health categories to comprehend and reliably manage. We don't have effective treatments for sexual offenders, and our ability to predict dangerousness is limited at best. Recommending treatment reflects an admirably optimistic view of the fundamental goodness of our species, but it's not an evidence-based proposal. Ethics isn't just about values - it's about facts as well!

  3. Emotion and moral judgment. The NYT article also tells about Judge James Graham, who sentenced a 67 year old man who had suffered a stroke to one day in jail, plus restrictions on computer use and registration as a sex offender. Judge Graham was quoted as follows: When you have to sit there on the bench and look at someone like my stroke victim and say, 'I have to send this man to prison for six years,' it just doesn’t feel right....It’s not right.In the Harvard Medical School class on medical ethics that just ended, I encouraged students to be very attentive to what they felt as they reflected on ethical matters, since emotional responses are relevant to our moral assessments. But we need to step back from those feelings to decide whether they reflect moral intuitions we should endorse or prejudices we should reject.

    That's how I interpret Judge Graham's comment. The initial "it just doesn't feel right" reflects his emotional reaction. His repetition, after a momentary pause - "it's not right" - reflects, I believe (and hope) his assessment of the initial "moral intuition."

05/30/2010 - 8:00am

Fourteen months ago I wrote a post about, a startup social networking site, that enabled patients with disorders like ALS, MS and Parkinson's Disease, to share experience and contribute to rapid pooling of clinical data in ways that might provide practical guidance. It's an exciting idea, but apart from the omnipresent risk of offering faulty guidance, present in medical appointments as well, it risks cooptation by industry. Here's the most prescient part of the post:The aim - "providing a better, more effective way to capture valuable results and share them with patients, healthcare professionals, and industry organizations that are trying to treat the disease" - is important. Patients gather information from other patients anyway, and a networking site potentially that lets them extend their opportunity for learning, as from the 1801 ALS patients who are part of the "community," offers a lot.

But it doesn't require Karl Marx to see the risk in a business model that invites partnering with industry. Word of mouth is potent advertising. It will be nothing short of miraculous if drug and device companies do not seek to influence the statistics, just as they influence CME activities...

Many physicians fear "disintermediation" - the process by which patients circumvent the "middleman" role, gather their own information, and develop their own plans for treatment. This is wrong. The emerging web ventures are like medications, with varying constellations of potential benefits, harms, true claims, and baloney. Physicians can provide a distinctive service as knowledgeable, honest brokers - encouraging patients to use PatientsLikeMe and other new ventures, but educating them about risks, side effects, and false claims.But an article in today's New York Times by Natasha Singer suggests that the concerns I voiced may be coming true.

If you're interested in the Jekyll and Hyde potential of social networking sites like PatientsLikeMe, I suggest that you start by looking at a YouTube video of co-founder Jamie Haywood. It shows the site's exciting potential to produce rapid summaries and analyses of pooled reports from large groups of patients who voluntarily participate. Then go to the PatientsLikeMe website, and click on "information for industry partners."

I'm not a startup expert, but to me it looks like a brilliant business model. I'm comfortable with the use of real time patient reports as a source of information for responsible medical groups and health plans. But the use of the same material by drug companies to hone direct-to-consumer advertising and other commercial goals is creepy. And with regard to privacy, I wasn't reassured by this statement: "Other members, and sometimes Partners (pursuant to written agreements designed to limit the use and disclosure of your personally identifiable information), will be able to view your Profile Data."

PatientsLikeMe and other entrepreneurial ventures that harness web technologies and social networking can transform health care. But there's a substantial risk of cooptation by industry and corruption by the money that can be made.

This isn't a reason for trying to slow down the entrepreneurial energies, but only naive fools would give blanket trust to the ethical integrity of the new ventures.

05/29/2010 - 4:07pm

For a few months now, the kindly editor of Yourprof (Michael Valerio) has been asking me to check out his website. Yourprof is in the business of commissioning learned folks to talk about their fields of expertise. Michael asked some of the most experienced people in research ethics to explain some of the challenges of conducting health-related research around the world, particularly in resource-poor settings. They go beyond the standard questions about informed consent to issues about community engagement, the impact of culture, priority setting in health research and the growth of private health research institutions.

05/29/2010 - 4:07pm

For a few months now, the kindly editor of Yourprof (Michael Valerio) has been asking me to check out his website. Yourprof is in the business of commissioning learned folks to talk about their fields of expertise. Michael asked some of the most experienced people in research ethics to explain some of the challenges of conducting health-related research around the world, particularly in resource-poor settings. They go beyond the standard questions about informed consent to issues about community engagement, the impact of culture, priority setting in health research and the growth of private health research institutions.

05/28/2010 - 1:14pm

There has been plenty of coverage in the news and on various blogs about the genetic testing of freshmen students at UC Berkeley. The students, as part of their admission package, are being offered an opportunity to take part in genetic testing to gather information on how their bodies metabolize alcohol, lactose and folate. Here’s a story about the study from The New York Times: College Bound, DNA Swab in Hand

Each freshman will get two bar code labels, one to put on the sample and one to keep. After the genotyping is complete, the results will be posted on a Web site using the bar code identification, so only the person who provided the DNA sample will know whose it is.

