A Conference on Bioethics and Humanities, and Future Planning

Last week I traveled to Atlanta, Georgia, where the American Society for Bioethics and Humanities (ASBH)* held its annual meeting. Most of a thousand people participated in the four-day conference. The sessions drew a mix of nerdy physicians like me, nurses, professional bioethicists, philosophy professors, a few lawyers, historians and artists.

It was really a lot of fun. Fun, that is, if you’re into subjects like philosophy in medicine, literature in medicine, medicine in literature, ethics in medicine, technology and privacy, justice and parsimony in health care, etc. I hadn’t heard the word “epistemic” so many times since I was in college. I felt young and idealistic, talking seriously about philosophy, as though it matters. (For the record: it does.)  This was, clearly, a medical society meeting unlike others. For instance, an academic named Woods Nash, of the University of Tennessee, gave a talk on David Foster Wallace’s story, “Luckily the Account Representative Knew CPR.”

original cover image (Wikipedia) - link to Random House (publisher)

original cover image (Wikipedia), publisher: Random House 

On the first day, I walked into a provocative plenary talk by Julian Savulescu, an ethicist and Oxford professor. He presented an argument that that using medical tools for the purpose of moral bioenhancement might be a good thing. (If this topic brings to mind A Clockwork Orange, you’re on track. Think also of Huxley’s soma, as a questioner raised.) All very serious. The next day, a packed ballroom of people heard from Amy Gutmann, President of the University of Pennsylvania and Chair of the Presidential Commission for the Study of Bioethical Issues. She spoke about the concept of deliberative democracy, and the value of teaching ethics. Toward the end, she entered into a humorous and seemingly candid discussion of men and women in the workplace, “having it all,” and common sense. “Time is finite,” she mentioned.

I could go on, and list all the lectures and smaller sessions, but this post would get dry. Besides, I couldn’t possibly attend each one, nor can I give all the speakers’ due credit. Some talks were better than others, as meetings necessarily go. But I can’t resist a plug for the presentation by Rosemarie Garland-Thomson, a professor of women’s studies and English at Emory, on perspective and disability. Another favorite had to do with technology and science. David Magnus, of Stanford University, considered whether research accomplished through gamification – a means of crowd-sourcing science – on platforms like FoldIt, EteRNA and EyeWire should be covered by the usual rules for biomedical research. “Are the players scientists?” he asked.

The tone, overall, was intense. Intellectual, brain-stimulating… By contrast to other medical meetings I’ve attended, there was little glitz, scant makeup and limited Wireless. Perhaps the most surprising aspect of the ASBH conference was the distribution of freebies at booths in a display area, where attendees gathered for an opening evening reception and, on other days, breakfasts. Of course it was all minor stuff handed out, like pens and candy, mainly from university departments seeking applicants for fellowships, and academic presses selling books. The most substantive, and useful, gift I received (or “accepted” – a term with greater moral accuracy, from my perspective) was a green umbrella from the Hastings Center – a bioethics stronghold where I’d love to spend some time learning and doing research, in the future.

On Sunday morning, I attended one of the last sessions, on decision aids in bioethics. We lingerers were treated to three terrific talks. I can’t cover them all. So to close this post, I’ll refer to the promising work of Michael Green, a physician and bioethicist at the Penn State College of Medicine. He and colleagues have been developing an on-line decision tool for advanced care planning with grant support from the NIH, the American Cancer Society and elsewhere. The website, MakingYourWishesKnown.com, enables individuals to detail their wishes through an interactive questionnaire. Green and his colleagues collect and publish data on users’ feelings upon using the decision aid. They can measure, for instance, if it gives people a sense of control, or reduces fear, and if patients’ families and doctors find the “outputs” useful. I, for one, intend to try out the MYWK website.

And I do hope to attend another ASBH meeting. Next year’s is planned for October, in San Diego.

All for a while,


*disclosure: I joined the society.

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NEJM Reports on 2 New Drugs for Hepatitis C

Last week’s NEJM delivered an intriguing, imperfect article on a new approach to treating hepatitis C (HCV). The paper’s careful title, Preliminary Study of Two Antiviral Agents for Hepatitis C Genotype 1, seems right. The analysis, with 17 authors listed, traces the response of 21 people with hepatitis C (HCV) who got two new anti-viral agents, with or without older drugs, in a clinical trial sponsored by Bristol-Meyers Squibb.

The 21 study participants all had chronic infection by HCV genotype 1, a strain that’s common in North America and relatively resistant to standard treatment. All subjects were between 18 and 70 years old, with a measurable level of HCV RNA in the blood, no evidence of cirrhosis, and no response to prior HCV treatment (according to criteria detailed in the paper). In the trial, 11 patients received a combination regimen of daclatasvir (60 mg once daily, by mouth) and asunaprevir (600 mg, twice daily by mouth) alone; the other 10 patients took the experimental drugs along with 2 older meds for HCV – Peginterferon (Pegasys, an injectible drug by Roche) and Ribavirin (Copegus, a pill, by Roche).