“In the decade ahead, the new genetics is going to penetrate everyday medical practice,” said Mark Schlissel, dean of biology at Berkeley. “We wanted to give students a sense of what’s coming, through genes that can provide them with useful information. I think it’s one of the best things we’ve done in years.”

But some bioethicists say the whole idea of genetic testing outside a medical setting is troubling.

“It’s a bad precedent to set up mass testing without some sort of counseling support,” said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. “I’d rather people get their results in a medical setting, where they can ask questions about the error rate or the chances of passing it on to their children, and not just see it posted on some Web site.”

The stories in the media have highlighted a number of objections to the idea of the study — the worry over consent, the method of recruitment (through the admissions process), the concern that participants aren’t being counselled thoroughly about the results and the the responsibility of the researchers to inform participants fully about how their genetic material will be used. All these concerns are well-founded and ones that any ethics review board would have hopefully addressed. It’s clear that Berkeley’s ethics review board approved this study and it’s reasonable to assume that those kinds of concerns would have been noted at the time of review and subsequent approval. Yet, without these kinds of details in the news stories, it’s also reasonable that ethicists and critics are voicing these concerns.

One of the lead researchers’ colleagues, however, posted a response to those who have questioned the study, in his own blog. Michael Eisen wrote a blog entry on the Science and Technology Berkeley Blog, called Geno-Luddites and Berkeley’s On the Same Page program.

There are certainly lots of complicated issues surrounding the coming age of personal genetics (see, for example, the DNA Age series published by the NY Times). But we are not going to deal with them by burying our heads in the sand and pretending that genetic testing is not going to happen. I simply cannot understand how these people – whose greatest fear seems to be exposing a genetically illiterate population to genetic information – could oppose a program whose main goal is to educate the next generation about genetics.

I think Eisen makes some good points. But I also think his pointed criticism (and even belittling) of those who are asking questions and raising concerns is misplaced. When I first read the stories about this study, I had concerns. But I didn’t think, for a moment, that the study shouldn’t be done or that we should take those concerns and apply them, in broad brushstrokes, to all kinds of genetic testing. I agree that the study is important, worthwhile. Not only are does this work aim to further knowledge about important genetic information that can easily be applied therapeutically, but it also exposes new University students (and potential future researchers!) to the realities of being involved in research. Having said all that, however, I still do wonder if students understand that, in their huge freshman application package of things that they must do, this is something that is optional. I wonder if they are getting adequate counselling about the findings and some sort of follow-up should their genetic information demonstrate anything worrying about their ability to metabolize alcohol, lactose or folate. I’m curious as to whether there are any strategies in place to address findings that might be unexpectedly problematic or pathological – which likely is a rare and unlikely possibility, but something that a research team should, at the very least, think about.

Certainly asking these kinds of questions and noting these kinds of concerns shouldn’t automatically place anyone who voices them in the category of “genetic luddite” nor is asking these kind of question equivalent to wanting a stop to all genetic research. Far from it. Even Eisen acknowledges that human genetics and genetic testing has “myriad scientific, medical, social and ethical issues that accompany it”. So a few thoughtful and well-founded questions that explore some of these issues shouldn’t be out of place.

05/26/2010 - 3:54pm

Robert Steiner, co-principal investigator in a fetal cell transplantation study involving the rare, fatal hereditary disease Neuronal Ceroid Lipofuscinosis (also known as Batten disease), presented results of a now completed phase 1 study. According to Steiner, the study involved the highest ever dose of stem cells delivered to the human brain. The trial involved six children with infantile and late-infantile forms of the disease.
Elsewhere, this safety study has been reported as "positive"- in the sense that there were no unexpected, stem cell related complications. Which is not to say the protocol was a picnic: the study involved (if I understood the presentation correctly) 14 trajectories to the brain, and an extended regime of immunosuppression that caused 23 adverse events. Steiner reported that none of the patients showed a clinical response- which is what one would expect in patients with such advanced forms of disease (hopefully, the research team conveyed the unexpectedness of clinical benefits to parents when they obtained informed consent).
Steiner also reported that, when one of the patients died due to natural course of illness, the family permitted the team to perform an autopsy. The autopsy ruled out the cell transplantation as a cause of mortality, and established that the tissues engrafted successfully. In the words of a press release, "By permitting the autopsy, the family allowed the researchers to learn very important details that will potentially benefit future patients."
Did the research team use the autopsy to determine whether the transplanted cells were expressing the therapeutic gene? If so, was the gene product taken up by surrounding tissues? Answering these questions would be key to maximizing the scientific value of the study, and thus redeeming the risks of surgery, immunosuppression, stem cell transplantation, and the many follow-up visits required of patients participating in the study. But from what I heard, the brain is in the hands of the company, and it is unclear whether they have performed these studies (and if so, whether the results will be reported). Let's hope the family's permission for autopsy allows the researchers to learn still more. (photo credit: dopamineharper 2009)