The main finding is that the 10 patients assigned to take 4 drugs all did strikingly well in terms of reducing detectable HCV in their blood over the course of 24 weeks. There was a dramatic response, also, in 4 of the 11 patients assigned to the new drugs only. An accompanying editorial highlighted the work as a Watershed Moment in the Treatment of Hepatitis C. The medical significance is that they’ve demonstrated proof of principle: by “hitting” a resistant HCV strain with multiple anti-viral drugs simultaneously, they could reduce it to undetectable levels.

The first question you have to ask about this report is why the NEJM – the most selective of medical journals – would publish findings of an exploratory analysis of two new pills paired with two older drugs for HCV. The best answer, probably, is that the virus infects some 4 million people in the U.S. and approximately 180 million people worldwide, according to the study authors. HCV can cause liver damage, cirrhosis, liver cancer (which is usually fatal) and, occasionally blood disorders.

The new drugs derive from some interesting science. This, maybe, also is a factor in why the article was published in the NEJMDaclatasvir (BMS-790052) blocks a viral protein, NS5A, that’s essential for HCV replication. The second new drug, asunaprevir (BMS-650032) inhibits a viral protease, NS3.

I have several concerns about this report. One is that the researchers screened 56 patients for possible registration but enrolled only 21 on the trial; according to a supplementary Figure 1, 35 potential subjects (over half) didn’t meet criteria for eligibility. This disparity makes any once-researcher wonder about bias in selecting patients for enrollment. If you’re a pharmaceutical company and want to show a new drug or combo is safe, you’re going to pick patients for a trial who are least likely to experience or display significant toxicity.

Toxicity seems like it could be problematic. Diarrhea, fatigue and headaches were common among the study subjects. Worrisome is that 6 patients (of 21, that would be 28.5% of those on the trial) had liver problems manifest by at least one enzyme (the ALT) rising over 3 times the normal limit.

Further complicating the picture is there’s no indication of how these new drugs mesh with the two drugs approved for HCV in 2011: Vic­trelis (boceprevir) and Incivek (telaprevir).

Given all these limitations, you might wonder about BMS’s influence at the Journal or, more likely, the manuscript’s peer reviewers. The 17 study authors, and the editorialist, separately, disclose a host of industry ties.

What I’m thinking, as much as I’m critical of this research work, is that this is probably the way of the future – smaller, pharma-funded studies of targeted new drugs in complicated combinations. Many will be authored by academics with ties to industry, if not put forth directly by company-employed researchers. These quick-and-promising studies in select patient groups will be routine. And while advocates push for rapid publication of new clinical research in patients with resistant, disabling diseases, it’ll be hard for physicians and patients to interpret these kinds of data.

So these particular findings may turn out to be true and life-saving, or not. The bigger concern is this: It would be helpful if the journals would take a really tough stance on full disclosure of authors and editors ties to industry. As Merrill Goozner has emphasized, the Physician Payment Sunshine Act – a small component of the 2010 HCR legislation – has important implications for academic medicine and reporting of clinical research studies.

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A Note on ‘Trial by Twitter’ and Peer Review in 2012

Nature just published a feature: Trial by Twitter. The piece considers the predicament of researchers who may find themselves ill-prepared to deal with a barrage of unsolicited and immediate on-line “reviews” of their published work. The author of the Nature News piece, science journalist A. Mandavilli, does a great job covering the pros and cons of Twitter “comments” on strengths and weaknesses of studies from the perspective of researchers whose work has been published by major journals.

She writes:

Papers are increasingly being taken apart in blogs, on Twitter and on other social media within hours rather than years, and in public, rather than at small conferences or in private conversation.

What I’d add is this:

Openness isn’t just about criticism. It can be a positive factor in bringing to light the work of small-lab researchers whose findings contradict dogma or conflict with heavily-financed work by leaders in a field. Through twitter and blogs, non-mainstream threads of data can gain attention, traction and, with time and merit, grant support.

Scientists who publish in major journals should be able to handle the flak. If their work is correct, it’ll stand through open peer review.


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NIH to Drop Requirement for Websites Disclosing Researchers’ Ties to Industry

sunshine image

Today’s word comes from Nature News that the NIH is dropping a proposed requirement for universities to disclose researchers’ financial ties to industry on websites. This is a loss for patients, who may not be aware of their doctors’ relationships with pharmaceutical companies and others who fund clinical trials, fellowships, conference junkets and other perks for physicians.

In 2010, NIH Director Francis Collins wrote: “As the nation’s biomedical research agency, the National Institutes of Health (NIH) must ensure that the research it funds on the behalf of US taxpayers is scientifically rigorous and free of bias.”

This sounds right to me, as it did to the folks at the health and safety arm of Public Citizen, according to the Nature report:

…a cornerstone of that transparency drive — a series of publicly accessible websites detailing such financial conflicts — has now been dropped. “They have pulled the rug out from under this,” says Sidney Wolfe, director of the Health Research Group at Public Citizen, a consumer-protection organization based in Washington DC. “It greatly diminishes the amount of vigilance that the public can exercise over financially conflicted research being funded by the NIH.”

As explained in the article, the proposal came about after evidence came to light that prominent NIH grant recipients had failed to inform their employers (universities and medical schools) about lucrative payments from companies that may have influenced their research. The problem now comes, in part, from lack of funding: the White House Office of Management and Budget (OMB) has no way to enforce the requirement.

That’s no surprise. But it turns out that academic groups lobbied against the requirement. According to the Nature News piece, the Association of American Universities and the Association of American Medical Colleges submitted a joint statement objecting that a website detailing physicians’ potential conflicts of interest (COI) would be onerous:

“There are serious and reasonable concerns among our members that the Web posting will be of little practical value to the public and, without context for the information, could lead to confusion rather than clarity regarding financial conflicts of interest and how they are managed.”

As a patient and as a physician who’s cared for patients in clinical trials and served on an institutional review board (IRB), I can’t be more clear in my thinking that the public should know about academic (and all) physicians’ ties with industry. Every institution with NIH funding should make this kind of information readily available and clear to patients. Otherwise, the faculty don’t deserve the NIH support they’re receiving for the research, nor do they deserve the public’s trust in their work.

Patients should be able to find this kind of information readily, before they enroll in clinical trials or decide to undergo any elective procedures, and even before they choose the physician who would guide them in health care decisions.


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Some Articles I Authored A While Ago

This post, on my research in cancer immunology, is strangely personal.

At one level, what follows is nothing more than a list, a narrative if you will, a sketch of a formative chunk of my career and personal history. I’ve wanted to put this out there (here) for quite a while, but couldn’t: It’s been hard for me, harder in some ways than was the breast cancer and spine surgery and all the other unpleasant illnesses I haven’t mentioned yet, to come to grips with my near-hit academic medial research career that stopped, which until today has been for the most part disconnected from this blog and my new on-line life.

So here goes, a partial list of my publications, selected from ~30:

On a novel mechanism for B-cell death, my first first-author article based on my research in lymphoma immunology, in The Journal of Experimental Medicine, 1995:

CD40 ligation induces Apo-1/Fas expression on human B lymphocytes and facilitates apoptosis through the Apo-1/Fas pathway

On how “helper” T cells can kill some forms of malignant B cells, in Blood, 1996:

CD4+ T-cell induction of Fas-mediated apoptosis in Burkitt’s lymphoma B cells

A solicited review of my early labwork, completed with my research mentor, in Immunologic Research, 1996:

Fas expression and apoptosis in human B cells

My first paper on CD40L and autoimmunity, in CLL, in Blood, 1998:

Chronic Lymphocytic Leukemia B Cells Can Express CD40 Ligand and Demonstrate T-Cell Type Costimulatory Capacity

A case report (as my lab and non-physical stature grew I became senior author), in the British Journal of Haemotology, 1998:

Novel association of haemophagocytic syndrome with Kaposi’s sarcoma-associated herpesvirus-related primary effusion lymphoma

On some experiments with mantle cell lymphoma cells, in Leukemia, 2000:

Proliferative response of mantle cell lymphoma cells stimulated by CD40 ligation and IL-4

Work accomplished with colleagues-now-friends, in Blood, 2000:

Inhibition of NF-kB induces apoptosis of KSHV-infected primary effusion lymphoma cells

The first major paper from my NIH-funded lab, in The Journal of Immunology, 2000:

Modulation of NF-kB Activity and Apoptosis in Chronic Lymphocytic Leukemia B Cells

We sent this one to Science. They declined. So did a bunch of other journals. Eventually it came out in Blood, 2001:

Survival of leukemic B cells promoted by engagement of the antigen receptor

A nearly life-eating chapter that took up way too much of my time but was probably worthwhile nonetheless, on immunology, for a Neoplastic Hematopathology textbook, in 2001:

Immune System: Structure and Function

An interesting story, we thought, in Autoimmunity, 2002:

Inhibition of Fas-mediated apoptosis by antigen: implications for lymphomagenesis

A monograph I wrote around the time I got sick, on how malignant lymphocytes die, somewhat theoretical, in Cancer Investigation, 2002:

Apoptosis in Lymphocytic Leukemias and Lymphomas

For there record, there’s earlier and later stuff too, by me alone and with others, and (sadly) reams of unpublished data, mainly from 1997 – 2002. These are the published papers I consider most my own.

Looking back, I’m pretty sure we were right, at least on most of these findings.

(Is there an opposite-of-decline effect?)

I’ve often wondered how differently things might have turned out if there’d been blogs and open-access journals with real-time comments when we in my lab were trying to get our work published in top, grant-renewing, tenure-securing journals.

Didn’t happen…

Well, now that this is done, I can keep moving forward!

With gratitude to my colleagues who collaborated, and especially to those who worked with me in the lab,


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